Determining the Impact of Peer-led Community-based PrEP Delivery Among Youth in Brazil: A Randomized Controlled Trial
| Registry | NCT06661356, acronym COMPrEP |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, prevention |
| Enrollment | 1400 (Estimated) |
| Sponsor | University of Alabama at Birmingham (Other); collaborators: National Institute of Mental Health (NIMH), University of Sao Paulo, Federal University of Bahia |
| Conditions | Pre-Exposure Prophylaxis (PrEP), HIV |
| Interventions | COMPrEP (Behavioral) |
| Dates | start 2026-12-01 (estimated), primary completion 2029-08-01 (estimated), completion 2029-08-01 (estimated), first posted 2024-10-28, last updated 2026-10-13 |
| Locations | 2 sites in Brazil |
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All trials for Pre-Exposure Prophylaxis (PrEP) All trials for HIV All trials of COMPrEP
The goal of this project is to conduct a series of studies to refine, test, and understand experiences with a peer-led community-based intervention in which youth will be integrated into health care teams and trained to deliver HIV pre-exposure prophylaxis (PrEP) to their peers. The study team will conduct a randomized trial to determine if peer delivery of PrEP to youth aged 15-24 in Brazil will increase PrEP uptake, persistence, and adherence compared to standard PrEP care provided in health facilities.
HIV is declining in many parts of the world, but rising in Latin America, including Brazil. The HIV epidemic in Brazil, including the number of new infections, is concentrated among youth aged 15-24. Youth in Brazil face obstacles to HIV prevention. Use of HIV pre-exposure prophylaxis (PrEP) lags far behind PrEP need in Brazil. There is international momentum to promote PrEP as prevention and to increase access to low barrier care. Peer lay workers are a promising approach to address the unmet need for PrEP uptake and adherence among youth in Brazil.
COMPrEP is a multi-site randomized controlled trial designed to determine if peer delivery of PrEP to youth aged 15-24 in Brazil will increase PrEP uptake, persistence, and adherence compared to standard PrEP care provided in affirming health facilities. Eligible youth (N=1400) in two municipalities in Brazil (i.e., Salvador and São Paulo) will be randomized to 1:1 to either the COMPrEP intervention arm (PrEP access through peer lay workers in community venues) or the standard care arm (PrEP access through health providers at health facilities). It is anticipated that approximately 245 and 140 youth will initiate PrEP in intervention and standard care arms, respectively, and these will be followed for 12 months, facilitating measurement of PrEP adherence and persistence outcomes on this subset.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Standard Care Arm | No intervention | Participants randomized to the standard care arm will receive PrEP at a health facility from a physician or nurse. | |
| COMPrEP Intervention | Experimental | Behavioral: COMPrEP | Participants randomized to the COMPrEP intervention will receive PrEP from peer lay workers at private community locations. |
Sex: All, ages: 15 Years to 24 Years, accepts healthy volunteers
Eligibility Criteria: * Aged 15-24 years * Candidate for HIV prevention * Sexually active * Not currently using PrEP * Willing to discuss oral PrEP * Agree to be randomized to either intervention or standard care arm Exclusion Criteria: * HIV positive test result * Not currently sexually active * Currently using PrEP
| Facility | City | Country | Status |
|---|---|---|---|
| Federal University of Bahia | Salvador, Estado de Bahia | Brazil | |
| University of São Paulo | São Paulo, São Paulo | Brazil |
NIH grants: R01MH135769