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

• Status: Completed
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Public Health Foundation Enterprises, Inc.
• Collaborators: API Wellness; California HIV/AIDS Research Program; San Francisco Community Health Center; San Francisco Department of Public Health; Tri-City Health Center; University of California, San Francisco
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

Criteria

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.