Peer-led Community-based PrEP Delivery Among Youth in Brazil

Not Applicable

Not yet recruiting

• Conditions: Pre-Exposure Prophylaxis (PrEP); HIV

• Registration Number: NCT06661356
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-10-18
• Study First Submitted QC: 2024-10-24
• Study First Posted: 2024-10-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04
• Study Start: 2026-04
• Primary Completion: 2029-08
• Study Completion: 2029-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1400

Inclusion Criteria

Not provided

Exclusion Criteria

• HIV positive test result
• Not currently sexually active
• Currently using PrEP

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
PrEP Uptake	Within 1 month of enrollment	Received at least one PrEP prescription

Secondary Outcome Measures

Name	Time	Method
PrEP Persistence	5 months and 13 months	Continuing to take PrEP at 5 months and 13 months
PrEP Adherence Biomarker	1 month	Positive point of care urine tenofovir assay
PrEP Adherence Self-Report	At 1, 5, 9, and 13 months	Number of pills taken in the past 30 days

Trial Locations

Locations (2)

Federal University of Bahia; 🇧🇷 Salvador, Bahia, Brazil

University of São Paulo; 🇧🇷 São Paulo, Brazil