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

Inclusion Criteria7

  • Eligible transgender adults must:
  • be 18 years of age or older;
  • speak primarily English;
  • live in the U.S.;
  • have a gender identity different from their assumed gender, or sex assigned, at birth;
  • identify as a person of transgender experience;
  • endorse having experienced two or more problem(s) related to alcohol or other drug use within the past 12 months.

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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