HIV, Pre-Exposure Prophylaxis (PrEP)
Conditions
Keywords
PrEP, Pre-Exposure Prophylaxis, HIV, Peer lay workers, Youth
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.
Interventions
BEHAVIORALCOMPrEP
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.
Sponsors
University of Alabama at Birmingham
National Institute of Mental Health (NIMH)
University of Sao Paulo
Federal University of Bahia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Blinding will not be possible for participants, peer lay workers, and health providers, but the data management and analysis teams will be blinded to the study arm.
Eligibility
Sex/Gender
ALL
Age
15 Years to 24 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Uptake | Within 1 month of enrollment | Received at least one PrEP prescription |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Adherence Self-Report | At 1, 5, 9, and 13 months | Number of pills taken in the past 30 days |
| PrEP Persistence | 5 months and 13 months | Continuing to take PrEP at 5 months and 13 months |
| PrEP Adherence Biomarker | 1 month | Positive point of care urine tenofovir assay |
Countries
Brazil
Contacts
CONTACTKatia J Bruxvoort, PhD
CONTACTMallie E Froehlich, MSW
PRINCIPAL_INVESTIGATORKatia J Bruxvoort, PhD
University of Alabama at Birmingham School of Public Health
Outcome results
None listed