HPTN 091

Integrating HIV Prevention, Gender-Affirmative Medical Care, and Peer Health Navigation to Prevent HIV Acquisition and HIV Transmission for Transgender Women in the Americas: A Vanguard Feasibility and Acceptability Study

Study Summary

What is HPTN 091?

HPTN 091 is a study assessing the feasibility, acceptability, preliminary impact of a multi-component strategy that provides HIV prevention services, gender-affirming hormone therapy, and Peer Health Navigation to improve pre-exposure prophylaxis (PrEP) uptake and adherence.

Who is participating in HPTN 091?

This study will be enrolling about 310 transgender women (TGW), ages 18 or older, not living with HIV.

Why is HPTN 091 important?

Transgender women bear a disproportionate burden of HIV infection globally. Gender-affirming hormone therapy is an unmet need and community priority for TGW. An accepted and feasible intervention that delivers HIV prevention services with hormonal therapy could significantly impact the HIV epidemic among TGW.

What will happen during HPTN 091?

Participants will be randomized to two arms: an Immediate Intervention Arm and a Deferred Intervention Arm.

  • Immediate Intervention Arm: participants will receive PrEP provision, co-located services and Peer Health Navigation using Strengths-Based Case Management for 18 months.
  • Deferred Intervention Arm: for the first 6 months, participants will receive PrEP provision and linkage to services. From 6-18 months, participants in this arm will receive the full intervention of PrEP provision, co-located services and Peer Health Navigation using Strengths-Based Case Management.

 

HPTN 091 Study Design

Study Documents

HPTN 091 Version 1.0