An AI-based Behavioral Intervention to Improve Pre-exposure Prophylaxis for HIV Prevention

An AI-based Behavioral Intervention to Improve Pre-exposure Prophylaxis for HIV Prevention is sponsored by National Institute of Mental Health (NIMH). Research grant to develop an AI-based intervention integrating motivational interviewing for HIV prevention.

HIV/AIDS - National Institute of Mental Health (NIMH) NIH Websites Are Changing Brochures and Fact Sheets Learn more about HIV/AIDS. Featured studies include only those currently recruiting participants . Studies with the most recent start date appear first.

PEP/PrEP Via Pharmacist-Prescribing Implementation (PEPPI) Study Type: INTERVENTIONAL Start Date: August 31, 2026 Eligibility: 18 Years to , t Location(s): EmpoweRx, Inc, Del Mar, California, United States The goal of this clinical trial is to learn if use of the PEPPI software can improve pharmacist-provided HIV prevention (PEP/PrEP) services. The main questions it aims to answer are: 1.

Does the PEPPI software make it easier for pharmacists to provide PEP/PrEP services in their pharmacy? 2. Does the PEPPI software make it easier for patients to access PEP/PrEP?

Researchers will compare pharmacists' implementation and patients' access when using the PEPPI software and when not using the PEPPI software to see if the software improves implementation and access. Participants will include pharmacists and patients. Pharmacists will be asked to provide PEP/PrEP services as normal while using the PEPPI software.

Patients will be asked to receive PEP/PrEP services from a pharmacist as normal, while using the PEPPI software.

BIG Chicago: A Trial of Basic Income Guarantee for Young People Living With HIV Study Type: INTERVENTIONAL Start Date: July 29, 2026 Eligibility: 18 Years to 35 Years, f Location(s): University of Chicago, Chicago, Illinois, United States The goal of this clinical trial is to compare two interventions - Basic Income Guarantee (BIG) + Treatment as Usual and Treatment as Usual among individuals living with HIV who have experienced financial hardships.

The main question it aims to answer is: Compared with the Treatment as Usual group, will participants in the BIG + Treatment as Usual group be more likely to improve care engagement and viral suppression? Participants on the study will be: * Randomly assigned (like the flip of a coin) to participate in either BIG + Treatment as Usual or Treatment as Usual. Participants will have an equal chance of being placed in either group.

* Complete 9 surveys over a 36 month period. * Complete a release of information so electronic medical record data can be accessed for the 18 months prior to treatment engagement and for 36 months from program enrollment. * Participants in the Treatment as Usual group will not receive any intervention.

* HIV viral load testing will be confirmed at 3 timepoints (baseline, 12 months, and 18 months). * Participants in the BIG + Treatment as Usual group will receive $500 monthly income for 18 months. * Participants in the BIG + Treatment as Usual group will complete 3 social network surveys to assess how receiving BIG impacts their social networks.

* A subset of participants in the BIG + Treatment as Usual group (30 participants) will complete 5 individual interviews over the course of receiving BIG and the 18 months after.

BetterInfo on Women's PrEP Choices and Outcomes in Malawi Study Type: INTERVENTIONAL Start Date: July 14, 2026 Eligibility: FEMALEs, 18 Years to 110 Years, t Location(s): Johns Hopkins Research Project Malawi, Blantyre, Malawi The purpose of this study is to understand PrEP user choices, preferences and implementation impact of the roll-out of long-acting injectable PrEP alongside oral PrEP among women in Blantyre, Malawi.

Study Type: INTERVENTIONAL Start Date: June 30, 2026 Eligibility: 18 Years to , t Location(s): Columbia University Irving Medical Center / NewYork-Presbyterian Hospital, New York, New York, United States The goal of the TAIL-PrEP study is to understand how to support the safe discontinuation of injectable long-acting cabotegravir (cab-LA) and lenacapavir (LEN) while maximizing the public health impact of biomedical HIV prevention interventions.

In Aim 1, the study will pilot test and assess the acceptability and feasibility of the TAIL-PrEP intervention: for participants discontinuing cab-LA, this will consist of monthly cabotegravir drug level monitoring to provide personalized HIV prevention coaching, for participants considering discontinuing cab-LA or LEN, this will consist of a one-time personalized HIV prevention coaching session.

