Peer-led Community-based PrEP Delivery Among Youth in Brazil
NCT ID: NCT06661356
Last Updated: 2025-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
1400 participants
INTERVENTIONAL
2026-04-30
2029-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Standard Care Arm
Participants randomized to the standard care arm will receive PrEP at a health facility from a physician or nurse.
No interventions assigned to this group
COMPrEP Intervention
Participants randomized to the COMPrEP intervention will receive PrEP from peer lay workers at private community locations.
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.
Interventions
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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.
Eligibility Criteria
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Exclusion Criteria
* Not currently sexually active
* Currently using PrEP
15 Years
24 Years
ALL
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of Sao Paulo
OTHER
Federal University of Bahia
OTHER
University of Alabama at Birmingham
OTHER
Responsible Party
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Katia J. Bruxvoort
Principal Investigator
Principal Investigators
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Katia J Bruxvoort, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham School of Public Health
Locations
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Federal University of Bahia
Salvador, Estado de Bahia, Brazil
University of São Paulo
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB-300013551
Identifier Type: -
Identifier Source: org_study_id
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