Recruiting

Observational Study

Sponsor:

Illinois Institute of Technology

Code:

NCT06880705

Conditions

Substance Abuse

Substance Addiction

Substance Use Disorder (SUD)

Substance Use (Drugs, Alcohol)

Human Immunodeficiency Virus (HIV)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

The TLC Program

Study Details

Brief 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.

Conditions

Substance Abuse

Substance Addiction

Substance Use Disorder (SUD)

Substance Use (Drugs, Alcohol)

Human Immunodeficiency Virus (HIV)

Study ID

NCT06880705

Start date

Apr 14, 2026

Status verified date

Jul, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Eligible transgender adults must:

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

Study Design

Enrollment

124 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Treatment as Usual (TAU)

Participants randomized to the control condition will receive treatment-as-usual (TAU), following SAMHSA guidelines for risky alcohol and other drug use and CDC established standards of care for STD/HIV prevention counseling. Participants meeting criteria for risky alcohol, drug use, or sexual behavior will be provided 15-25 minutes of brief counseling including: 1) a discussion that the participants drinking or drug use is more than the recommended limits for safe consumption, and that staying below these limits is important for their health; 2) a discussion of HIV risk-reduction interventions (i.e., consistent condom use, PrEP, ART treatment as prevention); and 3) referral to treatment (i.e., regular screening for HIV/STDs, HIV care, and/or substance use treatment).

experimental: The TLC Program

Participants randomized to the TLC Program will receive TAU plus the telehealth, peer-delivered group intervention, "the TLC Program."

Interventions

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.

Primary outcome measure

  • Gender Minority Stress and Resilience Scale Internalized Transphobia [ Time Frame: Reported at baseline assessment, post-assessment (12 weeks), and follow-up assessment (24 weeks) ]
  • Health Care Empowerment Inventory [ Time Frame: Reported at baseline assessment, post-assessment (12 weeks), and follow-up assessment (24 weeks) ]
  • Patient-Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: Reported weekly, as well as at baseline assessment, post assessment (12 weeks), and follow-up assessment (24 weeks) ]
  • Psychological Flexibility, Multidimensional Psychological Flexibility Inventory (MPFI) [ Time Frame: Reported at baseline assessment ]
  • The Acceptability of Intervention Measure (AIM) [ Time Frame: Reported at post-assessment (12 weeks) ]
  • Intervention Appropriateness Measure [ Time Frame: Reported at post-assessment (12 weeks) ]
  • Feasibility of Intervention Measure (FIM) [ Time Frame: Reported at post-assessment (12 weeks) ]

Central Contacts and Locations

Central contacts

Arryn Guy, PhD

312-567-6467aguy1@iit.edu

Locations

Illinois Institute of Technology

Recruiting

Chicago, Illinois, United States, 60616

Contacts

Arryn Guy, PhD

312-567-6467aguy1@iit.edu

Principal Investigator:

Arryn Guy, PhD

More Information

Sponsor

Illinois Institute of Technology

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Keywords

  • Substance misuse
  • HIV risk
  • Stigma
  • Psychological distress
  • Gender affirmation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Illinois Institute of Technology on 2026-07-15.