Actively Recruiting

Phase 4
Age: 15Years - 24Years
All Genders
Healthy Volunteers
NCT06474364

HIV Prevention and Care Interventions for Youth in Uganda

Led by MU-JHU CARE · Updated on 2025-07-29

600

Participants Needed

1

Research Sites

212 weeks

Total Duration

On this page

Sponsors

M

MU-JHU CARE

Lead Sponsor

M

Makerere University Joint AIDS Program

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

HIV Prevention and Care Interventions for Youth in Uganda

Who Can Participate

Age: 15Years - 24Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adolescents and young adults aged 15 to 24 years
  • Classified as high risk for HIV acquisition using the study screening tool
  • Documented HIV negative status by national testing algorithm and willing to use PrEP
  • Willing to provide written informed consent
  • No plans to relocate permanently within the next 6 months
  • No suspicion of acute HIV infection, Hepatitis B surface antigen negative and accepting Hepatitis B vaccination
  • No medical or social conditions that would interfere with study participation
  • For HIV positive participants: willing to receive antiretroviral therapy at participating health facilities
  • HIV positive participants must have high-risk features for viral load non-suppression such as missed visits, disengagement, new to care, or non-suppressed viral load on last test
  • Willing to provide written informed consent
  • No plans to relocate permanently within the next 6 months
  • No medical or social conditions that would interfere with study participation
Not Eligible

You will not qualify if you...

  • One or more reactive HIV test results at screening or enrollment for HIV negative group
  • Cognitive impairment preventing understanding of study procedures or informed consent
  • Plans to move out of the study area during the study period
  • Enrollment in another intervention study
  • Already on oral PrEP or unwilling/unable to commit to using CAB-LA
  • Ineligible for CAB-LA as per Uganda national PrEP guidelines
  • Hepatotoxicity or Hepatitis B infection
  • Potential HIV exposure in past 72 hours
  • Signs or symptoms of acute HIV infection
  • Current or chronic liver disease, seizure disorder, cardiovascular disease, coagulopathy, or inflammatory skin conditions
  • Hypersensitivity to CAB-LA or integrase inhibitors
  • For HIV positive group: unable to give written informed consent or not receiving care at selected facilities

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

MU-JHU Care Ltd

Kampala, Uganda

Actively Recruiting

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Research Team

P

Philippa Musoke, MBChB, PhD

CONTACT

J

Judith Mbanza, M.A. MSc.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

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