The Trans-Led Care Study

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Illinois Institute of Technology
Study ID
NCT06880705
Status
Recruiting
Apply to this trial

Conditions

  • Human Immunodeficiency Virus (HIV)
  • Substance Abuse
  • Substance Addiction
  • Substance Use (Drugs, Alcohol)
  • Substance Use Disorder (SUD)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • The TLC Program — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Feb 10, 2025
Status verified
Mar 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
124 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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."

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Illinois Institute of TechnologyChicagoIllinois60616
Arryn Guy, PhD
[email protected]
312-567-6467
Arryn Guy, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Illinois Institute of Technology· Chicago, IL

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