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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-08

Study Completion Date

2020-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Transgender Persons Pre-Exposure Prophylaxis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Main

Emtricitabine / Tenofovir Disoproxil Oral Tablet and PrEP support.

Group Type OTHER

Emtricitabine / Tenofovir Disoproxil Oral Tablet

Intervention Type DRUG

Open-label emtricitabine 200mg/tenofovir 300mg

PrEP support

Intervention Type BEHAVIORAL

HIV/STI testing and counseling, adherence counseling, medical exams, safety monitoring, short message system (SMS), ie text message, and peer support, panel management.

Interventions

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Emtricitabine / Tenofovir Disoproxil Oral Tablet

Open-label emtricitabine 200mg/tenofovir 300mg

Intervention Type DRUG

PrEP support

HIV/STI testing and counseling, adherence counseling, medical exams, safety monitoring, short message system (SMS), ie text message, and peer support, panel management.

Intervention Type BEHAVIORAL

Other Intervention Names

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Truvada PrEP

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes