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NCT Number: NCT06661356

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

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.

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Key information

Age range

15 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Bahia, Salvador, Estado de Bahia, Brazil

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. PrEP Uptake

    Time frame: Within 1 month of enrollment

    Received at least one PrEP prescription

Secondary outcomes

  1. PrEP Adherence Biomarker

    Time frame: 1 month

    Positive point of care urine tenofovir assay

  2. PrEP Adherence Self-Report

    Time frame: At 1, 5, 9, and 13 months

    Number of pills taken in the past 30 days

  3. PrEP Persistence

    Time frame: 5 months and 13 months

    Continuing to take PrEP at 5 months and 13 months

Study contacts

Contact information is provided by the study sponsor or research team.

Katia J Bruxvoort, PhD

CONTACT

[email protected]

(205) 975-8625

Mallie E Froehlich, MSW

CONTACT

[email protected]

205-478-1102

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Federal University of Bahia
  • National Institute of Mental Health (NIMH)
  • University of Sao Paulo

Registry information

Official study title

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

Acronym: COMPrEP

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Oct 28, 2024
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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