The Stay Study: A Demonstration Project Advancing PrEP Delivery in the San Francisco Bay Area Transgender Community

NCT03120936 | Completed Phase 4 FDA Drug

• 2 other identifiers: 16-20339PR15-SFDPH-026
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 5

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.

Conditions

Transgender Persons; Pre-Exposure Prophylaxis

Keywords

Adherence; Transgender; PrEP; HIV Prevention; Truvada; HIV Risk Reduction

Outcome Measures

Primary Outcomes (2)

• PrEP uptake and its correlates by gender identity, race/ethnicity, age, education, site, hormone status, and risk practices

  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.

  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 Outcomes (15)

• Reasons transgender people choose to initiate PrEP

  Baseline

• Reasons transgender people choose to decline PrEP

  Baseline

• Measure of changes in sexual risk taking behavior among Stay Study participants taking PrEP

  12 months

• Measure of changes in STI among Stay Study participants taking PrEP

  12 months

• Side effects and toxicities of PrEP among study participants

  12 months

Study Arms (1)

Main

OTHER

Emtricitabine / Tenofovir Disoproxil Oral Tablet and PrEP support.

Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet; Behavioral: PrEP support

Interventions

Emtricitabine / Tenofovir Disoproxil Oral Tablet DRUG

Open-label emtricitabine 200mg/tenofovir 300mg

Also known as: Truvada, PrEP

Main

PrEP support BEHAVIORAL

HIV/STI testing and counseling, adherence counseling, medical exams, safety monitoring, short message system (SMS), ie text message, and peer support, panel management.

Main

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Transgender or gender non-conforming
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Public Health Foundation Enterprises, Inc.: lead
• San Francisco Department of Public Health: collaborator
• University of California, San Francisco: collaborator
• San Francisco Community Health Center: collaborator
• Tri-City Health Center: collaborator
• California HIV/AIDS Research Program: collaborator

Study Sites (5)

Tri-City Health Center

Fremont, California, 94538, United States

Location

Bridge HIV, San Francisco Department of Public Health

San Francisco, California, 94102, United States

Location

Tom Waddell Urban Health Clinic

San Francisco, California, 94102, United States

Location

San Francisco Community Health Clinic

San Francisco, California, 94109, United States

Location

Castro-Mission Health Center

San Francisco, California, 94114, United States

Location

MeSH Terms

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Director

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 19, 2017
• Study Start: August 8, 2017
• Primary Completion: August 27, 2020
• Study Completion: December 1, 2020
• Last Updated: April 21, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)