The Trans-Led Care Study

NCT06880705 | Recruiting DMC

• 1 other identifier: R00DA055508
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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)

Keywords

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

Outcome Measures

Primary Outcomes (7)

• Gender Minority Stress and Resilience Scale Internalized Transphobia

  Minimum value = 0, Maximum value = 1, Higher score = worse outcome

  Reported at baseline assessment, post-assessment (12 weeks), and follow-up assessment (24 weeks)

• Health Care Empowerment Inventory

  Minimum value = 1, Maximum value = 5, Higher score = better outcome

  Reported at baseline assessment, post-assessment (12 weeks), and follow-up assessment (24 weeks)

• Patient-Reported Outcomes Measurement Information System (PROMIS)

  Measuring psychological distress (depression and anxiety), Minimum value = 1 (per subscale), Maximum value = 5 (per subscale), Higher score = worse outcome

  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)

  Minimum value = 1 (per subscale), Maximum value = 6 (per subscale), Higher score = worse outcome

  Reported at baseline assessment

• The Acceptability of Intervention Measure (AIM)

  Minimum value = 1, Maximum value = 5, Higher score = better outcome

  Reported at post-assessment (12 weeks)

• Intervention Appropriateness Measure

  Minimum value = 1, Maximum value = 5, Higher score = better outcome

  Reported at post-assessment (12 weeks)

• Feasibility of Intervention Measure (FIM)

  Minimum value = 1, Maximum value = 5, Higher score = better outcome

  Reported at post-assessment (12 weeks)

Secondary Outcomes (2)

• Substance Use Timeline Followback Interview

  Over the past 30 days

• HIV Risk Questionnaire

  Reported at baseline assessment, post-assessment (12 weeks), and follow-up assessment (24 weeks)

Other Outcomes (7)

• PTSD Life Events Checklist for DSM-5

  Reported at baseline assessment

• Intersectional Discrimination Index (InDI)

  Reported at baseline assessment

• Access to Gender Affirmation in Healthcare Questionnaire

  Reported at baseline assessment, post-assessment (12 weeks), and follow-up assessment (24 weeks)

Study Arms (2)

Treatment as Usual (TAU)

NO INTERVENTION

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).

The TLC Program

EXPERIMENTAL

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

Behavioral: The TLC Program

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.

The TLC Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Illinois Institute of Technology: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Illinois Institute of Technology

Chicago, Illinois, 60616, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders; Acquired Immunodeficiency Syndrome; Social Stigma

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Social Behavior; Behavior

Central Study Contacts

Arryn Guy, PhD

CONTACT

312-567-6467; aguy1@iit.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychology

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 18, 2025
• Study Start: February 10, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (1)