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.

HIV Prevention and Care Interventions for Youth in Uganda (NCT06474364) is a Phase 4 interventional studying HIV, sponsored by MU-JHU CARE. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 600 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

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 willing to sign a consent form. - 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 willing to sign a consent form. - 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 Who Should NOT Join This Trial: 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 willing to sign a consent form. - Plan to move out of the greater study catchment area during study period. - Enrolled in another intervention study. - Already on PrEP. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Long-acting Cabotegravir injection

Cabotegravir is a potent integrase inhibitor that has been approved for use as PrEP.

OTHER

SEARCH-YOUTH

It is a life stage informed HIV care model that dynamically supports adolescents and young adults living with HIV to achieve viral suppression and reduce depression through life event tailored solutions.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

MU-JHU Care Ltd

Kampala, Uganda

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06474364), the sponsor (MU-JHU CARE), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06474364 clinical trial studying?

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 c… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06474364?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06474364?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06474364. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06474364. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.