Selected Projects

PHIOS FACULTY FUNDED GRANTS AS OF NOVEMBER 2022 (ONLY NIH GRANTS IN WHICH FACULTY ARE PIs or MPIs  and with substance use outcomes are listed).

 

State-level opioid policies and policies that regulate substance use during pregnancy: a mixed methods exploration of their effects on maternal and infant outcomes

(August 1, 2022 – June 30, 2027)

Principal Investigator: Silvia S. Martins

Co-Principal Investigator: Morgan Mari Philbin

Act: R01 - Project: DA053745 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant):The opioid and overdose crisis in the United States (US) disproportionately affects women of childbearing age (15–44 years), particularly pregnant women and their newborns: 20% of pregnant women are prescribed opioids during pregnancy.1,2 States have enacted both general opioid policies (e.g., access to medication for opioid use disorder (MOUD)) and policies specific to substance use during pregnancy, but the effects of these policies on pregnant women’s opioid use and newborn outcomes remain poorly defined. States’ policy responses to prenatal opioid use vary widely, resulting in inconsistent approaches to pregnant women’s opioid use. In this mixed- methods project, we will apply a convergent parallel design to examine the separate and combined impacts and consequences of state opioid policies on pregnant women and their newborns using Medicaid and commercial insurance databases (MarketScan). We aim to: 1. Examine the separate effects of general and prenatal state opioid policies on pregnant/postpartum women and newborns. We will: 1a) systematically map all 50 states’ prenatal opioid policies (2011–2020) to categorize policy variations and build a publicly available time-varying dataset; 1b) use this prenatal policy dataset and existing data on general opioid policies to explore the individual- level impact of general and prenatal opioid policies on opioid use disorder (OUD), MOUD access, and neonatal opioid withdrawal syndrome (NOWS) for pregnant women and their newborns; and 1c) test for effect modification by maternal race/ethnicity and age. 2. Investigate the combined effects of general and prenatal state opioid policies on pregnant/postpartum women and their newborns (2011-2020). To move beyond the impact of single policies in isolation, we will: 2a) use a modified Delphi approach to create a time-varying taxonomy of each state’s overall opioid policy climate relevant to pregnant women, ranging from penalizing to health- promoting, based on states’ combination of prenatal and general opioid policies; and 2b) explore the individual- level impact of states’ overall policy climates on pregnant/postpartum women and newborns using the same outcomes and effect modification as Aim 1. 3. Explore how prenatal policy implementation affects daily life for pregnant women and their newborns. We will: 3a) apply the Consolidated Framework for Implementation Research (CFIR) to interviews with 60 key stakeholders across states that vary by their overall policy climate to explore multilevel drivers of prenatal opioid policy implementation and how variations in implementation affect maternal and newborn health; and 3b) create an ethnographic cohort of 40 pregnant women who use opioids across states with four different prenatal policy climates (punitive, prosocial, , mixed, inaction) and conduct three interviews with each over one year. We will explore how variations in prenatal opioid policy implementation affect how women navigate pre- and postnatal care, MOUD use, and state services. Findings will have concrete real- world impacts by describing the effects of state opioid policies on pregnant/postpartum women and their newborns and by identifying intervention points and policy changes that promote maternal and infant wellbeing.

 

Social safety net programs as interventions to reduce opioid-related harms in reproductive-age women 

(September 30, 2023 – August 31, 2028)
Principal Investigator: Silvia S. Martins

Act: R01 - Project: DA059376 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant):Social safety net programs are critical upstream factors that can offset economic stress and affect people’s ability to access basic shelter, health care and food-related needs, which are particularly salient among parenting women who use drugs. Parenting women, especially Black and Indigenous women, are over-represented among people living in poverty, highlighting the need to understand how social safety net programs affect them. They usually they are primary child caregivers, and many with opioid use disorder (OUD) in such roles do not seek treatment or stay in treatment due to lack of resources while fulfilling caregiving roles. Research suggests that individual safety net programs affect behavioral outcomes (e.g., alcohol use outcomes), including among women, but the effects of these programs on opioid outcomes remains underexplored. In addition, the joint impact of these programs on opioid-related outcomes has not been studied. Programs include Unemployment Insurance (UI), Supplemental Nutritional Assistance Programs (SNAP), Temporary Assistance for Needy Families (TANF), the Earned Income Tax Credit (EITC), and Medicaid. Nearly 75% of people living in poverty receive at least one safety net program, and program eligibility varies widely by state. We propose a mixed-methods convergent parallel design to comprehensively evaluate the separate and combined effects of UI, SNAP, TANF, EITC, and Medicaid (including pathways and mediators), on opioid-related outcomes among low-income parenting women. We will leverage the restricted National Survey on Drug Use and Health (NSDUH) from 2013-2022 to address NIDA’s RFA-DA-23-051 to examine how state social safety net programs influence, and can ameliorate, multiple opioid outcomes in low-income parenting women. We will test for differential policy effects by race and ethnicity and potential multi-level mediation mechanisms. Specific Aims are to: Aim 1. Examine the separate and combined effects of state social safety net programs (UI, SNAP, TANF, EITC, Medicaid) on opioid outcomes among low-income parenting women in restricted NSDUH data. In this Aim, we will update, expand and leverage a recently validated multi-program state safety net calculator that fully accounts for interactions between eligibility and generosity in social safety net programs. Aim 2. Investigate potential multi-level mediators of the relationship between social safety net programs (e.g., state-level food insecurity and child care cost burden) and opioid- related outcomes among low-income parenting women in restricted NSDUH data. Aim 3. Explore variations in the administration of state social safety net programs and their effects on the daily lives of low-income parenting women who report past-year nonmedical opioid use via qualitative interviews with key stakeholders and parenting women. This mixed-methods study will extensively examine the separate and combined impact of state social safety net program eligibility and administration on parenting women’s opioid-related outcomes. Findings will have concrete real-world impact providing actionable and politically feasible recommendations for changes in these programs to reduce opioid-related burden and promote women’s wellbeing.

 

Substance Abuse Epidemiology Training Program (SAETP) at Columbia University

(July 1, 2012 – June 30, 2027)
Principal Investigator: Silvia S. Martins

Co- Principal Investigator: Deborah S. Hasin

Act: T32 - Project: DA031099 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant):Substance use and substance use disorders (SUD) constitute major public health problems due to their associated disability, comorbidity and mortality. Addressing these burdens requires cutting-edge public health research conducted by scientists of the highest caliber. In 2012, the Substance Abuse Epidemiology Training Program (SAETP) at Columbia University Irving Medical Center (CUIMC) in New York City was established with the objective of training talented young scientists to become the next generation of leaders in substance abuse epidemiology. Through competitive applications, SAETP has successfully, attracted a diverse group of fellows that have been productive and successful during and after training. Completed SAETP fellows have attained prestigious research positions in academic research settings and many have obtained their own independent funding. We now propose the next 5-year renewal cycle for SAETP. SAETP exists in a very rich, stimulating environment, offering unparalleled academic medical center resources. With its specialized training for substance abuse epidemiology careers, SAETP is unique at CUIMC. Dr. Deborah Hasin and Dr. Silvia Martins, SAETP MPIs, are internationally recognized substance abuse epidemiologists with extensive successful mentoring experience. The 24 other SAETP faculty members offer interdisciplinary expertise (e.g., epidemiology, psychiatry, psychology, sociomedical sciences, biostatistics, nursing) and have outstanding records of publishing, funding, collaborations, and mentoring productive and successful trainees. At any given time in the renewal, SAETP will continue to train 4 pre-doctoral fellows for training periods of 3-5 years each, and 4 post-doctoral fellows for training periods of 2-3 years each, a number that has worked well in the current cycle. Fellows will be selected based on their prior accomplishments, commitment to substance abuse epidemiology careers, and fit with the SAETP program. Recruitment efforts to enroll under-represented minority trainees have been successful, with 33% of SAETP fellows from such groups to date (50% currently); we will continue these recruitment efforts. SAETP will provide broad, intensive training in substance abuse epidemiology and related areas; depth in one or more areas of specialization; cutting-edge methodological skills, development of conceptual skills, including formulation of key research questions and testable hypotheses, and the ability to design and conduct high-quality substance abuse epidemiology studies. Fellows will receive mentoring and participate in many training components, e.g., weekly substance abuse epidemiology faculty-fellow seminars, research internships, academic courses. Fellows will also receive training in the Responsible Conduct of Research and Rigor and Reproducibility in Research. SAETP training will enable fellows to publish papers, hone presentation skills, learn to write fundable grant proposals, and enhance collaboration and leadership skills. This rigorous, enriched training will prepare a new generation of outstanding researchers to address the epidemiology of substance use and SUD, which are urgent public health problems.

 

EXAMINING THE SYNERGISTIC EFFECTS OF CANNABIS AND PRESCRIPTION OPIOID POLICIES ON CHRONIC PAIN, OPIOID PRESCRIBING, AND OPIOID OVERDOSE (1/1/2019 - 11/30/2024)

Principal Investigator: Silvia S. Martins
Co-Principal Investigator: Magdalena Cerda 

Act: R01 - Project: DA045872 - Admin / Funding IC: NIDA

Abstract The rapid rise in opioid overdose deaths in the past 17 years has coincided with a tripling of prescription opioid (PO) prescriptions dispensed, largely to treat chronic pain. Increased co-prescription of benzodiazepines (BZDs) and opioids also substantially increased the risk of overdose. Cannabis has been proposed as an alternative treatment for chronic pain that could ameliorate opioid withdrawal symptoms and assist in recovery from opioid and BZD dependence. Two major policy shifts are likely to change prescribing practices and abuse of POs and BZDs. First, in the past decade, most states have enacted policies that regulate PO prescribing and dispensing. Second, since 1996, 29 states have legalized use of cannabis for medical purposes, and 9 states have legalized cannabis for recreational use. Policies that regulate access to POs may decrease the number of opioid prescriptions for chronic pain and co-occurring PO/BZD prescribing, while laws that allow greater access to cannabis may offer a substitute for POs, heroin, and BZDs. The combination of stricter PO policies and less restrictive cannabis laws may reduce opioid-related harm to a greater extent than either measure alone. As states make unprecedented changes to PO policies and cannabis laws, we need to examine the independent and synergistic contributions that both types of measures have on opioid prescribing practices and opioid overdoses, with and without BZDs. We propose to pursue this aim in two populations: (1) in the U.S. population, using repeated cross-sectional data of individuals nested in states from the National Survey on Drug Use and Health; and (2) among Medicaid patients with chronic pain (who have 10 times greater risk of opioid use disorder relative to privately insured patients), using a 45-state Medicaid Analytic Extract longitudinal cohort. Our specific aims are: (1) to examine, in NSDUH, whether nonmedical use of POs, BZDs and heroin, and opioid and BZD use disorders decrease (and cannabis use/disorder increases) following enactment of more restrictive PO policies and less restrictive cannabis laws in 2004-2019, compared to trends in states that did not enact these measures; and (2) to test whether Medicaid patients are less likely to have claims for opioid prescribing (alone and overlapping with BZDs), clinic visits for chronic pain, and opioid overdoses (with and without co-occurring BZD overdose) following enactment of more restrictive PO policies and less restrictive cannabis laws in 2001-2019, compared to patients in states that did not enact these measures. For Aim 2, we will sample 10,000 Medicaid patients with chronic pain per year, follow each cohort for 4 years (n=190,000), and combine the cohorts to construct an accelerated longitudinal cohort. States will be classified by how restrictive or lenient their PO policies are (e.g., prescription drug monitoring programs, pain clinic regulations), and whether they legalized cannabis for medical and/or recreational use. At a time when opioid overdose deaths are increasing at an unprecedented rate, this study will provide critical, policy-relevant findings about the types of policies that are most likely to end the opioid epidemic.

 

Impact of Social Cohesion and Social Capital in PrEP Uptake and Adherence Among Transwomen of Color

(September 11, 2018 – April 30, 2025)
Principal Investigator: Dustin T. Duncan

Act: Ro1 - Project: MD013554- Admin / Funding IC: NIMHD

DESCRIPTION (provided by applicant): This project seeks to use real-time geospatial methods to investigate relationships between social cohesion and social capital within Global Positioning System (GPS)-defined activity space neighborhoods and social networks in relation to HIV pre-exposure prophylaxis (PrEP) uptake and adherence cross-sectionally and longitudinally among transgender women (TW) of color (TWOC) in the New York City metropolitan statistical area (MSA) followed over two years. We will recruit 250 TWOC in the proposed The N2 Study: Transgender Women's Neighborhood and Networks Cohort Study to address the aims of the research. Eligibility requirements include: identifying as a transgender woman (individuals who were assigned a male sex at birth who identify as women, female, trans women, trans female, male-to-female or another diverse trans feminine gender identity on the spectrum) of color; HIV-seronegative; being 18 to 55 years old; residing in the New York City MSA; self-report no plans to move outside of the New York City metropolitan area in the next two years; self-reporting no restrictions to usual physical activity; and self-report willingness to carry a small GPS device for two-weeks at five points over the course of two years. Participants will wear the GPS device following protocols used in our previous feasibility research projects, including studies among TW. In this longitudinal study, six months after completing the initial 2-week GPS protocol, participants will carry the GPS device for an additional 2-weeks every six-months over the two-year study period—for a total of five times. Multiple GPS measures and multiple measures of social networks (atdifferent time points) can better capture the breadth of people's exposure to neighborhood-level factors and dynamics in social networks. Also, GPS activity space environment and social networks data at baseline could potentially influence PrEP outcomes over time, providing a clear temporal ordering and an ability to consider potential time-lags. The proposed study will be the largest GPS study of HIV disparities in any transgender population and presents a remarkable opportunity to study environmental influences on HIV. Findings from the proposed research will impact HIV prevention intervention activities. First, the project will inform specific neighborhood-level policy interventions. For example, increased community efforts through increased social cohesion in neighborhoods may be an HIV prevention intervention that can reduce HIV health disparities. Second, from the GPS dataset we will know the travel patterns of TW and therefore be able to identify optimal geographic locations for HIV prevention interventions. This will advance the literature given that such interventions are seldom geographically targeted.Third, examining changes in spatial mobility (i.e. activity spaces) over time will be useful in knowing whether the risks of particular spaces change or remain constant because different neighborhoods will have different risk profiles. Finally, our dynamic network analysis we propose will deepen understanding of the effects of social networks on HIV prevention behaviors and will improve network-based HIV prevention interventions.

 

Characterizing Sleep, ART Adherence and Viral Suppression Among Black Sexual Minority Men

(September 15, 2021 – July 31, 2026)
Principal Investigator: Dustin T. Duncan

Act: Ro1 - Project: HL160325- Admin / Funding IC: NHLBI

DESCRIPTION (provided by applicant): To address the aims of the proposed research and RFA-HL-21-018, we will use a syndemics and multi-level approach to investigate relationships between sleep and HIV treatment outcomes and behaviors (e.g., viral suppression and retention in care) cross-sectionally and longitudinally among Black gay, bisexual and other sexual minority men (SMM) followed over one year to inform interventions. We will enroll 250 Black SMM from the NIH-funded Neighborhoods and Networks (N2) Cohort Study in the proposed N2 Sleep Health Study to address the aims of the research. Eligibility requirements include: HIV-seropositive and self-reported willingness to wear a wrist actigraph for two-weeks at three points over the course of a year. In this longitudinal study, after completing the initial 2-week wrist actigraphy protocol, participants will carry the wrist actigraph for an additional 2-weeks every six-months over the one-year study period—for a total of three times. Objectively measured sleep data at baseline could potentially influence decision-making regarding HIV treatment (e.g., antiretroviral treatment[ART] outcomes) over time, providing a clear temporal ordering and an ability to consider potential time-lags. Multi-level factors – e.g., individual-level obesity, intimate partner violence, and spatial proximity to healthcare services – may modify these relationships. The proposed study will be the first objective sleep health study among any population of Black SMM. Findings from the proposed research have significantimplications for targeting contextually appropriate sleep and HIV interventions as there is a need for new approaches to inform the nextgeneration of HIV interventions (i.e., long-acting injectables), especially for Black SMM.

 

MyPEEPS Mobile LITE: Limited Interaction Efficacy Trial of MyPEEPS Mobile to Reduce HIV Incidence and Better Understand the Epidemiology of HIV among YMSM

(September 1, 2022 – July 31, 2027)
Principal Investigator: Dustin T. Duncan

Multiple Principal Investigators: Robert Garofalo; Rebecca Schnall

Act: UH3 - Project: AI169658- Admin / Funding IC: NIAID

DESCRIPTION (provided by applicant): There is a critical need to better understand the epidemiology of HIV acquisition in the United States (US), particularly among cisgender gay, bisexual and other men who have sex with men (MSM), one of the key populations essential to target for End the HIV Epidemic (EHE) initiatives. In direct response to RFA-AI-21-018, this study will use innovative technology to recruit and retain a large cohort of high-risk, HIV-negative young men who have sex with men (YMSM) focusing on racial/ethnic minority YMSM and high HIV prevalence geographic areas (known as “hot spots”). Furthermore, we will leverage this cohort to conduct a large-scale clinical trial while maintaining the standard of care control arm as a longitudinal observational cohort for epidemiologic analyses. Our study team is uniquely positioned and has all the relevant expertise to conduct this study having successfully recruited and retained more than 12,000 YMSM in a full range of research studies across the HIV continuum (e.g., epidemiology, intervention development, mHealth, PrEP, clinical trials, innovative geospatial methods). We have had specific success conducting prevention research with YMSM (17-25 years), including racially and ethnically diverse YMSM, our target demographic group. Further, we have previously leveraged advanced social media advertising techniques and used innovative geospatial analytics to target/study “communities within communities”, reaching hard-to-reach YMSM from diverse geographic areas (e.g., rural zip codes, U.S. tribal lands, etc.) and young ages (e.g., YMSM 13-18 years of age). We will harness innovative technology to recruit, during 36-months of enrollment, and then retain a large cohort (N = 5,000) of 17-25 year old YMSM, the majority being Black and Latino, who are at high-risk of HIV transmission (e.g., history of condomless anal sex) and follow them every 6 months thereafter. We will conduct an entirely virtual, digital clinical trial (Specific Aim #1) testing whether MyPEEPS Mobile (an evidence-based mHealth HIV prevention intervention) reduces HIV incidence among HIV-negative YMSM (17-25 years old) looking at the influence of theory-driven social, ecological, and geospatial factors on intervention uptake and efficacy inclusive of measures that align with traditional models of behavior change such as the Information Motivation Behavior Model. A social-ecological theoretical framework will also guide the analysis of the longitudinal observational cohort study (Specific Aim #2) of the 2,500 control arm participants to assess individual, network, geospatial, and public policy correlates of HIV risk and health seeking behaviors (e.g., PrEP uptake) comparing individuals who become HIV-positive to those who do not. Intervention Implications. The findings from this research will have important real-world implications for research and practice. For example, understanding how individual, network, geospatial, and public policy factors correlate with HIV incidence and moderate intervention effects will help inform how and where interventions should be delivered.

 

Cannabis use, PrEP and HIV transmission risk among Black MSM in Chicago 

(August 1, 2021 – May 31, 2026)

Principal Investigator: Dustin T. Duncan

Co-Principal Investigator: Knox, Justin

Act: R01 - Project: DA054553 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant): Black gay, bisexual and other men who have sex with men (MSM) face a disproportionate burden of HIV. Focused, high-coverage PrEP in populations heavily impacted by HIV, such as Black MSM, could rapidly reduce new HIV acquisition rates; however, its uptake among at-risk populations, especially Black MSM, has been limited. Therefore, we propose to conduct urgently needed research on PrEP in a cohort of Black MSM, including on the impact of relevant behaviors, particularly cannabis use, which is highly prevalent in Black MSM. Research on the impact of cannabis use on PrEP has achieved conflicting results, and it has not been rigorously studied in Black MSM. Therefore, the proposed R01 study will assess cross-sectional and longitudinal associations between cannabis use and PrEP outcomes (e.g., use, adherence) and HIV transmission risk (e.g. biological inflammation, sexual risk behavior) using event-level and objective biomarker data among HIV-negative Black SMM. To address these specific aims, we will conduct the Networks and Neighborhoods (N2) Cannabis PrEP Study in Chicago, IL. We will follow 250 HIV-negative participants from the original N2 cohort for an additional one-year period with 3 study waves. We will use innovative and rigorous methods, to collect additional data, such as Ecological Momentary Assessment methods and objective measures of cannabis use, PrEP use, and immune function over 14-day periods at each wave. Potential findings can impact intervention development and implementation, as well as inform policy to increase PrEP uptake and adherence, address substance use, and decrease HIV transmission rates, and disparities.

 

Leveraging harmonized data to improve external validity and efficiency of clinical trials for treating opioid use disorder 

(August 15, 2024 – May 31, 2029)

Principal Investigator: Caleb Hilliard Miles

Act: R01 - Project: DA059824 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant): Randomized clinical trials for the treatment of psychiatric and substance use disorders can be difficult, time- consuming, and expensive to conduct. Partially as a consequence, their sample sizes are typically underpow- ered for: 1) detecting moderately sized average treatment effects (ATEs) that may nonetheless be important for health at the population level, and 2) learning optimal individualized treatment rules (i.e., rules that match treatments to individuals based on demographic and clinical characteristics to optimize outcomes of interest), which are the cornerstone of personalized medicine. These are major barriers to 1) improving population drug use disorder outcomes in terms of broad implementation of treatments with moderate effects and 2) improving individual drug use disorder outcomes in terms of refining treatment strategies away from a “one- size-fits-all” approach to one incorporating a patient’s clinical characteristics. Data fusion typically involves combining individual patient data from similar studies to improve statistical power and answer questions that cannot be addressed by a single study alone. However, the statistical theory underlying data fusion is rel- atively new, and numerous open problems remain. One commonly occurring challenge is that studies will often measure different outcomes at follow-up such that a given outcome of interest will only be observed in a subset of studies. In practice, trials are typically combined when they have a common set of covariates, treatment, and outcome. This means that statistical efficiency and power gains from incorporating data from additional studies that do not share a common outcome, but do measure other related outcomes, are left on the table. Consequently, there is a critical need for principled, flexible, and efficient estimators that can be applied to multi-study, multi-outcome fused data sets to maximize statistical power and efficiency. Doing so is a prerequisite for learning individualized treatment rules that optimize the health outcomes relevant to each treatment and for detecting more moderately sized, yet meaningful treatment effects. The objectives of this project are: 1) to develop both simple parameteric and semiparametric efficient estimators of the ATE, conditional ATE (CATE) and optimal individualized treatment rules in multi-study, multi-outcome data-fusion settings (Aims 1a and 2a); 2) to develop sensitivity analyses for ATE and CATE estimation if the untestable transport identification assumption is not met (Aims 1b and 2b); 3) to apply these estimators to harmonized medication for the treatment of opioid use disorder (MOUD) trials with multiple outcomes to increase power to detect effects (Aims 1c and 2c); and 4) to develop and disseminate user-friendly software that implements all the above methods (Aim 3:). This proposal is expected to make a significant contribution to increasing the power and information gained from data fusion, and consequently, to improve the individualized treatment of psychiatric and substance use disorders.

 

Role of disability and pain in opioid overdose: mechanism and risk mitigation

(March 1, 2022 – January 31, 2027)
Principal Investigator: Kara Rudolph

Act: R01 - Project: DA053243 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant): Drug overdose deaths in the US have increased exponentially, driven by opioid overdoses. Concurrently, US surveillance studies have documented increased disability prevalence among adults in midlife. People with disabilities have higher rates of opioid use disorder (OUD) but are less likely to receive treatment for it, putting them at higher risk for opioid overdose. Despite these established risks, people with disabilities remain an understudied subpopulation in the context of the opioid crisis. Much of heightened risk among the disabled population may be due to chronic pain. Many people with physical disability experience chronic pain that either drives the disability, termed “high-impact chronic pain”, or that occurs concurrently. Chronic pain is frequently managed with prescription opioids, sometimes via risky prescribing practices. In addition to chronic pain, pathways through depression or through loss of economic opportunity and its accompanying stressors may link physical disability to overdose risk. Opioid prescribing for chronic pain has been linked to increased risk of opioid overdose, but any such risk conferred by having a physical disability, disentangled from chronic pain, has not been estimated—nor has the risk associated with co-occurring physical disability and chronic pain. Moreover, the mechanisms through which disability and chronic pain operate to affect overdose risk are unknown. Availability of recommended treatments for substance use disorders (SUDs), including OUD, and chronic pain may influence the relationships, mechanisms, and the associated disparities we propose to study, but is highly variable across localities. The objectives of this project are: Aim 1) to estimate the unique and joint contributions of physical disability and chronic pain conditions to opioid overdose risk and the extent to which pain management practices mediate these relationships; Aim 2) to develop novel statistical methods to transport mediated effects from one state to another, and to apply those methods in Aim 3) to identify SUD and pain management treatment metrics that, if improved, may reduce both overall overdose risk associated with physical disability and chronic pain and disparities in overdose risk by racial/ethnic-gender subgroup. We will harness geographic variation in the delivery of SUD and pain management treatment and predict the effects that realistic improvements in delivery would have on reducing opioid overdose in this vulnerable population. The proposed research is expected to estimate the extent to which physical disability increases risk of opioid overdose, the proportion of that increased risk attributable to chronic pain and attendant risky pain management practices (versus non-chronic pain mechanisms), and the extent to which risk may be mitigated by improvements in delivering appropriate chronic pain management and SUD (including OUD) treatment. This will allow for future prevention strategies to be tailored to the particular needs and challenges faced by people with physical disabilities, with the goal of ultimately making a significant contribution to improving prescribing practices and provision of recommended treatments to reduce their risk of opioid overdose.

