The Trans-Led Care Study

Not Applicable

Recruiting

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

• Registration Number: NCT06880705
• Lead Sponsor: Illinois Institute of Technology

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.

Detailed Description

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, we 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.

Study Timeline

• Study Start: 2025-02-10
• Study First Submitted: 2025-02-26
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-14
• Last Update Submitted: 2025-03-14
• Study First Posted: 2025-03-18
• Last Update Posted: 2025-03-18
• Primary Completion: 2027-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

Eligible transgender adults must:

1. be 18 years of age or older;
2. speak primarily English;
3. live in the U.S.;
4. have a gender identity different from their assumed gender, or sex assigned, at birth;
5. identify as a person of transgender experience;
6. endorse having experienced two or more problem(s) related to alcohol or other drug use within the past 12 months.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Gender Minority Stress and Resilience Scale Internalized Transphobia	Reported at baseline assessment, post-assessment (12 weeks), and follow-up assessment (24 weeks)	Minimum value = 0, Maximum value = 1, Higher score = worse outcome
Health Care Empowerment Inventory	Reported at baseline assessment, post-assessment (12 weeks), and follow-up assessment (24 weeks)	Minimum value = 1, Maximum value = 5, Higher score = better outcome
Patient-Reported Outcomes Measurement Information System (PROMIS)	Reported weekly, as well as at baseline assessment, post assessment (12 weeks), and follow-up assessment (24 weeks)	Measuring psychological distress (depression and anxiety), Minimum value = 1 (per subscale), Maximum value = 5 (per subscale), Higher score = worse outcome
Psychological Flexibility, Multidimensional Psychological Flexibility Inventory (MPFI)	Reported at baseline assessment	Minimum value = 1 (per subscale), Maximum value = 6 (per subscale), Higher score = worse outcome
The Acceptability of Intervention Measure (AIM)	Reported at post-assessment (12 weeks)	Minimum value = 1, Maximum value = 5, Higher score = better outcome
Intervention Appropriateness Measure	Reported at post-assessment (12 weeks)	Minimum value = 1, Maximum value = 5, Higher score = better outcome
Feasibility of Intervention Measure (FIM)	Reported at post-assessment (12 weeks)	Minimum value = 1, Maximum value = 5, Higher score = better outcome

Secondary Outcome Measures

Name	Time	Method
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)	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

Trial Locations

Locations (1)

Illinois Institute of Technology; 🇺🇸 Chicago, Illinois, United States