Clinical trial NCT06661356: Peer-led Community-based PrEP Delivery Among Youth in Brazil
Official title: Determining the Impact of Peer-led Community-based PrEP Delivery Among Youth in Brazil: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pre-Exposure Prophylaxis (PrEP)
HIV
Keywords: PrEP
Pre-Exposure Prophylaxis
HIV
Peer lay workers
Youth
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of Sao Paulo
name: Federal University of Bahia
First posted: 2024-10-28
Enrollment: 1400
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: PrEP Uptake
timeFrame: Within 1 month of enrollment
Secondary outcomes:
measure: PrEP Adherence Biomarker
timeFrame: 1 month
measure: PrEP Adherence Self-Report
timeFrame: At 1, 5, 9, and 13 months
measure: PrEP Persistence
timeFrame: 5 months and 13 months
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Federal University of Bahia
state: Bahia
city: São Paulo
country: Brazil
facility: University of São Paulo
Study officials:
affiliation: University of Alabama at Birmingham School of Public Health
name: Katia J Bruxvoort, PhD
role: PRINCIPAL_INVESTIGATOR
References: