Linkage of Transgender Individuals to PrEP

NCT ID: NCT03191474

Last Updated: 2021-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-28
• Study Completion Date: 2020-03-31

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.

Conditions

HIV Seronegativity; Linkage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard of Care Arm

Participants will receive standard of care HIV risk assessment, PrEP education, and an appointment for a PrEP evaluation visit at an affiliated clinic.

Group Type: NO_INTERVENTION

No interventions assigned to this group

T-POWr Intervention Arm

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.

Group Type: EXPERIMENTAL

T-POWr Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Los Angeles LGBT Center

OTHER

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Sheldon Morris

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sheldon Morris, MD MPH

Role: STUDY_CHAIR

CCTG, UCSD AVRC

Locations

Los Angeles Lesbian, Gay, Bisexual, and Transgender Center

Los Angeles, California, United States

UC San Diego AntiViral Research Center (AVRC)

San Diego, California, United States

Countries

United States

Other Identifiers

CCTG 602

Identifier Type: -

Identifier Source: org_study_id