An interventional study of The TLC Program in Substance Abuse, Substance Addiction and Substance Use Disorder (SUD), sponsored by Illinois Institute of Technology. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by Illinois Institute of Technology · Not applicable, Interventional, and Supportive care
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.
Transgender (trans) populations are disproportionately impacted by HIV compared to the general population (nearly 1 in 7 trans women are living with HIV; 3.2% of trans men are living with HIV compared to 0.3% in the general U.S. population). Trans people also experience stigma rooted in systems of oppression. To prevent the forward transmission of HIV, public health officials emphasize the need for consistent condom use, regular HIV testing, and linkage to HIV prevention and care services. Stigma, however, interferes with trans individuals' ability to engage in HIV prevention and care due to its negative affects across multiple socioecological levels, including structural policies that constrain resources for trans people, negative community attitudes and prejudicial norms towards trans people, interpersonal discrimination towards trans people resulting in social isolation, and trans individual's psychological and behavioral responses to such stigma and stress. This makes stigma a social and structural determinant of health.
Stigma also plays a significant role in increasing risk for substance misuse among trans adults broadly. Rates of current illicit drug use, cannabis consumption, and/or nonmedical prescription drug use among trans adults are high relative to the U.S. general population (29% vs. 10%, respectively). Heavy alcohol use is also high, with 23% of trans adults consuming alcohol on 11 or more days in the past month Prior research with trans women suggests that unmet gender affirmation needs (i.e., the multitude of ways people receive recognition and support for their gender identity) may lead trans women to seek affirmation in traumatizing and unsafe contexts, such as sex work and sex under the influence of substances. Trans women are also at an increased risk of being targeted for violence, including sexual and physical assault, and substance use is associated with increased risks of victimization.
The Model of Gender Affirmation illustrates that lack of gender affirmation (i.e., the multitude of ways people receive recognition and support for their gender identity) contributes to psychological distress, substance misuse, and HIV risk among trans women. Evidence demonstrates that those who experience stigma report attempts to cope by avoiding or controlling distressing thoughts or feelings (e.g., substance use), which in turn produces greater psychological distress, and interferes with self-care behaviors. Specialized evidence-based interventions delivered in community-based organizations have the potential to reduce the negative effects of internalized stigma on behavioral health.
Acceptance and Commitment Therapy (ACT) is one of the few evidence-based approaches that targets stigma related to a variety of conditions, including substance use disorders and HIV. ACT is a transdiagnostic psychotherapeutic intervention that increases psychological flexibility through mindfulness, acceptance, and behavior change processes. ACT for stigma focuses on the fears, shame, and identification with a stigmatized group that pose a barrier to living a life consistent with one's values. ACT is a promising, but not yet evaluated, intervention to improve stigma among trans adults.
Guided by a community-engaged research approach, the investigators are testing an ACT-based, peer-led, gender affirming mutual-help group (called "the TLC Program") to reduce substance misuse and HIV risk among trans adults. The TLC Program was developed through a needs assessment of adaptations to ACT for integration into community-based organizations serving trans populations. Focus groups and interviews with transgender adults and stakeholders (e.g., organization staff, providers who serve trans clients) identified necessary adaptations. A proof-of-concept test of the TLC Program in an open pilot with (N = 16) trans adults who experienced at least one substance use problem in the past year informed final refinements to the intervention. The TLC Program is now being tested in a randomized controlled feasibility/acceptability trial compared to standard of care.
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's planned enrollment of 124 is above the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →Illinois Institute of Technology is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
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Inclusion Criteria:
Eligible transgender adults must:
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).
Participants randomized to the TLC Program will receive TAU plus the telehealth, peer-delivered group intervention, "the TLC Program."
Behavioral: 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.
Gender Minority Stress and Resilience Scale Internalized Transphobia
Minimum value = 0, Maximum value = 1, Higher score = worse outcome
Time frame: 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
Time frame: 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
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)
Minimum value = 1 (per subscale), Maximum value = 6 (per subscale), Higher score = worse outcome
Time frame: Reported at baseline assessment
The Acceptability of Intervention Measure (AIM)
Minimum value = 1, Maximum value = 5, Higher score = better outcome
Time frame: Reported at post-assessment (12 weeks)
Intervention Appropriateness Measure
Minimum value = 1, Maximum value = 5, Higher score = better outcome
Time frame: Reported at post-assessment (12 weeks)
Feasibility of Intervention Measure (FIM)
Minimum value = 1, Maximum value = 5, Higher score = better outcome
Time frame: Reported at post-assessment (12 weeks)
Substance Use Timeline Followback Interview
Time frame: Over the past 30 days
HIV Risk Questionnaire
Participants will be reporting number of sexual partners, types of sexual activities, and various HIV risk factors including condom use, PrEP use, and treatment as prevention
Time frame: Reported at baseline assessment, post-assessment (12 weeks), and follow-up assessment (24 weeks)
PTSD Life Events Checklist for DSM-5
Participants will indicate whether certain difficult or stressful life events they have experienced
Time frame: Reported at baseline assessment
Intersectional Discrimination Index (InDI)
Minimum value = 0, Maximum value = 13, Higher score = worse outcome
Time frame: Reported at baseline assessment
Access to Gender Affirmation in Healthcare Questionnaire
Minimum value = 1, Maximum value = 5 Higher score = Better outcome
Time frame: Reported at baseline assessment, post-assessment (12 weeks), and follow-up assessment (24 weeks)
Need for Gender Affirmation Questionnaire
Minimum value = 1, Maximum value = 5
Time frame: Reported at baseline assessment, post-assessment (12 weeks), and follow-up assessment (24 weeks)
Satisfaction with Gender Affirmation Questionnaire
Minimum value = 1, Maximum value = 5, Higher score = better outcome
Time frame: Reported at baseline assessment, post-assessment (12 weeks), and follow-up assessment (24 weeks)
City Stress Index
Minimum value = 0, Maximum value = 3, Higher score = worse outcome
Time frame: Reported at baseline assessment
PCL-5
Minimum value = 0, Maximum value = 4, Higher score = worse outcome
Time frame: Reported at baseline, post-assessment (12 weeks), and follow-up assessment (24 weeks)
Plan to share: Undecided
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Illinois Institute of Technology