The Stay Study: A Demonstration Project Advancing PrEP Delivery in the San Francisco Bay Area Transgender Community
- Conditions
- Pre-Exposure ProphylaxisTransgender Persons
- Interventions
- Behavioral: PrEP support
- Registration Number
- NCT03120936
- Lead Sponsor
- Public Health Foundation Enterprises, Inc.
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 158
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Self-identify as a transgender woman, transgender man, or gender non-conforming
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Willing and able to provide written informed consent;
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Age ≥ 18 years;
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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)
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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;
- any anal or vaginal sex in the past 12 months; or
- any STI diagnosed or reported in the past 12 months; or
- an ongoing sexual relationship with an HIV-positive partner; or
- exchange of money, gifts, shelter, or drugs for sex
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Fluent in English or Spanish
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Main Emtricitabine / Tenofovir Disoproxil Oral Tablet Emtricitabine / Tenofovir Disoproxil Oral Tablet and PrEP support. Main PrEP support Emtricitabine / Tenofovir Disoproxil Oral Tablet and PrEP support.
- Primary Outcome Measures
Name Time Method Patterns and correlates of PrEP adherence among transgender individuals in the Stay Study. 12 months 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
PrEP uptake and its correlates by gender identity, race/ethnicity, age, education, site, hormone status, and risk practices Baseline Combined analysis of PrEP acceptance and refusal rates and sociodemographic correlates of PrEP acceptance and refusal.
- Secondary Outcome Measures
Name Time Method Reasons transgender people choose to initiate PrEP Baseline Reasons for initiating PrEP
Measure of changes in sexual risk taking behavior among Stay Study participants taking PrEP 12 months 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
Social harms experienced by study participants 12 months Social Impact questionnaire
Side effects and toxicities of PrEP among study participants 12 months Combined analysis of side effects and toxicities, including creatinine elevations
Differences in duration of PrEP use and study retention by sociodemographics, including race/ethnicity, age, education and risk practices 15 months Combined analysis of CASI and interview data.
Effects of PrEP on hormone levels 12 months Combined analysis of hormone levels as relates to measures of adherence, such as TFV-DP in DBS, tenofovir levels in plasma
The effect of hormone use on tenofovir-diphosphate concentrations among study participants 12 months Combined analysis of hormone levels as relates to measures of adherence, such as TFV-DP in DBS, tenofovir levels in plasma
Reasons transgender people choose to decline PrEP Baseline Reasons for declining PrEP
Measure of changes in STI among Stay Study participants taking PrEP 12 months STI testing
PrEP discontinuations and reasons for discontinuation 12 months PrEP discontinuations, reasons for discontinuation
The number of seroconversions and HIV drug resistance patterns among persons who become HIV infected in the project 12 months HIV drug resistance patterns among persons who become infected
Referrals to other HIV prevention services within the Stay Study 15 months Combined analysis of CASI and interview data
Social benefits experienced by study participants 12 months Social impact questionnaire
Access to and uptake of PrEP after project completion 3 months Combined analysis of the proportion of participants interested in continuing PrEP and successfully able to access PrEP
Acceptability and uptake of Stay Study PrEP support components 12 months Combined analysis of CASI and interview responses.
Trial Locations
- 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
Castro-Mission Health Center
🇺🇸San Francisco, California, United States
San Francisco Community Health Clinic
🇺🇸San Francisco, California, United States