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Pre-Exposure Prophylaxis for Transgender Women in the US and South America

NCT04742491 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2025-12-17

Study results available
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Summary

A study to assess the feasibility, acceptability, and preliminary impact of a multi-component strategy to improve pre-exposure prophylaxis (PrEP) uptake and adherence that integrates delivery of biomedical HIV prevention co-located with gender-affirming transgender care (hormonal therapy and medical monitoring) and Peer Health Navigation (PHN) using Strengths-Based Case Management (SBCM) professional supervision.

Multi-site, open-label study with each participant randomized 1:1 to Immediate Intervention vs. 6-month Deferred Intervention Arms. Both arms will be provided PrEP and sexually transmitted infection (STI) screening and treatment. Participants in the Immediate Intervention Arm will receive co-located gender-affirming medical care and PHN using SBCM starting at the Enrollment Visit. Participants in the Deferred Intervention Arm will receive linkage to external gender-affirming medical care and case management services during the deferred period and will transition to the study intervention six months following the Enrollment Visit.

Conditions

  • HIV Prevention

Interventions

DRUG

Immediate Intervention Arm

Truvada, Descovy in the United States; Truvada in Brazil

DRUG

Deferred Intervention Arm

Truvada, Descovy in the United States; Truvada in Brazil

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • HIV Prevention Trials Network

    lead NETWORK

Principal Investigators

  • Tonia Poteat, PhD, MPH · UNC Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-26
Primary Completion
2024-08-16
Completion
2024-08-16
FDA Drug
Yes

Countries

  • United States
  • Brazil

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04742491 on ClinicalTrials.gov