The Stay Study: A Demonstration Project Advancing PrEP Delivery in the San Francisco Bay Area Transgender Community

Public Health Foundation Enterprises, Inc.

Status and phase

Completed

Phase 4

Conditions

Pre-Exposure Prophylaxis

Transgender Persons

Treatments

Behavioral: PrEP support

Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT03120936

PR15-SFDPH-026 (Other Grant/Funding Number)

16-20339

Details and patient eligibility

About

The Stay Study is a multi-site, open-label HIV pre-exposure prophylaxis (PrEP) demonstration project for advancing PrEP delivery in the San Francisco Bay Area Transgender Community. Approximately 188 HIV-uninfected participants will be enrolled at 4 sites in San Francisco and Fremont and will be provided Truvada to take orally once daily as PrEP.

Full description

PrEP stands for Pre-Exposure Prophylaxis, an HIV prevention method that involves HIV negative people taking antiviral drugs daily to try to help prevent HIV infection. Studies with men who have sex with men (MSM) and transgender women showed that people who took PrEP were less likely to become infected with HIV than those who did not take it.

The main purpose of this PrEP Demonstration Project is to make PrEP accessible to people in the transgender community. As part of this project, we will study whether transgender women and men are interested in taking PrEP, and, if so, for how long and how frequently they take the medication and how these relate to demographics (such as race, age, and education). We will also assess reasons for stopping PrEP and measure sexual behaviors of participants in the demonstration project.

Enrollment

158 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Self-identify as a transgender woman, transgender man, or gender non-conforming
Willing and able to provide written informed consent;
Age ≥ 18 years;
HIV-1-uninfected defined per site HIV testing algorithm performed within 7 (and up to 14) days of enrollment if PrEP naïve or within 90 days if currently on PrEP (see SSP manual)
Expressed desired to use or continue PrEP, anticipated risk, or evidence of risk for acquiring HIV-1 infection including having any cisgender male or transgender female partners in the past 12 months and not in a mutually monogamous partnership with a recently tested, HIV-negative partner AND at least one of the following;
1. any anal or vaginal sex in the past 12 months; or
2. any STI diagnosed or reported in the past 12 months; or
3. an ongoing sexual relationship with an HIV-positive partner; or
4. exchange of money, gifts, shelter, or drugs for sex
Fluent in English or Spanish

Exclusion criteria

Individuals with any of the following will be excluded:
- confirmed HIV infection by laboratory testing
- clinical symptoms consistent with possible acute HIV infection [fatigue, fever, rash, night sweats, and adenopathy];
- underlying bone disease (osteopenia or osteoporosis)
- Receipt of prohibited medications: interleukin therapy, medications with significant nephrotoxic potential (including but not limited to amphotericin B, aminoglycosides, cidofovir, foscarnet and systemic chemotherapy), and medications that may inhibit or compete for elimination via active renal tubular secretion (including but not limited to probenecid)
- No prior or current participation in the active arm of an HIV vaccine trial with evidence of vaccine-induced seropositivity.
- Unwilling to attend quarterly follow-up visits, which will include risk reduction/adherence counseling and repeat laboratory testing
- Has any other condition that, based on the opinion of the investigator or designee, would preclude provision of informed consent; make participation in the project unsafe; complicate interpretation of outcome data; or otherwise interfere with achieving the project objectives.