In Aim 2, the study will refine the TAIL-PrEP intervention and implementation strategy based on findings from the pilot study.

Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV Study Type: INTERVENTIONAL Start Date: June 25, 2026 Eligibility: FEMALEs, 16 Years to 45 Years, f Location(s): Lurie Children's Hospital of Chicago, Chicago, Illinois, United States; USC LA, Los Angeles, California, United States; Bronx-Lebanon Hospital Center, The Bronx, New York, United States; Baylor College of Medicine//Texas Children's Hospital, Houston, Texas, United States; Univ.

of Florida Jacksonville, Jacksonville, Florida, United States; University of Colorado Denver, Aurora, Colorado, United States; Johns Hopkins University Baltimore, Baltimore, Maryland, United States; SUNY Stony Brook, Stony Brook, New York, United States This is a Phase I/II, multi-site, open-label, single arm study to describe the pharmacokinetics (PK) and safety of glecaprevir/pibrentasvir (GLE/PIB) initiated during pregnancy in women with hepatitis C virus (HCV) infection (acute or chronic) with or without HIV and to evaluate safety for their infants through 10 weeks postpartum.

Implementing Depression and Adherence Treatment Study Type: INTERVENTIONAL Eligibility: 18 Years to , f Location(s): Massachusetts General Hospital, Boston, Massachusetts, United States; University of Miami, Miami, Florida, United States; University of Cape Town, Cape Town, South Africa The goal of this clinical trial is to compare a core set and enhanced set of implementation strategies in increasing the reach of evidence-based treatments to patients with HIV and depression.

The main questions it aims to answer are: What proportion of patients start an evidence-based treatment for depression (reach)? What percentage of patients show clinical improvement in depression and what percentage attain viral undetectability within one year (effectiveness)? Researchers will compare high and low reach clinics to further inform tailored implementation strategies for uptake and maintenance.

Clinics will be randomized into one of two study arms: core versus enhanced strategies. In both arms, core strategies will be utilized. Enhanced clinics will also receive more resource-intensive training.

Improving Choice And Use Of Biomedical HIV Prevention For Women In Uganda: A Couples-based Approach Study Type: INTERVENTIONAL Eligibility: 18 Years to , t Location(s): Makerere University-Johns Hopkins University Research Collaboration MU-JHU Care, Kampala, Uganda 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.

Streamlining Telehealth for Expanded PrEP Utilization Through Community Partnerships Study Type: INTERVENTIONAL Start Date: March 26, 2026 Eligibility: 16 Years to , t Location(s): University of Pennsylvania, Philadelphia, Pennsylvania, United States The goal of this study is to learn if STEP-UP (Streamlining Telehealth for Expanded PrEP Utilization through community Partnerships) works to expand access to PrEP for people who could benefit from HIV prevention tools.

STEP-UP is an innovative model for PrEP delivery that positions community-based organizations (CBOs) as hubs for PrEP access. STEP-UP builds on the established trust, community expertise, and comprehensive services of CBOs serving individuals who could benefit from HIV prevention tools, integrating telehealth PrEP delivery into their existing infrastructure through partnership with a local telehealth PrEP program.

By enabling CBOs to offer telePrEP navigation within their array of health and social services, STEP-UP creates accessible, comprehensive care centers that address barriers to PrEP access faced by individuals who could benefit from HIV prevention tools. The main questions it aims to answer are: 1. Is STEP-UP acceptable and feasible to implement in community settings?

2. Does STEP-UP increase PrEP prescription rates compared to the existing direct-to-consumer telehealth model? Researchers will compare people who receive telehealth PrEP services through STEP-UP at community-based organizations to those who access telehealth PrEP through the existing direct-to-consumer telehealth model.

Some participants will: 1. Complete surveys about their experiences with the program 2. Participate in an interview to share their perspectives and feedback about the program.

HIV Self-testing for Partners of HIV-uninfected Postpartum Women Study Type: INTERVENTIONAL Start Date: March 19, 2026 Eligibility: 18 Years to , t Location(s): Wits MatCH Research Unit, Durban, KwaZulu-Natal, South Africa The purpose of this study is to test the feasibility and acceptability of a combination intervention to promote HIV self-testing (HIVST) for Partners and PrEP uptake for HIV-uninfected Postpartum Women ("H4P").

