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RECRUITING
NCT06880705
NA

The Trans-Led Care Study

Sponsor: Illinois Institute of Technology

View on ClinicalTrials.gov

Summary

This study is testing a new mutual-help group called "the TLC program" for transgender adults who use substances or are recently in recovery. The TLC Program is based on Acceptance and Commitment Therapy or "ACT" which is a type of mental health counseling that focuses on using mindfulness skills to connect a person to their values and improve their mental health. The TLC Program was developed by transgender and gender diverse community members, mental health providers, and researchers.

Official title: A Gender-Affirming Stigma Intervention to Improve Substance Misuse and HIV Risk Among Transgender Women

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2025-02-10

Completion Date

2027-07-31

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

BEHAVIORAL

The TLC Program

Participants randomized to the TLC Program will receive TAU plus the telehealth, peer-delivered group intervention. The TLC Program was adapted from Acceptance and Commitment Therapy (ACT) - an acceptance and mindfulness-based third wave cognitive behavioral therapy. The intervention will be delivered in a group format with peer facilitators via telehealth using videoconferencing. The protocol covers all six ACT core concepts (i.e., contact with the present, acceptance, defusion, self-as-context, values, and committed action) with tailored examples and exercises focused on gender affirmation, internalized stigma, and substance use. Additional sessions are included defining stigma, how stigma affects physical and sexual health and engagement with healthcare, and values-driven self-care goals of substance use reduction and healthcare engagement. Sessions are approximately 1.5 hours each and are delivered over 12 weeks.

Locations (1)

Illinois Institute of Technology

Chicago, Illinois, United States