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Clinical Trials/NCT06661356
NCT06661356
Not Yet Recruiting
N/A

Determining the Impact of Peer-led Community-based PrEP Delivery Among Youth in Brazil: A Randomized Controlled Trial

University of Alabama at Birmingham2 sites in 1 country1,400 target enrollmentApril 2026

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pre-Exposure Prophylaxis (PrEP)
Sponsor
University of Alabama at Birmingham
Enrollment
1400
Locations
2
Primary Endpoint
PrEP Uptake
Status
Not Yet Recruiting
Last Updated
12 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2026
End Date
August 2029
Last Updated
12 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Katia J. Bruxvoort

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

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

Outcomes

Primary Outcomes

PrEP Uptake

Time Frame: Within 1 month of enrollment

Received at least one PrEP prescription

Secondary Outcomes

  • PrEP Adherence Biomarker(1 month)
  • PrEP Adherence Self-Report(At 1, 5, 9, and 13 months)
  • PrEP Persistence(5 months and 13 months)

Study Sites (2)

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