H4P includes evidence-based cognitive behavioral therapy (CBT) strategies, such as communication skills training, motivational interviewing, and problem-solving.

The investigators will conduct a randomized pilot trial of the H4P intervention to evaluate the feasibility, acceptability, and preliminary effectiveness of a multi-step PrEP uptake and HIV self-test kit intervention for postpartum HIV-uninfected women (N = 60 and their male partners) who report a partner of unknown serostatus, and their partners, in the province of KwaZulu-Natal, South Africa.

Integrating PrEP Decision Making Into Counseling in Sexual and Reproductive Health Clinics Study Type: INTERVENTIONAL Start Date: March 11, 2026 Eligibility: FEMALEs, 18 Years to , t Location(s): Yale Clinical and Community Research, New Haven, Connecticut, United States This study addresses the need for HIV prevention to be integrated into counseling visits at sexual and reproductive health clinics.

Cash Transfers to Pregnant Women With HIV Study Type: INTERVENTIONAL Start Date: March 9, 2026 Eligibility: FEMALEs, 18 Years to , f Location(s): Broadhurst 3, Gaborone, Botswana; GWest Clinic, Gaborone, Botswana; Lesirane Clinc, Gaborone, Botswana; Mafitlhakgosi Clinic, Gaborone, Botswana; Mogoditshane Clinic, Gaborone, Botswana; Nkoyaphiri Clinic, Gaborone, Botswana; Old Naledi Clinic, Gaborone, Botswana; Bontleng Clinic, Gaborone, Botswana The goal of this study is to evaluate the effectiveness and implementation of an unconditional cash transfer intervention to improve mental bandwidth, ART adherence, and postpartum retention among pregnant women with HIV in Botswana.

The main questions it seeks to answer are: 1. Do unconditional monthly cash transfers improve mental bandwidth relative to usual care among pregnant women with HIV? 2.

Do unconditional monthly cash transfers improve ART adherence (PDC) during pregnancy and the postpartum period? 3. Is delivery of UCTs via mobile money feasible and acceptable in public ANC clinics in Botswana?

4. What barriers and facilitators affect implementation, and how should the model be adapted for a larger trial or a policy pilot (e.g., a pregnancy support grant)?

Adaptation and Implementation of an Evidence-based Approach to Advance HIV Prevention and Care Study Type: INTERVENTIONAL Start Date: March 1, 2026 Eligibility: MALEs, 16 Years to , f Location(s): University of Medicine and Pharmacy, Ho Chi Minh City, Vietnam Transgender women in the intervention condition will attend TransAction individual risk reduction sessions; skill building and open group support sessions, and social events between baseline and 3-month assessment.

Transgender women participants in the control condition will be invited to social events only.

PrOTECT AL: PrEP Optimization Through Enhanced Continuum Tracking Study Type: INTERVENTIONAL Start Date: February 9, 2026 Eligibility: 18 Years to , f Location(s): University of Alabama at Birmingham, Birmingham, Alabama, United States The purpose of this study is to enhance and evaluate the implementation of a PrEP Care Continuum data dashboard across seven distinct clinical sites in Alabama.

By leveraging real-time data and fostering collaborative partnerships, this project aims to accurately visualize care disparities, allocate resources strategically, identify and address care gaps in the delivery of PrEP services, and gauge its impact on HIV prevention efforts.

Peer-led Dynamic Choice HIV Prevention for Women: The Peer-led DCP Pilot Study Study Type: INTERVENTIONAL Start Date: January 27, 2026 Eligibility: FEMALEs, 15 Years to , t Location(s): Infectious Diseases Research Collaboration, Kampala, Uganda This study will refine and pilot test the Peer-led Dynamic Choice HIV Prevention (DCP) intervention in a single-arm pilot trial.

The study will test the hypothesis that the Peer-led Dynamic Choice HIV Prevention intervention will be feasible and increase biomedical HIV prevention coverage in the 6 months after receipt of the Peer-led DCP intervention compared to the standard of care in the 6 months prior to intervention implementation.

Universal Test and Connect for HIV Service Delivery in South Africa Study Type: OBSERVATIONAL Start Date: January 19, 2026 Eligibility: 12 Years to , t Location(s): Gugulethu Community Health Centre, Cape Town, Western Cape, South Africa The goal of this study is to determine how many patients with HIV or at high risk of getting HIV attend the Emergency Department (ED) in South Africa (SA).