 

Mechanisms linking neighborhood poverty to problematic adolescent drug use

(August 2, 2019 – December 31, 2024)
Principal Investigator: Kara Rudolph

Act: R00 - Project: DA042127 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant): Where a child grows up can influence his or her risk of problematic drug use. Surprisingly, policies and programs designed to improve neighborhood conditions have yielded conflicting results in which some children benefit but others are harmed. Understanding the mechanisms by which neighborhoods act to affect problem- atic drug use and how these mechanisms differ across subgroups and cities—that is, understanding where and for whom mechanisms apply—is essential to optimize the effectiveness of future neighborhood interventions. Mechanisms involving mediation by aspects of the school environment have been unexamined, but could prove promising for understanding differential effects of neighborhood on problematic drug use. The objective of this K99/R00 is to identify school-based mechanisms that mediate the relationship between neighborhood poverty and problematic drug use and to develop statistical methods to understand how mediation effects differ across subgroup and place. This objective contributes to the long-term goal of improving the effectiveness of interven- tions to prevent drug abuse and dependence by tailoring interventions to address the most relevant mechanisms of action for each target population based on place and individual-level characteristics. The K99 phase fills the following training gaps that are critical to achieving the research objective and long-term goal: 1) methodologic training in causal mediation analysis; 2) subject-matter training in drug abuse and dependence prevention in ur- ban populations; and 3) involvement in real-world school-based interventions to develop methods with practical utility. Aim 1 of the proposed research identifies the school environment mechanisms that mediate the relationship between neighborhood poverty and adolescent problematic drug use and modifiers of those mechanisms. Aim 2 extends a statistical method recently developed by the proposed research team for generalizing intervention ef- fects from one city to another to generalizing mediation effects. Finally, Aim 3 uses the method developed in Aim 2 to identify how the school environment mechanisms mediating neighborhood poverty and problematic drug use differ across major U.S. cities. The proposed research is expected to identify school-based mechanisms underly- ing differential effects of neighborhood poverty on adolescent problematic drug use by subgroup and place using the only study of randomized neighborhood residence. In addition, it is expected to contribute a novel statistical method that incorporates cutting-edge machine learning techniques to identify which mediation mechanisms can generalize across place, advancing translational research. Successful interventions are assumed to work in differ- ent settings, but that is not the case in practice. The proposed research will allow us to predict intervention effects while accounting for differences in population composition and modifiers of the mediation mechanism. This will make a significant contribution to improving health by informing the design and targeting of future neighborhood interventions to adolescents and places that may be most impacted in terms of problematic drug use prevention.

 

Design and analysis advances to improve generalizability of clinical trials for treating opioid use disorder

(September 15, 2022 – June 30, 2027)
Principal Investigator: Kara Rudolph

Co-Principal Investigator: Elizabeth A. Stuart

Act: R01 - Project: DA056407 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant): The opioid epidemic in the US is a public health emergency, exacerbated by the Covid-19 pandemic. Medi-cations for opioid use disorder (MOUD)-injection naltrexone, buprenorphine, and methadone-are the most effective tools for improving outcomes and preventing overdose among persons with OUD, but engagement in MOUD, especially long-term engagement typically required for a successful outcome, is unacceptably low. Long-term engagement rates tend to be even lower in real-world settings-what NIDA has termed the research-to-practice gap. This discrepancy between trial and real-world MOUD effectiveness could be par- tially attributable to differences between clinical trial versus real-world population characteristics (e.g., in terms of psychiatric and substance use comorbidities, previous treatment experience, immigration status, etc.) if treatment effects are modified (increased/decreased) by some of these characteristics that also relate to trial participation. Moreover, without knowing the relative effectiveness of MOUDs for certain real-world target pop- ulations, clinicians, researchers, and policymakers may be tasked with decision-making with biased evidence. Thus, there is a critical need to improve the generalizability of MOUD trials. Failing to meet this need would further ossify the research-to-practice gap, resulting in suboptimal treatment of OUD overall and within key subgroups. We propose to develop design and analytic approaches, what we call a generalizability through- line, to bridge MOUD trial evidence to real-world populations. The objectives of this project are: In Aim 1), to identify and characterize clinically meaningful, interpretable subgroups of persons seeking OUD treatment in US usual-care settings who are not represented or under-represented in MOUD trials based on multiple char- acteristics simultaneously. This will move us beyond existing approaches for assessing representation that have generally been limited to considering one individual-level characteristic at a time (e.g., race/ethnicity). We will apply the approach developed in the first part of Aim 1 to trial data (3 MOUD trials from NIDA CTN) and population data (California and New Jersey Medicaid claims) to characterize under-represented subgroups. In Aim 2), to generalize MOUD effectiveness to state-specific adult Medicaid populations, thereby estimating a realistic treatment goal if treatment retention supports, incentives, and dosing practices were improved to align with those in trials. Existing approaches for predicting generalized effects rely on extrapolation for non- and under-represented subgroups, which can result in biased and/or uninformative estimates. The approach developed in the first part of Aim 2 will make several improvements to limit extrapolation and increase effi- ciency. In Aim 3), to implement the methods developed for Aims 1 and 2 in user-friendly software to facilitate the easy adoption by applied trialists, researchers, and clinicians. The proposed research is expected to make a significant contribution to improving representation among trial participants and to understanding how and to whom trial findings generalize.

 

State-level opioid policies and policies that regulate substance use during pregnancy: a mixed methodsexploration of their effects on maternal and infantoutcomes

(August 1, 2022 – June 30, 2027)
Principal Investigator: Morgan Philibin

Co-Principal Investigator: Silvia Martins

Act: R01 - Project: DA053745 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant): The opioid and overdose crisis in the United States (US) disproportionately affects women of childbearing age (15–44 years), particularly pregnant women and their newborns: 20% of pregnant women are prescribed opioids during pregnancy.1,2 States have enacted both general opioid policies (e.g., access to medication for opioid use disorder (MOUD)) and policies specific to substance use during pregnancy, but the effects of these policies on pregnant women’s opioid use and newborn outcomes remain poorly defined. States’ policy responses to prenatal opioid use vary widely, resulting in inconsistent approaches to pregnant women’s opioid use. In this mixed- methods project, we will apply a convergent parallel design to examine the separate and combined impacts and consequences of state opioid policies on pregnant women and their newborns using Medicaid and commercial insurance databases (MarketScan). We aim to: 1. Examine the separate effects of general and prenatal state opioid policies on pregnant/postpartum women and newborns. We will: 1a) systematically map all 50 states’ prenatal opioid policies (2011–2020) to categorize policy variations and build a publicly available time-varying dataset; 1b) use this prenatal policy dataset and existing data on general opioid policies to explore the individual- level impact of general and prenatal opioid policies on opioid use disorder (OUD), MOUD access, and neonatal opioid withdrawal syndrome (NOWS) for pregnant women and their newborns; and 1c) test for effect modification by maternal race/ethnicity and age. 2. Investigate the combined effects of general and prenatal state opioid policies on pregnant/postpartum women and their newborns (2011-2020). To move beyond the impact of single policies in isolation, we will: 2a) use a modified Delphi approach to create a time-varying taxonomy of each state’s overall opioid policy climate relevant to pregnant women, ranging from penalizing to health- promoting, based on states’ combination of prenatal and general opioid policies; and 2b) explore the individual- level impact of states’ overall policy climates on pregnant/postpartum women and newborns using the same outcomes and effect modification as Aim 1. 3. Explore how prenatal policy implementation affects daily life for pregnant women and their newborns. We will: 3a) apply the Consolidated Framework for Implementation Research (CFIR) to interviews with 60 key stakeholders across states that vary by their overall policy climate to explore multilevel drivers of prenatal opioid policy implementation and how variations in implementation affect maternal and newborn health; and 3b) create an ethnographic cohort of 40 pregnant women who use opioids across states with four different prenatal policy climates (punitive, prosocial, mixed, inaction) and conduct three interviews with each over one year. We will explore how variations in prenatal opioid policy implementation affect how women navigate pre- and postnatal care, MOUD use, and state services. Findings will have concrete real- world impacts by describing the effects of state opioid policies on pregnant/postpartum women and their newborns and by identifying intervention points and policy changes that promote maternal and infant wellbeing.

 

Optimizing HIV adherence by developing a shared decision support tool to facilitate women's choice between oral and LAI ART

(March 15, 2021 – January 31, 2025)
Principal Investigator: Morgan Philibin

Act: R34 - Project: MH124552 - Admin / Funding IC: NIMH

DESCRIPTION (provided by applicant): Efforts to curb the HIV epidemic in the United States (US) are impeded by suboptimal adherence: only 63% of people diagnosed with HIV are virally suppressed. Women have lower adherence to oral antiretroviral therapy (ART) and viral suppression than men, contributing to their increased morbidity, mortality and onward HIV transmission. There is thus an urgent need for strategies to optimize women's viral suppression. Long-acting injectable (LAI) ART, an every 4 or 8 weeks intramuscular injection that was non-inferior to oral ART in Phase 3 trials, has the potential to transform HIV treatment by eliminating the need for daily pills. LAI ART may significantly reduce women's adherence barriers, but women constituted only 8%-33% of trial participants and their experiences with LAI ART are under-explored. To help fill this gap, our team conducted formative qualitative research with women living with HIV (WLWH) to explore their interest in LAI ART and barriers and facilitators to its use. Our research demonstrated that for LAI ART to reach its full potential we must: identify the women most likely to adhere to LAI ART, address barriers to its use, and support shared decision-making to ensure that a woman and her provider choose the HIV treatment modality that will best facilitate adherence to ART. Since no tools exist to support WLWH's shared decision-making of oral vs. LAI HIV medication, we propose to conduct a mixed-method study to develop a web-based patient decision aid, i.ART+support (i.ARTs). This R34 is led by an early-stage investigator and expert study team with a history of productive collaboration within the MACS/WIHS Combined Cohort Study (MWCCS). The R34 study will include MWCCS providers and WLWH (both in and out of care), who will eventually choose between oral and LAI ART. In Aim 1 we will generate i.ARTs content through in-depth interviews with 45 providers and survey data from 1,500 women across nine MWCCS sites. This will identify the characteristics of women most likely to adhere to LAI ART, gender-specific drivers of women's LAI ART use and solutions to support LAI ART adherence. In Aim 2 we will conduct five focus groups each with MWCCS providers and WLWH to iteratively develop i.ARTs content and assess and refine the web-based version of i.ARTs. In Aim 3 we will pilot test i.ARTs with 180 WLWH in a Miami, FL clinic and compare outcomes between the i.ARTs arm and control arm (n=90 in each). We will assess i.ARTs' feasibility, usability and acceptability and its impact on women's ART-related decisional conflict, viral suppression, clinic attendance and medication refills. We will also interview women who choose LAI ART to explore “real-world” barriers to use. In sum, this R34 will develop and pilot test a web-based patient decision aid to facilitate shared decision-making between WLWH and their provider to help identify whether oral or LAI ART best matches a woman's preferences and facilitates her ART adherence. The proposed R34 will develop a patient decision aid to help ensure that the full potential of LAI ART can be realized as it is being rolled out, and thus maximize its ability to significantly and sustainably impact the HIV epidemic.

 

Impacts of subsidized ridesharing on drunk driving, alcohol consumption, and mobility 

(May 15, 2021 – March 31, 2026)
Principal Investigator: Christopher Neil Morrison

Act: R01 - Project: AA029112 - Admin / Funding IC: NIAAA

DESCRIPTION (provided by applicant):  Over 10,000 people die in alcohol-involved motor vehicle crashes per year in the US. Most available evidence identifies that access to ridesharing is associated with fewer alcohol-involved motor vehicle crashes. Providing access to subsidized rideshare trips could be a high impact intervention to reduce crash incidence and save lives. Some municipalities have begun implementing this strategy. Theoretically, access to subsidized ridesharing will replace trips by prospective impaired drivers by altering the financial and convenience costs of taking alternative forms of transit compared to driving while impaired. The strength of this association will differ according to an individuals’ income and local access to public transit. However, access to subsidized ridesharing may produce concomitant increases in alcohol consumption because greater mobility makes it cheaper and easier for consumers to obtain and consume alcohol. Few studies have tested these hypotheses, and there is no evidence from experimental studies. The broad objective of this two-arm single-blinded randomized controlled trial is to test the effects of access to subsidized ridesharing on drunk driving and alcohol consumption. We will recruit 160 individuals through digital social media advertisements from a stratified sample of 50 US cities (n = 8,000), including 25 cities with high access to public transit (as measured using the Transit Score) and 25 cities with low access to public transit. Participants will (i) reside in a selected city, (ii) be aged ≥ 21 years, (iii) have a drivers’ license and access to a motor vehicle, (iv) report consuming alcohol at a bar in the last 7 days, (v) own a smartphone, and (vi) speak English. We will randomize participants to receiving a $35 ridesharing voucher (the intervention group) or a $35 online shopping voucher (the control group). We will follow participants for one week pre-intervention and one week post-intervention using weekly surveys. A sub-sample of 2,000 participants will download a custom mobile application and will be tracked using GPS for the two-week study period. The specific aims are 1) to test whether access to subsidized ridesharing reduces individuals’ risks for drunk driving, 2) to test whether access to subsidized ridesharing affects individuals’ alcohol consumption, and 3) to test whether access to ridesharing affects individuals’ mobility, including access to retail alcohol outlets. We will assess moderation by individuals’ income and by the Transit Score for their city of residence. The results of this study will fill important gaps in scientific evidence regarding a disruptive technology with strong potential to be harnessed as a preventive intervention to reduce alcohol-involved motor vehicle crashes and improve public health. The work will inform the design of interventions that use subsidized ridesharing to reduce alcohol-involved motor vehicle crashes—including by identifying the individuals who will benefit most substantially, the locations where impacts will be greatest, and the unintended effects on alcohol consumption—and the mechanism by which the intervention achieves these outcomes (i.e. by altering individuals’ mobility and exposure to alcohol outlets).

 

Impacts of subsidized ridesharing on drunk driving, alcohol consumption, and mobility 

(September 11, 2024 – August 31, 2026)
Principal Investigator: Christopher Neil Morrison

Act: K18 - Project: HD117390 - Admin / Funding IC: NICHD

DESCRIPTION (provided by applicant):  This K18 Career Enhancement Award will provide 2-years protected time for Dr. Christopher Morrison (Assistant Professor of Epidemiology, Columbia University) to become a leader in applied prevention science, with new content-area expertise in firearm injury prevention. A program of collaboration with four new senior colleagues, coursework, and research will allow him to accomplish three Training Objectives—A) to develop comprehensive skills in leadership in firearm violence prevention research and policy; B) to develop comprehensive skills in designing and implementing cohort studies; and C) to develop comprehensive skills in community engagement for firearm violence prevention. Dr. Morrison will accomplish this training in the Department of Epidemiology at Columbia University with a Visiting Scholar position at the Yale New Haven Hospital—Violence Intervention Program (YNHH-VIP). This training is tailored specifically to develop expertise necessary to advance the science of firearm violence prevention, including by leading the development of protocol for a multi-site prospective cohort study for people at risk of experiencing firearm violence. Preventing firearm violence is a high priority for research, but data are sparse. A social ecological systems framework provides a theoretical basis for understanding the complex processes that contribute to individuals’ risks for firearm violence victimization and perpetration, and emphasizes that contributors to firearm violence operate at multiple scales of organization (e.g., individuals, households, neighborhoods, cities, states) and over the lifecourse. To examine these complex processes we require longitudinal data collected at the individual level over many years, including detailed measurement of outcomes and theoretically relevant exposures related to firearm violence. We will use data from the National Longitudinal Study of Adolescent to Adult Health (Add Health), which is the largest longitudinal study in the US that includes measures of firearm violence perpetration and victimization, as well as critical contextual measures that are theoretically relevant for firearm violence prevention over the lifecourse. The specific aims are: 1) To assess longitudinal relationships between social ecological exposures during adolescence and trajectories of firearm violence perpetration into adulthood; 2) To assess longitudinal relationships between social ecological exposures and nonfatal firearm violence victimization over the lifecourse; and 3) To assess longitudinal relationships between social ecological exposures during adolescence and fatal firearm violence victimization into adulthood. Research activities will complement the collaboration and coursework portions of the proposed career development plan, provide ideal opportunities to apply new skills, and ultimately consolidate the candidate as a leading prevention scientist conducting high-impact studies, including expanding available interventions to reduce firearm violence.

 

Assessing the impact, equity, and mechanisms of a novel policy intervention to reduce tobacco retailer density in communities 

(February 1, 2023 – January 31, 2028)
Principal Investigator: Daniel Giovenco

Act: R01 - Project: CA269848 - Admin / Funding IC: NCI

DESCRIPTION (provided by applicant): Tobacco retailer density is disproportionately high in low-income communities and certain racial/ethnic enclaves, contributing to severe socioeconomic and social disparities in smoking and its resultant health harms. Local, environmental-level interventions that aim to reduce the number of tobacco retailers are a new policy frontier in tobacco control that may be particularly effective in promoting health equity, but the impact of these initiatives is critically understudied in real-world settings. Three major US cities – San Francisco, Philadelphia, and New York City (NYC) – recently enacted novel measures that establish caps on the number of tobacco retail licenses permitted in city districts. Density reduction under this intervention occurs not through license revocation, but gradually through retailer attrition. The effects of these “capping” policies on retailer density reduction and the resultant tobacco product marketplace largely depend on temporal, spatial, and store-level patterns in license forfeiture, which are not well-understood. Moreover, to comprehensively assess public health impact, it is critical to conduct stakeholder analyses after implementation, describe the policy’s impact on and mechanisms of behavior change, and identify potential unintended effects. The proposed mixed-methods, comparative case study will use archival tobacco retail licensing data, annual audits of tobacco retailers, semi-structured interviews with key community stakeholders, and geocoded health survey data to evaluate this intervention and examine differential policy impact across neighborhoods and population subgroups. Specifically, the project will: 1) Measure tobacco retailer density reduction and its association with community demographics across study sites; 2) Longitudinally characterize changes in the tobacco marketplace during policy implementation; 3) Qualitatively assess key stakeholder perceptions of the policy, its mechanisms of action, and its behavioral impact; and 4) Identify associations between tobacco retailer density reduction and smoking trends in NYC neighborhoods using a unique, annual population survey with geocoded respondent data. Given the lack of empirical support for this nascent, environmental-level tobacco control intervention, study results will provide timely, essential, and experiential evidence to inform equitable policy formation and improve implementation in order to maximize impact and reduce persistent health disparities.

 

Implementation, reach, and impact of court-ordered tobacco corrective statement postings at the point-of-sale

(September 1, 2024 – August 31, 2025)
Principal Investigator: Daniel Giovenco

Multiple Principal Investigators: Wackowski Olivia; Mercincavage Melissa

Act: R61 - Project: CA297714 - Admin / Funding IC: NCI

DESCRIPTION (provided by applicant): Tobacco use remains a leading cause of premature disease and death in the United States, including those attributable to cancer. In a landmark racketeering lawsuit filed by the US Department of Justice in 1999, several major tobacco manufacturers were found guilty of consumer fraud, which included deceptive tactics such as lying to consumers about the deadly effects of cigarettes, manipulating cigarettes to make them more addictive, and marketing their products to young people. To help remedy these actions, the court ordered the manufacturers to run a series of “corrective statements” in several communication channels in the US, including television, newspapers, and signage displays in stores at the point-of-sale. After nearly two decades of tobacco industry litigation to delay the corrective statement requirement in retail settings – one of the industry’s most valuable marketing channels – a 2022 court order finally mandated that the signs be posted from October 1, 2023 through June 30, 2025, a 21-month period. More than 200,000 retailers that have marketing agreements with the affected manufacturers – approximately 2 in 3 retailers nationwide – are required to display these large, eye-catching signs that inform consumers about the health risks of tobacco and the tobacco industry’s history of deception. While this historic retail-based intervention has the potential to positively impact public health, critical questions remain about the nature of its implementation, reach, and effects on consumers, including impacts on health equity. For example, it is unknown how implementation features of the signage (e.g., presence, number, placement) may vary by store type and neighborhood; if, and to what extent, consumers notice and retain the corrective messages; and whether exposure impacts tobacco knowledge, beliefs, intentions and behaviors (e.g., quit attempts). The finite window of intervention delivery offers a unique and time-sensitive opportunity to answer these questions, which may inform future large-scale tobacco information dissemination efforts, as well as identify subpopulations who may benefit from supplemental health education programs or other services. The specific aims of the study are to: (1) Characterize both implementation and reach by collecting detailed information about corrective statement implementation features through a retailer audit study. Supplemental analyses will calculate the prevalence/density of retailers required to display the statements across the United States. (2) Use eye- tracking methodologies to explore attention to the corrective statements (i.e., reach and impact) in the context of real-world exposures. (3) Field longitudinal surveys of adults and youth to examine reach and impact of the statements among a nationally representative sample, including reported exposures, message perceptions, and impact on tobacco knowledge, attitudes, intentions and behaviors.

 

Columbia Center for Injury Science and Prevention (CCISP) 

(August 1, 2024 – July 31, 2029)

Principal Investigator: Charles Branas

Act: R49 - Project: CE003555 - Admin / Funding IC: CE24-001

DESCRIPTION (provided by applicant): Columbia Center for Injury Science and Prevention – Project Summary The Columbia Center for Injury Science and Prevention (CCISP) will build upon its many past successes as a previously funded CDC Injury Control Research Center (ICRC) and will also, at the same time, thoughtfully progress into important new directions in seeking to usher in a new era of injury science with an explicit focus on reducing health inequities. The proposed Center will meet these objectives through synergistic efforts that actively strengthen our existing infrastructure; bring together scientific expertise, policy, and practice; produce an inclusive and diverse injury prevention workforce; foster interdisciplinary collaborations and far-reaching partnerships across our university, city, region, and other ICRCs in newly advancing the field of injury prevention with a focus on equity and social justice; and ultimately reduce morbidity and mortality from injuries through the creation, dissemination, and translation of scientific knowledge, the development of innovative and multi-level training programs, and the promotion of equitable best practices and evidence-based interventions. The CCISP will integrate and sustain its primary activities — leadership, research, training and education, and outreach — ensuring the “whole is greater than the sum of its parts” and maximizing the impact far beyond what would be achieved in conducting each of these activities separately in isolation. The mission and overall objective of the CCISP will be “Accelerating Equity through the Science of Safety”, leveraging the unique value of scientific inquiry in assembling a large group of university, community, and government partners to fast-track injury prevention research and programs with the greatest potential to equitably impact the safety and health of marginalized communities. This objective will be met by: 1) further developing infrastructure that brings together scientific expertise, policy, and practice through a lens of equity; 2) creating diverse, interdisciplinary collaborations and far-reaching partnerships across our university, city, region, state and other national ICRCs in newly advancing the injury prevention field; and 3) reducing injuries level through the creation, translation, and dissemination of scientific knowledge, training and education programs, and best practices and evidence-based solutions. The CCISP will bring together a team of highly experienced individuals with a long history of leadership of, engagement in, and connection to a multitude of injury prevention societies and stakeholders locally, nationally, and globally. The Center will be led by a robust Administrative Core, as well as an Outreach Core and a Training and Education Core and will include four Centerpiece Research Projects. These projects will focus on injury prevention topics that are a priority for the CDC National Center for Injury Prevention and Control and its Director, injury prevention issues of health equity and social justice, and translation to marginalized communities most in need, and will prominently include early-stage investigators.

 

Place Matters - Adaptable Solutions to Violence at the Community Level

(August 1, 2018 – July 31, 2025)

Principal Investigator: Charles Branas

Co-Principal Investigator: Katherine P. Theall 

Act: R01 - Project: HD095609 - Admin / Funding IC: NICHD

DESCRIPTION (provided by applicant): Place matters - Adaptable Solutions to Violence at the Community Level Violence is a leading health burden in the U.S. and globally, and plays a significant role in shaping population health and health disparities, given both immediate and long-term consequences.4 Remediation of abandoned buildings and vacant lots has been shown to be an effective and cost-beneficial solution to violence, especially firearm violence, in U.S. cities.9-11 This place-based blight remediation may be an effective population-based strategy for primary prevention of serious and lethal violence among youth but few studies have tested this approach among youth, specifically.12 Furthermore, it may have an impact on violence in the home or family violence, including child abuse and intimate partner violence (IPV); but no studies have examined this effect, although research on other forms of neighborhood disorder and the nature of family violence suggest that it may have a substantial impact.15 The objective of the proposed project aims to conduct the first community-level randomized controlled trial aimed at blight remediation for youth and family violence prevention. Our long-term goal is to define and address the role of community infrastructure and its potential impact on multiple forms of violence, and to identify potential buffers that may be included in prevention efforts. Our central hypothesis is that blight remediation will provide fewer locations for illegal weapons storage but will also improve residential sense of community and social control, and reduce stress among residents. This proposal is feasible because it leverages our ongoing evaluation of blight reduction efforts by the City of New Orleans and ongoing neighborhood-based violence research by the PIs. To address the current research gaps and achieve our objectives, we propose to conduct a cluster randomized trial with 600 lots and two intervention arms (n=150 lots in each arm)—one without buildings/structures and greened and one greened and with buildings/structures treated—propensity score matched 1:1 to control lots (n=300) across four New Orleans communities experiencing high rates of violence. A qualitative evaluation will also be conducted to examine the personal impact of blight remediation strategies. Confirmation of our hypotheses that reduction of neighborhood blight impacts not only youth violence (including serious and lethal) but also child abuse and IPV will provide critical information for policy and prevention efforts. Furthermore, examination of potential structural buffers or deterrents will aid in scaling up and translation of this highly innovative community-level program as well as providing further evidence for the interaction between multiple neighborhood conditions on violence-related outcomes.

