HIV prevention and care for youth in Uganda
Using Implementation Science to Understand and Design Stakeholder Informed Innovative Interventions to Improve Youth HIV Prevention and Care Continuums in Rural and Urban Uganda.
This project will try long-acting cabotegravir injections for HIV prevention alongside a youth-focused care package (SEARCH-Youth) to help 15–24-year-olds in Uganda stay HIV-negative or, if living with HIV, achieve viral suppression.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 15 Years to 24 Years |
| Sex | All |
| Sponsor | Mu-Jhu Care Academic / other |
| Locations | 1 site (Kampala) |
| Trial ID | NCT06474364 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are 15–24-year-olds in Uganda identified as high risk by the study screening tool who are HIV-negative and willing to use PrEP (including injections) or who are living with HIV and willing to receive ART at participating sites.
Not a fit: People outside the 15–24 age range, not classified as high risk, unwilling to receive long-acting injections or HBV vaccination, with suspected acute HIV infection, or planning to relocate soon are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could increase PrEP uptake and persistence among youth and raise viral suppression rates, reducing new infections and improving health outcomes for adolescents and young adults.
How similar studies have performed: Previous large trials have shown cabotegravir long-acting is highly effective for PrEP and SEARCH-style community interventions have improved HIV outcomes, so this work adapts proven elements to a youth-focused implementation setting.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Kampala
- MU-JHU Care Ltd — Kampala, Uganda (Recruiting)
Study contacts
- Study coordinator: Philippa Musoke, MBChB, PhD
- Email: pmusoke@mujhu.org
- Phone: +256200404100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.