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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 : Completed
First Posted : April 19, 2017
Last Update Posted : April 21, 2021
Sponsor:
Collaborators:
San Francisco Department of Public Health
University of California, San Francisco
San Francisco Community Health Center
Tri-City Health Center
California HIV/AIDS Research Program
Information provided by (Responsible Party):
Albert Liu, Public Health Foundation Enterprises, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Transgender Persons Pre-Exposure Prophylaxis Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet Behavioral: PrEP support Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Primary Completion Date : August 27, 2020
Actual Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Main
Emtricitabine / Tenofovir Disoproxil Oral Tablet and PrEP support.
 Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet
Open-label emtricitabine 200mg/tenofovir 300mg
Other Names:
  • Truvada
  • PrEP

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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. Reasons transgender people choose to initiate PrEP [ Time Frame: Baseline ]
    Reasons for initiating PrEP

  2. Reasons transgender people choose to decline PrEP [ Time Frame: Baseline ]
    Reasons for declining PrEP

  3. 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

  4. Measure of changes in STI among Stay Study participants taking PrEP [ Time Frame: 12 months ]
    STI testing

  5. Side effects and toxicities of PrEP among study participants [ Time Frame: 12 months ]
    Combined analysis of side effects and toxicities, including creatinine elevations

  6. PrEP discontinuations and reasons for discontinuation [ Time Frame: 12 months ]
    PrEP discontinuations, reasons for discontinuation

  7. 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.

  8. 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

  9. 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

  10. 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

  11. Social harms experienced by study participants [ Time Frame: 12 months ]
    Social Impact questionnaire

  12. Social benefits experienced by study participants [ Time Frame: 12 months ]
    Social impact questionnaire

  13. Referrals to other HIV prevention services within the Stay Study [ Time Frame: 15 months ]
    Combined analysis of CASI and interview data

  14. 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

  15. Acceptability and uptake of Stay Study PrEP support components [ Time Frame: 12 months ]
    Combined analysis of CASI and interview responses.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Transgender or gender non-conforming
Accepts Healthy Volunteers:   Yes
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;

    1. any anal or vaginal sex in the past 12 months; or
    2. any STI diagnosed or reported in the past 12 months; or
    3. an ongoing sexual relationship with an HIV-positive partner; or
    4. 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, California
Tri-City Health Center
Fremont, California, United States, 94538
Bridge HIV, San Francisco Department of Public Health
San Francisco, California, United States, 94102
Tom Waddell Urban Health Clinic
San Francisco, California, United States, 94102
San Francisco Community Health Clinic
San Francisco, California, United States, 94109
Castro-Mission Health Center
San Francisco, California, United States, 94114
Sponsors and Collaborators
Public Health Foundation Enterprises, Inc.
San Francisco Department of Public Health
University of California, San Francisco
San Francisco Community Health Center
Tri-City Health Center
California HIV/AIDS Research Program
Investigators
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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
More Information
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Additional Information:

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Responsible Party: Albert Liu, Clinical Research Director, Public Health Foundation Enterprises, Inc.
ClinicalTrials.gov Identifier: NCT03120936    
Other Study ID Numbers: 16-20339
PR15-SFDPH-026 ( Other Grant/Funding Number: California HIV/AIDS Research Program )
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: April 21, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Albert Liu, Public Health Foundation Enterprises, Inc.:
Adherence
Transgender
PrEP
 HIV Prevention
Truvada
HIV Risk Reduction
Additional relevant MeSH terms:
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Tenofovir
Emtricitabine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
 Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents