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

Pre-Exposure Prophylaxis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03120936
• Other study ID #: 16-20339
• Secondary ID: PR15-SFDPH-026
• Status: Completed
• Phase: Phase 4
• Start date: August 8, 2017
• Est. completion date: December 1, 2020

Study information

• Verified date: April 2021
• Source: Public Health Foundation Enterprises, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: December 1, 2020
• Est. primary completion date: August 27, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pre-Exposure Prophylaxis
• Transgender Persons

Intervention

Drug:
• Emtricitabine / Tenofovir Disoproxil Oral Tablet
Open-label emtricitabine 200mg/tenofovir 300mg

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Tri-City Health Center	Fremont	California
United States	Bridge HIV, San Francisco Department of Public Health	San Francisco	California
United States	Castro-Mission Health Center	San Francisco	California
United States	San Francisco Community Health Clinic	San Francisco	California
United States	Tom Waddell Urban Health Clinic	San Francisco	California

Sponsors (6)

Lead Sponsor	Collaborator
Public Health Foundation Enterprises, Inc.	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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PrEP uptake and its correlates by gender identity, race/ethnicity, age, education, site, hormone status, and risk practices	Combined analysis of PrEP acceptance and refusal rates and sociodemographic correlates of PrEP acceptance and refusal.	Baseline
Primary	Patterns and correlates of PrEP adherence among transgender individuals in the Stay Study.	Combined analysis of PrEP adherence rates as measured by: Tenofovir-diphosphate (TFV-DP) levels in dried blood spots (DBS); medication possession ratio; self-reported adherence. Patterns and correlates of adherence	12 months
Secondary	Reasons transgender people choose to initiate PrEP	Reasons for initiating PrEP	Baseline
Secondary	Reasons transgender people choose to decline PrEP	Reasons for declining PrEP	Baseline
Secondary	Measure of changes in sexual risk taking behavior among Stay Study participants taking PrEP	Computer-Assisted Self-interview (CASI) data: Numbers of sexual partners, by serostatus and condom use, and anal/vaginal sex episodes, by partner serostatus, role of respondent, and condom use; sexually transmitted infection (STI) testing	12 months
Secondary	Measure of changes in STI among Stay Study participants taking PrEP	STI testing	12 months
Secondary	Side effects and toxicities of PrEP among study participants	Combined analysis of side effects and toxicities, including creatinine elevations	12 months
Secondary	PrEP discontinuations and reasons for discontinuation	PrEP discontinuations, reasons for discontinuation	12 months
Secondary	Differences in duration of PrEP use and study retention by sociodemographics, including race/ethnicity, age, education and risk practices	Combined analysis of CASI and interview data.	15 months
Secondary	The number of seroconversions and HIV drug resistance patterns among persons who become HIV infected in the project	HIV drug resistance patterns among persons who become infected	12 months
Secondary	Effects of PrEP on hormone levels	Combined analysis of hormone levels as relates to measures of adherence, such as TFV-DP in DBS, tenofovir levels in plasma	12 months
Secondary	The effect of hormone use on tenofovir-diphosphate concentrations among study participants	Combined analysis of hormone levels as relates to measures of adherence, such as TFV-DP in DBS, tenofovir levels in plasma	12 months
Secondary	Social harms experienced by study participants	Social Impact questionnaire	12 months
Secondary	Social benefits experienced by study participants	Social impact questionnaire	12 months
Secondary	Referrals to other HIV prevention services within the Stay Study	Combined analysis of CASI and interview data	15 months
Secondary	Access to and uptake of PrEP after project completion	Combined analysis of the proportion of participants interested in continuing PrEP and successfully able to access PrEP	3 months
Secondary	Acceptability and uptake of Stay Study PrEP support components	Combined analysis of CASI and interview responses.	12 months

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