Clinical trials

The primary aim of this study is to adapt the Comprehensive Adherence Resource and Empowerment Support (CARES) intervention to support adolescent girls and young women (AGYW) aged 16-24 in Zimbabwe and South Africa in effectively using various forms of pre-exposure prophylaxis (PrEP), specifically oral, ring, and injectable PrEP. Originally developed for a clinical trial setting, CARES has shown promising results in enhancing effective PrEP use through a structured mix of counseling, SMS/phone calls, and peer support for daily oral PrEP and the PrEP ring. However, its resource-intensive design requires adaptation for routine public health settings to ensure feasibility, fidelity, acceptability, and effectiveness. This adapted intervention will be tailored with input from AGYW, PrEP providers, and local stakeholders to support sustainable PrEP use and address HIV prevention needs among AGYW. Additionally, it will incorporate injectable PrEP and be modified to suit routine public health contexts. Once the components are finalized, the adapted CARES intervention will be evaluated for effectiveness, feasibility, fidelity, and acceptability.

The objective of this study is to develop and pilot a program designed to improve mental health outcomes and reduce suicide risk during the transition from military to civilian life. It is hypothesized that the Transition Health and Resilience through Valued Experiences (THRiVE) program, to be developed as part of this study, will meet participant recruitment, retention, and satisfaction benchmarks (primary outcomes) and show positive preliminary effects on mental health symptoms, risk factors for suicidal ideation, and psychosocial functioning outcomes (secondary outcomes). The specific aims of this study are to: 1. Develop a small-group, peer-led, cross-cutting prevention program for newly separated veterans (NSVs) called THRiVE and 2. Evaluate the feasibility, acceptability, and preliminary effects of the THRiVE program on mental health symptoms, risk factors for suicidal ideation, and psychosocial functioning outcomes. Up to 40 NSVs participating in this Stage 1 pilot study will complete validated self-report measures at baseline, immediately after completing the THRiVE program (post-THRiVE), and 3 months after completing the THRiVE program (follow-up). The duration of a participant's time in the study is anticipated to be 5 months.

The goal of this Nutrition for Precision Health (NPH) powered by All of Us research study is to develop Artificial Intelligence/Machine Learning (AI/ML) algorithms that predict individual responses to diet patterns using rich multimodal data streams collected across multiple domains (e.g., behavior, social, environmental, clinical and molecular biomarkers). NPH includes a large phenotyping cohort (Module 1, N=8000) and two separate follow-up groups drawn from a subset of Module 1participants. One group (Module 2, N=1200) receives three distinct diets in a 14-day crossover sequence, with at least a 14-day washout period between diets, while living in their own homes. A second group (Module 3, N=150) receives the same three diets under full-time supervision in a residential research setting. We will train and test AI/ML models to predict 0-4 hour postprandial response curves for glucose, insulin, triglycerides, and GLP-1, to the standardized diet-specific meal test (DSMT) collected after each of the three different diets delivered in Module 2. Each diet functions as a controlled stimulus to reveal biological features (such as individual variables, patterns, or clusters of measurements) that best predict a person's response. The Module 2 DSMT response curves are the primary outcomes (dependent variables) for AI/ML algorithms that predict individual responses to diet patterns. As a secondary objective, NPH will evaluate the validity and acceptability of technology-based dietary assessment tools. The Automated Self-Administered 24-hour recall (ASA24), Automatic Ingestion Monitor-2 (AIM-2), and the mobile food record (mFR) will be evaluated in Modules 2 and 3, and the ASA24 food record and the image-assisted ASA24 recall will be evaluated only in Module 3. Total energy intake, macronutrient and dietary fiber intake data are the main outcomes for validity testing compared against measures of actual intake. Acceptability will be determined from feedback surveys.

The Collaboration for Down Syndrome Progress (CDP) is a long-term study that follows people with Down syndrome of all ages. The goal is to better understand their health, development, and everyday experiences over time. Participants and their caregivers will answer questions, share medical information, and may give samples like blood or saliva. Some participants may also take part in optional activities such as sleep studies, movement tracking, or brain imaging. By collecting the same types of information at many sites, the CDP will help researchers learn why certain health conditions are more common in people with Down syndrome and how to improve care and quality of life.

