HIV Prevention and Care Interventions for Youth in Uganda

Recruiting now · Phase 4

Conditions studied: HIV

In brief

Several studies show that Adolescents and Young Adults (AYA) have poor outcomes along the entire Human Immunodeficiency Virus (HIV) prevention and care cascades compared to adults. The investigators propose to evaluate novel evidence-based HIV prevention and care interventions (including Cabotegravir LongActing (CABLA) to determine implementation outcomes among AYA who are at particularly high risk for HIV acquisition and poor viral suppression in five geographically distinct research performance sites in Uganda. The results will provide important evidence to inform Uganda and other regional countries' policy on integrated HIV prevention, care and treatment for AYA at high risk for HIV and Sexually Transmitted Infections (STIs) in order to reach the UNAIDS 95-95-95 targets and HIV epidemic control.

Key facts

Study ID

NCT06474364

Run by

MU-JHU CARE

People needed

600

Starts

2024-08-05

Expected to finish

2028-08-31

Last updated by the study team

2025-07-29

Who can join

Age: 15 and older, up to 24. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• 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 is running

• MU-JHU Care Ltd — Kampala, Uganda (enrolling)

Full record on ClinicalTrials.gov

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