Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06880705

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote) for eligibility assessment

Outpatient Treatment

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

Outpatient Treatment

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

Follow-up

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

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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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