 

Atlanta MACS/WIHS Combined Cohort Study Clinical Research Site

(April 1, 2019 – March 31, 2026)

Principal Investigator: Ighovwerha Ofotokun

Co-Principal Investigator: Anandi Nyan Sheth 

Act: U01 - Project: HL146241 - Admin / Funding IC: NHLBI

DESCRIPTION (provided by applicant): The overarching goal of the Atlanta Clinical Research Site (CRS) is to advance the unified scientific agenda of the MACS/WIHS CCS by: a) providing leadership in the development of the unified science protocols; b) serving as a local reading center and support laboratory for studies; and c) leveraging our research infrastructure to implement the CCS protocols by retaining current participants, recruiting new participants from under-represented minority groups, and engaging Emory scientists and the local community in CCS science and activities. The Atlanta CRS is well poised to accomplish these goals because of our unique location at the epicenter of the U.S. epidemic, the robustness of our HIV research program, and our track record of successful and collaborative contribution to the unified science of the WIHS over the past 5 years. Georgia now has the third highest rate of new HIV diagnoses among the Southern states1 and the 5th largest HIV epidemic among the U.S. states2. While HIV rates are high in both rural and urban Georgia, Atlanta is home to most (62%) of the state’s affected patients, and the majority reside within 10 miles of the Atlanta CRS. Importantly, nearly two-thirds of people living with HIV in Atlanta and ~20% in Georgia receive care in Emory associated HIV clinics (n=10,354). HIV+ and negative volunteers that have consented to be contacted for research are available via the CFAR HIV Disease Registry (> 13,000 unique patients), the PRISM Health MSM cohorts led by Emory faculty Dr. Patrick Sullivan, and the Georgia CTSA database (>100,000 individuals), providing us access to a diverse population of HIV+ and at-risk HIV- individuals from across the state. Leveraging these institutional resources, the Atlanta CRS will contribute to the CCS unified science in the following manner: 1) Provide leadership to support the CCS unified specific aims through expert contribution by Emory investigators, including scientific specific leadership roles in the following aims: (a) age related co- morbidities; (b) health disparities; (c) HIV pathogenesis; and (d) career development; 2) Leverage our state-of- the-art research infrastructure to implement all components of the CCS unified science, including adjudication of clinical events, development of data quality control procedures and good laboratory practices, staff training in relevant CCS research activities, and enrollment of new participants; 3) Enhance our vibrant community engagement to support our efforts to enroll new participants, expand our CAB to be representative of the combined cohort of women and men, and introduce use of innovative technology to enhance community outreach and support accrual and engagement of our combined cohort; and 4) Build on our track record of mentorship by expanding HIV research opportunities for early stage investigators in coordination with the CCS Investigator Developmental Award Advisory Committee.

 

Social Determinants of HIV

(July 1, 2021 – June 30, 2026)

Principal Investigator: Gina Maria Wingood 

Act: T32 - Project: MH128395 - Admin / Funding IC: NIMH

DESCRIPTION (provided by applicant): Social determinants of health (SDH) comprise overlapping social structures and economic systems that account for most health inequities. Examining SDH may be useful in identifying and monitoring HIV-related inequities, such as racial and gender disparities in HIV testing, engagement in care, and treatment. This proposal requests funding for a pre-doctoral research training program to address SDH including structural racism and gender inequality, intersectional stigma, residential segregation, aging, and marginalizing structures influencing HIV. Combatting the ongoing syndemic of SDH, HIV, affiliated co-morbidities, and other potentially overlapping infectious diseases such as Coronavirus, requires cutting edge public health research conducted by scientists of the highest caliber. This pre-doctoral program will be located in the department of Sociomedical Sciences within Columbia University, Mailman School of Public Health (MSPH). The training program will take advantage of the interdisciplinary expertise across MSPH in mentoring experience and expertise in SDH among people at risk and living with HIV. We also propose to collaborate with faculty at the HIV Center on Clinical and Behavioral Studies at Columbia University Irving Medical Center (CUIMC), the International Center for AIDS Care and Treatment Program, at MSPH, and the Social Interventions Group at the Columbia University School of Social Work. This wealth of faculty have outstanding records in publishing, funding, and successfully mentoring trainees. We propose to fund ten MSPH pre-doctoral fellows. Recruitment will be focused such that at least 50% of fellows enrolled will be under-represented trainees. Eligible trainees are pre-doctoral students admitted to Columbia University's MSPH departments of Sociomedical Sciences, Biostatistics, Epidemiology, and Population and Family Health, and committed to understanding social determinants of HIV. Trainees are required to complete in their primary department, specific theoretical, methodological, and biostatistical pre-doctoral department requirements. All fellows will receive mentoring and co-mentoring and will be required to complete the following training components: (1) a Faculty-Fellow seminar that alternates hosting guest speakers discussing professional development, structural interventions, social policies, community-engaged research, and social determinants of HIV, with a student-led journal club, (2) coursework on social and economic determinants of health, (3) coursework on social epidemiology, (4) coursework on HIV, (5) coursework on multilevel modeling, (6) attendance in HIV Grand Rounds at CUIMC, (7) a course in the responsible conduct of research, (8) grantsmanship, (9) experiential training to hone publication, and presentation skills, and (10) doctoral research on the social determinants of HIV. This pre-doctoral program aims to prepare MSPH students for research and teaching careers that examine SHD, and marginalizing structural factors that influence HIV, nationally and globally.

 

Identifying Reproducible Brain Signatures of Obsessive-Compulsive Profiles

(August 1, 2017 – April 30, 2025)

Principal Investigator: Helen Blair Simpson 

Act: R01 - Project: MH113250 - Admin / Funding IC: NIMH

DESCRIPTION (provided by applicant): Anxiety and related disorders, including obsessive-compulsive disorder (OCD), are leading causes of global disability. Brain circuit abnormalities have been identified, but important knowledge gaps remain. It is unclear which abnormalities underlie what symptom profiles, how dysfunction develops and thus which brain abnormalities to target with new interventions. Moreover, circuit abnormalities likely cut across traditional diagnostic categories and, within a diagnostic category, there is individual variability. Our approach is to identify reproducible brain signatures of measurable behaviors and clinical symptoms; these brain signatures can then be used to reveal trans-diagnostic disease dimensions, to chart their development, and to develop treatments that target these circuit abnormalities directly. The goal of this proposal is to identify reproducible brain signatures associated with cognitive and clinical profiles that are common in individuals with OCD. To accomplish this, we will study 250 unmedicated OCD and 250 healthy control subjects (HCs) at five expert research sites spanning five countries (U.S., Brazil, India, Netherlands, and South Africa). Using imaging methods that could ultimately be adapted for clinical use, we will examine multiple brain circuits thought to underlie OCD behaviors, focusing on morphometry (using T1- weighted MRI), structural connectivity (using Diffusion Tensor Imaging [DTI]), and functional connectivity (using resting-state fMRI [rs-fMRI]). We will identify neuroimaging signatures that distinguish individuals with OCD from HCs by analyzing each modality with standardized protocols and by using multi-modal fusion with modern machine learning statistical methods. We will then examine how these imaging signatures are linked to behavioral performance on cognitive tasks that probe these same circuits and to a range of clinical profiles that are common to OCD. Finally, we will explore how specific environmental features (childhood trauma, socioeconomic status, religiosity) may moderate this brain-behavior relationship. Our short-term goal is to identify brain signatures of OCD cognitive and clinical profiles, leveraging our global collaboration both to recruit a very large unmedicated sample and to prove these signatures' reproducibility. Our long-term goal is to identify brain signatures for measurable behaviors and clinical symptoms that cut across traditional diagnostic categories and to use these signatures to transform how we conceptualize, diagnose and ultimately treat mental illnesses like OCD.

 

As adolescent substance use declines, internalizing symptoms increase: identifying high-risk substance using groups and the role of social media, parental supervision, and unsupervised time 

(June 15, 2019 – March 31, 2025)
Principal Investigator: Katherine Keyes 

Act: R01 - Project: DA048853 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant): Multiple data sources indicate that adolescent psychopathology, particularly internalizing symptoms, is at historically unprecedented highs in the United States. These include cognitive (low self-esteem, self- derogation), affective (depressive affect), and social (loneliness) dimensions of adolescent internalizing symptoms, which have been rapidly increasing since ~ 2009. Coinciding with these trends has been declines in adolescent alcohol and other drug (AOD) use (except marijuana), contrary to what would be expected given the historically strong relationship between AOD use and internalizing symptoms. Declines are also apparent in high intensity alcohol use (e.g. 10+ drinks per drinking occasion), high-frequency AOD use (although not marijuana), and simultaneous use of AOD (including marijuana). The strength of the relationship between internalizing symptoms and AOD use among adolescents is also decreasing; for the first time approaching null in 2016, which has serious implications for risk factor assessment, prevention and intervention. Divergences may vary across demographic subgroups, however. Little work has estimated why these diverging trends are occurring; the most prominent hypothesis is smartphones and social media. These technologies are hypothesized to underlie less face-to-face time among adolescents, increase real-time parental monitoring, and negative feelings such as envy and low self-worth. Such a shift may underlie decreases in AOD use (less unsupervised time with other adolescents, more parental monitoring) and increases in internalizing symptoms (negative feelings and self-worth). However, existing literature is not based on nationally-representative data, and the relationship with AOD use has not been investigated. The present study will utilize the Monitoring the Future (MTF) cross-sectional surveys of ~45,000 adolescents per year. MTF includes a breadth measures related to internalizing symptoms, substance use, adolescent interaction, as well as a diverse array of potential confounders. We will address three aims: (1) Examine time trends in the relationship between internalizing symptoms (low self-esteem, self-derogation, depressive affect, loneliness) with any, high-intensity, high frequency AOD use, testing the magnitude of the relationship across time and by race, sex, and SES; (2) Examine time trends in the relationship between internalizing symptoms and simultaneous use of AOD (e.g., alcohol and marijuana use, alcohol and opioid use, others), testing the magnitude of the relationship across time and by subgroups; (3) Test the extent to which social media use, parental supervision, and unsupervised time with friends are associated with internalizing symptoms, AOD use, simultaneous use of AOD, and whether the magnitude of these associations explains changes in trends over time. Methods to address these aims will include time-varying effect modeling as well as parallel process growth models. This study will provide evidence for public health action by delineating the relationship between AOD and internalizing symptoms over time, and by examining the role of new technology and the changing landscape of adolescent interaction.

 

Suicide as a contagion: modeling and forecasting emergent outbreaks

(January 24, 2020 – November 30, 2025)
Principal Investigator: Katherine Keyes 

Co-Principal Investigator: Jeffrey L. Shaman 

Act: R01 - Project: MH121410 - Admin / Funding IC: NIMH

DESCRIPTION (provided by applicant): Suicide rates continue to increase in every age group in the United States and in almost every state—in 2016, 44,965 individuals in the US died by suicide. Developing scientifically rigorous surveillance, reporting, and forecasting systems for suicide is essential to craft appropriate public health responses. Here we will bring together geo-located data from Google Extended Trends, National Suicide Prevention Lifeline, Health Cost and Utilization Project, and vital statistics coupled with the National Violent Death Registry to build and validate statistical and mathematical models of queries, calls, attempts, and completions of suicide. Our models aim to address the epidemic by studying it as a communicable process. Our overarching goal is to provide an anticipatory warning system to inform school-based and community-based prevention and treatment capacity. Our first Aim is to estimate how suicidal queries, calls, attempts, and completions cluster in space and time. Temporal and spatial autocorrelation of suicidal behavior shares many features with communicable diseases that can be conceptualized in terms of the epidemiological triad—agent (media reporting, person-to-person transmission, lethal vectors), host (history of attempts and psychiatric disorder), and environment (weather, elevation, and temperature)—for which rigorous statistical models have been used to study geographic and temporal risk factors associated with infectious disease, even in the face of incomplete surveillance data. We will estimate the unique and shared autocorrelation of suicide queries, calls, attempts, and completions and test the extent to which autocorrelation varies by developmental stage (i.e., adolescents and young adults versus older adults). Our second Aim is to understand the dynamics of suicide risk across developmental stages through simulation of anomalous suicidal outbreaks using mathematical models that represent suicide as a contagion. The models will be coupled with Bayesian inference algorithms to enable simulation, optimization, and estimation of key epidemiological parameters that characterize system dynamics. This effort will bring together 4 data sources (queries, calls, attempts, and completions) to consider the system as a whole, rather than as separate streams of information. We will answer critical questions about the extent to which local and temporal anomalous increases in suicidal outcomes vary across events, as well as the force of contagious transmission, length of time of contagious suicidal crises, and contribution of lethal means. For our third Aim, we will use the model-inference framework to produce granular, local, 6-month predictions of suicide outbreak events. The generated forecasts will help inform when, where, and among whom we can expect suicide outbreaks to develop, and for how long unless prevention efforts are rapidly disseminated. This project brings together experts in mathematical modeling, communicable disease and suicide epidemiology, prevention, and intervention, who will apply state-of-the-art modeling approaches to suicide surveillance and forecasting.

 

Temperature, shade, and adolescent psychopathology: understanding how place shapes health

(September 15, 2021 – June 30, 2026)
Principal Investigator: Katherine Keyes 

Co-Principal Investigator: Andrew G. Rundle 

Act: R01 - Project: MH128734 - Admin / Funding IC: NIMH

DESCRIPTION (provided by applicant): Adapting to climate change requires countermeasures that can protect public mental health and community well- being. Cities and states increasingly incorporate population health promotion into urban planning decisions, yet the impacts of such decision decisions on mental health outcomes remain largely unstudied. With respect to climate change cities have significant capacity to help offset the adverse effects of increasing temperatures and enhance community resilience, through altering the design of natural and built environments. However, such decisions require empiric evidence on the health effects of both increasing temperature and offsetting designs to increase shade, particularly given the racial and socioeconomic inequalities in shade access. On a given day, significant spatial variation in temperature can occur within a city or urban region, mostly driven by local differences in shade. Temperature and shade exposure have been linked to psychopathology for centuries, with ample biological plausibility, but few modern studies have provided comprehensive data. We propose to utilize a cohort study of 3,396 high school students, with substantial diversity in race, income, and neighborhood, recruited in 9th grade in 2013 in Los Angeles County, and followed up eight times with <1% attrition at each wave, to innovatively study how intra-city differences in temperature, access to shade, and green space influence the incidence of internalizing and externalizing symptoms and transdiagnostic psychopathological traits. We will link geocoded residential, commuter, and school location information to remotely sensed data and local land use to create high-resolution estimates of neighborhood surface temperatures, tree canopy cover, other built environment sources of shade, and green space of each of the cohort participants. We will also measure neighborhood-level factors known or hypothesized to influence psychopathology risk, including air quality, neighborhood economic conditions, and crime. State-of-the-science confounder control strategies using multi- dimensional g-formula mediated moderation models will generate robust associations. Through these assessments we will construct neighborhood typologies of health risk that include social, environmental, and physical factors. We will: 1) intensively characterize the home and school neighborhoods of >3,000 longitudinally followed adolescents and identify transdiagnostic psychopathological symptoms and trajectories; 2) determine the impact of neighborhood surface temperature, shaded areas, and greenspace on internalizing and externalizing dimensions, transdiagnostic traits; and 3) construct and compare neighborhood typologies of psychopathological risk incorporating physical and social environmental data and novel latent variable techniques. Our research team has extensive expertise in spatial and psychiatric epidemiology and experience in translating science to policy. This work will provide critical missing data on the effects of green infrastructure on psychopathology among adolescents. Such data are needed to support decision-making around urban planning, investment, and climate change mitigation to improve population health for local communities.

 

Research Training Program in Psychiatric Epidemiology

(July 1, 2022 – June 30, 2027)
Principal Investigator: Katherine Keyes 

Act: T32 - Project: MH013043 - Admin / Funding IC: NIMH

DESCRIPTION (provided by applicant): Training programs in psychiatric epidemiology are increasingly critical to advance science and develop prevention and intervention efforts that positively affect public health. The events of 2020 brought into stark focus the economic, geographic, educational, and racial inequalities in the US that deeply affect mental health and wellbeing. They deepen the need to consider how the social environment and psychiatric disorders intersect with biological determinants of health, for which new data sources and technology are rapidly accelerating, and to plan for strengthening of public mental health infrastructure. Changes in recent years in the incidence and prevalence of psychiatric disorders, and accelerating data collection and technological capacity, are impacting how psychiatric research is conceptualized, research participants are recruited, and mental health data are analyzed across research domains, and these factors will inform how mental healthcare is delivered, accessed, and evaluated. Since 1972, the Columbia Psychiatric Epidemiology Training (PET) program has produced productive scientists who emerge as leading voices on how to assess etiology, epidemiology, biology, and intervention in mental health scholarship and services to respond to emerging needs. We believe that the success of this program is due to five foundational features: 1) training in theory- and hypothesis-driven scientific inquiry; 2) interrogation of multiple levels of causation with dynamic interactions; 3) development and application of methods for prediction and causal inference; 4) responding to changes in public health and mental health; and 5) training and research in ethical principles that underpin work with disadvantaged populations such as those with mental disorders. In the next five years of our program, we will continue to grow each of these areas through scholarship and training. Our focus has drawn scholars from numerous disciplines to engage with our faculty, coursework, and training—scholars who then become leaders with impact across academic and non-academic settings assessing social and biological psychiatry, service equity and delivery, and designing and evaluating evidence-based treatments. These scholars are better informed and their workforce better situated to significantly impact science and practice when trained to interrogate multi-level frameworks, causal inference, and the ways in which social factors influence etiology, diagnosis, and access to systems of care. Over the next stage of growth of the PET program, we will build upon these foundations with additional faculty, training, and expertise. By balancing growth of historical legacies and new intellectual resources, the PET program will be poised to prepare the next generation of scholars and change-makers to address critical challenges among those with mental illness across the globe. Epidemiologists trained by the PET program have the skills necessary to strengthen the public mental health infrastructure to prepare for future global crises, including pandemics.

 

Leveraging social media to develop the Cannabis Exposure Index (CEI), a standardized measure of cannabis use

(September 30, 2020 – July 31, 2025)

Principal Investigator: Borodovsky, Jacob T

Act: R01 - Project: DA050032 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant): Americans increasingly believe cannabis to be a harmless substance with therapeutic benefits; cannabis is increasingly legal in the U.S.; a burgeoning industry has introduced novel, high potency products; and the prevalence of use and cannabis use disorder (CUD) has increased. The scientific and public health communities have struggled to keep pace in determining the impact of this changing cannabis landscape. An important barrier to progress is the lack of an adequate measure of cannabis consumption. Unlike measures of alcohol use that can discriminate high and low risk drinking patterns, current cannabis measures are inadequate to investigate cannabis risks and benefits, the impact of policy changes, and the outcomes of clinical trials. Developing valid measures faces challenges, e.g., estimation of quantity; data collection from sufficiently large and diverse samples for validation. Leveraging our expertise in cannabis research, measure development, and social media survey methods, we propose to address these challenges via a rigorous mixed-methods study to develop and test a family of measures of cannabis exposure: The Cannabis Exposure Inventory (CEI; timeframe, past 30 days), a short form (CEI-S), and a daily form (CEI-D; timeframe, last 24 hours). Aim 1: Prepare initial CEI. Our expert team will assemble and program an initial version of the CEI using novel items and images to estimate use. Through cognitive interviewing and a preliminary test-retest study, we will examine how users understand the items and response categories, and iteratively adjust the CEI. Aim 2: Initial examination of CEI validity. We will administer an on-line survey with the CEI, validators (e.g., CUD severity) and covariates to 3,000 cannabis users using well-tested social media survey methods and research panels. Analyses will assess associations between the different exposure item domains (construct validity) and identify the combination of items most associated with external validators (convergent validity) to inform further refinement of the CEI. A definitive test- retest sub study (n=600) will indicate reliability. Aim 3: Confirm CEI validity in a large sample of current users; develop the CEI-S. We will administer the CEI to 12,000 users to confirm construct and convergent validity, overall and across major subgroups (e.g., gender, race/ethnicity). We will derive the CEI-S for use in studies where time does not permit the full CEI. We will conduct a biological validation sub study with n=150 participants, examining THCCOOH. Aim 4: Prepare and validate the CEI-D. We will create the CEI-D, adjusting the CEI-S timeframe to the prior 24 hours for use as a daily measure, and examine its validity in a subsample from Aim 3 (n=400). They will complete the CEI-S, then complete the CEI-D, functioning, and mood items for 30 days on a mobile device. Consistent with FDA guidelines on demonstrating validity of outcome measures, we will test how CEI-D scores, functioning and mood covary over time. Accomplishing these aims will provide the field with a set of greatly improved measures of cannabis use that will enhance clinical and epidemiologic research, and lead to more informed communication about cannabis to clinicians, health educators and policy makers.

 

Impact of medical and recreational marijuana laws on cannabis, opioids, and psychiatric medications: national study of VA patients, 2000 - 2024 

(July 1, 2019 – April 30, 2025)
Principal Investigator: Deborah Hasin

Act: R01 - Project: DA048860 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant): Thirty states now have medical marijuana laws (MML), 9 have recreational marijuana laws (RML), and many more states are considering such laws. The health effects of cannabis laws are controversial; understanding them is a major public health and NIDA priority (PA-17-135). Thus far, only 3 studies of adults (2 of them ours; Hasin et al., 2017, Martins et al., 2016) used multi-level modeling to examine MML effects on cannabis outcomes with individual data. These studies suggested post-MML increases in cannabis use and Cannabis Use Disorder (CUD). However, they left many questions unanswered, including whether MML have stronger effects in those with key vulnerability factors (chronic pain, psychiatric disorders). In addition, soaring rates of opioid prescriptions and overdoses have led to calls for MML as part of the solution to the US opioid crisis, but most MML-opioid studies are ecological (a weak design to study individual behavior), and results from individual-level studies leave the evidence unclear. Ecological studies also suggest that through cannabis substitution, MML reduce medication prescriptions for common psychiatric disorders (e.g., PTSD, depression), but no individual-level studies of this have been conducted. Importantly, RML effects are almost entirely unknown, a major gap in knowledge. In Veterans Administration (VA) patients, CUD prevalence has doubled since 2002, and in those age ≥35, is 2-6 times higher than in the general population. VA patients also have high rates of opioid prescriptions, overdoses, and of chronic pain and psychiatric disorders that may increase their vulnerability to adverse MML and RML effects. They thus are a large, vulnerable population in whom MML and RML effects are unknown. We will investigate MML and RML effects utilizing a major resource, the individual data from the VA Electronic Medical Record, available since 2000 from the ~5,000,000 patients served each year by the VA healthcare system. We will create yearly EMR datasets, and merge this with National Death Index data, Medicare data (for those age ≥65) and state-year MML and RML variables that we will create. Using multi-level models and difference-in-difference tests, we will examine MML and RML effects on three main outcomes: cannabis (use, CUD), opioids (prescriptions, fatal and non-fatal overdoses, opioid use disorders), and psychotropic medication prescriptions (antidepressants, anxiolytics, sedatives/hypnotics). Importantly, we will determine if pain, psychiatric disorders or demographics (sex, age, race/ethnicity) modify MML/RML effects. We will also examine specific MML/RML provisions, time lags, and breakpoints in trends reflecting federal policy changes. Analyses will incorporate individual- and state-level confounders, e.g., state norms, economic factors. We will also explore alcohol and tobacco outcomes. The research team includes substance epidemiology/policy experts and VA addiction and internal medicine experts. Findings will be disseminated to clinicians and policy-makers. Determining MML/RML effects in VA patients will make a major contribution to the limited adult literature on MML/RML, contributing to knowledge that will inform policy and the care of individuals with vulnerability factors.

 

COVID-19, heavy drinking and alcohol use disorders: a national study of Veterans Administration patients

(April 1, 2022 – March 31, 2025)

Principal Investigator: Deborah Hasin

Act: R21 - Project: AA029153 - Admin / Funding IC: NIAAA

DESCRIPTION (provided by applicant): Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2 is a global pandemic. While most COVID-19 cases are mild or moderate, severe cases (~15%) require hospitalization, critical cases (~5%) require intensive care, and many deaths occur. Males, Blacks and Hispanics are at greater risk for COVID-19 infection, and poor prognosis is predicted by older age, race/ethnicity, and prior underlying medical conditions. A potentially critical factor not yet studied is heavy alcohol use or alcohol use disorder (AU/AUD). AU/AUD could increase the risk for COVID-19 infection and poor prognosis through poor health behaviors, by direct effects of alcohol on the immune system, or by indirect effects due to the greater prevalence of underlying medical conditions that predict poor COVID-19 prognosis. Little is known about the relationship of AU/AUD to the likelihood of COVID-19 vaccination, infection, or poor prognosis, and if these relationships are modified by medical conditions (e.g., hypertension, obesity, diabetes), spatially-defined socioenvironmental or exposure variables (e.g., county poverty or COVID-19 rates) or demographic characteristics (sex, age, race/ethnicity, poverty). To study this, large databases are needed that include AU/AUD, demographic characteristics, spatial identifiers, diagnostic, treatment and mortality information. Responding to PA-20-195 (and addressing issues in NOT-AA-20-011), we will utilize the Veterans Administration (VA) Electronic Medical Record (EMR) system for this purpose. The VA treats 6.3 million veterans a year. VA patients have high rates of COVID-19 vulnerability factors, e.g., male, older age, chronic medical conditions. A VA Shared Data Resource identifies COVID-19 cases (now N=186,174, with 9,299 deaths). The many VA patients with ICD-10-CM AUD or positive alcohol (AUDIT-C) screens provide extensive data on whether the likelihood of COVID-19 outcomes differ by AU/AUD status. Leveraging a research infrastructure established in an existing project, we propose a 2-year study to comprehensively address the relationship of AU/AUD to COVID-19 vaccination, infection and prognosis, and how these relationships are affected by demographic, medical, spatial exposure characteristics. Aim1: Determine the relationship of AU/AUD to COVID-19 vaccination, infection, and in those infected, poor prognosis (e.g., hospitalization, ICU treatment, death). Aim 2: Determine if associations of AU/AUD with COVID-19 outcomes vary over time, medical conditions (e.g., hypertension, obesity, diabetes), spatial exposures or demographic characteristics. In Year 01, we will analyze EMR diagnostic, treatment, and vital status death data, using a 12-month lookback period to determine AU/AUD and medical conditions that preceded COVID-19 outcome variables. In Year 02, we will incorporate National Death Index data to examine causes of death, and expand information on veterans ≥age 65 with Medicare data. Logistic regression will evaluate differences in COVID-19 outcomes by AU/AUD status. Among those with COVID-19, survival models will determine if time to poor prognosis events differs by AU/AUD. Results will fill major gaps in knowledge about the risks for and prognosis of COVID-19 among those with AU/AUD.

 

Scientific Conferences for The College on Problems of Drug Dependence (CPDD)

(April 1, 2021 – March 31, 2026)

Principal Investigator: Deborah Hasin

Act: R13 - Project: DA013192 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant): This is a request for a 5-year renewal of grant R13DA013192 to continue to support travel awards for trainees and early career researchers to attend annual meetings of the College on Problems of Drug Dependence (CPDD). CPDD is the oldest scientific society dedicated to substance use research. As the only annual national or international meeting that brings together researchers studying all aspects and approaches to the problems of substance use, CPDD’s conference provides a particularly enriching experience for trainees and early career researchers in the field. The meeting attracts basic and clinical researchers from throughout the United States and about 40 countries, at all career stages from predoctoral students through senior investigators, as well as representatives from government and industry. It includes scientists, physicians, nurses, clinical psychologists, administrators, policy makers, journalists and others working on or interested in substance use research. Our meetings are a forum for researchers from a broad range of disciplines (e.g., medicinal chemistry, molecular biology, pharmacology, genetics, neuroimaging, psychology, sociology, addiction medicine, public health, epidemiology) to share their recent findings, network and learn from one another in formal and informal exchanges. We expect 1000-1300 attendees at each of our future meetings supported by this competing renewal. In the next funding period, we propose to continue to support travel awards for trainees and early career researchers to attend the CPDD annual meetings. Topics addressed at the meeting change with emerging concerns and cutting-edge research in the field, and, each year, sessions highly relevant to NIDA's major program areas (e.g., epidemiology, prevention, health services, medications development, neuroscience, behavior, HIV/AIDS and health disparities) are included. Presentations span the full range of drugs of abuse, including opioids, stimulants, sedatives, cannabis, hallucinogens, nicotine and alcohol. The conference includes awards lectures and forums on policy, animal and human research, industry/academia/government collaboration and media outreach, as well as activities directed towards trainees, early career researchers, underrepresented minorities and international scientists. We expect our annual meetings to accelerate innovation in substance use research through the translational nature of our content and through the collaborations that are built between attendees across the disciplines represented at the meeting. We also expect findings presented at the meeting to reach a broader audience due to our media outreach activities and newly developed virtual offerings, which can significantly improve prevention and treatment of substance use disorders and inform policy as it relates to substance use.

 

Substance Abuse Epidemiology Training Program (SAETP) at Columbia University

(July 1, 2012 – June 30, 2027)

Principal Investigator: Deborah Hasin

Co-Principal Investigator: Silvia S. Martins

Act: T32 - Project: DA031099 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant): Substance use and substance use disorders (SUD) constitute major public health problems due to their associated disability, comorbidity and mortality. Addressing these burdens requires cutting-edge public health research conducted by scientists of the highest caliber. In 2012, the Substance Abuse Epidemiology Training Program (SAETP) at Columbia University Irving Medical Center (CUIMC) in New York City was established with the objective of training talented young scientists to become the next generation of leaders in substance abuse epidemiology. Through competitive applications, SAETP has successfully, attracted a diverse group of fellows that have been productive and successful during and after training. Completed SAETP fellows have attained prestigious research positions in academic research settings and many have obtained their own independent funding. We now propose the next 5-year renewal cycle for SAETP. SAETP exists in a very rich, stimulating environment, offering unparalleled academic medical center resources. With its specialized training for substance abuse epidemiology careers, SAETP is unique at CUIMC. Dr. Deborah Hasin and Dr. Silvia Martins, SAETP MPIs, are internationally recognized substance abuse epidemiologists with extensive successful mentoring experience. The 24 other SAETP faculty members offer interdisciplinary expertise (e.g., epidemiology, psychiatry, psychology, sociomedical sciences, biostatistics, nursing) and have outstanding records of publishing, funding, collaborations, and mentoring productive and successful trainees. At any given time in the renewal, SAETP will continue to train 4 pre-doctoral fellows for training periods of 3-5 years each, and 4 post-doctoral fellows for training periods of 2-3 years each, a number that has worked well in the current cycle. Fellows will be selected based on their prior accomplishments, commitment to substance abuse epidemiology careers, and fit with the SAETP program. Recruitment efforts to enroll under-represented minority trainees have been successful, with 33% of SAETP fellows from such groups to date (50% currently); we will continue these recruitment efforts. SAETP will provide broad, intensive training in substance abuse epidemiology and related areas; depth in one or more areas of specialization; cutting-edge methodological skills, development of conceptual skills, including formulation of key research questions and testable hypotheses, and the ability to design and conduct high-quality substance abuse epidemiology studies. Fellows will receive mentoring and participate in many training components, e.g., weekly substance abuse epidemiology faculty-fellow seminars, research internships, academic courses. Fellows will also receive training in the Responsible Conduct of Research and Rigor and Reproducibility in Research. SAETP training will enable fellows to publish papers, hone presentation skills, learn to write fundable grant proposals, and enhance collaboration and leadership skills. This rigorous, enriched training will prepare a new generation of outstanding researchers to address the epidemiology of substance use and SUD, which are urgent public health problems.

 

Testing tailored text reminders and financial incentives to enhance antidepressant adherence for depressed adults in primary care

(August 15, 2024 – May 31, 2029)

Principal Investigator: Steven C. Marcus

Act: R01 - Project: MH135011 - Admin / Funding IC: NIMH

DESCRIPTION (provided by applicant): Improving outcomes for adult depression in primary care is a leading health care priority and antidepressants are a cornerstone of evidence-based treatment. However, patient non-adherence and discontinuation are common. The proposed study examines use of modest financial incentives in conjunction with tailored text message reminders to determine the most effective and cost-effective support for establishing consistent antidepressant medication taking routines to improve clinical outcomes of adult primary care patients with depression. We propose to conduct a 3-arm RCT (N=525, n=175 per arm) to compare with usual care the short-term and extended effectiveness of two adherence support strategies for primary care patients with depression who have been newly prescribed antidepressant medications. We will examine whether personalized daily text messages with and without financial incentives improves antidepressant adherence and depression symptoms. Adherence will be measured with a wireless pill bottle at 6 and 12 weeks and by assessment of electronic health prescription records at 24 and 52 weeks. Depression symptoms will be collected via telephone by a trained assessor at 6 and 12 weeks. Our Specific Aims are to: 1. Determine the relative effectiveness of 1) 12 weeks of personalized daily text reminders without financial incentives (reminders alone), 2) 12 weeks of the text reminders paired with 6 weeks of financial incentives (reminders and incentives), compared with 3) usual care, and with each other (non-inferiority). The primary outcome will be symptom response on the PHQ-9 depression rating scale at 12 weeks. 2. Explore the effectiveness of each study intervention arm compared to usual care and to each other on antidepressant adherence at 6, 12, 24, and 52 weeks, and whether these effects are moderated by baseline financial security and adherence intentions. We also will assess whether the intervention effects in Aim 1 are mediated by antidepressant adherence. 3. Use qualitative inquiry of antidepressant adherent and non-adherent study patients to explore opportunities to maximize the effectiveness of the financial incentives and reminders to increase antidepressant medication adherence. Widespread problems with antidepressant adherence, especially during the early stage of treatment, undermine the primary care treatment of depression. This study will test whether personalized daily text messages grounded in behavioral economics principles alone or combined with financial incentives based on contingency management principles improves depression outcomes. These two interventions are designed to be readily adapted into primary care workflows through an automated patient-facing system to improve clinical outcomes of adult primary care patients with depression.

 

Development and clinical interpretation of machine learning emergency department suicide prediction algorithms using electronic health records and claims

(August 5, 2021 – May 31, 2025)

Principal Investigator: Steven C. Marcus

Act: R01 - Project: MH126895 - Admin / Funding IC: NIMH

DESCRIPTION (provided by applicant): Preventing suicide is one of the great public health challenges facing the US health care system. People who seek emergency care for mental health complaints are at high short-term risk of non-fatal suicide events and suicide. Yet identifying high-risk patients is challenging as risk fluctuates in a poorly understood manner. It is especially difficult to evaluate risk in emergency settings, where access to the patient's mental health history is often limited. The proposed project seeks to address this critical knowledge gap by pairing data mining and machine learning methods with rich data sources in order to develop short-term prediction models of non-fatal suicidal events and suicide for patients presenting to EDs with mental health problems. The specific aims of this study are to 1) apply advanced machine learning data analytic techniques to electronic health record (EHR) data to develop a clinically rich description of ED mental health patient characteristics that predict suicide and non-fatal suicidal events over a 90- day follow-up period; 2) use longitudinal and temporal features of EHR and claims data from the 180 days preceding the ED mental health visit to generate clinically interpretable suicide and suicidal event risk scores; and 3) convene ED physicians to enhance model development, clinical interpretability, and utility of a suicide risk assessment clinical decision support tool. We will achieve these aims by leveraging several different sophisticated machine learning analytic methods of existing longitudinal clinical and service use information. We seek to develop point-in-time, short-term risk scores for suicidal symptoms and suicide death and the clinical features that drive that risk that may be used to inform clinical risk assessment and management of patients who present to EDs with mental health complaints. Risk algorithms will be developed and validated using health information from a large combined EHR and claims dataset with over 24 million commercially insured patients, which is linked to the National Death Index. Findings will yield new insights regarding patient-specific risk factors and potential targets for intervention. By drawing on data sources common to most health care systems and using efficient computer algorithms this approach has the potential to develop clinically interpretable suicide risk scores at the point of ED evaluation and following disposition. This will help front- line clinicians focus their efforts on high risk patients during high risk periods to inform intervention decisions about suicide risk.

 

1/4 Leveraging EHR-linked biobanks for deep phenotyping, polygenic risk score modeling, and outcomes analysis in psychiatric disorders

(September 10, 2019 – February 28, 2025)

Principal Investigator: Mark Olfson

Act: R01 - Project: MH121921 - Admin / Funding IC: NIMH

DESCRIPTION (provided by applicant): Major depressive disorder (MDD), anxiety disorders, and substance use disorders (SUDs) are common, complex psychiatric traits that frequently co-occur and are associated with significant functional impairment, increased healthcare utilization and cost, and higher mortality risk. Not only are these three conditions highly prevalent in the general population and generate a huge societal burden, but recent studies by our team and others have shown that shared covariance from common genetic variation significantly contributes to these psychiatric comorbidities. Large data sets are needed to understand how the multifaceted interplay of genetics, including polygenic risk scores (PRSs), and social determinants of health factors, such as employment and educational attainment, can increase the risk of these psychiatric disorders and clinical outcomes, such as multiple psychiatric hospitalizations. PRSs have shown potential for risk prediction, but the clinical utility of PRSs for psychiatric conditions is just starting to be explored. Use of Electronic Health Records (EHRs) offers the promise of large data sets to examine these relationships in cohorts of patients seen in clinical practice. However, the use of EHRs is in its infancy in the study of psychiatric disorders and their treatment. This study will address critical knowledge gaps in “genotype-psychiatric phenotype” relationships in large, demographically and geographically diverse population-based samples derived from EHR-linked biobanks across four medical centers - Columbia, Cornell, Mayo Clinic and Mount Sinai. Our objectives are to (1) develop improved methods for EHR phenotyping of MDD, anxiety, and SUDs, and related outcomes based on a data-set of >30 million EHRs, (2) evaluate associations between PRSs and these conditions, as well as (3) assess the association between PRSs and outcomes including treatment resistance in MDD and healthcare utilization in patients with MDD, anxiety and SUD. The PRS analyses will utilize data from biobanks with >50,000 persons with both EHR and GWAS data. Successful completion of this study will generate new data in improving our understanding of the clinical utility of PRSs for commonly occurring psychiatric disorders.

 

Substance use treatment and county incarceration: reducing inequities in substance use treatment need, availability, use, and outcomes 

(September 15, 2023 – June 30, 2028)
Principal Investigator: Pia M. Mauro

Act: R01 - Project: DA055606 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant): Substance use disorder (SUD) treatment availability and use remain low despite an ongoing drug overdose epidemic in the United States. In 2019, 19.3 million non-institutionalized adults met the criteria for SUD, but only 2.6 million received specialty treatment services. People referred to SUD treatment through the criminal legal system are less likely to receive evidence-based services (e.g., medication for opioid use disorder) than those who self-refer to specialty treatment. Because racial/ethnic minoritized groups are more likely to be criminalized than their white counterparts, as are men versus women, criminal-legal-system-based referrals may contribute to racialized and gendered inequities in SUD treatment use and outcomes. Substantial knowledge gaps remain about how the criminal legal system, specifically county-level incarceration, affects community-level SUD treatment need, availability, use, and related outcomes. These gaps are exacerbated by the siloing of healthcare delivery system and criminal legal system data. To fill these gaps, we will link comprehensive multi-level data from counties in all 50 states from 2004-2023. We will quantify how county jail and prison incarceration rates are associated with: (Aim 1) community SUD treatment need (drug-related mortality rate, drug-related emergency department visit rate, SUD prevalence); (Aim 2) SUD treatment availability (number and types of available treatment services); and (Aim 3) SUD treatment use (self-reported, admission rates) and treatment outcomes (completion, retention) across communities and individuals. We hypothesize that greater county incarceration is associated with greater SUD treatment need (and vice versa), lower treatment availability, smaller increases in treatment use, and worse treatment outcomes. We anticipate that these relationships will have important spatial dependencies and be modified by race/ethnicity and gender. Our hypothesized pathways are grounded in the Socio-Cultural Framework for the Study of Health Service Disparities; our research process is informed by Public Health Critical Race Praxis and the CDC Policy Analytical Framework adapted for systems thinking. Our team, led by an Early-Stage Investigator, has expertise in substance use epidemiology and treatment, criminology, criminal legal systems, health policy and health systems, structural discrimination, minoritized populations, biostatistics, and spatial methods. We will apply this expertise to study the criminal legal system, focusing on modifiable reform targets that can perpetuate and worsen inequities in SUD treatment over time. Our study addresses NIDA’s Notice of Special Interest (NOT-DA- 19-037) calling for multi-level health services research on SUD treatment for vulnerable populations. By leveraging multi-level data sources and engaging with stakeholders, this innovative R01 examines how multiple systems converge to affect community health. We will incorporate experts and people with lived experience in the research process. Our multi-pronged dissemination plan will ensure that findings reach target audiences and inform antiracist health policies and programs that improve community-based SUD treatment-related outcomes.

 

Racial inequities in opioid overdose prevention: the role of local context in the effectiveness of state-level overdose prevention policies

 (April 15, 2023 – March 31, 2028)
Principal Investigator: John Pamplin

Act: K01 - Project: DA058085 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant): Deaths due to opioid overdose are a pressing public health crisis and the number of deaths per year is increasing. Rates of fatal overdose are rising faster for Black people than for any other racial/ethnic group, largely driven by the increased prominence of synthetic opioids. Black people have the highest percentage of overdose mortality attributable to synthetic opioids and have experienced the greatest increase in related mortality rates. Interventions are critically needed that can effectively reduce overdose mortality and do so equitably for Black people. Overdose prevention policies (OPPs) (i.e., Good Samaritan laws and naloxone access laws), a class of state-level policy interventions intended to reduce overdose mortality, may be able to address rising racial inequities in fatal overdose. However, there are critical gaps in the literature regarding the effectiveness of OPPs, including a lack of prior research into which provisions may better reduce overdose deaths for Black people, and a lack of prior research into the extent to which local contextual factors modify the effects of state-level OPP provisions. Additionally, the common practice of enacting OPP provisions in packages creates a significant methodological challenge for standard causal inference approaches of assessing the effectiveness of individual OPP provisions. The scientific objective of this research plan is to assess the effectiveness of state-level OPP provisions to equitably reduce overdose mortality and identify local-level factors that may produce racialized effectiveness of provisions. This project uses novel causal machine learning methods in conjunction with a combination of restricted mortality data from the National Vital Statistics System and multiple publicly available data sources to address the methodological challenge and fill the critical gaps outlined above. This innovative data-driven approach will be complemented by taxonomies of hypothesized OPP provision effectiveness produced by a panel of opioid policy experts using the Delphi method. By doing so, this project will empirically evaluate which sets of OPP provisions are most effective at reducing overdose mortality overall, and specifically among Black people, and estimate the role of local contextual factors (e.g., access to harm reduction services or local law enforcement practices) in producing varied effects of OPP provisions. This research plan is complemented by a career development plan that builds upon the applicant’s background in epidemiology and biostatistics and includes new training in (1) development and implementation of state-level drug policies; (2) measurement and evaluation of policy intervention effectiveness; and (3) machine learning methods to identify salient causal measures from high- dimensional data. The combined research and training plan will prepare the applicant to successfully transition to an independent research career aimed at using novel statistical and computational methods to identify and evaluate interventions to reduce racial inequities in substance use related harms.

 

Cannabis use, PrEP and HIV transmission risk Among Black MSM in Chicago

 (August 1, 2022 – May 31, 2026)
Principal Investigator: Dustin Duncan

Act: R01 - Project: DA054553 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant): Black gay, bisexual and other men who have sex with men (MSM) face a disproportionate burden of HIV. Focused, high-coverage PrEP in populations heavily impacted by HIV, such as Black MSM, could rapidly reduce new HIV acquisition rates; however, its uptake among at-risk populations, especially Black MSM, has been limited. Therefore, we propose to conduct urgently needed research on PrEP in a cohort of Black MSM, including on the impact of relevant behaviors, particularly cannabis use, which is highly prevalent in Black MSM. Research on the impact of cannabis use on PrEP has achieved conflicting results, and it has not been rigorously studied in Black MSM. Therefore, the proposed R01 study will assess cross-sectional and longitudinal associations between cannabis use and PrEP outcomes (e.g., use, adherence) and HIV transmission risk (e.g. biological inflammation, sexual risk behavior) using event-level and objective biomarker data among HIV-negative Black SMM. To address these specific aims, we will conduct the Networks and Neighborhoods (N2) Cannabis PrEP Study in Chicago, IL. We will follow 250 HIV-negative participants from the original N2 cohort for an additional one-year period with 3 study waves. We will use innovative and rigorous methods, to collect additional data, such as Ecological Momentary Assessment methods and objective measures of cannabis use, PrEP use, and immune function over 14-day periods at each wave. Potential findings can impact intervention development and implementation, as well as inform policy to increase PrEP uptake and adherence, address substance use, and decrease HIV transmission rates, and disparities.

 

Social environmental drivers of stimulant use and its impact on HIV prevention and treatment in Black men who have sex with men 

(August 15, 2021 – July 31, 2025)
Principal Investigator: Justin Knox

Act: R21 - Project: DA053156 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant): Use of stimulants is a growing problem in the US. This growing public health crisis requires expanded research to explore its reach, drivers and impact, including on marginalized groups, such as Black gay, bisexual and other men who have sex with men (MSM), a critical population that is disproportionately impacted by HIV. Estimates of the incidence and persistence of stimulant use in Black MSM is needed, as well as research on how it co-occurs with other drug use (i.e. polysubstance use), its social-environmental drivers, and its impact on HIV transmission. Research Plan. In Aim 1, we will characterize stimulant use in an established cohort of Black MSM, including co-occurring use with other drugs (i.e. polysubstance use) and use over time (e.g., incidence, persistence). In Aim 2, we will identify network-level (e.g. disassortative racial mixing, network turnover) and neighborhood-level (e.g., social cohesion, time spent in gay neighborhoods) drivers of stimulant use in Black MSM. In Aim 3, we will assess how stimulant use impacts HIV transmission in Black MSM through HIV prevention (e.g. PrEP adherence, condom use), HIV treatment (e.g. ART adherence, viral suppression) and biological vulnerability (e.g. rectal cytokines). The ongoing Neighborhoods and Networks (N2) Cohort Study (R01MH112406; PIs: Duncan & Schneider) provides an ideal opportunity to conduct the proposed study. N2 includes 186 HIV-positive and 227 HIV-negative Black MSM living in Chicago. Data being collected include stimulant use at multiple cycles, in-depth assessments of neighborhoods (including real-time geospatial methods to track mobility within and between neighborhoods), multiple social network typologies, and HIV-related prevention and treatment behaviors. The proposed study will use N2 data to conduct Aims 1-3. We also propose to use existing N2 infrastructure to recruit 30 current stimulant-using and 10 non-stimulant-using HIV-negative Black MSM from the N2 study, and conduct in-depth interviews with them using a timeline follow-back survey focused on stimulant use and sexual risk behavior, as well as collect rectal swabs, urine and blood samples as objective biomarkers, in order to explore in-depth how stimulant use contributes to HIV transmission. The results of this study will inform the development of an R34 proposal to develop and test an intervention that addresses stimulant use and HIV in a critical population. Team. Investigators with expertise in stimulant use, HIV, social network analysis, spatial epidemiology, immunology, integration of biological and behavioral research, and mixed methods research will conduct this research together. Public Health Impact. The proposed study will be a large, rigorous and innovative study of stimulant use, its social-environmental drivers and its impact on HIV transmission in Black MSM, a group with a heavy burden of stimulant use and HIV. The proposed study is aligned with multiple NIDA funding priorities, including NOT-DA-19-066 Epidemiology of Drug Abuse, has a high likelihood of success by leveraging an existing cohort, and will directly inform an R34 proposal to develop and test an intervention that addresses stimulant use and HIV in a critical population.

 

Intervening to improve HIV treatment and reduce drinking in young, black men who have sex with men

(September 1, 2020 – August 31, 2025)
Principal Investigator: Justin Knox

Act: K01 - Project: AA028199 - Admin / Funding IC: NIAAA

DESCRIPTION (provided by applicant): In the US, young, black men who have sex with men (YBMSM) are disparately impacted by HIV. For many YBMSM, heavy drinking or problems related to alcohol use adversely impacts their HIV care and treatment. Thus, interventions to improve HIV treatment outcomes and reduce heavy drinking in HIV-infected YBMSM in HIV treatment are urgently needed. Career Development Plan. Dr. Knox's training will include developing critical skills in intervention research and implementation science, and substantive training in HIV care and treatment. This will be achieved through a plan that includes seminars, workshops, coursework, conferences, and tailored mentoring. These activities will help Dr. Knoxbecome an independent investigator with a research program focused on understanding and addressing HIV and alcohol use in vulnerable populations. Research Plan. In Aim 1, Dr. Knox's proposed research involves conducting formative work to inform the development of an intervention that addresses HIV treatment and alcohol use in heavy-drinking, HIV- infected, YBMSM. The intervention will borrow components from two distinct and potentially complementary, evidence-based clinic-based interventions that are brief and theory-driven. The first improves HIV treatment outcomes in HIV-infected YBMSM by involving a member of their social network to support them in HIV care. The second intervention addresses alcohol use by using smartphone technology to engage participants daily in self-monitoring relative to drinking reduction goals formed during a brief, motivational component of the baseline intervention session. In Aim 2, the information from this formative work will be synthesized with the help of consultant workgroups made up of YBMSM and implementation partners. The product of Aims 1 and 2 will be an innovative intervention that leverages both social network support and technology to improve HIV treatment outcomes and reduce alcohol use in heavy-drinking, HIV-infected YBMSM. It will be administered as a single- session baseline intervention with brief follow-up check-ins. In Aim 3, the new intervention will be pilot tested to assess its potential efficacy, acceptability, feasibility and implementation against a randomly assigned control condition among 60 heavy-drinking, HIV-infected YBMSM in an HIV clinic in New York City (NYC). As an epicenter of the HIV epidemic, interventions for young, black MSM in HIV treatment are urgently needed in NYC. The results of this pilot test will inform the development of an R01 proposal for a fully powered randomized controlled trial to evaluate the efficacy and implementation of the developed intervention. Mentorship. A team of expert investigators in alcohol and drug use, HIV, racial and sexual minorities, intervention development, implementation science and mixed methods will support this research. Public Health Impact. The project aims to reduce disparities in HIV treatment outcomes and, in turn, incidence of new HIV infections, a high research priority of the NIH Office of AIDS Research. Developing HIV interventions targeted for critical, underserved populations also works towards achieving important End the HIV Epidemic milestones.

 

Heavy cannabis use, neurocognition, and PrEP care engagement among young Black sexual minority men

(September 15, 2022 – June 30, 2027)

Principal Investigators: Schneider, John

C0-Principal Investigator: Keedy, Sarah K

Act: R01 - Projects: DA057351-03, 3R01DA057351-03S1 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant): We propose to conduct research that will determine the impact of relevant behaviors on HIV prevention among Young Black Sexual Minority Men (YBSMM), such as heavy cannabis use. Data from our group and others demonstrate heavy cannabis use as prevalent and increasing in YBSMM, is associated with HIV acquisition, use as a sex-drug, greater likelihood of membership in an HIV transmission cluster, and decreased HIV testing. We propose to explore mechanisms, specifically neurocognitive impacts of heavy cannabis use, linking heavy cannabis use to HIV prevention outcomes, and whether motivations for cannabis use, amidst a changing cannabis regulatory, social acceptance and legal landscape, modify its effects on HIV prevention. In the proposed study, we will rigorously examine links between heavy cannabis use, neurocognition, sex behavior and PrEP care engagement. First, we will elucidate the effects of cannabis use on neurocognition – specifically, brain systems supporting risk/reward (RR) processing, as well as higher order organizational functions collectively referred to as executive function (EF) in YBSMM. Second, we will explore how cannabis use, directly and via neurocognitive impacts, is associated with HIV prevention, and particularly PrEP care engagement (primary outcome). The proposed study will integrate and expand these lines of research within the context of traditional health department and CDC supported HIV prevention programs that engage YBSMM in the South Side of Chicago and adjacent suburbs, home to the largest contiguous majority Black population in the US. We will use rigorous objective measures to assess cannabis use (e.g., quantification of cannabis metabolites in plasma), neurocognition (e.g., neuroimaging) and PrEP outcomes (e.g., EMR measured persistence), and triangulate that data using validated survey measures. We will also rigorously account for other substance use, as a proportion of YBSMM who use cannabis also use other substances (e.g., alcohol), and there is increasing recognition of the need to study substance use as it occurs in real-world settings, including polysubstance use. We will assess these factors longitudinally over 1.5 years (3 times 9 months apart) in a cohort of 280 YBSMM, to permit examination of within-individual biological changes and the dynamic nature of cannabis use and its association with prevention care outcomes. We aim to: 1) Determine cross-sectional and longitudinal associations between cannabis use and neurocognition (i.e., neural response to risk/reward processing and executive function) in a cohort of YBSMM; 2) Evaluate overall, direct and indirect (via neurocognition) associations between cannabis use and PrEP care (e.g., persistence [primary]) and HIV transmission behaviors (e.g., group sex [secondary]); and 3) Determine whether motivations for cannabis use modify associations between cannabis use and HIV prevention outcomes. Identifying neurocognitive mechanisms through which cannabis use affects HIV prevention and the importance of motivations for cannabis use in understanding clinical outcomes will provide targets for future HIV prevention efforts.

 

The Siyaphambili Substance Use Study: Exploring substance use and its treatment in the context of achieving sustained ART adherence among female sex workers

(September 1, 2023 – August 31, 2025)

Principal Investigator: Sheree Renae Schwartz

Act: R21 - Projects: DA056304 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant): The goal of this project is to increase an understanding of substance use, how it impacts HIV care, and how to address it in a critical population, female sex workers (FSW) aged 18 years and older, in South Africa (SA), using data and infrastructure from an ongoing adaptive intervention, the Siyaphambili trial. Mathematical models suggest that nearly half of the 200,000 annual HIV infections among adults in SA are acquired by FSW, their clients, or partners of their clients and thus treating these unmet needs could result in better health outcomes for women and the population as a whole. Specific Aim 1: Characterize substance use among the FSW living with HIV who participated in the Siyaphambili trial, with a focus on identifying temporal patterns of polysubstance use, using Latent Transition Analysis (LTA), their associated determinants (e.g., violence, stigma, economic vulnerability), and if they modify the effectiveness of the sequentially adaptive strategy to improve HIV care outcomes. Specific Aim 2: Conduct mixed methods formative research on how to deliver substance use treatment for FSW in the context of HIV care through semi-structured interviews with 200 FSW engaged in the Siyaphambili study or in the TB HIV Care (THC) treatment and prevention sex worker program who report any illicit drug use, to ascertain experiences with substances, treatment (e.g. types, relapse), willingness for treatment, and preferences for treatment using a discrete choice experiment. This data will be supplemented by in-depth interviews with 10 implementation partners (e.g., nurses, clinic management) recruited through our partnership with THC. Specific Aim 3: Organize an Implementation Development Workgroup to initiate crosstalk with domestic and international collaborators on substance in FSW to refine emergent implementation strategies for evaluation across contexts. This R21 will allow an additional focus on substance use in the Siyaphambili trial, including bringing on the additional content and methodological expertise needed to achieve the proposed aims. We will also collect primary data to inform the development and implementation of interventions that address substance use among FSW in the context of HIV care, as well as conduct activities that strengthen international collaborations working toward this end. The proposed R21 is aligned with multiple NIH OAR priorities, including reducing HIV incidence (through optimized treatment), has a high likelihood of success by leveraging an existing cohort, and will directly inform an R01 study on the implementation of substance use treatment and HIV care among this key population.

 

The impact of changes in social determinants of health on adolescent and young adult mental health during the COVID-19 pandemic: A longitudinal study of the Asenze cohort in South Africa 

(August 15, 2023 – August 14, 2026)

Multiple Principal Investigator: Desmond, Chris

Act: RF1 - Project: MH134561 - Admin / Funding IC: NIMH

DESCRIPTION (provided by applicant): Social determinants of health (SDOH), such as education, employment, housing, and food security, were all impacted by the COVID-19 pandemic and associated lockdowns. These changes to SDOH were particularly impactful in low-and-middle-income countries (LMIC) such as South Africa in which populations have a high risk of exposure to adversities that were exacerbated by COVID-19 lockdowns (e.g., economic instability, violence, family separation and loss). Although several studies conducted during the pandemic linked lockdowns and changes in SDOH to adverse mental health outcomes, these studies were predominantly cross-sectional, which precludes the ability to evaluate: i) the impact of changes in SDOH on mental health over time; ii) whether initial impacts of COVID-19 persist long-term; and iii) the mechanisms through which changes in SDOH impact mental health, which are necessary for identifying potential intervention points. Further, adolescents and young adults (AYA; ages 18-25) have not been a major focus of COVID-19 mental health research, which is a gap because this is an age range during which individuals finish education and transition into new roles, both professional and personal. This period is also when incident mental health disorders often first occur and shapes the probability that they will continue. This study addresses these gaps by leveraging an existing large, population-based cohort of over 1100 AYA and their caregivers in in South Africa, the Asenze cohort. Four waves of data collection through 2022 have captured longitudinal measurements on mental, behavioral, and physical health outcomes as well as SDOH correlates. This provides a rare opportunity to investigate changes in AYA mental health before, during, and after the height of the pandemic in a LMIC that has been substantially impacted by COVID-19 – South Africa has experienced the highest number of COVID-19 cases, deaths, and excess mortality due to the pandemic in Africa. In this mixed methods study, we will investigate the impact of COVID-19-related SDOH changes on mental health among AYA in the Asenze cohort. Specifically, we will model changes in mental health outcomes from pre-COVID-19 and the acute COVID-19 phases (Asenze Wave 3, collected 2020-2021 and Wave 4, collected 2022) to the post-acute COVID phase (Wave 5, 2024-2025) and how these changes may have been impacted by SDOH (e.g., access to education, employment, availability of health care, food security, exposure to violence). We will examine mechanisms (mediators) underlying the relationship between SDOH and mental health and key populations (moderators) to foster resilience. Qualitative data building on prior qualitative and quantitative data, will provide an in-depth, complementary, and contextual understanding on AYA mental health during and COVID-19 and perceptions on the acceptability and appropriateness of interventions that target mechanisms and key populations identified in the quantitative data. The findings will provide near-term information on possible intervention points through which SDOH impacts mental health in the context of COVID- 19, and long-term information to inform intervention approaches in future public health emergencies.

 

Improving measurement of alcohol consumption among HIV-affected youth in sub-Saharan Africa: evaluation and implementation of biomarkers

(May 1, 2020 – April 30, 2025)

Principal Investigator: Jeremy Kane

Act: K01 - Projects: AA026523 - Admin / Funding IC: NIAAA

DESCRIPTION (provided by applicant): HIV-affected adolescents and young adults (AYA) in sub-Saharan Africa (SSA) experience stressors that increase their risk for problematic alcohol use, which in turn can lead to HIV infection or transmission and poor HIV outcomes, including linkage to care and ART adherence. Efforts to address the HIV epidemic among adolescents and young adults in SSA have therefore focused, in part, on treating risky alcohol use. Yet, the vast majority of HIV-affected AYA in SSA who need alcohol services do not receive them, resulting in a substantial treatment gap. A critical barrier to the accurate screening for risky alcohol use among AYA and provision of appropriate treatment is a lack of objective measures for alcohol consumption in HIV care settings, which rely primarily on self-report alone. This K01 mentored research scientist development proposal aims to examine the role of biomarkers in improving alcohol screening and treatment referral among AYA in HIV prevention and treatment clinics. Specifically, the proposal will investigate a urine-based biomarker, ethyl glucuronide (UEtG), which has displayed potential as a point-of-care diagnostic tool among clinic-based populations in the U.S. but has not been investigated as a valid and feasible method within HIV care settings among AYA. Research activities for this proposal will take place in Zambia, a country with one of the highest HIV prevalence estimates in the world. The research will leverage over a decade of HIV research in Zambia by Johns Hopkins University and a longstanding collaboration with Centre for Infectious Disease Research in Zambia (CIDRZ), the local implementing partner. Specific aims of the proposal are to: 1) assess the test characteristics of UEtG among HIV-affected AYA in Zambia; 2) develop a protocol for the use of rapid UEtG dip card testing embedded within AYA HIV prevention and treatment; and 3) pilot the UEtG protocol developed in Aim 2 and refine procedures with a formative evaluation process. Findings will inform implementation strategies that can be tested in a follow-up study. The research is designed to be an integral component of a rigorous training and career development plan focused on HIV/AIDS, alcohol biomarkers, and implementation science. Training will take the form of coursework, lab training, and one-on-one mentorship with an experienced and dedicated team of multidisciplinary mentors and consultants who are widely considered to be experts in their respective fields. The goal of the professional development plan is to facilitate the candidate's transition into an independent investigator in alcohol epidemiology and implementation science with specific expertise in HIV and biomarkers. The proposal is directly in line with Goal 2 (“improve diagnosis and tracking of alcohol misuse”) and Objective 5c (“facilitating dissemination and implementation of evidence-based practices for diagnosing alcohol misuse”) of the NIAAA Strategic plan 2017-2021. The proposal is consistent with NIH high priority HIV research in addressing “health disparities in the incidence of new HIV infections” and “research training of the workforce required to conduct high priority HIV/AIDS or HIV/AIDS-related research.”

 

Substance Use Prevention for Recently Displaced Adults (SUPRA) 

(April 1, 2024 – March 31, 2026)

Principal Investigator: Lunze, Karsten
Co-Principal Investigator: Hook, Kimberly Michelle

Act: R61 - Project: DA059856 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant): The war in Ukraine has provoked the world’s current largest humanitarian displacement: since February 2022, over 13 million people, i.e., one-third of Ukrainians, have been forced to leave their homes, resulting in nearly 6 million internally displaced persons (IDPs). War and humanitarian emergencies may exacerbate substance use, but the incidence and prevalence of unhealthy substance use in humanitarian settings, including Ukraine, are currently largely unknown. This lack of data limits the ability to tailor targeted, effective preventive substance use interventions for these mobile populations. Addressing this knowledge gap is an immense priority for Ukraine, where rates of substance use were high even prior to the Russian invasion in February 2022, and in other settings hosting large populations of IDPs, including the United States. We propose to conduct an epidemiological substance use survey among IDPs in Ukraine during the R61 phase, followed by R33-supported development and evaluation in a randomized controlled trial of a substance use prevention intervention for this population. Due to burgeoning evidence and our own preliminary data, we anticipate adapting an Acceptance and Commitment Therapy (ACT)-informed intervention, though final intervention decisions will be responsive to the needs identified in the epidemiological phase. ACT for substance use prevention will use acceptance, mindfulness, and behavior change processes to improve psychological flexibility and thus support people in refraining from use. Our transnational, multidisciplinary team of community partners, mental health experts, and behavioral clinical trial scientists has conducted studies with war-affected populations in Ukraine and successfully used ACT to improve health behaviors among disadvantaged populations in Eastern Europe. We will work closely with our community partner, the Alliance for Public Health (“Alliance,” a leading non-governmental organization in Ukraine) and academic experts in Ukraine. In the R61 phase of the grant, we will conduct an epidemiological survey (n=577) evaluating substance use patterns and risk factors among IDPs seeking medical services at mobile medical points established by the Alliance. Directly informed by findings from the epidemiology study, we will transition to the R33 phase and will engage community members to co-design the most appropriate prevention intervention. We will adapt the intervention using qualitative methods (focus groups and stakeholder interviews) and conduct a pilot randomized controlled trial (n=144) evaluating the intervention on preventing the development of substance use disorders among IDPs, with primary outcomes including feasibility and acceptability. The expected outcome of this award is a potentially effective and scalable intervention that could prevent at scale the development of substance use disorders among IDPs affected by humanitarian crises. The key innovation is that this study will expand on limited epidemiological data specific to substance use in humanitarian settings and be among the first to demonstrate the effectiveness of an intervention to prevent substance use disorders in humanitarian contexts.

 

The Empilisweni Center for Women's Health - Advancing Implementation of Equitable Cervical Cancer Control

(September 19, 2023 – August 31, 2028)

Principal Investigator: Delivette Castor
Multiple Principal Investigators: Juanita Olivia Arendse; Nomonde Hazel Mbatani; Rakiya Saidu; Parisa Tehranifar 

Act: U54 - Project: CA284030 - Admin / Funding IC: NCI

DESCRIPTION (provided by applicant): Cervical cancer is a leading cause of cancer-related deaths among women in low- and middle-income countries (LMICs), and it is almost entirely preventable.1,2-4 In 2020, the World Health Organization (WHO) announced a global strategy to accelerate the elimination of cervical by the end of this millennium by vaccinating 90% of girls by aged 15 and screening 70% of women and treating 90% of treatment eligible women by 2030.5 Based on strong empirical evidence of effectiveness and safety, the WHO recommends Human Papillomavirus (HPV)-based testing followed by immediate treatment of pre-cancerous lesions, an approach called screen-and-treat (SAT) for achieving cervical cancer control in LMICs.6 Our investigator team at Columbia University Irving Medical Center (CUIM) and the University of Cape Town (UCT), through a nearly thirty-year collaboration under the Khayelitsha Cervical Cancer Screening Program (KCCP), have conducted seminal clinical trials demonstrating the safety and effectiveness of HPV-based screening and treatment.7-9 Although endorsed in global and national guidelines, the SAT approach has not yet been widely implemented. Like most LMICs, South Africa is grappling with how to operationalize and promote the widespread and equitable integration and uptake of HPV screening in healthcare settings. Stakeholders cite a lack of context-specific implementation, costs, and financing as important implementation barriers. Aligned with RFA-CA-22-019 and in partnership between the KCCP and the Western Cape Department of Health (WCDoH), we propose the Empilisweni (isiXhosa for a place of healing) Center for Women’s Health with the overarching mission to accelerate the integration and scale-up of evidence-based interventions for equitable cervical cancer elimination among women in resource-constrained settings. Led by MPIs; Denny (UCT), and Kuhn (CUIMC), who founded KCCSP, will be joined by MPI Castor (Contact: CUIMC), Mbatani (UCT), Saidu (UCT), Shelton (CUIMC), Tehranifar (CUIMC); and Arendse (UCT/WCDoH) and collaborator Cloete (WCDoH) Informed by implementation science frameworks and stakeholder engagement approaches, we propose to: Aim 1: Support the WHO’s global strategy to accelerate the elimination of cervical cancer by the end of this millennium by equitably integrating scalable, affordable HPV-based point-of-care screen-and-treat (POC-SAT) strategies to achieve the secondary prevention cascade goal of 70% screening and 90% treatment of women who screen positive by 2030 in the Western Cape Province of South Africa; and Aim 2. Catalyze equitable integration and sustainable scale-up of POC-SAT by fostering effective collaboration, coordination, capacity-building, and knowledge sharing across multiple key stakeholders. By the end of the five years, POC SAT will increase the proportion of women who are screened and treated regionally, will complement centralized HPV testing, and be economically feasible. We will have a strengthened capacity for leading implementation research in the region and advanced work on strategies to inform scalable delivery and innovative financing of cervical cancer control for population-level impact.

 

Strategies for Reaching and Impacting Our Communities Sustainably (NWP-ROCS Program)

(April 1, 2024 – March 31, 2029)

Principal Investigator: Rachel Shelton

Act: R01 - Project: CA289295 - Admin / Funding IC: NCI

DESCRIPTION (provided by applicant): Widespread implementation, scale-up, and sustainability of culturally-appropriate, evidence-based programs is critical to reducing the significant and disproportionate burden of cancer among Black women. Community- engaged Lay Health Advisor (LHA) programs are highly successful in reducing health inequities for cancer. One of the most robust evidence-based and nationally disseminated LHA cancer prevention/screening programs is The National Witness Project (NWP). NWP is one of the few equity-focused LHA programs with both longevity and evidence of impact in Black communities nationally. Despite its impact, NWP continues to face challenges to sustainability and the long-term delivery of the program. Advancing the science of sustainability is urgent, as inequities in cancer and challenges to the sustainability of evidence-based programs were exacerbated during the COVID pandemic. Research is critically needed on sustainability, particularly among low-resource settings and communities that face historical and ongoing structural and systemic barriers to health, to make progress towards racial equity for cancer screening and outcomes. Our team is uniquely poised to lead and advance research in this area. Building off of our work on sustainability and a long-term partnership with NWP, we propose a national mixed-methods prospective study with the following aims. First, in aim 1 we will refine, with a sub-sample of NWP sites nationally (n=6), a package of sustainability strategies to support the ongoing delivery of NWP at scale, with the long-term goal of addressing cancer screening inequities among Black women. We will focus on strategies for building capacity and partnerships to enhance sustained impact and delivery of NWP and support retention of LHAs (e.g. novel curricula/training; tailored technical assistance; Community of Practice model to share lessons across sites), with the goal of enhancing capacity for: 1) building partnerships/identifying champions at academic/healthcare centers to leverage organizational resources; 2) building business case for program’s value; 3) adapting to local community needs and context. In Aim 2, we propose to deliver and examine the impact of this refined package of sustainability strategies on multiple sustainability outcomes annually over four years across 16 NWP sites nationally using a pre-post cluster prospective design. Finally, in aim 3, we plan to apply a concurrent mixed-methods approach (n=200 surveys and 50-65 in-depth interviews) to examine the uptake, acceptability, appropriateness, feasibility and impact of sustainability strategies among 16 NWP sites to explore the processes through which strategies build capacity for and influence sustainability of equity-focused EBIs in community settings over the 4 years. This research is timely, providing a key opportunity to advance scientific understanding of strategies to promote sustainability among a generalizable, nationally disseminated program. Findings lay the groundwork for enhancing sustainability of trusted community-led programs and making progress towards racial equity in cancer and cancer screening.

 

Stress, Epigenetics and Aging

(July 1, 2018 – February 28, 2025)

Principal Investigator: Rachel Shelton

Co-Principal Investigator: Shakira Franco Suglia

Act: R01 - Project: AG058704 - Admin / Funding IC: NIA

DESCRIPTION (provided by applicant): There is extensive evidence that socioeconomic status (SES) and social stressors shape the development of numerous chronic conditions and aging-related illnesses. However, the processes through which SES and social stress affect biological processes related to aging and disease development have not been fully elucidated, particularly at the cellular level. This is important to investigate among African Americans who have higher mortality, shorter lifespan, and experience a disproportionate burden of disease than whites. Research examining associations between stressors and biological aging processes have been predominately cross- sectional in nature and have included predominately racially and ethnically homogenous samples. No prior studies have assessed the independent and cumulative impact of SES and stress at multiple time points across the life course in relation to biomarkers of aging (e.g. telomere length, DNA methylation age). Furthermore, little is know as to whether behavioral and psychological factors mediate the association between stress and biological aging processes, and whether forms of resilience (e.g., coping response, social support) may modify these associations. We propose to leverage existing data from the Disparities (DISPAR) study to examine the relationship between stressors and resilience across the life course in relation to biological aging processes. The DISPAR study conducted a 50-year follow-up of women who participated in a pregnancy cohort between 1959 and 1957 in Alameda County, California. Subsets of offspring were followed at ages 5 y, 9-11 y, 15-17y, and 50 years. The DISPAR sample includes a representative subsample (n=605) of these children interviewed as adults (mean age of 50 years), 42% African-American and 50% female. Validated measures of negative life events, discrimination, caregiving stress, mental health, social support, and coping mechanisms among others were collected. In addition, anthropometric measures, blood pressure and a blood sample were collected. For this study (N=372), we propose to assay existing stored blood collected at age 50 for biomarkers of biological aging (telomere length, methylation age). We will examine the role of childhood and adult SES and psychosocial stressors (e.g. child adversity, caregiving stress, job stress, racial discrimination) on telomere length and methylation age in adulthood. Additionally, we propose to examine behavioral (e.g. physical activity, smoking) and psychological (e.g. distress) responses to stress as potential mediators of these associations, and positive and negative coping factors as potential modifiers of the associations between SES, stress and biological processes. Given that half of our sample is African-American, we will have the opportunity to assess how stress, resilience-based factors, and associated biological aging processes differ by race. Completion of this project would allow us to elucidate important biological, genetic, and epigenetic pathways that help explain how stress and resilience shapes population health disparities among aging populations.

 

De-implementation of Mammography Overuse in Older Racially and Ethnically Diverse Women

(February 3, 2021 – July 31, 2026)

Principal Investigator: Parisa Tehranifar

C0- Principal Investigator: Nathalie Moise

Act: R01 - Project: CA255382 - Admin / Funding IC: NCI

DESCRIPTION (provided by applicant): De-implementation is recognized as a critical but understudied area within implementation science (IS). Research is needed to determine the optimal methods and approaches for identifying, selecting, and tailoring de-implementation strategies. De-implementation of routine cancer screening in older adults, such as mammography screening for breast cancer, offers excellent opportunities for both advancing the science of de- implementation and improving care delivery and health outcomes in older adults. While national guidelines do not support routine mammography in older women and recommend consideration of morbidities, life expectancy and patients’ informed preferences, ~56% of women ≥75 years report receiving mammography, including 50% of women with life expectancy <10 years. Our preliminary research identified multi-level barriers and facilitators to de-implementation of mammography overuse among older women at the organizational (e.g. system alerts, patient reminder letters), provider/clinic (e.g., knowledge, clinic norms), and patient (e.g. habit, knowledge) levels. Informed by the Knowledge-to-Action Model, we propose a study for de-implementation of mammography overuse in older women (i.e., reducing the frequency or cessation of mammography) in older women across a large healthcare system serving a racially/ethnically diverse population in New York City. In Aim 1, we will identify a range of de-implementation strategies at the patient, provider, and organizational levels for reducing mammography overuse in women ages ≥75 years. We will use a crowdsourcing method, successfully applied in an emerging participatory IS approach (innovation tournament) to generate rapid data collection from diverse stakeholders (80-100 patients/family members, 80-100 providers/administrators from the community and multiple healthcare systems) on factors that influence de-implementation. Combining this data with our rich qualitative preliminary data, and principles from Dual Process Theory, we will develop distinct de-implementation strategies for refinement in Aim 2. In Aim 2, we will prioritize and tailor de-implementation strategies at patient, provider/clinic, and organizational levels. We will recruit 12-15 experts to prioritize strategies based on feasibility and acceptability, and propose key attributes (e.g., duration, frequency, content) for each strategy, and employ discrete choice experiment to elicit patient (n=75-100) and provider (n=75-100) preferences for modifiable attributes of each prioritized strategy. In Aim 3, we will evaluate the feasibility, acceptability, and use of the tailored de-implementation strategies in a pilot cluster randomized trial (8 clinics). Using a sequential mixed-methods design, we will assess use of strategies, de-adoption outcomes (e.g. reduction of mammography overuse), and theoretical mechanisms of strategies at the patient, provider, and organizational levels. Data will establish feasibility and provide preliminary data for effectiveness of strategies to be tested in future Hybrid 2 trial, and lay the groundwork for advancing de-implementation frameworks and methodological approaches for selecting de-implementation strategies to reduce the use of low-value care.

 

Leveraging harmonized data to improve external validity and efficiency of clinical trials for treating opioid use disorder 

(August 15, 2024 – May 31, 2029)

Principal Investigator: Caleb Hilliard Miles

Act: R01 - Project: DA059824 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant): Randomized clinical trials for the treatment of psychiatric and substance use disorders can be difficult, time- consuming, and expensive to conduct. Partially as a consequence, their sample sizes are typically underpowered for: 1) detecting moderately sized average treatment effects (ATEs) that may nonetheless be important for health at the population level, and 2) learning optimal individualized treatment rules (i.e., rules that match treatments to individuals based on demographic and clinical characteristics to optimize outcomes of interest), which are the cornerstone of personalized medicine. These are major barriers to 1) improving population drug use disorder outcomes in terms of broad implementation of treatments with moderate effects and 2) improving individual drug use disorder outcomes in terms of refining treatment strategies away from a “one- size-fits-all” approach to one incorporating a patient’s clinical characteristics. Data fusion typically involves combining individual patient data from similar studies to improve statistical power and answer questions that cannot be addressed by a single study alone. However, the statistical theory underlying data fusion is relatively new, and numerous open problems remain. One commonly occurring challenge is that studies will often measure different outcomes at follow-up such that a given outcome of interest will only be observed in a subset of studies. In practice, trials are typically combined when they have a common set of covariates, treatment, and outcome. This means that statistical efficiency and power gains from incorporating data from additional studies that do not share a common outcome, but do measure other related outcomes, are left on the table. Consequently, there is a critical need for principled, flexible, and efficient estimators that can be applied to multi-study, multi-outcome fused data sets to maximize statistical power and efficiency. Doing so is a prerequisite for learning individualized treatment rules that optimize the health outcomes relevant to each treatment and for detecting more moderately sized, yet meaningful treatment effects. The objectives of this project are: 1) to develop both simple parametric and semiparametric efficient estimators of the ATE, conditional ATE (CATE) and optimal individualized treatment rules in multi-study, multi-outcome data-fusion settings (Aims 1a and 2a); 2) to develop sensitivity analyses for ATE and CATE estimation if the untestable transport identification assumption is not met (Aims 1b and 2b); 3) to apply these estimators to harmonized medication for the treatment of opioid use disorder (MOUD) trials with multiple outcomes to increase power to detect effects (Aims 1c and 2c); and 4) to develop and disseminate user-friendly software that implements all the above methods (Aim 3:). This proposal is expected to make a significant contribution to increasing the power and information gained from data fusion, and consequently, to improve the individualized treatment of psychiatric and substance use disorders.

 

Improving the analysis and use of contaminated immunoassays: from methods development to implementation

(September 1, 2024 – June 30, 2029)

Principal Investigator: Qixuan Chen

Co-Principal Investigator: Andrew Gelman

Act: R01 - Project: ES035784 - Admin / Funding IC: NIEHS

DESCRIPTION (provided by applicant): Immunoassays – tests that estimate the concentration of analytes in a sample using antibody-antigen binding reactions – are widely used for clinical diagnostics, biopharmaceutical analysis, and environmental monitoring. The current method for estimating concentrations of analytes measured in immunoassays has several limitations, including large measurement errors, difficulty in estimating very low or high concentrations, and noisy estimation. In addition, with the advance of new technologies using multiplex assays, multiple analytes can be measured simultaneously in a single plate, but the current method fails to account for the potential correlations between multiple analytes of the same sample. Further, operator error may arise and environmental samples can be contaminated, resulting in assay errors. Although some Bayesian methods exist that use immunoassay data more efficiently, they have not yet been incorporated into a practical workflow, in part because of concerns about robustness to model error. Motivated by these challenges, the proposed research aims to develop a new Bayesian workflow for the analysis of immunoassay data, considering possible error and contamination in the samples and providing a step-by-step guide to model building, checking, and validation. Further, to enhance the proper use of immunoassay data, a joint modeling and a two-step model approach will be developed to analyze exposure- outcome associations accounting for the uncertainty in the exposure measure by immunoassays. The methods will be developed and validated using immunoassay data of indoor allergens with dust samples from the New York City Neighborhood Asthma and Allergy Study. A lab protocol and a graphical user interface will be developed and tested to facilitate the uptake of the proposed methods. Once completed, the proposed research will provide methods and tools for the analysis and use of potential contaminated immunoassay data, advance research in the broader scientific field when dealing with model contamination and uncertainty in predictors, and provide important insights into allergic sensitization and asthma morbidity among asthmatic children.

 

Flexible causal inference methods for estimating longitudinal effects of air pollution on chronic lung disease

(August 16, 2022 – May 31, 2027)

Principal Investigator: Daniel Malinsky

Act: K25 - Project: ES034064 - Admin / Funding IC: NIEHS

DESCRIPTION (provided by applicant): This application for a Mentored Quantitative Research Career Development Award has been submitted with the goal of supporting Dr. Malinsky’s career as a quantitative researcher at the intersection of biostatistics, epidemiology, and data science for environmental health. The training and research plan build on Dr. Malinsky’s quantitative interdisciplinary background in statistics and computer science, in particular his expertise in causal inference and machine learning. The overarching research goal is to develop novel statistical methods for causal inference that meet important analytical challenges in observational environmental epidemiology and apply these methods to the study of air pollution and chronic lung diseases, using data from the longstanding Multi-Ethnic Study of Atherosclerosis (MESA). The methods will be used to estimate the effects of several ambient air pollutants (ozone, fine particulate matter, and oxides of nitrogen) on progression of emphysema and decline in lung function over an extended time period. Rigorously investigating these relationships is important both for advancing our understanding of the etiology and mechanisms underlying lung disease and to inform regulatory policies concerning pollution concentration levels. The focus will be on extending and adapting methods for causal inference from observational longitudinal data, which have been previously developed to accommodate time-varying confounding and quantify uncertainty due to unmeasured confounding, but never applied to complex longitudinal data on air pollution and chronic lung disease. These will be used to estimate the long-term lung disease consequences of hypothetical changes to air pollution exposure levels. Aim 1 of the research plan extends existing methods to address challenges specific to air pollution epidemiology, namely by exploiting advances in machine learning to estimate robust exposure propensities and flexible dose-response functions. Aim 2 of the research plan leverages these methods to investigate hypotheses about the relationships between the aforementioned pollutants and measures of lung disease in the MESA data and identify vulnerable subpopulations. Aim 3 will extend an approach to counterfactual sensitivity analysis in the statistical literature that quantifies uncertainty due to unmeasured confounding to the setting of MESA and apply this approach to the MESA data. The application delineates plans for mentoring and career development via supervision and didactic instruction in the areas of air pollution science, environmental epidemiology, climate, longitudinal study design, and other topics relevant to the construction of credible analysis models for the MESA data. Dr. Malinsky will be supported by a mentoring team with considerable expertise in air pollution science & measurement, lung disease, biostatistical methods, and environmental determinants of health. The award will establish Dr. Malinsky as an independent investigator in this interdisciplinary area and enable him to successfully compete for R01 funding.

 

Optimizing implementation of evidence-based mental health interventions to promote reach and retention among migrants in transit in humanitarian emergencies

(September 1, 2022 – August 31, 2027)

Principal Investigator: Claire Greene 

Act: K01 - Project: MH129572 - Admin / Funding IC: NIMH

DESCRIPTION (provided by applicant): The prevalence of mental disorder is three times greater in humanitarian settings relative to global averages. Challenges to implementing mental health services in complex emergencies amplify health disparities for hard- to-reach populations. Migrants transiting to a destination country are among those hardest to reach and retain in care given their mobility and peripheral connections with established health systems. Innovative strategies are needed to improve access to mental health services for migrants in transit. The goal of this K01 Mentored Research Scientist Development Award is to prepare the candidate for an independent research career dedicated to improving access to evidence-based mental health services for the hardest-to-reach populations in humanitarian emergencies. Through this K01 award, the candidate will leverage the training resources available through Columbia University and her mentorship team to acquire the skills needed in systems science and human-centered design to develop and test strategies for improving reach and retention of migrants in transit in scalable psychological interventions. The goal of this K01 research is to optimize implementation of Problem Management Plus (PM+), a scalable psychological intervention, to improve reach and retention of Venezuelan migrants transiting through Colombia. This research builds on an ongoing research partnership between Columbia University and HIAS, a humanitarian non-governmental organization in Colombia. The specific aims are: 1) To describe the individual-, community-, and systems-level relationships that influence reach and retention in mental health services among Venezuelan migrants in transit in Colombia using group model building; 2) To design and optimize an implementation plan to improve reach and retention in PM+ among Venezuelan migrants in transit in Colombia through human-centered design; and 3) To compare reach and retention in PM+ using the locally designed implementation plan relative to PM+ implementation-as-usual among Venezuelan migrants in transit in Colombia with a comparative interrupted time series analysis. This research is an integral component of a rigorous training and career development plan involving intensive training and mentorship in systems science, human-centered design, adapting implementation strategies, and understanding structural, cultural, and social determinants of access to care among migrants in transit in Latin America. This study will be the first to optimize implementation of mental health services for migrants in transit and will provide critical preliminary data to inform an R01 application to test promising implementation approaches at scale. This research aligns with NIMH’s strategic objective to develop innovative service delivery models to improve mental health in diverse communities and populations, as well as the priorities of the NIMH Global Mental Health and Human Mobility Research Program.

 

Risk and protective factors for common mental disorders among populations during migration. A pilot cohort study among migrants and asylum seekers in Mexico

(August 14, 2023 – August 13, 2026)

Principal Investigator: Claire Greene 

Act: R34 - Project: MH134046 - Admin / Funding IC: NIMH

DESCRIPTION (provided by applicant): Forced displacement has reached unprecedented levels and is becoming increasingly protracted with over 75% of the estimated 100 million displaced persons globally expected to live in exile for over five years. Latin America has experienced the greatest proportional increase in forced displacement across international borders since 2017. Due to delays in processing asylum applications and policies permitting the widespread expulsion of migrants and asylum seekers, many migrants and displaced persons are temporarily residing in northern Mexico near the US border awaiting safety and more durable solutions in another destination. Displaced populations face significant adversity, human rights violations, and potentially traumatic events that increase their risk for common mental disorders (CMDs) during their migration journey. The point prevalence of CMDs is more than three times higher in displaced populations relative to global averages. Despite this elevated burden, migrants without legal status in the transit or destination country face significant barriers in accessing basic needs and services, further contributing to distress and the risk of CMDs. Most available data on mental health among migrants is cross-sectional due to practical and ethical challenges following mobile populations over time. Longitudinal data are needed to identify modifiable risk and protective factors that could serve as targets for CMD prevention interventions in this population. Our study team, which represents an established academic-humanitarian partnership, has expertise conducting mental health research among displaced populations and providing community-based mental health and psychosocial support to these communities, including in Mexico. We aim to further this partnership by piloting feasible, effective, and ethical strategies for recruiting and retaining a prospective cohort of 300 migrants in transit to clarify the factors that contribute to prevention of CMDs. Using data from this cohort this study aims to: 1) identify risk and protective factors for CMDs; 2) Estimate the short-term effect of economic services, social protection, legal assistance, and mental health interventions on reducing the risk of CMDs; and 3) evaluate the feasibility and acceptability of conducting a fully powered prospective cohort study of migrants in transit in Mexico followed over three years. This research is the first longitudinal investigation of mental health among migrants in transit, including underrepresented groups (women, children, separated families), and will innovatively measure the impact of multisectoral services on mental health outcomes among migrants during this critical phase of migration. Results from this study will provide critical and novel insights into the epidemiology of CMDs and will enable the development of targeted and efficient strategies to reduce the incidence of CMDs among migrants in transit in humanitarian emergencies.

 

Improving Maternal and Child Health in the Year After Birth: An Early Evaluation of Postpartum Medicaid Eligibility Extensions

(September 30, 2022 – July 31, 2027)

Principal Investigator: Lindsay Kennedy Admon

Act: R01 - Project: HS029159 - Admin / Funding IC: NIH

DESCRIPTION (provided by applicant): State Medicaid programs pay for nearly half of all births in the United States (U.S.), financing over 1.6 million births in 2019. Federal law requires states to provide pregnancy-related Medicaid coverage to low-income pregnant individuals through 60 days postpartum, after which 1 in 4 become uninsured. A substantial and increasing proportion of adverse pregnancy-related outcomes, including maternal morbidity and mortality, are occurring among individuals with Medicaid-paid births and after pregnancy-related Medicaid coverage ends. Postpartum Medicaid eligibility extensions (PMEs) to one year postpartum are an emerging strategy for improving insurance enrollment, healthcare access, and health for low-income mothers and children. Passed in response to the COVID-19 Public Health Emergency, two federal laws have accelerated implementation of PMEs. First, the Families First Coronavirus Response Act (FFCRA) of March 2020 prevented states from disenrolling Medicaid beneficiaries during the public health emergency. In turn, the FFCRA created a national de facto PME. Second, the American Rescue Plan Act (ARPA) of March 2021 allows states to adopt PMEs starting in April 2022 with federal matching funds. Rigorous evaluations of these policies are urgently needed to inform state decisions to adopt PMEs and determine whether these polices are having the intended effect of improving maternal, child, and pregnancy-related health in the year after birth. To inform ongoing, evidence-based policymaking and fill this significant gap in maternal and child health research, our multi-disciplinary team will conduct rigorous, quasi-experimental evaluations that exploit state variation in policy adoption to provide timely data on the FFCRA and ARPA and associated changes in 1) maternal insurance enrollment, healthcare use, and health; 2) children’s insurance enrollment, healthcare use, and health; and 3) outcomes among subsequent pregnancies including rates of short interpregnancy interval and preterm births (NOT-HS-14-004). Given that a disproportionate share of those with Medicaid-paid births and experiencing adverse health events in the postpartum year are low-income and Black, Indigenous, or people of color (AHRQ priority populations), we will also measure the impact of PMEs on racial health equity (NOT-HS-21-014). The proposed set of evaluations will produce data directly informing whether these unprecedented, large-scale policy interventions have been associated with improvements in maternal and child health or racial and ethnic disparities in the year after birth. We will generate timely findings to inform ongoing, evidence-based policymaking to address the U.S. maternal health crisis. Ultimately, we aim to improve health and reduce disparities in the year after birth among low-income mothers and children at the population level.

 

 

The Postpartum Assessment of Women Survey (PAWS): Informing Medicaid Policies to Improve Health in the "Fourth Trimester"

(May 1, 2023 – November 30, 2027)

Principal Investigator: Jamie Daw

Co-Principal Investigator: Heidi Lynn Allen

Act: R01 - Project: MD017460 - Admin / Funding IC: NIMHD

DESCRIPTION (provided by applicant): The year after birth, also known as the “fourth trimester”, is a growing focus of efforts to address high rates of maternal morbidity and mortality in the United States (U.S.), which disproportionally affect racial-ethnic minorities, rural women and women insured by Medicaid at delivery. More than half of pregnancy-related deaths occur in the year after delivery and a significant share of women experience postpartum morbidity due to physical and mental health conditions. As the payer for nearly half of U.S. births and a larger share of births among Black and Indigenous women, Medicaid is a key lever to improve population-level postpartum health disparities. As the COVID-19 pandemic subsides, policymakers are considering a range of Medicaid policy changes—alone and in conjunction with other social policy sectors—aimed to improve postpartum health, such as extending pregnancy Medicaid one year postpartum or addressing social risk factors. Yet, the determinants of postpartum wellbeing and health disparities are poorly understood. This is largely because the fourth trimester has been a neglected focus of maternal health policy and research. To drive evidence-based policymaking and fill the significant gap in high quality, representative data on postpartum health, our multidisciplinary team developed a large-scale follow-up survey administered one year after birth in collaboration with six states and New York City: the Postpartum Assessment of Women Survey (PAWS). The 2020 PAWS captured the postpartum experience of women who gave birth in 2020, during the height of the public health emergency (PHE). This proposed project leverages and builds on this first-of-its kind data collection effort to respond to the urgent needs of policymakers to improve postpartum health in the new public health, policy and social context that will emerge as the pandemic subsides, as the policies and protections of the PHE end, and as new policies begin (e.g. postpartum Medicaid extensions in 2022). Specifically, we will launch a new PAWS survey round following a 2023 birth cohort (data collected in 2024) to measure (1) maternal health outcome disparities in the postpartum year (by insurance, race-ethnicity, and urban/rural residence), (2) health care-related disparities and their contribution to disparities in postpartum health outcomes, and (3) social and economic disparities and their contribution to disparities in postpartum health outcomes. Drawing on expertise from our diverse, interdisciplinary team of junior and senior investigators, and in deep collaboration with state and city government partners, we will produce a highly valuable scientific resource and generate timely, rigorous findings to inform evidence-based policies with the potential to advance maternal health equity in the U.S.

 

 

Integrated Supportive Care Policies to Improve Maternal Health Equity: Evaluating the Multi-level Effects and Implementation of Doula Programs for Medicaid-Eligible Birthing People in New York City

(September 21, 2023 – June 30, 2028)

Principal Investigator: Jamie Daw

Multiple Principal Investigators: Madeleine Dorval-Moller; Kelli Stidham Hall; Alison Whitney

Act: R01 - Project: NR021108 - Admin / Funding IC: NINR

DESCRIPTION (provided by applicant): In New York City (NYC) and State (NYS), pervasive inequalities in access to respectful, culturally congruent, patient-centered maternity services drive maternal mortality (MM) rates that are 8× higher for Black versus White individuals and severe maternal mortality (SMM) rates that are 2.3× higher. Policy interventions that emphasize Medicaid, which serves low-income and racially and ethnically minoritized populations at greatest risk of SMM/MM, and that increase access to quality obstetric services and improve the social and structural determinants of health (SDOH) - i.e., integrated supportive care (ISC) - hold significant promise. NYC and NYS are at the forefront of Medicaid-relevant doula programs, with recent policy advances to expand the Maternity Hospital Quality Improvement Network (MHQIN), which supports hospitals in integrating doulas, Standards for Respectful Care, implicit bias trainings, SDOH clinical reviews, and community linkages into care structures, and the Citywide Doula Initiative (CDI), which trains and provides doulas at no cost for NYC residents in select neighborhoods who are income-eligible for Medicaid. However, there is little empirical evidence on the effectiveness of doula care models or the facilitators and barriers doulas face in practicing within their full scope, integrating into the care team, and strategies for effective, sustainable ISC policy implementation, in part because state Medicaid programs have not included doula services and the community and governmental organizations delivering them have limited research capacity. Guided by our multi-sector partnership and novel integrated conceptual framework, we propose a rigorous mixed-methods evaluation of the multi-level impacts and implementation of NYC’s doula programs. In Aim 1, we will use a quasi-experimental design and unique Medicaid claims linked to social services data to evaluate the overall and differential effects by race, ethnicity, age, socioeconomic status, and geography of the CDI on 1a) birth, mental health, cardiovascular, and SMM outcomes; 1b) prenatal and postpartum healthcare utilization; and 1c) receipt of social services, among Medicaid-eligible birthing people from 2022 to 2027. In Aim 2, we will analyze diverse perspectives on and experiences with the MHQIN program components and its implementation among birthing clients and hospital, Medicaid, and doulas/community stakeholders via in-depth individual interviews, focus group discussions, and surveys. In Aim 3, our Community Coalition Research Leadership Advisory Board will lead a co-design process to develop an evidence-based strategic plan for policy implementation to scale and sustain Medicaid-supported ISC, including doula reimbursement. We will generate new evidence on the role that doulas play in improving maternal health equity, strengthen local partnerships for policy action, and serve as a model for national replicability. Our proposal is highly aligned with NIH’s strategic plan for innovative research to advance community-derived, multi-level policy solutions to redress the crisis of MM for birthing people across the U.S.

 

Hypertension, Blood Pressure Targets, and Alzheimer’s Disease and Dementia Risk and Disparities among Nationally Representative US Veterans

(September 30, 2024 – June 30, 2029)

Principal Investigator: Kristine Yaffe

Co-Principal Investigator: Adina Zeki Al Hazzouri

Act: R01 - Project: AG085481 - Admin / Funding IC: NIA

DESCRIPTION (provided by applicant): U.S. veterans are an increasingly racially, ethnically, and geographically diverse group that has a high risk of Alzheimer's Disease and Related Dementias (ADRD) due to their high prevalence of cardiovascular risk factors including hypertension and heightened exposure to ADRD risk factors such as traumatic brain injury (TBI), posttraumatic stress disorder (PTSD), and depression (hereafter, military-related exposures). Although veterans are understudied in ADRD research, these characteristics make this high-risk population well-suited to improve understanding of psychosocial and vascular drivers of ADRD risk and disparities. In particular, several lines of evidence suggest that hypertension is a major dementia risk factor and that antihypertensive treatment may be a promising strategy for ADRD risk reduction and prevention. Yet, hypertension, its treatment and target goals, and association with dementia risk all vary by race/ethnicity, geography, and other risk factors, necessitating the use of large and diverse cohorts to robustly examine these associations within important potentially high-risk subgroups. The Veterans Health Administration (VHA) provides health care to veterans that in turn is captured in electronic health records (EHR) stored in a national repository. This rich dataset will enable investigation of hypertension and ADRD risk, including within subgroups defined by military-related exposures, race/ethnic groups, and US region. Further, because the VHA is a single-payer healthcare system, we expect treatment guidelines to be relatively standard across providers, enabling the use of contemporary econometric methods, such as regression discontinuity designs (RDD), to estimate causal effects of hypertension treatment with different treatment cutoffs for optimized ADRD risk reduction. Using a sample of 1,415,230 older veterans (mean age: 66 years; 149,436 from under-represented minority groups; 32,551 women and 1,122,016 with hypertension), we propose to estimate the association between hypertension and ADRD risk among US veterans and within race/ethnicity and geographical region subgroups (Aim 1) and then assess if military-related exposures (e.g., TBI, PTSD, depression) modify this association, overall and within subgroups (Aim 2). We will then estimate hypertension treatment effects on ADRD risk using a regression discontinuity design and different treatment targets and assess if this varies by subgroup and military-related exposures (Aim 3a). Finally, we will quantify the reduction in ADRD cases that could be achieved at different treatment targets (Aim 3b). This innovative study will provide multiple public health relevant estimates for the relationship of hypertension, treatment targets, and ADRD risk. By also examining these associations within subgroups of race/ethnicity, region, and presence of military-related exposures, this study will enable identification and prioritization of groups at highest risk of ADRD. As we proposed to investigate several key modifiable risk factors (e.g., hypertension, depression, PTSD) that occur, not only among veterans, but among members of the US general population as well, our findings could have broad-reaching implications for ADRD prevention and reduction.

 

Illuminating our understanding of statins and Alzheimers Disease and Dementia using modern causal inference methods

(April 1, 2024 – February 28, 2027)

Principal Investigator: Adina Zeki Al Hazzouri

Co-Principal Investigator: Michelle Christina Odden

Act: R01 - Project: AG081973 - Admin / Funding IC: NIA

DESCRIPTION (provided by applicant): Antihyperlipidemic agents, including statins, currently rank as the second most frequently prescribed drugs in the U.S. While there is adequate evidence supporting the benefits of statins for the prevention of CVD events, evidence to support the beneficial or harmful effects of statins on cognition and the risk of Alzheimer’s disease and related dementias (ADRD) is inconclusive. Findings from two large randomized controlled trials of statins found no effect on cognitive outcomes over the short-term (4 to 5 years). Results from observational studies have been mixed. Given the widespread use of statins, this knowledge gap represents a huge opportunity for illuminating viable prevention strategies for ADRD. The most plausible explanation for these inconsistent results is that the effectiveness of statin treatment varies across patient characteristics such as age, sex, and the presence of chronic conditions. Importantly, most trials do not have adequate statistical power to examine these heterogeneous treatment effects (HTEs). Further, trials typically include participants who are healthier than the general population of statin-users and less likely to experience side effects, and often exclude participants who do not tolerate statins. Large, administrative observational data sources can provide sufficient sample sizes to address these limitations, but traditional analytical techniques are insufficient in the presence of strong confounding. In this study, we propose to leverage a widespread clinical prescription guideline and established statistical methods in economics, specifically regression discontinuity (RD) designs, to address confounding and approximate a randomized trial. Our data (N=175,234) will come from the Health Improvement Network (THIN) database which includes general practices in the UK covering about 5% of the total population. In 2008, the National Institute for Health and Care Excellence in the UK passed a guideline which recommends statin use when a patient’s 10-year CVD risk score exceeds 20%. Since treatment is given or withheld according to this guideline, we assume that patients who are “near” the 20% cutoff will be similar except for the treatment received, thus creating the ideal setup to estimate the causal effect of statins. We will also apply an honest causal forest, a state-of-the-art causal inference and supervised learning method, to flexibly identify novel patient subgroups who could most benefit from statin use. The proposed research will (Aim 1) estimate the effect of statins on ADRD risk, using an RD design, accounting for adherence. We will (Aim 2) then estimate the effect of statins on ADRD risk across a priori (hypothesis-driven HTEs) and newly identified (data-driven HTEs) patient subgroups, using RD and machine-learning methods. Finally, we will (Aim 3) quantify the reduction in ADRD cases that could be achieved if specific subgroups of the population are treated with statins. Using contemporary methods, this innovative study will provide more valid and public health relevant estimates of the effects of statins on ADRD risk. By also examining HTEs and identifying groups that may particularly benefit or be harmed from statins, this study will allow us to move towards targeted “precision medicine” approach for the prevention of ADRD.

 

E-CONNECT: A SERVICE SYSTEM INTERVENTION FOR JUSTICE YOUTH AT RISK FOR SUICIDE

(September 1, 2017 – June 30, 2025)

Principal Investigator: Katherine Elkington

Act: R01 - Project: MH113599 - Admin / Funding IC: NIMH

DESCRIPTION (provided by applicant): While youth at all juvenile justice (JJ) processing points are at increased risk for suicidal behavior (SB) and associated behavioral health (BH) issues, those supervised in community settings (e.g., probation), may be at greatest risk: (a) protocols for identification and service referral are far more common in secure settings, (b) national policy increasingly favors community supervision/diversion over incarceration, (c) youth supervised in the community have far more access to means and opportunity than do those in secure settings, and (d) the multi- system coordination challenges to accessing BH care for community JJ youth are far greater than for those secure care. We propose to adapt and test the utility of a multi-level service delivery model that increases identification of SB and related BH problems, guides targeted referral, trains staff and structures interagency collaboration to increase uptake of BH services by youth on probation; and document the organizational elements required to widely-implement this model in juvenile probation and community treatment settings. The model is based on our earlier, evidence-based linkage protocols from Project Connect, and capitalizes on technological advances unavailable at Connect’s 2007 development, so as to address earlier implementation issues. Working in 9 NYS counties, project specific aims are (1) to develop a technologically advanced cross-system identification/linkage service model that trains staff, formalizes interagency collaboration and referral decision-making and uses a mobile application to seamlessly combine (a) screening for SB and related BH problems, (b) classification of clinical need and (c) county-specific streamlined referral plans for BH services; (2) to examine the degree to which, compared to Baseline, e- Connect improves (a) intermediary PO practice outcomes (service need identification, cross-system referral) and increasing (b) youth BH service use (access, engagement); and (3) to elucidate multi-level factors (e.g., staff, organizational, youth/family, community,) that influence implementation (feasibility, acceptability, sustainability) of e-Connect across various probation department processing categories (e.g. status offenders, diversion cases) to inform comprehensive scale-up. The theoretically based mechanisms (e.g., changes in staff knowledge and self-efficacy; agency structural characteristics) by which PO practice change affects BH service use will also be examined. Guided by the GPM and CFIR framework, this 5-year study will comprise 4 project phases: (1) Development, (2) Baseline data collection, (3) Implementation, and (4) Sustainment. After development, counties are randomized to one of 4 Waves to begin implementation of e-Connect at 4-month intervals in a stepped-wedge design. Implementation activities continue for 18m and sites’ use of e-Connect protocols after 18m will be an indication of sustainability. This initiative is one of the first to address SB and advance JJ youth enrollment in BH treatment. Because we propose addressing risk and acute SB, this study has the likelihood of identifying and linking to services high-risk, high need youth that are often overlooked.