The investigators will integrate HIV assessment in the ED and see how many people who would be a candidate for a drug that prevents HIV (PrEP). Universal test and connect (UTC) is a strategy that universally tests all patients and connects patients to long-term care, whether HIV positive or negative, including referrals for PrEP. The investigator's goal is to use UTC across two busy 24-hr EDs in Cape Town, SA.

HIV Suicide Prevention With AI-DBT Study Type: INTERVENTIONAL Start Date: January 7, 2026 Eligibility: 50 Years to , f Location(s): New Jersey Community Research Initiative, Newark, New Jersey, United States One in four older persons living with HIV/AIDS (PLWHA) report at least one suicide attempt in their lifetime, and the risk for death by suicide is 100 times higher in PLWHA than in the general population.

Currently, there are no behavioral interventions that specifically address suicide prevention for older PLWHA, despite their unique biopsychosocial and structural risk factors. Through this work, investigators will adapt Dialectical Behavior Therapy, an evidence-based intervention for suicide prevention, for patients with PLWHA to be delivered by an AI-powered conversational Agent developed by our industry partner, Empower Health.

Investigators will then pilot test the feasibility, usability, acceptability and preliminary efficacy to improve self-efficacy to manage negative emotions in n=50 older adults living with HIV/AIDS.

Reducing Mobility-associated Interruption in HIV Treatment in Malawi Study Type: INTERVENTIONAL Start Date: December 18, 2025 Eligibility: 15 Years to , f Location(s): Partners in Hope, Lilongwe, Malawi The goal of this pilot clinical trial is to assess the feasibility and acceptability of an intervention package designed to reduce mobility-associated interruptions in HIV treatment in people living with HIV in Malawi who are initiating or returning to antiretroviral treatment (ART) after interruption.

The main questions it aims to answer are: * Is the intervention acceptable to healthcare workers and ART clients? * Is the intervention feasible in the context of Malawi's health system, and what are the major operational challenges, resource requirements, and implementation barriers?

In addition, researchers will compare HIV treatment outcomes (specifically ART retention rates) between intervention and control groups to establish a preliminary estimate of the intervention's efficacy. Participants will complete a survey on the day of enrollment and some participants will complete an in-depth interview and/or a survey after completion of the 6-month follow-up period.

Facilities assigned to the intervention group will receive the full package of interventions (training on mobility-specific counseling for counsellors, access to a toll-free hotline for clients and healthcare workers, and training on multi-month dispensing for providers), while facilities assigned to the control group will provide standard of care.

Integrating HIV Prevention With TB Household Contact Evaluation in Uganda Study Type: INTERVENTIONAL Start Date: December 10, 2025 Eligibility: 15 Years to , t Location(s): Infectious Diseases Institute, Kampala, Uganda This household randomized implementation study assesses the implementation and effectiveness of home-based HIV self- testing and PrEP initiation versus standard clinic referral for PrEP initiation during modified standard-of-care (modified SOC) household TB contact investigation in Uganda.

It uses qualitative methods to evaluate the process of implementing the intervention and a health economic evaluation to assess the financial sustainability of this strategy.

IBIS Megastudy of Interventions to Encourage HIV Retesting Study Type: INTERVENTIONAL Start Date: December 9, 2025 Eligibility: 15 Years to , t Location(s): Kenya Medical Research Institution (KEMRI), Mbita, Kenya; Infectious Diseases Research Collaboration (IDRC), Mbarara, Uganda In this study, the investigators will test the effectiveness of multiple low-cost behavioral interventions, designed with end-user input, to promote HIV retesting among adults in rural Kenya and Uganda who have higher risk of HIV exposure.

HIV Testing Counselor-led Care to Catalyze Integration of PrEP Delivery in Family Planning Clinics Study Type: INTERVENTIONAL Start Date: December 1, 2025 Eligibility: 15 Years to , t Location(s): Kenyatta National Hospital, Kisumu, Kenya This is a cluster randomized, stepped wedge implementation study to introduce HIV testing services (HTS) counselor-led PrEP care in public health clinics in Kenya.

