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

HIV Prevention Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

entered elsewhere ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04742491
Study type Interventional
Source HIV Prevention Trials Network
Contact
Status Active, not recruiting
Phase Phase 2/Phase 3
Start date March 26, 2021
Completion date September 16, 2024
View Details
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