Linkage of Transgender Individuals to PrEP

HIV Seronegativity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03191474
• Other study ID #: CCTG 602
• Status: Completed
• Phase: N/A
• Start date: July 28, 2017
• Est. completion date: March 31, 2020

Study information

• Verified date: September 2021
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Seronegativity
• Linkage

Intervention

Behavioral:
• T-POWr Intervention
All participants will be asked to complete a secure confidential online survey focusing on needs assessment. Participants in the T-POWr Intervention Arm will receive a client-centered case management consultation based on how the participant responds to the online survey. The T-POWr will refer participants to assistance services based on the needs assessment, including accessing general health care, health insurance, hormone replacement therapy, housing, mental health care, domestic violence care, substance use treatment, etc. Each resource is extensively vetted to assure a trans-friendly experience and will be tailored to each geographic area across the project enrollment sites. The study facilitates referrals for services but will not provide extensive and ongoing case management.

Locations

Country	Name	City	State
United States	Los Angeles Lesbian, Gay, Bisexual, and Transgender Center	Los Angeles	California
United States	UC San Diego AntiViral Research Center (AVRC)	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	Los Angeles LGBT Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Facilitated Linkage	To evaluate the effectiveness of a T-POWr intervention to effectively link transgender / gender non-conforming persons to a PrEP evaluation visit.	Baseline up to Week 28