Testing the WeCare Intervention to Address Mental Health and Medication Adherence Challenges Among MSM in South Africa Study Type: INTERVENTIONAL Start Date: December 1, 2025 Eligibility: MALEs, 18 Years to , t Location(s): Aurum Institute, Johannesburg, South Africa The goal of this clinical trial is to learn if the WeCare intervention-an adapted Friendship Bench program that integrates problem-solving therapy, minority-stress-informed content, and explicit PrEP/ART adherence skills-improves mental health and HIV medication adherence among men who have sex with men (MSM).

It will also assess the safety, acceptability, and feasibility of delivering WeCare through trained lay coaches in community clinics. Main questions the trial aims to answer: * Does WeCare reduce symptoms of depression and anxiety among MSM? * Does WeCare improve PrEP and ART adherence and increase rates of viral suppression among participants on ART?

* Is WeCare acceptable, feasible, and safe when delivered by lay coaches in POP INN clinics compared with usual care?

Ongoing Dynamic Choice to Address HIV Treatment Interruption in Malawi Study Type: INTERVENTIONAL Start Date: November 17, 2025 Eligibility: 15 Years to , f Location(s): Partners in Hope, Lilongwe, Malawi Repeat and prolonged treatment interruption (TI) is common and the major threat to HIV epidemic control in eastern and southern Africa.

The proposed project will test an innovative long-term dynamic choice intervention for ART clients experiencing TI in Malawi. Findings will provide essential information on how to improve sustained retention among TI client, a critical step to curbing the HIV epidemic. TI clients need long-term, responsive interventions.

There are no one-size fits all intervention to support long-term care for TI clients because clients experience vastly different and changing barriers to care. While health facilities do have limited capacity for adding new services, existing services can be packaged differently to meet clients' needs. Long-term, dynamic choice of services is one way to provide responsive services and promotes client ownership over care.

The investigators propose to give TI clients long-term, dynamic choice of what services they receive and how they receive it (drawing from key building blocks of DSD). Long-term, dynamic choice puts clients in the driver's seat and may be the best practical strategy to provide long-term and responsive TI interventions that are tailored to clients' evolving life circumstances.

Dynamic choice is frequently used for HIV prevention and family planning products, whereby clients select the type of health product that works best for them (i.e., condoms, injectables, etc.). Choice of these services is strongly associated with improved outcomes. The goal of this clinical trial is to determine if CHOICE can improve outcomes in TI clients, compared to standard of care (SOC).

Participants will be randomly assigned to either the CHOICE or SOC group, and follow them for 12 months. The primary outcome will be viral suppression at 12 months.

Behavioral Activation and Risk Reduction for Stimulant Use Among Sexually Active Adolescents and Young Adults Study Type: INTERVENTIONAL Start Date: November 4, 2025 Eligibility: 16 Years to 24 Years, t Location(s): Brown University, Providence, Rhode Island, United States; University of California, Los Angeles, Los Angeles, California, United States The use of behavioral intervention to reduce stimulant use and concurrent HIV sexual transmission risk.

Reducing Stigma in People Who Inject Drugs (PWID) With HIV Using a Rapid Start Antiretroviral Therapy Intervention (ART) Study Type: INTERVENTIONAL Start Date: November 4, 2025 Eligibility: 18 Years to , f Location(s): Kajang Prison, Kajang, Malaysia; Primary Healthcare Centers, Kuala Lumpur, Malaysia This study seeks to develop an RS-ART implementation strategy by utilizing the Delphi method and interviewing experts and PWID regarding their experiences with ART.

This strategy will then be pilot tested in a randomized controlled trial (Aim 3). The research will not impact the type of medication and dose prescribed, but rather, how soon providers are able to prescribe ART after diagnosis. The focus of this registration is Aim 3.

A Behavioral mHealth Intervention for People With HIV With Anxiety and Depression Study Type: INTERVENTIONAL Start Date: July 31, 2025 Eligibility: 18 Years to 90 Years, f Location(s): University of Florida, Gainesville, Florida, United States This study will adapt and assess the preliminary effectiveness of a community health worker-delivered mental health counselling intervention delivered remotely to reduce anxiety and depression among people with HIV in Florida.

HomeLink2: Reducing Posthospitalization Mortality Through Structured Home Care and Nutritional Support Study Type: INTERVENTIONAL Start Date: July 24, 2025 Eligibility: 18 Years to , f Location(s): Tshepong Hospital, Klerksdorp, North West, South Africa People living with HIV (PLWH) are at high risk of poor health outcomes after being discharged from the hospital.

