Actively Recruiting
A Gender-Affirming Stigma Intervention to Improve Substance Misuse and HIV Risk Among Transgender Adults
Led by Illinois Institute of Technology · Updated on 2026-03-27
124
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Illinois Institute of Technology
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new mutual-help program called the TLC Program designed specifically for transgender adults who use substances or have recently been in recovery. This program is based on Acceptance and Commitment Therapy (ACT), a counseling approach that uses mindfulness to help people connect with their values and improve mental health. The TLC Program was developed collaboratively by transgender and gender diverse community members, mental health providers, and researchers to address stigma and substance misuse among transgender populations who face high rates of HIV and social challenges. The study compares two groups: one receiving treatment-as-usual (TAU) following established guidelines for alcohol, drug use, and HIV prevention, and another receiving TAU plus the TLC Program. The TLC Program is a peer-led, telehealth group intervention delivered via videoconferencing over 12 weeks. Sessions last about 1.5 hours and cover ACT core concepts with a focus on gender affirmation, internalized stigma, and substance use reduction. Additional sessions explain stigma's impact on health and promote self-care goals related to substance use and healthcare engagement. Participants will be involved in assessments at baseline, after 12 weeks, and at 24-week follow-up. These include questionnaires measuring internalized transphobia, healthcare empowerment, psychological flexibility, substance use, and HIV risk. Weekly patient-reported outcomes will also be collected. Researchers will monitor intervention acceptability, appropriateness, and feasibility. The study aims to understand whether the TLC Program can reduce stigma and improve health behaviors among transgender adults facing substance use challenges.
CONDITIONS
Brief Title
The Trans-Led Care Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years of age or older
- Primarily speak English
- Live in the United States
- Have a gender identity different from sex assigned at birth
- Identify as a person with transgender experience
- Have experienced two or more problems related to alcohol or drug use within the past 12 months
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Duration - 12 weeks
Participants randomized to the TLC Program receive a telehealth, peer-delivered group intervention based on Acceptance and Commitment Therapy, delivered via videoconferencing. The intervention focuses on gender affirmation, stigma, substance use, and self-care goals.
Weekly group sessions via telehealth, each approximately 1.5 hours
Duration - 12 weeks
Participants randomized to Treatment as Usual receive brief counseling following SAMHSA and CDC guidelines focused on substance use and HIV risk reduction.
1 to 3 brief counseling visits as needed
Duration - 12 weeks
Participants are assessed to evaluate outcomes after the intervention period.
1 visit at 24 weeks post-baseline
Trial Site Locations
Total: 1 location
1
Illinois Institute of Technology
Chicago, Illinois, United States, 60616
Actively Recruiting
Research Team
A
Arryn Guy, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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