Summary

for people ages 18 years and up (full criteria)
healthy people welcome
at San Diego, California and other locations
study started
estimated completion:
Sheldon Morris

Description

Summary

CCTG 602 is a multisite demonstration project to evaluate the effectiveness of facilitated linkage to PrEP using a community-based transgender PrEP outreach worker (T-POWr) versus standard of care (SOC).

Official Title

CCTG 602: Linkage of Transgender Individuals to PrEP, A Multicenter Trial of the California Collaborative Treatment Group (CCTG)

Details

Up to 500 self-identified transgender / gender non-conforming persons seeking daily Pre-Exposure Prophylaxis (PrEP) for the prevention of HIV will be enrolled into this study. Each participant will be followed up to 28 weeks after enrollment. The primary endpoint, successful linkage to a PrEP evaluation visit, will be measured after 30 days of enrollment.

Participants expressing interest in PrEP will be referred to the regional transgender PrEP outreach work (T-POWr) via phone call. Enrolled participants will be randomized (1:1) to either SOC PrEP linkage vs T-POWr facilitated PrEP linkage. Participants randomized into the SOC Arm will receive an HIV risk assessment, PrEP education, and an appointment for a linkage visit. Participants randomized into the T-POWr arm will receive SOC and a thorough client-centered case management evaluation that will assess needs including access to health insurance, general health care, assessment of current hormone administration, housing, mental health care, domestic violence care, substance use treatment, and other services.

Participants will be contacted at Week 4 to verify linkage, and at Weeks 16 and 28 to assess PrEP and HIV status, and access to referred services.

Keywords

HIV Seronegativity Linkage PrEP Pre-exposure Prophylaxis Truvada Client-centered case management Transgender Gender non-conforming T-POWr Intervention

Eligibility

You can join if…

Open to people ages 18 years and up

  • Age 18 years or older
  • Self-identifies as a transgender or gender non-conforming person
  • Self-identifies as HIV-negative or unknown status
  • Ability to provide informed consent
  • English or Spanish speaking

You CAN'T join if...

  • Severe active substance abuse or mental illness that the investigator feels will interfere with the ability to provide informed consent

Locations

  • University of California, San Diego accepting new patients
    San Diego California 92103 United States
  • Los Angeles Lesbian, Gay, Bisexual, and Transgender Center accepting new patients
    Los Angeles California 90027 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
California Collaborative Treatment Group
ID
NCT03191474
Lead Scientist
Sheldon Morris
Study Type
Interventional
Last Updated
August 2017