Clinical trial NCT06880705: The Trans-Led Care Study
Official title: A Gender-Affirming Stigma Intervention to Improve Substance Misuse and HIV Risk Among Transgender Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Illinois Institute of Technology
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-03-18
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gender Minority Stress and Resilience Scale Internalized Transphobia
timeFrame: Reported at baseline assessment, post-assessment (12 weeks), and follow-up assessment (24 weeks)
measure: Health Care Empowerment Inventory
timeFrame: Reported at baseline assessment, post-assessment (12 weeks), and follow-up assessment (24 weeks)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: Reported weekly, as well as at baseline assessment, post assessment (12 weeks), and follow-up assessment (24 weeks)
measure: Psychological Flexibility, Multidimensional Psychological Flexibility Inventory (MPFI)
timeFrame: Reported at baseline assessment
measure: The Acceptability of Intervention Measure (AIM)
timeFrame: Reported at post-assessment (12 weeks)
measure: Intervention Appropriateness Measure
timeFrame: Reported at post-assessment (12 weeks)
measure: Feasibility of Intervention Measure (FIM)
timeFrame: Reported at post-assessment (12 weeks)
Secondary outcomes:
measure: Substance Use Timeline Followback Interview
timeFrame: Over the past 30 days
measure: HIV Risk Questionnaire
timeFrame: Reported at baseline assessment, post-assessment (12 weeks), and follow-up assessment (24 weeks)
Other outcomes:
measure: PTSD Life Events Checklist for DSM-5
timeFrame: Reported at baseline assessment
measure: Intersectional Discrimination Index (InDI)
timeFrame: Reported at baseline assessment
measure: Access to Gender Affirmation in Healthcare Questionnaire
timeFrame: Reported at baseline assessment, post-assessment (12 weeks), and follow-up assessment (24 weeks)
measure: Need for Gender Affirmation Questionnaire
timeFrame: Reported at baseline assessment, post-assessment (12 weeks), and follow-up assessment (24 weeks)
measure: Satisfaction with Gender Affirmation Questionnaire
timeFrame: Reported at baseline assessment, post-assessment (12 weeks), and follow-up assessment (24 weeks)
measure: City Stress Index
timeFrame: Reported at baseline assessment
measure: PCL-5
timeFrame: Reported at baseline, post-assessment (12 weeks), and follow-up assessment (24 weeks)
Locations:
city: Chicago
country: United States
facility: Illinois Institute of Technology
state: Illinois
Study officials:
References: