HIV Prevention and Care Interventions for Youth in Uganda
NCT Number: NCT06474364
Acronym: HIPCY
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: HIV
Interventions: DRUG: Long-acting Cabotegravir injection|OTHER: SEARCH-YOUTH
Sponsor: MU-JHU CARE
Collaborators: Makerere University Joint AIDS Program|Infectious Diseases Research Collaboration, Uganda|Baylor College of Medicine|University of California, San Francisco
Sex: ALL
Age: CHILD, ADULT
Enrollment: 600
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07-15
Completion Date: 2028-08-31

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.

Primary Outcome Measures: 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