The Stay Study: A Demonstration Project Advancing PrEP Delivery in the San Francisco Bay Area Transgender Community
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 5
- 主要终点
- Patterns and correlates of PrEP adherence among transgender individuals in the Stay Study.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Main
Emtricitabine / Tenofovir Disoproxil Oral Tablet and PrEP support.
干预措施: Emtricitabine / Tenofovir Disoproxil Oral Tablet (Drug)
Main
Emtricitabine / Tenofovir Disoproxil Oral Tablet and PrEP support.
干预措施: PrEP support (Behavioral)
结局指标
主要结局
Patterns and correlates of PrEP adherence among transgender individuals in the Stay Study.
时间窗: 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
时间窗: Baseline
Combined analysis of PrEP acceptance and refusal rates and sociodemographic correlates of PrEP acceptance and refusal.
次要结局
- Reasons transgender people choose to initiate PrEP(Baseline)
- Measure of changes in sexual risk taking behavior among Stay Study participants taking PrEP(12 months)
- Social harms experienced by study participants(12 months)
- Reasons transgender people choose to decline PrEP(Baseline)
- Measure of changes in STI among Stay Study participants taking PrEP(12 months)
- PrEP discontinuations and reasons for discontinuation(12 months)
- The number of seroconversions and HIV drug resistance patterns among persons who become HIV infected in the project(12 months)
- Referrals to other HIV prevention services within the Stay Study(15 months)
- Social benefits experienced by study participants(12 months)
- Side effects and toxicities of PrEP among study participants(12 months)
- Differences in duration of PrEP use and study retention by sociodemographics, including race/ethnicity, age, education and risk practices(15 months)
- Effects of PrEP on hormone levels(12 months)
- The effect of hormone use on tenofovir-diphosphate concentrations among study participants(12 months)
- Acceptability and uptake of Stay Study PrEP support components(12 months)
- Access to and uptake of PrEP after project completion(3 months)
研究者
Albert Liu
Clinical Research Director
Public Health Foundation Enterprises, Inc.