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

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.

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.