This study is designed to test whether providing structured care at home-either with or without nutritional support-can help reduce the risk of death within six months of discharge and improve long-term health outcomes. The investigators are conducting a randomized clinical trial to evaluate the effectiveness of home-based care on post-hospital recovery.

Participants are randomly assigned to one of three groups: (1) standard post-discharge care, (2) home-based care that includes medical assessments, support for taking HIV medications (adherence support), and psychosocial counseling, or (3) the same home-based care plus food parcels to support nutrition.

This is a three-arm, individually randomized clinical trial and a type-1 hybrid implementation-effectiveness study, which means the investigators are not only testing whether the interventions improve health outcomes, but also examining how the interventions are delivered and whether the interventions are practical and acceptable in real-world settings.

The trial begins with a pilot phase to test the investigators enrollment procedures and improve baseline data collection. In addition to measuring whether the interventions reduce the risk of death, the study will assess how many people receive the intervention, whether it is acceptable to patients and families, and how consistently it is delivered.

The investigators are also evaluating the economic impact of illness, hospitalization, and death on households, and analyzing the cost and resource needs of delivering home-based care, with or without food support. The investigators goal is to provide evidence that can improve care for people living with HIV after hospital discharge.

If effective, this approach may be applied more broadly to improve outcomes for other high-risk patients in similar settings. Findings from the study will be used to inform health policy and clinical practice, particularly in areas with limited resources and high HIV burden.

Suicide Assessment and Feasible Evidence-based Treatments for Youth Living With HIV in Lilongwe Study Type: INTERVENTIONAL Eligibility: 13 Years to 19 Years, f Location(s): Area 18 Health Center, Lilongwe, Malawi; Area 25 Health Center, Lilongwe, Malawi; Kawale Health Center, Lilongwe, Malawi; Lighthouse Health Center, Lilongwe, Malawi The overall aim of this study is to determine the feasibility, fidelity, acceptability, and preliminary effectiveness of the Friendship Bench +Safety Planning intervention in reducing suicidal ideation and behaviors (SIBs) and improving HIV engagement amongst adolescents living with HIV (ALWH) when compared to augmented usual care.

Multi-product PrEP Delivery to Young Women Seeking Reproductive Health Services and Coverage of HIV Prevention Study Type: INTERVENTIONAL Eligibility: FEMALEs, 18 Years to 30 Years, t Location(s): Kenya Medical Research Institute and Partners in Health & Research Development, Thika, Kiambu County, Kenya Following on the heels of large implementation science projects that participated in the launch of widespread daily oral PrEP availability, investigators will launch and study the integration of novel PrEP products - beginning with the dapivirine ring- into existing PrEP programs that reach women seeking reproductive health care at health facilities in Kenya.

Intervention delivery will be launched among 12 participating clinics with approximately 1400 AGYW seeking reproductive health services and counseled about PrEP through a stepped wedge cluster randomized trial. investigators will support participating clinics to add dapivirine ring into their existing PrEP services offered to women seeking reproductive health care.

The primary aim of the study will be to determine whether the availability of multiple PrEP products to young women will result in greater frequency of PrEP initiation and persistence.

Assessing the Effects of a Multisectoral Agricultural Intervention on the Reproductive and Sexual Health of Adolescent Girls and Young Women Study Type: INTERVENTIONAL Eligibility: 15 Years to , t Location(s): Kenya Medical Research Institute (KEMRI), Kisumu, Kenya In Kenya, HIV incidence among adolescent girls and young women (AGYW) ages 15-24 years is 1-2 per 100 person-years and approximately 30% of AGYW have had at least one sexually transmitted infection (STI).

Kisumu and Migori counties in Western Kenya have some of the highest HIV/STI incidence in the country. Food insecurity (FI) and poverty are also highly prevalent in Western Kenya. FI and poverty are important drivers of vulnerability to HIV and STIs among AGYW.

Poverty alleviation interventions have the potential to reduce STIs and HIV risk among AGYW but, to date, these interventions have reported mixed findings on HIV/STI outcomes, have been primarily targeted at the individual level, and none have focused on agriculture or FI. Therefore, there remains a critical need to develop sustainable, multi-level, economic and FI interventions that improve AGYW STI/HIV prevention outcomes.

