Pre-Exposure Prophylaxis for Transgender Women in the US and South America
Status:
Enrolling by invitation
Trial end date:
2024-11-21
Target enrollment:
Participant gender:
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.