HIV prevention and care for youth in Uganda

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multi-site Phase 4 interventional program enrolls adolescents and young adults (15–24) classified as high risk using a screening tool and delivers long-acting cabotegravir (CAB-LA) as PrEP for HIV-negative participants while implementing the SEARCH-Youth multi-component package to support HIV-positive youth on ART. The team will use Ministry of Health–approved community differentiated delivery models and youth-focused implementation strategies across five Ugandan research sites. Outcomes focus on real-world implementation measures such as uptake, persistence, and viral suppression rather than initial efficacy. Results are intended to inform national and regional policy for integrated HIV prevention and care for high-risk youth.

Why it matters

Who can join: the full rules

Adolescents and young adults with increased likelihood of HIV acquisition

* AYA 15 to 24 years of age
* Classified as high risk using our screening tool.
* Documented HIV un-infected as per the national HIV testing algorithm.
* Willing to use PrEP
* Willing to provide written informed consent.
* No plans to relocate permanently in the next 6 months
* No suspicion of acute HIV infection:
* Hepatitis B virus surface antigen (HBsAg)-negative and accepts HB vaccination
* Having no medical or social condition that, in the opinion of the study investigator, would interfere with the conduct of the study or interpretation of study results.
* HIV-uninfected, based on HIV test results obtained at screening and enrolment visit and just prior to randomization. All HIV test results must be obtained and must all be negative/non-reactive according to national HIV testing algorithm. Adolescents and young adults living with HIV
* AYA 15-24 years' old
* Willing to receive ART at participating health facilities
* Have high-risk characteristics for viral load non-suppression, such as missed visits, disengagement from care, new to care, and non-suppressed viral load (VL) on the last VL testing.
* Willing to provide written informed consent.
* No plans to relocate permanently in the next 6 months
* Having no medical or social condition that, in the opinion of the study investigator, would interfere with the conduct of the study or interpretation of study results

Exclusion Criteria:

Adolescents and young adults with increased likelihood of HIV acquisition

* One or more reactive HIV test results at Screening or Enrollment, even if HIV infection is not confirmed.
* Has a cognitive impairment that prevents understanding of study procedures and precludes informed consent.
* Plan to move out of the greater study catchment area during study period.
* Enrolled in another intervention study.
* Already on PrEP.
* Unwilling or unable to commit to using CAB LA
* Ineligible to initiate CAB-LA as per the Uganda national PrEP guidelines
* Hepatotoxicity and or Hepatitis B infection
* Potential exposure to HIV in past 72 hours
* Signs/symptoms of acute HIV infection
* Current or chronic history of liver disease or known hepatic/biliary abnormalities, history of seizure disorder, clinically significant cardiovascular disease, coagulopathy, and inflammatory skin conditions, as defined in Human Subjects Protection document. (Cabotegravir IB or package insert)
* Hypersensitivity to any active substances or other substances in CAB-LA
* Allergic or hypersensitivity reaction(s) with previous use of CAB or other integrase inhibitor medications Adolescents and young adults living with HIV
* Not able to give written informed consent.
* Not receiving care in selected facilities

Where it's running

• MU-JHU Care Ltd
  Kampala, Uganda Recruiting

Study contacts

• Study coordinator: Philippa Musoke, MBChB, PhD
• Email: pmusoke@mujhu.org
• Phone: +256200404100

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Project SHIELD 2.0: Police Education to Support Public Health in Kentucky

  Aimed at police in Kentucky, this program tests whether SHIELD training given to officers, with health workers helping deliver it, can reduce drug-related arrests and steer people who use drugs toward MOUD and other health services.

  Recruiting Johns Hopkins Bloomberg School of Public Health · Lexington, Kentucky · NCT07804121

• New ways to diagnose lymphoma and multicentric Castleman disease in people living with HIV

  This study tests a quick, point-of-care nucleic acid test to help diagnose lymphoma and multicentric Castleman disease in people living with HIV in sub-Saharan Africa.

  Recruiting Indiana University · Lilongwe · NCT07793006

• Bridge to Belonging: A Peer‑Led Program to Reduce Loneliness and Depression in older gay and bisexual men with HIV

  This program tests a peer-delivered, manualized approach to help men aged 50+ with HIV connect to LGBTQ+-affirming elder services to see if it reduces loneliness and depressive symptoms.

  Recruiting Fenway Community Health · Boston, Massachusetts · NCT07762066

• HIV vaccine test in healthy adults using CH505 nanoparticles and mRNA boosters

  This early-stage study will test the safety and immune responses of CH505 vaccine regimens in healthy adults to see if they can trigger HIV-specific immune protection.

  Recruiting at 2 sites Phase 1 National Institute of Allergy and Infectious Diseases (NIAID) · San Francisco, California and 7 other locations · NCT07757802

• Stigma-reducing program to help women who use drugs stay in HIV care

  This test checks whether a stigma-reduction program helps women living with HIV who use drugs stay engaged in HIV care in Ukraine.

  Recruiting Johns Hopkins Bloomberg School of Public Health · Kyiv, Kyiv Oblast · NCT07751978

• Platelets and HIV Reservoirs: A look at how platelets might harbor HIV in people living with HIV

  This observational study tests whether HIV can be found inside platelets in adults with suppressed HIV on therapy.

  Recruiting Tourcoing Hospital · Tourcoing · NCT07745530

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.