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

NCT06661356 | Not Yet Recruiting DMC

• 2 other identifiers: IRB-3000135511R01MH135769-01A1
• Study Type: interventional
• Target: 1,400
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV; Pre-Exposure Prophylaxis (PrEP)

Keywords

PrEP; Pre-Exposure Prophylaxis; HIV; Peer lay workers; Youth

Outcome Measures

Primary Outcomes (1)

• PrEP Uptake

  Received at least one PrEP prescription

  Within 1 month of enrollment

Secondary Outcomes (3)

• PrEP Adherence Biomarker

  1 month

• PrEP Adherence Self-Report

  At 1, 5, 9, and 13 months

• PrEP Persistence

  5 months and 13 months

Study Arms (2)

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

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

Behavioral: COMPrEP

Interventions

COMPrEP BEHAVIORAL

Participants will be paired with peer lay workers and will meet with peer lay workers at private community location. They will discuss options for oral PrEP with peer lay workers and be provided provide daily oral PrEP or event-driven (2-1-1) PrEP. Participants will take part in rapid HIV testing at each visit. They will also meet with peer lay workers at private community location for follow-up at 1, 5, 9, and 13 months.

COMPrEP Intervention

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:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute of Mental Health (NIMH): collaborator
• University of Sao Paulo: collaborator
• Federal University of Bahia: collaborator

Study Sites (2)

Federal University of Bahia

Salvador, Estado de Bahia, Brazil

Location

University of São Paulo

São Paulo, São Paulo, Brazil

Location

Study Officials

• Katia J Bruxvoort, PhD

  University of Alabama at Birmingham School of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katia J Bruxvoort, PhD

CONTACT

(205) 975-8625; kbruxvoort@uab.edu

Mallie E Froehlich, MSW

CONTACT

205-478-1102; mefroehl@uab.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding will not be possible for participants, peer lay workers, and health providers, but the data management and analysis teams will be blinded to the study arm.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 28, 2024
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)