Menu
Not yet recruiting NCT06661356

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

No phase Interventional Pre-Exposure Prophylaxis (PrEP) HIV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: COMPrEP.
Who it may be relevant to
Registry conditions: Pre-Exposure Prophylaxis (PrEP), HIV. Basic parameters: 15 years — 24 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral COMPrEP
    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 outcome measures

  • PrEP Uptake [Time frame: Within 1 month of enrollment]
Secondary outcome measures (3)
  • PrEP Adherence Biomarker [Time frame: 1 month]
  • PrEP Adherence Self-Report [Time frame: At 1, 5, 9, and 13 months]
  • PrEP Persistence [Time frame: 5 months and 13 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Brazil · 2 centers
  • Federal University of Bahia — Salvador
  • University of São Paulo — São Paulo

Identifiers

NCT: NCT06661356 · IRB-300013551 · 1R01MH135769-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