Peer-led Community-based PrEP Delivery Among Youth in Brazil | NCT06661356

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

NCT06661356

Sponsor

University of Alabama at Birmingham

Status

Not yet recruiting

Last Update Posted

Mar 5, 2026Actual

Enrollment

1,400Estimated

Phase

Not Applicable

Conditions

Pre-Exposure Prophylaxis (PrEP)
HIV

Interventions

COMPrEP

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R01MH135769-01A1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2026Estimated

Primary Completion Date

Aug 2029Estimated

Completion Date

Aug 2029Estimated

First Submitted Date

Oct 18, 2024

First Submission Date that Met QC Criteria

Oct 24, 2024

First Posted Date

Oct 28, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2026

Last Update Posted Date

Mar 5, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Katia J. Bruxvoort, Principal Investigator, University of Alabama at BirminghamPrincipal Investigator

Lead Sponsor

University of Alabama at BirminghamOTHER

Collaborators

Name	Class
National Institute of Mental Health (NIMH)	NIH
University of Sao Paulo	OTHER
Federal University of Bahia	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard Care Arm	No Intervention	Participants randomized to the standard care arm will receive PrEP at a health facility from a physician or nurse.
COMPrEP Intervention	Experimental	Participants randomized to the COMPrEP intervention will receive PrEP from peer lay workers at private community locations.	Behavioral: COMPrEP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PrEP Uptake	Received at least one PrEP prescription	Within 1 month of enrollment

Secondary Outcomes

Measure	Description	Time Frame
PrEP Adherence Biomarker	Positive point of care urine tenofovir assay	1 month
PrEP Adherence Self-Report	Number of pills taken in the past 30 days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

24 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Katia J Bruxvoort, PhD	Contact	(205) 975-8625		kbruxvoort@uab.edu
Mallie E Froehlich, MSW	Contact	205-478-1102		mefroehl@uab.edu

Overall Officials

Name	Affiliation	Role
Katia J Bruxvoort, PhD	University of Alabama at Birmingham School of Public Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Federal University of Bahia		Salvador	Estado de Bahia		Brazil

IPD Sharing Statement Module

Plan to Share IPD

Description

IPD will not be shared with anyone outside of the study team.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Masking Info

Masking

Single

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.

Who Masked

Outcomes Assessor