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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-24
SponsorUniversity of Alabama at Birmingham

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 15-24 years

Candidate for HIV prevention

Sexually active

Not currently using PrEP

Disqualifiers

HIV positive test result

Not currently sexually active

Currently using PrEP

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

1,400 Participants
are divided into 2 treatment groups
Group A: Standard Care ArmNo intervention 0 interventions
Group B: COMPrEP InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

PrEP Uptake

Received at least one PrEP prescription

Time frame
Within 1 month of enrollment

Secondary outcomes

1

PrEP Adherence Biomarker

Positive point of care urine tenofovir assay

Time frame
1 month
2

PrEP Adherence Self-Report

Number of pills taken in the past 30 days

Time frame
At 1, 5, 9, and 13 months
3

PrEP Persistence

Continuing to take PrEP at 5 months and 13 months

Time frame
5 months and 13 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

University of Sao Paulo

Collaborator

Federal University of Bahia

Collaborator

This trial is not recruiting at the moment. You can still explore other options: