Clinical trial NCT03120936: The Stay Study: A Demonstration Project Advancing PrEP Delivery in the San Francisco Bay Area Transgender Community
Official title: The Stay Study: A Demonstration Project Advancing PrEP Delivery in the San Francisco Bay Area Transgender Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Transgender Persons
Pre-Exposure Prophylaxis
Keywords: Adherence
Transgender
PrEP
HIV Prevention
Truvada
HIV Risk Reduction
Lead sponsor: Public Health Foundation Enterprises, Inc.
Sponsor class: OTHER
Collaborators: name: San Francisco Department of Public Health
name: University of California, San Francisco
name: San Francisco Community Health Center
name: Tri-City Health Center
name: California HIV/AIDS Research Program
First posted: 2017-04-19
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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;

  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.

Primary outcomes:
measure: PrEP uptake and its correlates by gender identity, race/ethnicity, age, education, site, hormone status, and risk practices
timeFrame: Baseline
measure: Patterns and correlates of PrEP adherence among transgender individuals in the Stay Study.
timeFrame: 12 months
Secondary outcomes:
measure: Reasons transgender people choose to initiate PrEP
timeFrame: Baseline
measure: Reasons transgender people choose to decline PrEP
timeFrame: Baseline
measure: Measure of changes in sexual risk taking behavior among Stay Study participants taking PrEP
timeFrame: 12 months
measure: Measure of changes in STI among Stay Study participants taking PrEP
timeFrame: 12 months
measure: Side effects and toxicities of PrEP among study participants
timeFrame: 12 months
measure: PrEP discontinuations and reasons for discontinuation
timeFrame: 12 months
measure: Differences in duration of PrEP use and study retention by sociodemographics, including race/ethnicity, age, education and risk practices
timeFrame: 15 months
measure: The number of seroconversions and HIV drug resistance patterns among persons who become HIV infected in the project
timeFrame: 12 months
measure: Effects of PrEP on hormone levels
timeFrame: 12 months
measure: The effect of hormone use on tenofovir-diphosphate concentrations among study participants
timeFrame: 12 months
measure: Social harms experienced by study participants
timeFrame: 12 months
measure: Social benefits experienced by study participants
timeFrame: 12 months
measure: Referrals to other HIV prevention services within the Stay Study
timeFrame: 15 months
measure: Access to and uptake of PrEP after project completion
timeFrame: 3 months
measure: Acceptability and uptake of Stay Study PrEP support components
timeFrame: 12 months
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Tri-City Health Center
state: California
city: San Francisco
country: United States
facility: Bridge HIV, San Francisco Department of Public Health
state: California
city: San Francisco
country: United States
facility: Tom Waddell Urban Health Clinic
state: California
city: San Francisco
country: United States
facility: San Francisco Community Health Clinic
state: California
city: San Francisco
country: United States
facility: Castro-Mission Health Center
state: California
Study officials:
affiliation: Bridge HIV, San Francisco Department of Public Health
name: Albert Y Liu, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Public Health Research, San Francisco Department of Public Health
name: Erin Wilson, DrPH
role: PRINCIPAL_INVESTIGATOR
References: