FAQ

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 oral pre-exposure prophylaxis, also known as oral PrEP, co-located gender affirming services and Peer Health Navigation using Strengths-Based Case Management to improve PrEP uptake and adherence among transgender women. 

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.

HPTN 091 will enroll about 310 people who identify as women, transgender women, or along a trans feminine spectrum, were assigned male at birth, ages 18 or older, who are not living with HIV. 

HPTN 091 will be enrolling volunteers at 5 sites

• Harlem, New York
• Houston, Texas
• Philadelphia, Pennsylvania
• Rio de Janeiro, Brazil
• San Francisco, California

Participants will be randomly (like a flip of a coin) assigned to one of two study arms:

1. Immediate Intervention Arm
   • Participants will receive oral 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.
2. Deferred Intervention Arm
   • For the first 6 months, participants will receive oral 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 oral PrEP, STI screening and treatment, co-located gender affirming services and Peer Health Navigation using Strengths-Based Case Management at the study site.

HPTN 091 plans to begin enrolling volunteers in December 2020 and is expected to last about three years (36 months) including about a year to enroll study participants. Once enrolled, participants will have eight follow-up visits over a year and a half (18 months).

Participants who test positive for HIV during HPTN 091 will stop taking oral PrEP and will be asked to come to another visit to confirm the test results. Study staff will help them get services for people living with HIV as well as hormonal treatment services. Participants will have one additional visit 13 weeks later (about 3 months) to talk about the services they are getting outside the study site. This visit will be the last study visit.

The HPTN 091 study is conducted by the HIV Prevention Trials Network (HPTN) and sponsored by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Study drugs are provided by Gilead Sciences, Inc.