 

Facilitating Opioid Care Connections: System-level strategies to improve use of MAT and movement through the opioid care cascade for defendants in a new Opioid Court system 

(July 15, 2019 – April 30, 2025)

Principal Investigator: Katherine Elkington

Multiple Principal Investigators: Nunes, Edward V.; Wainberg, Milton L

Act: UG1 - Project: DA050071 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant): In the context of a nationwide opioid epidemic, rates of opioid use (OU), opioid use disorder (OUD) and overdose (OD) disproportionately affect those in the justice system. Yet despite such high rates of OU and OUD, screening for and use of evidence-based treatments for OU and OUD, including medication to treat OUD (MOUD), are substantially underused in justice populations. Courts are an ideal point of intervention in the justice system to identify OU or OUD, and OD risk, and link defendants to treatment/MOUD in the community. However, less than 5% of defendants with drug problems are served by drug treatment courts. In response to the opioid crisis in New York State (NYS), where the proposed project will take place, the Unified Court System (UCS) developed a new treatment court model – the opioid court model (OCM) - designed around 10 practice guidelines to address the flaws of existing drug courts and reduce OD, OUD, and recidivism via rapid screening and linkage to MOUD. In 2018, NYS began to expand the OCM across NYS with 9 “initial adopter” counties. Yet, given the innovation of the OCM, the exact barriers to implementation in disparate counties with a range of resources – and the strategies to overcome them – are largely unknown. We propose to integrate evidence-based implementation strategies to refine and evaluate OCM RISE, an implementation intervention that will allow the OCM, as framed by the 10 practice guidelines, to be scaled up across NYS. This UG1 proposal is from three PIs with complimentary expertise in the justice system, implementation science and developing treatment for OUD and its delivery in community settings and is supported by a strong multi-disciplinary team to achieve study aims. Guided by Exploration Preparation Implementation Sustainment (EPIS) model and Social Cognitive Theory (SCT), Specific Aims are: 1) To refine OCM RISE using formative work with “initial adopter” counties that (a) identifies gaps in service provision by documenting OCM/opioid cascade outcomes; (b) identifies successes/challenges in operationalizing guidelines; and (c) characterizes the working relationships between county opioid court and treatment systems. 2). In a stepped-wedge design in 10 new counties compared to baseline treatment as usual (drug courts), to test, (a) the implementation impact of OCM RISE in improving implementation outcomes along the opioid cascade (screening/identification, referral, treatment enrollment, MOUD initiation); and (b) the clinical and cost effectiveness of OCM RISE in improving public health (treatment retention/court graduation) and public safety (recidivism) outcomes, exploring moderators: defendant gender, age, charge; county urbanicity and county OD rates. 3) To characterize and compare advancement through the stages of implementation of the OCM in the 10 new adopter counties, elucidating the inner- and outer-level EPIS- and SCT-derived factors that influence delivery of implementation strategies to inform OCM scale up; and (b) to explore the relationship between implementation stage completion and all opioid cascade, public health and public safety outcomes.
 

Scaling up eConnect in Juvenile Probation Settings: a hybrid implementation-effectiveness trial of a digital suicide risk/behavior identification and linkage-to-treatment system

(September 1, 2022 – June 30, 2027)

Principal Investigator: Katherine Elkington

Co- Principal Investigator: Matthew Aalsma

Act: R01 - Project: MH130845 - Admin / Funding IC: NIMH

DESCRIPTION (provided by applicant): Among US adolescents, suicide is the second leading cause of death1. Suicide risk is not uniform across youth, and those involved in the juvenile justice (JJ) system are at even greater risk for suicidal behavior (SB) given their increased prevalence of mood and substance use disorders, trauma exposure, and access to firearms. While SB screening and service provision for youth in secure JJ settings occurs more systematically, such practices are rarer for youth who are supervised in their community (i.e., probation settings). The proposed study will examine strategies to bolster the successful scale-up of e-Connect, one of the few evidence-based suicide behavior identification and cross-system linkage programs for youth on under community supervision. This proposal is from two PIs with complimentary expertise in the justice system, implementation science, clinical decision support systems, and use of large administrative data sets, and is supported by a strong multi- disciplinary team to achieve study aims. Guided by the Gateway Provider Model (GPM) and the Exploration, Preparation, Implementation Sustainment (EPIS) implementation framework, we now propose to extend ourwork of e-Connect, to develop and test a “purveyor model” of implementation scale-up (i.e., e-Connect-scaleup). In e- Connect-scaleup, researchteamleadershipwill serveas External Facilitatorsto support Local Facilitators to ensure the successful transfer of knowledge, skill and expertise in delivering e-Connect in a new JJ system and geographic context, utilizing implementation strategies to support the more widespread, sustained and rigorous adoption of e-Connect. Working in 9 Indiana counties, randomly assigned to one of three waves in a stepped- wedge, implementation-effectivenesshybrid type-2 design ,the specificaims are to examine the clinical and cost- effectiveness of e-Connect-scaleup on (i) identification of youth service need (SB and BH correlates) in juvenile probationers; (ii) cross-system (probation-BH agency) referral; and (iii) youth BH service use (initial BH contact; primary outcome) by comparing the performance of e-Connect to (a) standard probation officer practice (baseline) and (b) to rates achieved in the prior efficacy trial of e-Connect (Aim 1). We will examine potential mediating or moderating effects of EPIS/GPM inner and outer context factors. We will also determine whether e-Connect-scaleup can reduce race or gender health disparities in SB/BH service need identification, cross- system referral and youth SB/BH service use (e.g. as compared to standard probation practice (baseline), which would replicate the disparity-reducing performance of e-Connect in NYS (Aim 2). Finally, we will examine the implementation of e-Connect-scaleup in terms of fidelity and acceptability and compare advancement through the stages of implementation through to sustainment across the 9 counties in order to demonstrate the feasibility of scaling-up e-Connect in probation settings beyond NYS (Aim 3). We will elucidate the inner- and outer-level EPIS- and GPM- derived factors that promote or hinder delivery of implementation strategies and practice change to inform scale up across a variety of contexts.

 

COVID-19 Pandemic: Natural Experiment in Telehealth on Buprenorphine Treatment in a Large Integrated Healthcare System 

(March 1, 2023 – February 28, 2026)
Principal Investigator: David Fink

Act: K99 - Project: DA055724 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant): Expanded use of telemedicine for buprenorphine prescribing may reduce barriers to buprenorphine prescribers. However, federal regulations that require prescribers to conduct in-person medical evaluations to induct patients on buprenorphine and limit maintenance visits to real-time, two-way, interactive audio-visual communication (i.e., telehealth) has prevented research on the potential role of expanding telehealth for buprenorphine prescribing. The initial surge of COVID-19 cases in the US in March 2020 led federal agencies to ease the in-person evaluation requirement, allowing providers to use telemedicine or telephone-only visits for medical evaluations to start patients on buprenorphine. We propose a study that leverages these COVID-related regulator reforms to answer important clinical and policy questions regarding the regulations governing the use of telehealth for buprenorphine initiation and treatment among Veterans Administration (VA) patients. Serving ~5,000,000 patients each year, we will leverage the VA electronic health record data to answer three important clinical and policy questions. (1) What was the effect of the relaxed buprenorphine prescribing guidelines on buprenorphine treatment rates change during the COVID-19 pandemic overall and by treatment stage (new patients vs. long- standing patients)? (2) What is the effect on treatment outcomes of more flexible telehealth regulations on patients initiating buprenorphine treatment? (3) What is the effect of telehealth use on treatment outcomes on patients in long-standing buprenorphine treatment (in care ≥6 months)? We will answer these questions in three steps: (1) We will use time-series methods to model the monthly counts of VA patients in buprenorphine treatment prior to March 2020, predict the monthly count in treatment from April to December 2020 and compare it to the observe counts to quantify the change in buprenorphine treatment rates associated with more flexible treatment regulations; (2) Test whether: (a) clinical treatment outcomes in patients initiating buprenorphine via telehealth post-Policy changes differ from patients initiating treatment in the year before the outbreak and (b) Investigate individual, facility, and area-level modifiers of the policy effects on clinical treatment outcomes; and (3) Among long-standing patients: (a) Examine the relationship between telehealth use and clinical treatment outcomes and (b) Determine individual, facility, and area-level differences in telehealth buprenorphine treatment. Determining the effects of more flexible telehealth regulations will provide critical information on a potential policy lever to increase access to critical life-saving medications for OUD. The complementary training program comprising of formal courses, workshops, directed readings, and experiential learning will let me develop the skill and expertise to launch my career as a substance use epidemiologist and prepare me to successfully compete for R01 funding as an independent investigator with a focus on understanding the causes of addiction and policy evaluation to inform interventions, prevent, and treat OUD and its related harms.

 

Reducing Intersectional and HIV Stigma among High Risk Women who use Drugs in Kazakhstan, Central Asia: A Multilevel Stigma Resistance and Enacted Stigma Reduction Intervention for Women and Providers

(September 1, 2022 – June 30, 2025)
Principal Investigator: Brooke West

Co-Principal Investigator: Victoria Frye

Act: K99 - Project: DA055724 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant): Suboptimal linkage to and retention in HIV prevention and care is prevalent among high risk women who use or inject drugs in both the US and globally, stemming, in part, from high levels of stigma. In Kazakhstan, increasing engagement in the HIV care and prevention continuum is a major public health goal, as the number of new HIV infections doubled from 2010 to 2017 and AIDS-related deaths increased by 32%. Among high risk women who use drugs in this context, our research has found that ~30% are HIV-infected and that they are less likely to test and receive care. Numerous studies have documented that experienced, anticipated and internalized stigma, especially from health care providers (HCP), are key barriers to HIV testing and treatment in global contexts. For high risk women who use drugs, HIV and associated stigmas, specifically stigma related to sex and drug use, as well as gender discrimination, work independently and synergistically to inhibit access to HIV prevention and treatment; yet, there are no existing anti-stigma interventions designed and tested in Kazakhstan for this key population of women and that focus on HCP as sources of stigma. Here we propose to design and assess acceptability, feasibility, and generate information in order to power a preliminary effectiveness trial of a three component, multi-level participatory intervention to reduce HIV-associated and intersectional stigma - and thus increase access to HIV prevention and care. The first component is aimed at high risk women and designed to increase stigma resistance/coping and reduce anticipated/internalized stigma via: a) crowdsourcing of anti- stigma messaging for HCP; and b) adaptation of a HCP training for optimal sexual health and healthcare engagement among high risk women who used drugs. The second and third components, aimed at the HCP and other clinic staff and emerging from the execution of the first component, include: a) the resultant messaging campaign; and b) the training that will be delivered to HCP. Both the messaging campaign and the training components will be designed to reduce enacted stigma by HCP/staff (and thus experienced stigma among women) and increase stigma resistance and resilience among high risk women who use drugs. All components will work synergistically to reduce enacted, experienced and internalized, intersectional stigma. The approach relies on evidence-based methods, including media campaigns, to reduce HCP enacted stigma, and integrates innovative methods, like crowdsourcing and participatory research, to increase stigma resistance. Results of this study will be unique in utilizing multilevel anti-stigma approaches for both high risk women who use drugs and HCP and have important implications for advancing HIV prevention and care engagement among highly stigmatized populations globally and in the US.

 

Analytical Core

(August 15, 2023 – June 30, 2028)
Principal Investigator: Stephen Crystal

Act: P30 - Project: AG083257 - Admin / Funding IC: NIA

DESCRIPTION (provided by applicant): The Resource Center for Alzheimer’s and Dementia Research in Asian and Pacific Americans (RCASIA) has missions of 1) increasing scientists underrepresented in AD/ADRD-related Behavioral, Social, and Economic Research biomedical research through innovative models of mentoring and community interaction; 2) advancing the rigor and impact of AD/ADRD pilot studies in older APAs through Common Data Elements and data-sharing; 3) serving as a national resource for linguistically/culturally tested and validated tools to assess cognition, function, and AD/ADRD care in APA populations. The Measurement and Analytical Core (AnC) – led by Stephen Crystal, PhD and Donald Hoover, PhD – will oversee the analytical infrastructure of RCASIA to support RCASIA Scientists in their pilot study design, analysis, and modeling; introduce rigor and reproducibility into pilot measures through a linguistically/culturally-grounded framework; participate in Pod meetings to guide measurement-related discussions; support the collection of Common Data Elements, the free web-based universal Clinical Research ID, and data-sharing; continue to support data requests for the Population Study of Chinese Elderly (PINE); and hosts the repository for linguistically/culturally tested/validated instruments. The AnC will built on its expertise in health services research, fit-for-purpose primary data analysis, harmonizing large secondary datasets, and partnerships with specialized analytical experts to help RCASIA Scientists complete their pilot projects and build new collaborative projects. Two current Center-based innovations – due to complete in FY 2022 – will also be available for Scientists’ use: probability-based APA subgroups from linking Medicare data with American Community Survey, and the linked survey-genomic data from Health and Retirement Study. Finally, the AnC will report on the acceptability of Common Data Elements and universal Clinical Research ID towards the eventual goal of a future pilot RCASIA Research Registry for older APA in the NYC/NJ area.

 

Opioid overdoses among Medicaid beneficiaries: predictors, outcomes, and state policy effects 

(March 1, 2019 – January 31, 2025)

Principal Investigator: Stephen Crystal
Act: R01 - Project: DA047347 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant): Reducing opioid overdose is an urgent national goal that needs to be supported with the best available understanding of the clinical, treatment, and health system factors that predict overdoses, and points of intervention for their reduction. For individuals surviving medically treated overdoses, there is a need to better understand the factors affecting risk of fatal overdose, including effects of post-overdose treatment, in order to reduce the death toll in this high-risk population. To inform systemic intervention, there is an urgent need for evidence on the role of state policies in reducing risk and improving outcomes. These issues are particularly vital in the Medicaid population, which contributes disproportionately to the national overdose toll. To build evidence on these vital issues, we will use 45-state Medicaid data from 2001-2019, linked to the National Death Index (NDI), supplemented with regularly updated state data from New Jersey and Missouri, to identify the interacting factors contributing to overdose risk and to outcomes for overdose survivors. Under Aim 1, overdose risk will be examined in national incidence cohorts of Medicaid beneficiaries with new episodes of persistent opioid use, and those with new diagnoses of opioid use disorder (OUD). To analyze both non-fatal and fatal overdoses, we will link Medicaid data with the NDI for 50,000 individuals with new persistent use, and 50,000 individuals with new OUD diagnoses, for each year of the Medicaid data, totaling 950,000 in each cohort over the study period. Under Aim 2, we will examine treatment engagement and survival following non-fatal medically treated overdoses, linking Medicaid and NDI data on these overdoses to identify factors affecting post-overdose treatment and outcomes. Under Aim 3, we will examine the impact of an important natural experiment in state policy: the 2017 enactment of major New Jersey legislation. Changes included new limitations on opioid prescribing; use of pain management contracts; and expanded access to medication assisted treatment (MAT) for opioid use disorder. Substantial increases in Medicaid rates for MAT and other OUD treatment were implemented concurrently. Using analytic models similar to those in Aims 1 and 2, we will examine changes in overdose risk among individuals with new long- term opioid use, and among those with new OUD diagnoses, before and after the implementation of the new legislation, relative to comparison populations in states that did not implement similar policies. These analyses will advance our fundamental understanding of opioid risks and outcomes in the Medicaid population with its distinctive demographic characteristics and clinical challenges. By grounding intervention policy in a more comprehensive understanding of overdose risk, and the complex intersection of disability, multi-morbidity, and treatment services within which overdose events are embedded, results can change the paradigm of overdose prevention to one that is informed by a better understanding of these events and the individuals experiencing them.

 

Advancing Patient Safety for Antipsychotic-Treated Children: Examining State Implementation of Safe Use Practices

(September 30, 2018 – July 31, 2025)

Principal Investigator: Stephen Crystal
Act: R01 - Project: HS026001 - Admin / Funding IC: NIH

DESCRIPTION (provided by applicant): This project will address, at scale, improvement of safe use practices for antipsychotic (AP) treatment of Medicaid children. Safe and judicious management of APs poses significant challenges, given hazards that include elevated risk of Type 2 diabetes, weight gain, hyperglycemia, hyperlipidemia, and potential long-term impact on brain development. Safety evidence and guidelines highlight the importance of several key safe-use practices that can help mitigate these risks, including monitoring blood glucose and lipids; avoiding concurrent use of multiple different APs; first-line use of non-pharmacological mental health services; and minimizing use among pre-school children. Prior AHRQ-supported projects have led to HEDIS/CMS quality metrics for these practices, but their implementation is highly inconsistent. Many state initiatives have been implemented to improve these safe-use practices, but the impact of alternative strategies for increasing safe-use is unknown. Evidence on their effects is critically needed. We will use a mixed-methods strategy to identify and document state implementation of safe-use initiatives; assess their impact on safe use metrics; investigate causal mechanisms underlying effectiveness; and actively disseminate results to state decisionmakers, health plans, clinical communities, and other stakeholders. This process will support translation, implementation, and improvement of effective strategies across states. We will provide a comprehensive analysis of systems-level strategies, using a national survey and case studies in 8 purposively sampled states, to investigate distinctive approaches. We will use key informant interviews and systematic document review to identify implementation timelines, strategies, causal mechanisms, barriers and solutions, and tools utilized. We will then use Medicaid claims data to assess change in the use of the targeted practices following the implementation of state systems-level strategies, using difference-in-difference, triple-difference and other modeling strategies. States that did not implement similar initiatives will serve as comparators. Finally, we will actively disseminate an evidence-informed toolkit to state and stakeholder communities, utilizing active dissemination strategies successfully employed in prior AHRQ-supported partnerships. This toolkit will be developed to facilitate a self- assessment and prioritization of improvement initiatives, identification of other state strategies, and provide quality improvement and evaluation tools to assess effectiveness over time. Evidence development and active dissemination will assure that evidence on effective system-improvement processes is available, understood, and effectively used to improve patient safety across populations of vulnerable children served by state Medicaid/CHIP systems and reduce AP-related harms.

 

Improving MOUD Access, Opioid-Related Outcomes and Equity Among Medicare Beneficiaries with Disability

(September 1, 2022 – July 30, 2027)

Principal Investigator: Stephen Crystal
Act: R01 - Project: DA057568 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant): Medications for opioid use disorder (MOUD) are a key tool in reducing harms of the opioid epidemic. Yet only a minority of those with OUD initiate treatment, early discontinuation is typical, and disparities are endemic. People with disabilities are at especially high risk and epitomize the challenges of OUD with multimorbidity. Preliminary analyses identified 45,035 fatal opioid overdoses among Medicare disability beneficiaries (MDBs) from 2008-2016, and continuing under-utilization and disparities in MOUD, including among overdose survivors. With its wide influence in the health care system, Medicare's role is vital; it is essential to examine the Medicare system's successes and failures in engaging and retaining MDBs in treatment. Several recent policy changes are promising, with important implications for other payers, but their impact across beneficiary subgroups, time and communities needs to be better understood to inform action to improve uptake and reduce disparities. This study, responding to RFA-DA-22-037, will use national Medicare data linked with the National Death Index, Medicaid claims, community resources, prescription drug plan (PDP) formulary policies, and other data sources to assess how policy, community, provider and patient factors interact to shape MOUD initiation and retention, and in turn overdose and other clinical outcomes. With annual updates through 2025, the project will provide a powerful framework for assessing evolving treatment patterns and outcomes in a rapidly evolving environment, as well as potential changes in policy impacts over time. We will assess the drivers of racial/ethnic and other disparities in access; MOUD changes following policy and formulary changes by Medicare and its PDPs; and how these policies interact with the evolving MOUD provider system, community resources and patient characteristics. We will analyze trends and disparities in MOUD treatment and overdoses among MDBs. In cohorts of beneficiaries with new OUD diagnoses or non-fatal overdoses, we will assess factors associated with treatment initiation and retention, and association of treatment with clinical outcomes including non-fatal and fatal overdose. We will assess MOUD uptake across community, provider, and patient subgroups; changes in MOUD treatment patterns associated with the shift to tele-health; and associated changes in the MOUD treatment network serving MDBs. We will examine the sequelae of changes in formulary policies across Medicare's more than 6000 PDPs, including prior authorization requirements for MOUD, across beneficiary subgroups. Expanded reimbursement for tele-MOUD and elimination of prior authorization have the potential to save many lives, but it is critical to better understand their impact on access and disparities. An active dissemination strategy supported by a Stakeholder Advisory Board, complementing peer-reviewed publication, will support translation into evidence-informed policy. Results of this innovative and comprehensive assessment of the multi-level factors shaping MOUD uptake and outcomes among MDBs will have important implications for policy and practice across patient subgroups, payers and health care systems.

 

Improving outcomes and equity for released prisoners with SUD: trajectories of participation in pre-release and post-release MOUD, peer navigation, and outcomes 

(May 1, 2024 – February 28, 2029)
Principal Investigator: Stephen Crystal

Act: R01 - Project: DA058664 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant): Following prison release, individuals with substance use disorders (SUDs) experience high rates of return to substance use and overdose. Justice-involved people account for an important part of the population with high overdose risk; therefore, a high priority for national overdose prevention strategies is to identify and implement better interventions to support them in safe re-entry. Promising strategies include pre-release medication for opioid use disorder (P-MOUD) and peer navigation (PN). To assess implementation and effectiveness, and support translation across the nation's prison systems, it is vital to assess uptake and re-entry outcomes; identify what components are effective, for whom, how and why, and for how long; document barriers and facilitators to program success; and assess PN's effectiveness in supporting post-release MOUD retention and recovery. New Jersey has implemented both interventions at large scale across all of its 11 prisons, with more than 4,000 individuals receiving P-MOUD and 2,500 PN through 2022, creating a unique research opportunity to develop and disseminate knowledge on these interventions when implemented systemwide as standard practice. Use of richly linked clinical and administrative data, for an unprecedently large cohort of individuals with SUD released from 2016-2027, will provide power to assess interactions among interventions and their effects in key subgroups, with longitudinal follow-up to examine long-term outcomes, using state-of-the-art analytic models to produce robust estimates across subgroups of concern. Innovative mixed-methods strategies, leveraging linked data and first-hand experiences, will assess patterns and disparities in pre-release MOUD and PN participation; retention in services during re-entry; and recovery outcomes among participants and non-participants. In-depth interviews during re-entry will document participants' experiences with the programs, in the context of their broader re-entry experience, their decision making about MOUD and illicit drug use, and recovery barriers and facilitators. Interviews with policymakers, providers, and other stakeholders will elicit their perspectives on implementation and generate evidence to support cross-state translation. Among releasees with SUDs, the study will: 1.) examine patterns/predictors of pre- and post-release MOUD and PN; 2.) examine recovery outcomes over the re-entry period and their relationship to PN and MOUD, separately and jointly, utilizing innovative event history analysis strategies incorporating propensity scoring and machine learning strategies; and 3.) utilize qualitative interviews to elicit experiences of implementation and adaptation of PN and MOUD from the perspectives of participants and multiple other stakeholders. Implementation and dissemination will be guided by a Stakeholder Advisory Board including persons with lived experience, providers, correctional leaders, prisoner rights advocates and experts. This study of NJ's innovative, large- scale interventions provides a unique opportunity to build knowledge that can help save lives and improve outcomes during community re-entry, with important implications for intervention in other at-risk populations.

 

Enhanced Assessment of Overdose Mortality, Other OUD-Related Outcomes, Treatment Access and Equity Among Medicare Beneficiaries with Disability, Across Racial/Ethnic Subgroups and Communities

(September 1, 2022 – June 30, 2027)
Principal Investigator: Stephen Crystal

Act: R01 - Project: DA057568 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant): Analyses of MOUD access and medically treated overdoses in samples of Medicare disability beneficiaries (MDBs) have provided important insights, but it is vital to extend these to incorporate linkage with the National Death Index (NDI) to better understand predictors of fatal overdoses involving opioids and health system strategies to reduce them. Particularly critical is the need for firmer understanding of treatment history, clinical, demographic, community, and other factors associated with increasing fatal-overdose risk among minoritized communities, using 100% Medicare data with the statistical power to support accurate assessment across racial/ethnic subgroups and communities, providing insights with broad significance for overdose prevention across populations and payers. Under new CMS policies, NDI-claims linkage is available only in CMS’s Virtual Data Research Warehouse (VRDC) through purchase of a VRDC seat. At the same time, newly-available data from a 100% NDI-claims match now in the VRDC offer an opportunity to expand statistical power and outcomes assessment to accurately measure MOUD uptake and fatal-overdose risk. Linkage of NDI data with diagnostic and treatment histories from Medicare claims for the full MDB population offers a unique, timely opportunity to improve statistically significant estimation across subgroups and communities from the original sample of fee-for-service beneficiaries to the broader population of Medicare disability beneficiaries (MDBs), adding NDI linkage. This will enhance power for variations and outcomes across minoritized populations and communities, and provide access to mortality outcomes that is no longer possible through investigator- managed physical-data linkage as originally planned, due to new CMS policy changes. Under this supplement, we will utilize 100% linked NDI-Medicare claims data in the VRDC to identify evolving patterns of diagnostic and treatment history for fatal drug overdoses across racial-ethnic subgroups; construct 100% cohorts of opioid overdose survivors; and analyze MOUD treatment trajectories and fatal overdose risk in these expanded high-risk cohorts. This will greatly enhance resolving power for variations across racial/ethnic subgroups, improve generalizability by including the managed care population; incorporate more-recent years of data; and incorporate methadone treatment, added to Medicare in 2020. We will utilize the linked data to assess evolving patterns of fatal drug overdoses across racial/ethnic subgroups and communities; create 100% cohorts of MDBs treated for non-fatal overdose, anchored on overdose date as index date; implement event history analyses of MOUD treatment and overdose fatality risk in these cohorts; assess the role of components of treatment disparities on outcome disparities including risk of fatal overdose; and identify the most promising targets in the treatment cascade for intervention to reduce outcome disparities.

