The HPTN 091 study is testing the feasibility (will it work?), acceptability (do people like it?) and possible impact (does it make a difference?) of providing pre-exposure prophylaxis, also known as PrEP, co-located gender affirming services and Peer Health Navigation using Strengths-Based Case Management to improve PrEP uptake and adherence among transgender women. This study will be enrolling about 310 transgender women, ages 18 or older, not living with HIV.
Gender-affirming hormone therapy is an unmet need and community priority for transgender women. An accepted and feasible intervention that delivers HIV prevention services with hormonal therapy could significantly impact the HIV epidemic among transgender women.
Participants will be randomly (like a flip of a coin) assigned to one of two study arms: an Immediate Intervention Arm and a Deferred Intervention Arm.
- Immediate Intervention Arm: will receive PrEP, STI screening and treatment, co-located gender affirming services and Peer Health Navigation using Strengths-Based Case Management at the study site for 18 months.
- Deferred Intervention Arm: for the first 6 months, participants will receive PrEP, STI screening and treatment, but will be referred to receive gender affirming and health navigation services outside the study site. From 6-18 months, participants in this arm will receive PrEP, STI screening and treatment, co-located gender affirming services and Peer Health Navigation using Strengths-Based Case Management at the study site.
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