HIV Prevention and Care Interventions for Youth in Uganda

NCT06474364 | Recruiting Phase 4 DMC

• 1 other identifier: UG1HD113241
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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

HIV

Outcome Measures

Primary Outcomes (5)

• Understanding the implementation science outcomes

  Understanding of implementation outcomes: 1. adoption, 2. preference for delivery models and reasons for preference, 3. scale-up feasibility (different from trial feasibility), 4. experiences implementing the intervention components, 5. mechanisms of action of the intervention that result in success or failure (suppressed or unsuppressed, and uptake and persistence of CAB-LA), 6. sustainability, 7. key factors that impact the effectiveness of individual components of each intervention, and 8. implementation barriers and facilitators from the delivery side.

  18 months

• Effectiveness of 2 delivery models of increasing uptake and persistence of CABLA

  Using a hybrid implementation-effectiveness type II design, we will assess the effectiveness of the intervention in increasing uptake and persistence of CABLA in five CRPS and their catchment areas as well as the Implementation Science indicators of feasibility, acceptability, adoption and maintenance using RE-AIM framework.

  24 months

• To evaluate scale up of the real-world implementation of the SEARCH-YOUTH multi-level intervention in routine HIV clinics in Uganda.

  This aim will use a hybrid effectiveness implementation type III design to assess co-primary aims of the implementation science indicators of adoption, fidelity, and sustainment as well as effectiveness of the intervention on virologic suppression.

  24 months

• Cost and cost-effectiveness of the implementation of two evidence-based interventions for HIV prevention and HIV care among Adolescents and Young Adults (AYAs) in Uganda.

  We will use standard micro-costing techniques and time-and-motion studies to measure the cost of the implementation strategies.

  24 months

• Research and non-research team members trained in implementation science.

  The formation of the project ImS interest group, the number of the research consortium members and other key stakeholders trained in ImS, and the number of ImS trainings/meetings conducted. The long-term outcomes for the capacity building are; the number of research consortium members that enroll in the longitudinal ImS training at the Mak-ImS training program and the number of ImS projects developed by the regional ImS interest groups.

  60 months

Study Arms (3)

Health facilty delivery model

EXPERIMENTAL

AYA will be randomized to access CABLA at the health facility.

Drug: Long-acting Cabotegravir injection

Community venue delivery model

EXPERIMENTAL

AYA will be randomized to receive Cabotegravir from a community pharmacy/drop-in center.

Drug: Long-acting Cabotegravir injection

SEARCH-YOUTH

OTHER

Virally unsuppressed or likely to be unsuppressed AYA, Youth living with HIV will receive the SEARCH-YOUTH intervention in addition to the standard MoH HIV care package.

Other: SEARCH-YOUTH

Interventions

Long-acting Cabotegravir injection DRUG

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

Community venue delivery model; Health facilty delivery model

SEARCH-YOUTH OTHER

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.

SEARCH-YOUTH

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

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.

Sponsors & Collaborators

• MU-JHU CARE: lead
• Makerere University Joint AIDS Program: collaborator
• Infectious Diseases Research Collaboration, Uganda: collaborator
• Baylor College of Medicine: collaborator
• University of California, San Francisco: collaborator

Study Sites (1)

MU-JHU Care Ltd

Kampala, Uganda

RECRUITING

Central Study Contacts

Philippa Musoke, MBChB, PhD

CONTACT

+256200404100; pmusoke@mujhu.org

Judith Mbanza, M.A. MSc.

CONTACT

+256200404100; jmbanza@mujhu.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director

Model Details: Youth with high likelihood of HIV acquisition shall be randomized to receive injectable PrEP (CABLA) services in either the facility model (at CRPS) or in the community model via drop-in centers or alternative community, drug distribution points. Participants shall receive PrEP (CAB-LA) at baseline or enrolment, 4 weeks after 1st dose and every 8 weeks until end of the study. Participants shall undergo blood tests for safety monitoring prior to and after initiation (6 monthly) of CAB-LA. Youth living with HIV will be identified from existing CRPS cohorts or from newly diagnosed patients seeking care. These participants shall either be non-suppressed in spite of ART experience (existing cohorts) or have a high risk for non-suppression (e.g. those newly identified, those who use alcohol, those who interrupt care or those that have not disclosed their status). Participants will receive the standard MOH plus the SY HIV care package.

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 25, 2024
• Study Start: August 5, 2024
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: July 29, 2025

Record last verified: 2025-07

Locations

UG (1)