Linkage of Transgender Individuals to PrEP

NCT03191474 | Completed

• 1 other identifier: CCTG 602
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 2

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).

Conditions

HIV Seronegativity; Linkage

Keywords

PrEP; Pre-exposure Prophylaxis; Truvada; Client-centered case management; Transgender; Gender non-conforming

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Standard of Care Arm

NO INTERVENTION

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

T-POWr Intervention Arm

EXPERIMENTAL

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.

Behavioral: T-POWr Intervention

Interventions

T-POWr Intervention 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.

T-POWr Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Transgender or Gender Non-conforming, defined as identifying with a gender different from sex assigned at birth.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

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

Sponsors & Collaborators

• University of California, San Diego: lead
• Los Angeles LGBT Center: collaborator

Study Sites (2)

Los Angeles Lesbian, Gay, Bisexual, and Transgender Center

Los Angeles, California, 90027, United States

Location

UC San Diego AntiViral Research Center (AVRC)

San Diego, California, 92103, United States

Location

Study Officials

• Sheldon Morris, MD MPH

  CCTG, UCSD AVRC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: June 19, 2017
• Study Start: July 28, 2017
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: September 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)