 

Informing national overdose prevention and treatment strategies for high-risk adolescents 

(September 30, 2024 – September 29, 2026)

Principal Investigator: Bushnell, Greta

Act: R21 - Project: DA062273 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant): Drug overdose is now a leading cause of death among U.S. adolescents, with mortality increasing in recent years with the proliferation and involvement of illicitly manufactured fentanyl (IMF). In parallel, nonfatal adolescent drug overdoses treated in emergency department (ED) settings have also increased. In contrast to fatal overdoses, nonfatal overdoses mainly involve non-opioid drugs, including psychostimulant and other psychotropic drugs that adolescents may use with a prescription or misuse from illicit sources with high risk of IMF adulteration. To reduce morbidity and mortality from adolescent drug overdose, we need to better understand the epidemiology of specific drug involvement in nonfatal overdoses, focusing on drugs commonly containing IMF. Overdoses treated in acute care (ED) settings represent critical opportunities for risk assessment and intervention, as mortality is significantly elevated in the period after a nonfatal event. However, limited research suggests that receipt of comprehensive behavioral health care after overdose is exceedingly low in adolescents, related to the lack of pharmacological treatments for substance use disorders, limited access to developmentally appropriate behavioral therapies, and high rates of co-occurring mental illness and suicide symptoms that complicate treatment decisions. Thus, we need to address the large gaps in evidence on the type and timing of treatment adolescents receive following a nonfatal overdose and understand the relationship between follow-up care and risk of repeat overdose. To generate evidence that can be used to inform effective prevention and treatment strategies, this proposal’s overall goal is to identify individual and clinical care factors associated with adolescent overdose risk. The specific aims are to: (1) estimate the prevalence of adolescent nonfatal drug overdose and identify high-risk demographic and clinical subgroups, stratifying by drug involvement (e.g., fentanyl) and overdose intent; (2) examine receipt of behavioral health treatment (type, timing) after nonfatal drug overdose and variation in treatment receipt by demographic and clinical characteristics; and (3) estimate incidence, critical high-risk periods, and risk factors for repeat overdoses, including the relationship with behavioral health care received after the initial event. Our central hypothesis is that drug overdose patterns differ by adolescent characteristics (e.g., sex, age group, mental health diagnoses) and that follow-up care is limited but impacts the risk of repeat overdoses. To achieve these goals, the study team will leverage national longitudinal Medicaid claims data (2016-2022) comprising over 400,000 overdose events in adolescents aged 12-18 years. Our proposal offers a valid and timely approach to yield novel, generalizable, and up-to-date evidence on overdose risk and treatment in a vulnerable adolescent population. Findings will generate actionable estimates to inform targeted prevention and treatment strategies as well as a future R01 application to integrate health systems and structural factors in research on the effectiveness of behavioral health treatment modalities on reducing risk of subsequent fatal and nonfatal overdose events.

 

Cannabis use patterns and associations with cognitive impairment in older adults

(March 1, 2023 – February 29, 2028)
Principal Investigator: Ofir Livne

Act: K23 - Project: DA057417 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant): Cannabis use is increasing exponentially among older US adults (≥65 years), a population that is expected to comprise over 20% of the population in coming decades. Older adults are particularly vulnerable to cognitive impairment associated with cannabis use, and demonstrate increasingly heterogeneous patterns of cannabis use (including cannabis use histories and current use profiles). Consequently, this rapidly growing population of cannabis users will become a public health concern in coming years and merit preventive and therapeutic interventions. Extant information on cannabis use patterns and their associations with cognitive impairment is lacking in this critically understudied population. This research proposal examines associations between a range of cannabis use measures and cognitive impairment, particularly residual impairment (i.e., cognitive effects observed after acute intoxication has passed), in older adult cannabis users. Career Development Plan. Dr. Livne’s training program will include coursework and mentorship to develop his skills and expertise in survey design, aging and cognition-related research, and generalized linear modeling, causal modeling and longitudinal analyses. These are necessary for achieving his career goals of becoming an independent investigator performing impactful research on the intersection between cannabis use, cognition, and the aging population. Mentorship. Dr. Livne’s will be supported by a highly accomplished team of mentors who are experts in substance use epidemiology, biostatistics, aging, and cognition. Research Plan. For Aim 1, Dr. Livne will use data from the Health and Retirement Study, a large nationally representative study of older US adults, to examine associations between cannabis use predictors and domain-specific cognitive impairment, including residual impairment, among adults ≥65 years. For Aim 2a, Dr. Livne will recruit a large online sample of older adults via social media platforms, to describe cannabis use patterns (i.e., cannabis use histories, current profiles of use) and examine the associations between such patterns. For Aim 2b, Dr. Livne will conduct a pilot study of a subset of respondents from the online sample as well as sociodemographic ally comparable older adults with no lifetime cannabis use. Using self-administered neuropsychological assessments, he will assess the feasibility of integrating cognitive tests in online samples of older adults and provide preliminary data on associations between detailed measures of cannabis use patterns and domain-specific residual cognitive impairment, expanding on analyses from Aim 1. Public Health Impact. This project will illuminate patterns of cannabis use and associated cognitive impairment among older adults, thus informing clinicians, researchers, and policymakers of individual and public health risks in a growing yet understudied cannabis user population. Subsequently, findings will inform the development of harm reduction strategies and the feasibility of utilizing online research tools for cost-effective cognitive assessment of older adult substance users.

 

Neighborhoods, mental health, and the prevention of opioid overdose: a mixed methods approach 

(July 15, 2020 – June 30, 2025)
Principal Investigator: Elizabeth Nesoff

Act: K01 - Project: DA049900 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant): Increasing opioid use in the U.S. has led to a dramatic increase in opioid-related fatal and non-fatal overdoses (OD), and adults with mental health disorders, including anxiety and mood disorders, are significantly more likely to use nonprescription opioids. Mental health and associated drug use are directly and significantly impacted by the neighborhood environment, but few studies have examined the impact of modifiable neighborhood features on OD risk. The broad objective of this study is to investigate modifiable neighborhood factors which impact mental health and which may contribute to opioid OD. The proposed research will achieve the following interconnected specific aims using mixed quantitative/qualitative approaches with fatal OD data from New York City, Chicago, and Seattle and original in-depth interviews with people who use drugs: (1) investigate the associations between modifiable physical and social neighborhood factors and opioid OD; (2) examine key mental health indicators as mediators of the relationship between modifiable neighborhood factors and opioid OD; (3) comparatively investigate the associations between modifiable neighborhood factors, mental health indicators, and opioid OD, comparing the locations where people who use opioids lived versus the locations where they overdosed. In-depth interviews with people who use drugs will provide context for quantitative results, identifying mechanisms by which neighborhood impacts drug using and associated OD risk and informing novel strategies for OD prevention. This K01 mentored research scientist development proposal will provide the training and expertise needed to transition to research independence in drug use research. Five specific training areas will be incorporated to carry out these research goals: (1) obtain advanced skills in structural equation modeling and Bayesian modeling methods, and causal inference theory and methods; (2) develop expertise in mixed quantitative and qualitative methods research theory, design, and analysis, and build capacity in collecting and analyzing qualitative data; (3) develop subject matter expertise in psychiatric epidemiology and associated drug use risk factors, in particular, major depression, general anxiety disorders, and diagnostic criteria for psychiatric disorders; (4) obtain additional training in the ethical conduct of research among marginalized and stigmatized populations; (5) build professional skills for a successful research career as an independent scientist leading multidisciplinary teams to build new knowledge and address major challenges in drug use and abuse. These training goals will be achieved through a combination of didactic courses, specialized workshops, hands-on research, and mentoring from an interdisciplinary team of experts. This research and training will lead to a subsequent R01 proposal that formally tests implementation strategies and effectiveness of neighborhood-level interventions for OD prevention.

 

The impact of community infrastructure reinvestment programs on opioid misuse and opioid overdose 

(September 30, 2023 – August 31, 2028)
Principal Investigator: Elizabeth Nesoff

Act: R01 - Project: DA059371 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant): Discriminatory housing and zoning policies that cause residential racial segregation, concentrated poverty, and lack of economic opportunity often result in neighborhood disinvestment and increased neighborhood disorder. Neighborhood disorder—deterioration of the urban landscape, also known as blight—significantly impacts opioid misuse, including opioid initiation, injection drug use, opioid use disorder development and duration, and risk of opioid-involved overdose. Interventions to improve disorder have shown significant positive impacts on neighborhood crime, gun violence, and mental health. No studies have yet investigated the degree to which neighborhood disorder interventions influence opioid misuse or associated overdose risk. The broad objective of this study is to investigate the impact of community infrastructure reinvestment programs on opioid misuse and opioid overdose. In Philadelphia, government, community, and academic partnerships have resulted in structural interventions (PHS Philadelphia LandCare and Basic Systems Repair Program) to remediate vacant lots, abandoned buildings, and dilapidated homes. These programs are designed to improve neighborhood disorder in resource-deprived, minority-majority neighborhoods with little to no green space and may have distal effects on opioid misuse and associated overdose risk. Previous Philadelphia studies have shown significant reductions in crime and improved stress and depression for residents on blocks with blight remediation. This study will use spatial analysis methods and systematic social observation to address HEAL's RFA DA-23-051 Preventing Opioid Misuse and Co-Occurring Conditions by Intervening on Social Determinants. Specific aims are: (1) Investigate whether street block-level indicators of opioid misuse differ on blocks with blight remediation activities using systematic social observation methods for primary data collection of litter from opioid misuse (e.g., syringes, tourniquets) and harm reduction paraphernalia (e.g., wound care, naloxone); (2) Examine if fatal and nonfatal opioid overdose rates improved with remediation activities using a longitudinal spatial panel approach with fatal overdose data from Philadelphia's medical examiner and nonfatal overdose data from hospital emergency care visits; (3) Explore mechanisms by which remediation activities improve neighborhood indicators of opioid misuse and fatal and nonfatal overdose rates, including improved community mental health (measured by BRFSS data) and improved community social capital and social cohesion (measured by primary data collection of neighborhood structures related to these concepts), using systematic social observation and spatial analysis methods. This study will examine the impact of highly innovative place-based public health interventions on opioid misuse and fatal and nonfatal opioid overdose. Findings will provide support for expanding neighborhood disorder remediation projects in Philadelphia and promote similar public health-based policy and community-level health interventions for opioid misuse and overdose prevention in other cities.

 

Optimizing long-acting injectable PrEP strategies for sexual minority men who use methamphetamine 

(September 30, 2024 – September 29, 2026)
Principal Investigator: Christian Grov

Co-Principal Investigator: Patel, Viraj V

Act: R21 - Project: DA062591 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant): This exploratory R21 proposal addresses a critical gap in HIV prevention by identifying preferences and care components to optimize the delivery of long-acting injectable (LAI) PrEP for sexual minority men (SMM) who use methamphetamine (meth). In the U.S., SMM are disproportionately affected by HIV, exacerbated by the resurging meth epidemic. SMM who use meth have a quadrupled risk of HIV seroconversion, and those who use stimulants face a 3-fold risk of disengagement from PrEP care and 5-fold risk of sub-optimal oral PrEP adherence. Bimonthly LAI PrEP has proven more effective than daily oral PrEP, and is generally preferred by people who inject drugs. LAI PrEP could be well-received and a game-changer to improve adherence and reduce HIV risk. However, there is a lack of data that has systematically assessed acceptable and preferred strategies to maximize LAI PrEP implementation for SMM who use meth. Our study leverages the participant pool from the ongoing AMETHST U.S. national cohort of SMM who use meth (UH3AI169652, Grov/Carrico) to first qualitatively identify modifiable care options for LAI PrEP use, followed by a large Discrete Choice Experiment (DCE) to quantitatively assess care preferences. Aim 1: Conduct rapid qualitative interviews to develop the DCE. We will interview 30-36 SMM who use meth (10-12 Black, 10-12 Latinx, and 10-12 others) and 20-30 healthcare providers with diverse experiences (e.g., LAI PrEP implementation experience, primary care or specialized clinic providers, and PrEP educators/navigators). Open-ended questions will gather insights on familiarity and preferences for LAI PrEP delivery, barriers and facilitators, healthcare settings and providers, and social, behavioral, and practical considerations. These insights will help develop DCE attributes and levels and inform choice architecture for testing. Aim 2: Elicit the preferred choice architecture for LAI PrEP care delivery using a rigorous DCE among a sample of 600 SMM who use meth, stratified by race/ethnicity: 200 Black, 200 Latinx, and 200 others. Plus, we will collect additional data on demographics, risk behaviors (e.g., sexual practices, current meth/substance use), and LAI PrEP experiences. After pilot testing the DCE, we will recruit participants for this new study from the ongoing AMETHST cohort (an available participant pool of 2,820 HIV-negative SMM who use meth, 56.5% persons of color), n = 600 of whom will complete an online DCE (via Sawtooth Software) and survey (via Qualtrics). Hierarchical Bayesian regression models will evaluate utilities for each attribute level and determine the relative importance of attributes among diverse SMM who use meth subgroups (e.g., race/ethnicity, rural/urban). Impact: This timely R21 developmental study will generate critical insights on care preferences among diverse subgroups of SMM who use meth to inform LAI PrEP implementation in the U.S., providing actionable data to guide targeted, scalable strategies for novel prevention products and delivery systems, ultimately reducing HIV incidence in this highly affected population.

 

Optimizing HIV prevention for highly vulnerable methamphetamine-using sexual minority men

(April 8, 2022 – April 30, 2027)
Principal Investigator: Christian Grov

Co-Principal Investigator: Adam Wayne Carrico

Act: U53 - Project: AI169652 - Admin / Funding IC: NIAID

DESCRIPTION (provided by applicant): This LITE-2 (RFA-AI-21-018) initiative responds to a resurgent epidemic of methamphetamine (meth) use in sexual minority men (SMM), which is a primary driver of HIV incidence. The overarching goals are two-fold: 1) identify multi-level and bio-behavioral determinants of amplified HIV seroconversion risk in meth-using SMM; and 2) test the effectiveness of telehealth motivational enhancement interventions for optimizing entry or re-entry of SMM who use meth into the PrEP care continuum. Findings from our LITE-1 cohort (UG3/UH3 AI-133675, RFA-AI-16-031) and others provide compelling evidence that meth use is increasing, disproportionally impacts racial/ethnic minorities, and accounts for one-in-three new HIV infections in SMM. In response to LITE-2 (RFA- AI-21-018) we propose a multi-component initiative zeroing in on the “Where,” “How,” and “Why” of meth use and HIV risk. Where: What are the geospatial determinants of the association of meth use with HIV incidence? How: How can we support (re-)entry into the PrEP care continuum with this high priority population of SMM who use meth? Why: Does meth amplify biological risk of HIV by potentiating rectal immune dysregulation? Aim 1: Examine multi-level structural, psychological, and social determinants of amplified HIV seroconversion risk in SMM who use meth. The centerpiece of our LITE-2 initiative is a new prospective, bio-behavioral cohort with N=5,000 SMM (n=3,000 SMM who use meth, n=2,000 who do not). Participants will complete assessments over 36 months and provide biological samples for HIV testing, drug toxicology testing, rectal STIs, and rectal cytokines/chemokines. Our primary goal will be to investigate the role of geospatial determinants (e.g., background meth and HIV prevalence, urbanicity) and other structural determinants (e.g., structural stigma of sexual minorities as evidenced by policies/laws) in relation to the association of meth use with amplified HIV seroconversion risk. Aim 2: Test the comparative and combined effectiveness of telehealth motivational enhancement interventions for optimizing PrEP use. PrEP Readiness Interventions for Supporting Motivation (PRISM) is a hybrid type I, modified factorial randomized controlled trial (RCT) of telehealth CM that provides incentives for filling a PrEP prescription, and a 2-session telehealth MI intervention that we adapted with meth- using SMM (R34-DA046367, Carrico/Grov). PRISM will enroll 840 meth-using SMM who are not currently taking PrEP from the LITE-2 cohort (Aim 1) to examine the effectiveness of CM (n = 280), MI (n = 280), and MI+CM (n = 280) on the primary outcome – filling a PrEP prescription. Aim 3: Determine whether greater rectal immune dysregulation partially explains amplified risk of HIV seroconversion in SMM who use meth. Using a case-cohort design, we will compare HIV seroconverters (n=450) with matched seronegative controls (n=450) to examine the clinical relevance of meth-induced alterations in rectal cytokines with respect to HIV seroconversion. This LITE-2 initiative could have an exceptional impact by transforming HIV prevention with SMM.

 

The role of adverse community-level policing exposure on disparities in Alzheimer's disease related dementias and deleterious multidimensional aging

(April 15, 2023 – January 31, 2028)
Principal Investigator: Paris Adkins-Jackson

Act: K01 - Project: AG081454 - Admin / Funding IC: NIA

DESCRIPTION (provided by applicant): To reduce racial disparities in Alzheimer’s disease related dementias (ADRD) for US Black and Latinx/a/o older adults, it is crucial to examine key structural determinants of health that occur across the life course, like structural racism. However, limited research explores a prominent component of structural racism, adverse community-level policing (CLP), that Black and Latinx/a/o older adults have consistently encountered across the life course from historical police-sanctioned lynchings during early life, to police-involved killings, arrests, and incarcerations of Black and Latinx/a/o persons during midlife. The National Institute of Aging’s Health Disparities Research Framework identifies political factors as a priority area of research on aging, yet minimal research exists on this determinant. In this study, I will fill major gaps in understanding how adverse CLP exposure increases risk for incident dementia, cognitive decline, accelerated aging, and poor psychological health for Black and Latinx/a/o older adults. The specific research aims are to examine the following among Black and Latinx/a/o participants in the Health and Retirement Study: Aim 1) Estimate the association between midlife adverse CLP exposure with depressive symptoms and subjective cognitive function over a 20-year period starting from the onset of the Violent Crime Control and Law Enforcement Act of 1994. Aim 2) Explore the relationship between early life adverse CLP exposure with incident dementia and accelerated biological age after 50. Aim 3) Compare the effects of early and midlife adverse CLP exposure on objectively measured memory performance in late life. These aims lay the groundwork for a R01 application exploring interventions to the pathway from adverse CLP exposure to ADRD. Dr. Paris Adkins-Jackson’s long-term career goal is to become an independent investigator that leads research that explicates the role of structural determinants like structural racism on ADRD and multidimensional aging for historically marginalized groups like Black and Latinx/a/o communities. She seeks a K01 Mentored Research Scientist Development Award to obtain critical content area knowledge on ADRD, cognitive function, and biological aging to complement her expertise in structural racism and psychological health, which will lead to an independently funded research program. Her career development plan includes didactic courses and mentored research in ADRD, cognitive function, and biological aging, and leadership in ADRD disparities research. This training will occur in the rich environment at Columbia University, including the Mailman School of Public Health and the Gertrude H. Sergievsky Center at Columbia University Irving Medical Center. Dr. Adkins-Jackson will receive guidance from an experienced team with a strong track record of mentoring and funding in ADRD, cognitive function, biological aging, and adverse CLP exposure—many of whom wrote seminal literature on structural racism and ADRD disparities. Building on such work, this study determines the magnitude of a modifiable factor that may lead to neurodegeneration and harmful aging.

 

Estimating the impact of the school-to-prison pipeline on adolescent health: racialized, spatial disparities in policing, school discipline, substance use, and mental illness 

(May 15, 2023 – March 31, 2028)
Principal Investigator: Seth Prins

Act: R01 - Project: DA058028 - Admin / Funding IC: NIDA

DESCRIPTION (provided by applicant): Over 10 million students in the US attend schools with police but no counselor, nurse, psychologist, or social worker. Yet, more than a third of the low proportion of adolescents who receive the substance use treatment they need (6%) access it only at school; they are disproportionately Black and low- income. Schools are thus crucial public health intervention targets for substance use and mental health treatment, prevention, and health equity therein. But instead, many adolescents experience school as a school- to-prison pipeline; a set of policies and practices that criminalize adolescents and ensnare them in the legal system rather than provide support for underlying educational and developmental needs. School-based arrests increased 300-500% and exclusionary school discipline (suspensions and expulsions) doubled over the past 40 years. Black students are more than three times as likely to be suspended or expelled as white students, all else equal, and students removed from school are more than twice as likely to be arrested in the same month than those not removed. Our preliminary evidence suggests that the school-to-prison pipeline is a previously unidentified population driver of adolescent substance use and mental illness. Moreover, the pipeline coincides with rises in aggressive community policing in schools’ surrounding communities. However, there is no research on the public health implications of these intersecting trends. In the proposed R01, we will collaborate with the New York City Office of School Health (OSH) to quantify relationships between aggressive community policing, school discipline, and student substance use/mental illness in NYC. We will create a unique geocoded 2000- 2022 dataset linking all police stops/arrests; school- and student-level exclusionary discipline; restricted school- level Youth Risk Behavior Survey (YRBS) data (e.g., tobacco, alcohol, cannabis, other drug use); and OSH’s database of student health services records (e.g., nurse, counselor visits, referrals to mental health/substance use treatment). We will (Aim 1) characterize direct and mediated relationships between community policing and school discipline on school-level and (Aim 2) student-level substance use and mental health outcomes; and test (Aim 3) whether the intensity of policing around schools modifies the relationship between school discipline and student substance use/mental health. In all aims, we will test whether structural and institutional racism in policing and school discipline modify hypothesized relationships. This high-impact project responds to NIDA’s interest in improving SUD treatment for vulnerable populations in schools and the juvenile justice system, as well as leveraging data science to improve SUD prevention. Our diverse, interdisciplinary team, led by an early-stage investigator PI, has expertise in substance use, psychiatric, and social epidemiology; school health; the sociology of racialized disparities in population health, education, and policing; spatial epidemiology/health geography; and data science. Findings will be utilized by policymakers and project stakeholders (including city, state, and federal policymakers) working to end the school-to-prison pipeline and prevent adolescent substance use/mental illness.

 

Adolescent substance use as determinant and consequence of the school-to-prison pipeline: Disentangling individual risk, social determinants, and group disparities 

(February 1, 2019 – January 31, 2025)
Principal Investigator: Seth Prins

DESCRIPTION (provided by applicant): The purpose of this Mentored Research Scientist Development Award (K01) is to help me become an independent investigator who conducts interdisciplinary, policy-relevant research on the individual, school, and community factors that put adolescents at risk for substance use and justice system contact. Specifically, I propose to investigate an issue previously unexplored: the role of substance use as a determinant and consequence of the “school-to-prison pipeline”—a set of policies and practices that make it more likely for some adolescents to become entrenched in the criminal justice system than to receive a quality education. The training from this K01 will allow me to (1) learn and apply more specialized, advance quantitative methods in complex nested data and causal inference for mediation and interaction; (2) gain expertise in racial and LGBTQ health disparities and (3) adolescent health and juvenile justice; and (4) gain skills in grant-writing, professional development, sampling methods, and data collection/acquisition necessary for submitting my first R01 proposal. My career development plan includes specific seminars, workshops, coursework, conferences, and tailored mentoring from a multidisciplinary team comprising experts in social/behavioral sciences, advanced quantitative methods, adolescent trajectories of substance use and mental illness, racial and LGBTQ disparities in health and school discipline, school policy and adolescent health, adolescent exposure to the criminal justice system, and criminological theory and juvenile justice. The proposed research is particularly important because school- based arrests have skyrocketed 300-500% since the 1990s, and out-of-school suspensions (which double the risk of arrest) have more than doubled over the past 40 years. However, there is a substantial gap in knowledge about the public health consequences of these trends, given that (1) adolescents with substance use problems have increased risk of exposure to the justice system, and exposure to the justice system increases subsequent risk of substance use problems; (2) substance use is a prototypical “zero tolerance” infraction implicated in school discipline/arrest; and (3) there are known racial and sexual orientation disparities in school discipline and substance use. To fill this gap, the proposed research will (1) investigate prospective associations among substance use, teacher/school factors, school discipline, community factors, and school-based arrests with unprecedented multi-level, multi-source data on students, teachers, schools, and communities; (2) determine whether modifiable individual, teacher, school, and community factors explain racial and LGBTQ disparities in substance-use-related school discipline/arrests; and (3) test whether there is a reciprocal relationship between substance use, school discipline, and school-based arrests. This project will inform a NIDA R01 proposal that will expand and further develop K01 research findings. The new skills I acquire through this K01 will position me to become an independent researcher who integrates substance use, public health, and criminal justice research, and one of the few investigators studying the substance-use-related school-to-prison pipeline.

 

Summer Institute for Training in Biostatistics and Data Science at Columbia (SIBDS@Columbia)

(January 15, 2022 – December 31, 2026)
Principal Investigator: Kiros T. Berhane 

Act: R25 - Project: HL161786 - Admin / Funding IC: NHLBI

DESCRIPTION (provided by applicant): We propose to establish an innovative summer training program to introduce fundamental principles of biostatistics and data science to a diverse pool of promising undergraduate and beginning graduate students for careers as quantitative scientists with a focus on biomedical research. The proposed seven-week program, Summer Institute for Training in Biostatistics and Data Science at Columbia (SIBDS@Columbia), will be taught by a pool of world-renowned faculty with expertise and extensive funded research in several key areas of biostatistics and data science, hailing from diverse backgrounds and including women, African, Latino, and first in their family to attain a college education, with passion for hands-on mentoring of students and diversity in the workforce. Trainees will have the opportunity to interact with world-class experts in domain areas relevant to the missions of NHLBI and NIAID and will be immersed in research through carefully designed projects utilizing quantitative skills acquired from the program on data from studies involving heart, lung, blood, and sleep disorders and infectious disease epidemiology. The program will be housed within the Department of Biostatistics at Columbia University, which has a long and successful history of training promising undergraduate students from diverse backgrounds through its long-running BEST (Biostatistics and Epidemiology Summer Training) Diversity Program and past cycles of the Columbia SIBS (CSIBS) program. Under the proposed training program, we will create a pipeline complimentary to (and synergistic with) the existing BEST program by focusing on state- of-the-art data science skills, as opposed to the BEST program’s focus on the intersection of biostatistics and epidemiology. There will also be new innovations to demonstrate the value of biostatistics and data science in interdisciplinary research and also a new added focus on research of infectious diseases. Specifically, we propose to (i) identify and recruit a diverse and quantitatively skilled group of 14 undergraduate and beginning graduate college students every summer; (ii) immerse trainee cohorts in a carefully designed curriculum of fundamental concepts of biostatistics and data science, computing skills, and hands-on biomedical data analysis; (iii) mentor trainees on professional development toward graduate studies in biostatistics and data science and subsequent careers; and (iv) ensure success of trainees by a well-structured tracking system through degree completion, pursuit of graduate studies, and subsequent careers as quantitative scientists. Given Columbia’s reputation as a major research hub, its extensive portfolio in NIH-funded research, its expert faculty and mentors, an existing network of successful alumni from previous BEST/CSIBS cycles as models for trainees, and its location in ethnically diverse and culturally rich New York City, we are poised to continue to contribute substantially toward expanding a diverse pool of well-trained biostatisticians and data scientists that can handle the complex data analyses needed to address today’s most pressing research questions.