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

NCT03120936 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2021-04-21

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • San Francisco Department of Public Health

    collaborator OTHER_GOV

  • University of California, San Francisco

    collaborator OTHER

  • San Francisco Community Health Center

    collaborator UNKNOWN

  • Tri-City Health Center

    collaborator UNKNOWN

  • California HIV/AIDS Research Program

    collaborator OTHER

  • Public Health Foundation Enterprises, Inc.

    lead OTHER

Principal Investigators

  • Albert Y Liu, MD, MPH · Bridge HIV, San Francisco Department of Public Health

  • Erin Wilson, DrPH · Center for Public Health Research, San Francisco Department of Public Health

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-08
Primary Completion
2020-08-27
Completion
2020-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03120936 on ClinicalTrials.gov