The goal of this trial is to test a modified mobile health intervention (with a group component) relative to a mobile health intervention in a two-arm randomized trial with up to 500 young women who are human immunodeficiency virus (HIV)-negative and who misuse alcohol. The expected outcomes are to: (1) determine the efficacy of the virtual group component in reducing alcohol use and sexual risk and increasing pre-exposure prophylaxis (PrEP) utilization; and (2) understand selected outcomes for implementation. Participants will be randomized to receive either the mHealth app or the mHealth app plus the group component, and followed up at 3- and 6-months post-enrollment.

This research will evaluate the effectiveness and implementation of a couples shared decision-making intervention, CUPID (Couples United in HIV Prevention Informed Decisions), delivered in community and clinic settings to support women's pre-exposure prophylaxis (PrEP) choice and use through male partner support and shared decision-making. Through a partnership with Ministry of Health clinics already providing choices for PrEP in Uganda, the investigators will evaluate whether CUPID is effective in increasing PrEP uptake, persistence, and use among Ugandan women and assess implementation outcomes to determine whether it is acceptable and feasible to implement. If successful, CUPID will offer a community-based strategy for engaging male partners to support PrEP choice and improve HIV prevention among women and provide a scalable and sustainable intervention that will contribute to a more comprehensive approach to HIV prevention.

The goal of this study is to evaluate the active bystander training provided by Safe Bars, Inc. and their local chapter organizations to staff at alcohol-serving establishments (e.g., bars). The training aims to improve norms about violence, create safer environments by teaching staff to intervene in potentially harmful situations, and help prevent sexual violence in the venue community. The study will examine the implementation and effectiveness of the training. The main questions it aims to answer are: 1. Do staff and patrons at venues that have received Safe Bars training experience lower rates of sexual violence at the venue than staff and patrons at venues that have not received the training? 2. Are staff at venues that have received Safe Bars training more likely to intervene in potentially risky situations than staff at venues that have not received the training? 3. What characteristics of venue environments and staff and patron beliefs and perceptions are responsible for effects of the training on sexual violence and bystander behavior outcomes? 4. What characteristics and conditions are necessary for effective Safe Bars implementation and improved staff and patron outcomes? Researchers will compare staff and patron experiences at venues that have received the training with venues that are offered a delayed training. Staff and patron participants will be asked to complete surveys over about 12 months, research staff will conduct observations of training and observations in the venues, and selected venue managers and staff will be asked to complete individual interviews.

Primary Objective: Conduct a rigorous evaluation of a prevention-based intervention designed to mitigate the harms of adverse childhood experiences (ACEs) exposure and prevent future ACEs, substance use, and overdose within 36 communities experiencing a disproportionate burden of substance use and ACEs. The study has three aims: (1) use a cluster randomized controlled trial to test effectiveness of the Strengthening Families Program (SFP) + Family Advocate (FA) intervention on substance use, overdose, and ACEs in 18 communities compared with SFP-only in 18 communities; (2) conduct a robust process evaluation informed by the Consolidated Framework for Implementation Research (CFIR) to explore implementation barriers and facilitators; and (3) conduct a cost evaluation to accurately estimate the costs required to implement SFP and SFP+FA and assess the cost-effectiveness of SFP+FA relative to SFP alone. Findings will provide a roadmap about the best ways to help disproportionately affected communities prevent substance use, overdose, and ACEs.

This study tests ways to help opioid treatment programs (OTPs) keep patients in care. Staying on methadone or buprenorphine is linked to better outcomes, yet many people leave treatment early. The project will compare two approaches that provide clinics with retention/outcome quality measures and a quality-improvement (QI) toolkit-either alone or with added facilitation-against usual care. Forty-five BayMark OTPs in multiple states will be randomly assigned to one of three groups: (1) quality measures + QI toolkit; (2) quality measures + QI toolkit + external QI facilitation; or (3) usual care. The primary outcome is 90-day retention in treatment, measured from OTP electronic health records and Medicaid claims. Secondary outcomes include emergency department visits, hospitalizations, overdoses, and mortality. Findings will identify practical, scalable strategies to improve patient retention in OTPs.

This project will study virtual delivery of Safe Dates for Young Parents (SDYP), a 10-session, group-based intimate partner violence (IPV) prevention program tailored for adolescents and young adults who are pregnant or parenting. This program has the potential to improve the health and well-being of young parents and their children, and virtual delivery may improve participants' ability to attend. The main questions it aims to answer are: (1) Is it feasible and acceptable to implement SDYP in a virtual setting? (2) Are SDYP participants less likely to experience IPV than participants in an alternate health education program? Participants will be invited to a series of virtual program sessions for either SDYP or a health education program focused on physical activity and nutrition and will be asked to complete surveys before the programs begin and up to 6 months later.

The goal of this trial is to learn how the Safe Dates for Young Parents (SDYP) intervention affects the sexual and reproductive health behaviors, and quality of, and attitudes surrounding intimate partner relationships in adolescents and young adults (AYA) assigned female sex at birth who are pregnant or parenting. The main questions it aims to answer are: * Will the SDYP intervention have any effect on the sexual and reproductive health behaviors during the study period? * Will the SDYP intervention have any effect on the prevention or reduction of intimate partner violence (IPV)? * Will the SDYP intervention have any effect on the attitudes and beliefs about healthy relationships? Researchers will compare the behaviors, attitudes, and beliefs about sexual and reproductive health and relationships of participants assigned to the SDYP intervention group to participants assigned to the control (non-SDYP intervention) group to see if there is any difference or changes in those behaviors, attitudes, and beliefs before-and-after or without the SDYP intervention. Participants in the SDYP intervention will attend ten (10) 50-minute group sessions that will involve interactive discussions, thinking through life-like scenarios, games, role-plays, brainstorming, and a poster contest and theatrical play.

The goal of this observational study is to help us understand more about the best ways to help individuals living with Sickle Cell Disease (SCD) get the best care. The main question it aims to answer is: How to find individuals unaffiliated from SCD specialist care use three distinct pathways? Once unaffiliated individuals are found using the pathways, Investigators will employ linkage coordinators (trained staff) to engage these patients in care. Participants will be asked to fill out an assessment survey which will cover areas such as previous and current treatment, clinic and hospital experience, pain, and quality of life. Participants will also be given the option of participation in a 1-hour long interview how they feel about treatment for sickle cell disease including clinic experience, pain, and quality of life?

The Enhancing Access to Safe and Nutritious Diets 2.0 (ENSAND) (2024-2026) project is designed to address the low per capita consumption of vegetables and variety of vegetable consumption in northern Nigeria by working with smallholder farmers to increase production and promoting healthier diets through greater vegetable consumption among farmers and their neighbors. The objective of this evaluation is to assess the effectiveness of GAIN's ENSAND program for increasing the quantity and variety of vegetables consumed by smallholder farmer households participating in the program and neighbor households paired with the farmers. This evaluation will use a quasi-experimental design to assess the impact of GAIN's ENSAND programs on the quantity and diversity of vegetables consumed by smallholder farmers and their neighbors. The evaluation will be guided by the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework. RE-AIM is a framework that is useful for evaluating the program impact of multifaceted and multilevel interventions.

The DEcent LIVelihoods for small-scale producers delivered through Economic \& Resilient food systems in Nigeria (DELIVER) (2024-2027) project is designed to address the low per capita consumption of vegetables and variety of vegetable consumption in northern Nigeria by working with smallholder farmers to increase production and promoting healthier diets through greater vegetable consumption among farmers and their neighbors. The objective of this evaluation is to assess the effectiveness of GAIN's DELIVER program for increasing the quantity and variety of vegetables consumed by smallholder farmer households participating in the program and by neighbor households. This evaluation will use a quasi-experimental design to assess the impact of GAIN's DELIVER programs on the quantity and diversity of vegetables consumed by smallholder farmers and non-farming neighbor households. The evaluation will be guided by the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework. RE-AIM is a framework that is useful for evaluating the program impact of multifaceted and multilevel interventions.