NCT06474364RecruitingPhase 4

HIV Prevention and Care Interventions 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.

Source: ClinicalTrials.gov · Last updated 29 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Phase (registry): Phase 4
Study type: Interventional
Enrollment: 600 (estimated)
First submitted: 5 Jun 2024
Start date: 5 Aug 2024
Primary completion date: 31 Aug 2028
Lead sponsor: MU-JHU CARE
Diseases: HIV
NCT number: NCT06474364

What you commit to

Study type: Interventional · Phase 4
Planned participants: 600
From 5 Aug 2024 to the primary completion date, 31 Aug 2028
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Allergic or hypersensitivity reaction(s) with previous use of CAB or other integrase inhibitor medications Adolescents and young adults living with HIV
Not receiving care in selected facilities

Other illness

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.
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

Other

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
Not able to give written informed consent.

Criteria the registry did not label

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

Age in the registry: 15 years to 24 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

Site	City	Country	Site status
MU-JHU Care Ltd Coordinator of this site? Confirm its status	Kampala	Uganda	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.