NCT04742491

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

HPTN 091: Integrating HIV Prevention, Gender-Affirmative Medical Care, and Peer Health Navigation for Transgender Women in the Americas: A Vanguard Study

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 304 (actual)
• Sponsor: HIV Prevention Trials Network · Network
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

entered elsewhere

Conditions

• HIV Prevention

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-03-26
• Primary completion: 2024-08-16
• Completion: 2024-08-16
• First posted: 2021-02-08
• Last updated: 2025-12-17
• Results posted: 2025-12-17

Locations

5 sites across 2 countries: United States, Brazil

Regulatory

• FDA-regulated drug study