Peer-led Community-based PrEP Delivery Among Youth in Brazil (COMPrEP)

The University of Alabama at Birmingham

Status: Begins enrollment in 1 month

Conditions: Pre-Exposure Prophylaxis (PrEP); HIV

Treatments: Behavioral: COMPrEP

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06661356

IRB-300013551

1R01MH135769-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,400 estimated patients

Sex: All

Ages: 15 to 24 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,400 participants in 2 patient groups

Standard Care Arm

No Intervention group

Description:

Participants randomized to the standard care arm will receive PrEP at a health facility from a physician or nurse.

COMPrEP Intervention

Experimental group

Description:

Participants randomized to the COMPrEP intervention will receive PrEP from peer lay workers at private community locations.

Treatment:

Behavioral: COMPrEP