- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03120936
The Stay Study: A Demonstration Project Advancing PrEP Delivery in the San Francisco Bay Area Transgender Community
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
California
-
Fremont, California, United States, 94538
- Tri-City Health Center
-
San Francisco, California, United States, 94102
- Bridge HIV, San Francisco Department of Public Health
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San Francisco, California, United States, 94102
- Tom Waddell Urban Health Clinic
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San Francisco, California, United States, 94109
- San Francisco Community Health Clinic
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San Francisco, California, United States, 94114
- Castro-Mission Health Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Main
Emtricitabine / Tenofovir Disoproxil Oral Tablet and PrEP support.
|
Open-label emtricitabine 200mg/tenofovir 300mg
Other Names:
HIV/STI testing and counseling, adherence counseling, medical exams, safety monitoring, short message system (SMS), ie text message, and peer support, panel management.
|
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
Time Frame: Baseline
|
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.
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
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reasons transgender people choose to initiate PrEP
Time Frame: Baseline
|
Reasons for initiating PrEP
|
Baseline
|
Reasons transgender people choose to decline PrEP
Time Frame: Baseline
|
Reasons for declining PrEP
|
Baseline
|
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
|
12 months
|
Measure of changes in STI among Stay Study participants taking PrEP
Time Frame: 12 months
|
STI testing
|
12 months
|
Side effects and toxicities of PrEP among study participants
Time Frame: 12 months
|
Combined analysis of side effects and toxicities, including creatinine elevations
|
12 months
|
PrEP discontinuations and reasons for discontinuation
Time Frame: 12 months
|
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
Time Frame: 15 months
|
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
Time Frame: 12 months
|
HIV drug resistance patterns among persons who become infected
|
12 months
|
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
|
12 months
|
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
|
12 months
|
Social harms experienced by study participants
Time Frame: 12 months
|
Social Impact questionnaire
|
12 months
|
Social benefits experienced by study participants
Time Frame: 12 months
|
Social impact questionnaire
|
12 months
|
Referrals to other HIV prevention services within the Stay Study
Time Frame: 15 months
|
Combined analysis of CASI and interview data
|
15 months
|
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
|
3 months
|
Acceptability and uptake of Stay Study PrEP support components
Time Frame: 12 months
|
Combined analysis of CASI and interview responses.
|
12 months
|
Collaborators and Investigators
Collaborators
Investigators
- 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
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-20339
- PR15-SFDPH-026 (Other Grant/Funding Number: California HIV/AIDS Research Program)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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