The Stay Study: A Demonstration Project Advancing PrEP Delivery in the San Francisco Bay Area Transgender Community
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|ClinicalTrials.gov Identifier: NCT03120936|
Recruitment Status : Recruiting
First Posted : April 19, 2017
Last Update Posted : April 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Transgender Persons Pre-Exposure Prophylaxis||Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet Behavioral: PrEP support||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||188 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Stay Study: A Demonstration Project Advancing PrEP Delivery in the San Francisco Bay Area Transgender Community|
|Actual Study Start Date :||August 8, 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||March 2020|
Emtricitabine / Tenofovir Disoproxil Oral Tablet and PrEP support.
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.
- PrEP uptake and its correlates by gender identity, race/ethnicity, age, education, site, hormone status, and risk practices [ Time Frame: Baseline ]Combined analysis of PrEP acceptance and refusal rates and sociodemographic correlates of PrEP acceptance and refusal.
- Patterns and correlates of PrEP adherence among transgender individuals in the Stay Study. [ Time Frame: 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
- Reasons transgender people choose to initiate PrEP [ Time Frame: Baseline ]Reasons for initiating PrEP
- Reasons transgender people choose to decline PrEP [ Time Frame: Baseline ]Reasons for declining PrEP
- Measure of changes in sexual risk taking behavior among Stay Study participants taking PrEP [ Time Frame: 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
- Measure of changes in STI among Stay Study participants taking PrEP [ Time Frame: 12 months ]STI testing
- Side effects and toxicities of PrEP among study participants [ Time Frame: 12 months ]Combined analysis of side effects and toxicities, including creatinine elevations
- PrEP discontinuations and reasons for discontinuation [ Time Frame: 12 months ]PrEP discontinuations, reasons for discontinuation
- Differences in duration of PrEP use and study retention by sociodemographics, including race/ethnicity, age, education and risk practices [ Time Frame: 15 months ]Combined analysis of CASI and interview data.
- The number of seroconversions and HIV drug resistance patterns among persons who become HIV infected in the project [ Time Frame: 12 months ]HIV drug resistance patterns among persons who become infected
- Effects of PrEP on hormone levels [ Time Frame: 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 [ Time Frame: 12 months ]Combined analysis of hormone levels as relates to measures of adherence, such as TFV-DP in DBS, tenofovir levels in plasma
- Social harms experienced by study participants [ Time Frame: 12 months ]Social Impact questionnaire
- Social benefits experienced by study participants [ Time Frame: 12 months ]Social impact questionnaire
- Referrals to other HIV prevention services within the Stay Study [ Time Frame: 15 months ]Combined analysis of CASI and interview data
- Access to and uptake of PrEP after project completion [ Time Frame: 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 [ Time Frame: 12 months ]Combined analysis of CASI and interview responses.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03120936
|Contact: Sean Arayasinkul, MSPH, PhD(c)||email@example.com|
|United States, California|
|Tri-City Health Center||Recruiting|
|Fremont, California, United States, 94538|
|Tom Waddell Urban Health Clinic||Recruiting|
|San Francisco, California, United States, 94102|
|Asian and Pacific Islander Wellness Center||Recruiting|
|San Francisco, California, United States, 94109|
|Castro-Mission Health Center||Recruiting|
|San Francisco, California, United States, 94114|
|Principal Investigator:||Albert Y Liu, MD, MPH||Bridge HIV, San Francisco Department of Public Health|
|Principal Investigator:||Erin Wilson, DrPH||Center for Public Health Research, San Francisco Department of Public Health|