RecruitingNot ApplicableNCT06880705

The Trans-Led Care Study

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


Sponsor

Illinois Institute of Technology

Enrollment

124 participants

Start Date

Feb 10, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a healthcare model where transgender people are cared for by providers from within the transgender community ("trans-led care") for people who struggle with both gender dysphoria and substance use. The study focuses on whether care delivered by community members who share lived experiences improves outcomes for transgender adults with alcohol or drug use problems. **You may be eligible if:** - You are 18 or older - You live in the United States - You primarily speak English - You identify as transgender or have a gender identity different from your sex assigned at birth - You have experienced 2 or more problems related to alcohol or other drug use in the past 12 months **You may NOT be eligible if:** - You are under 18 years old - You do not identify as transgender - You live outside the United States - You have not experienced substance use-related problems in the past year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALThe 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

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NCT06880705


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