Linkage of Transgender Individuals to PrEP

Not Applicable

Completed

• Conditions: HIV Seronegativity; Linkage
• Interventions: Behavioral: T-POWr Intervention

• Registration Number: NCT03191474
• Lead Sponsor: University of California, San Diego

Brief 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).

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-06-15
• Study First Submitted QC: 2017-06-15
• Study First Posted: 2017-06-19
• Study Start: 2017-07-28
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-09
• Last Update Posted: 2021-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T-POWr Intervention Arm	T-POWr Intervention	Participants will receive the same HIV risk assessment, PrEP education, and appointment for a PrEP evaluation visit as the Control Arm. Participants in the Intervention Arm will also receive 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.

Primary Outcome Measures

Name	Time	Method
Facilitated Linkage	Baseline up to Week 28	To evaluate the effectiveness of a T-POWr intervention to effectively link transgender / gender non-conforming persons to a PrEP evaluation visit.

Trial Locations

Locations (2)

UC San Diego AntiViral Research Center (AVRC); 🇺🇸 San Diego, California, United States

Los Angeles Lesbian, Gay, Bisexual, and Transgender Center; 🇺🇸 Los Angeles, California, United States