Our team has successfully developed a household-level agricultural intervention in Western Kenya called Shamba Maisha ("farm life" in Kiswahili; SM) to reduce household FI. In our prior pilot study with AGYW, the investigators found that SM was feasible, acceptable, and associated with less FI and improved mental health.

In this proposal, the investigators will build upon our promising SM work by examining the effectiveness and implementation of our SM intervention, including provision of a water pump and agricultural implements for use at home, training in agriculture delivered at school-based demonstration farms, and adolescent-caregiver relationship strengthening training.

The investigators plan to conduct this school- and home-based cluster randomized trial with 800 AGYW and their primary caregivers recruited from schools in Kisumu and Migori counties. The investigators will randomize 20 schools in Kisumu and Migori in a 1:1 ratio to intervention or control conditions and follow AGYW-caregiver dyads for 18 months with surveys and STI/pregnancy testing to assess intervention impacts.

The study has the following aims: Aim 1. Determine the impact of SM on adolescent HIV prevention and sexual and reproductive health outcomes (primary outcome is gonorrhea and/or chlamydia incidence). Aim 2.

Assess the effect of SM on intermediate outcomes theorized from our published conceptual framework to be on the causal pathway, including household food security and wealth, and adolescent and caregiver factors including mental health and aspects of the caregiver-AGYW relationship dyad (e.g., communication). Aim 3.

Identify critical implementation facilitators and barriers influencing SM effectiveness and delivery and conduct a programmatic cost assessment. The investigators will also evaluate the extent to which SM can have "spillover" nutritional benefits for a larger population of adolescents who had access to demonstration farms at intervention schools but did not receive other aspects of the intervention.

The ultimate goal is to provide an innovative household-level intervention to halt the cycle of FI, and poor HIV-related outcomes among vulnerable populations including AGYW, consistent with the "Ending the HIV Epidemic".

Prepping for The Talk: Helping Trusted Adults and Youth Talk About Sexual Health Study Type: INTERVENTIONAL Eligibility: MALEs, 14 Years to 17 Years, t Location(s): Rhode Island Hospital, Providence, Rhode Island, United States The goal of this study is to help young people talk to trusted adults (including their parents, but also other adults) about sexual health more openly and honestly- including how to prevent sexually transmitted diseases like HIV - while also respecting a young person's right to privacy.

If youth don't have a parent they can talk to about sexual health, we want to help them find a trusted adult to talk to. We also want to help youth take control of their own health by learning about different ways to protect their health.

Work2Prevent Plus: Structural Intervention to Promote HIV Care in Black Sexual Minority Men Study Type: OBSERVATIONAL Start Date: April 22, 2025 Eligibility: 18 Years to , t Location(s): University of Chicago, Chicago, Illinois, United States The goal of this observational study is to learn about the pilot test of the employment program among young Black sexual minority men.

The main question it aims to answer is: What is the feasibility and acceptability of the employment program? Young Black sexual minority male participants will attend the two day employment program and will complete four study surveys over the course of 13 months. Employment program facilitators will complete a study survey and participate in a focus group over the course of 1 day.

Study Type: INTERVENTIONAL Start Date: April 10, 2025 Eligibility: 18 Years to , t Location(s): University of Miami, Miami, Florida, United States To compare the effectiveness of two social network strategies (direct distribution and referral-based distribution) in increasing HIV self-testing (HIVST) completion rates among social network contacts of current Pre-Exposure Prophylaxis (PrEP) clients.

INcentives and ReMINDers to Improve Long-term Medication Adherence (INMIND) Study Type: INTERVENTIONAL Start Date: April 2, 2025 Eligibility: 18 Years to , f Location(s): Mildmay Uganda, Kampala, Uganda HOTSPOT Study: Implement and Evaluate the PrEP (Pre-exposure Prophylaxis) Implementation Strategy Study Type: INTERVENTIONAL Start Date: March 1, 2025 Eligibility: 18 Years to , t Location(s): Dallas County Jail, Dallas, Texas, United States The goal of this study is to measure the implementation and effectiveness of a multicomponent strategy for PrEP for people who are incarcerated at the Dallas County Jail.

Specifically, based on a patients risk score on an electronic medical record HIV prediction model, referrals from providers and/or patient self-referrals, a PrEP patient navigator will meet with individuals at the jail