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The Stay Study: A Demonstration Project Advancing PrEP Delivery in the San Francisco Bay Area Transgender Community | Clinical Trials | Clareo Health

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

NCT03120936•Public Health Foundation Enterprises, Inc.

View on ClinicalTrials.gov

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.

Detailed 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (5)

Tri-City Health Center

Fremont, California, United States

Bridge HIV, San Francisco Department of Public Health

San Francisco, California, United States

Tom Waddell Urban Health Clinic

San Francisco, California, United States

San Francisco Community Health Clinic

San Francisco, California, United States

Castro-Mission Health Center

San Francisco, California, United States

Key Dates

Start Date

August 8, 2017

Primary Completion Date

August 27, 2020

Completion Date

December 1, 2020

Last Updated

April 21, 2021

Enrollment

158

ACTUAL participants

Conditions

Transgender PersonsPre-Exposure Prophylaxis

Interventions

Emtricitabine / Tenofovir Disoproxil Oral Tablet

DRUG

PrEP support

BEHAVIORAL

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

NCT07071623

Human Immunodeficiency Virus (HIV)HIV Pre-Exposure Prophylaxis

View study

RECRUITINGNA

TransHealthGUIDE: Transforming Health for Gender-Diverse Young Adults

NCT06177600

Transgender PersonsHealth Services for Transgender Persons+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 21, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

TransHealthGUIDE: Transforming Health for Gender-Diverse Young Adults

Client-Centered Care Coordination for Black Men Who Have Sex With Men

UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study

New-onset Chronic Pelvic Pain in Transgender People Using Testosterone Therapy: an Exploratory Qualitative Study.

Hybrid Evaluation of a Home-based HIV Pre-exposure Prophylaxis Program