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

Study Overview
=================
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.

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

Conditions
-----------------
Transgender Persons, Pre-Exposure Prophylaxis

Intervention / Treatment
-----------------
* Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet
* Behavioral: PrEP support


Participation Criteria
=================
Eligibility Criteria
-----------------
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; 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 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Main<br>Emtricitabine / Tenofovir Disoproxil Oral Tablet and PrEP support. | Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet<br>* Open-label emtricitabine 200mg/tenofovir 300mg<br>* Other names: PrEP;Behavioral: PrEP support<br>* HIV/STI testing and counseling, adherence counseling, medical exams, safety monitoring, short message system (SMS), ie text message, and peer support, panel management.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reasons transgender people choose to initiate PrEP | Reasons for initiating PrEP | Baseline | 
| Reasons transgender people choose to decline PrEP | Reasons for declining PrEP | Baseline | 
| 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 | 
| Measure of changes in STI among Stay Study participants taking PrEP | STI testing | 12 months | 
| Side effects and toxicities of PrEP among study participants | Combined analysis of side effects and toxicities, including creatinine elevations | 12 months | 
| PrEP discontinuations and reasons for discontinuation | PrEP discontinuations, reasons for discontinuation | 12 months | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Social harms experienced by study participants | Social Impact questionnaire | 12 months | 
| Social benefits experienced by study participants | Social impact questionnaire | 12 months | 
| Referrals to other HIV prevention services within the Stay Study | Combined analysis of CASI and interview data | 15 months | 
| 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 | 
| Acceptability and uptake of Stay Study PrEP support components | Combined analysis of CASI and interview responses. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adherence, Transgender, PrEP, HIV Prevention, Truvada, HIV Risk Reduction