Substance AbuseTLCNCT06880705
The Trans-Led Care Study
A study testing The TLC Program in people with Substance Abuse and Substance Addiction, run by Illinois Institute of Technology at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Abuse, Substance Addiction, Substance Use Disorder (SUD)
- What is being tested?
- The TLC Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Illinois Institute of Technology
Chicago, Illinois, 60616
Arryn Guy, PhD, 312-567-6467, aguy1@iit.edu
Arryn Guy, PhD
About this study
Official title: A Gender-Affirming Stigma Intervention to Improve Substance Misuse and HIV Risk Among Transgender Women
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.
Read the 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, 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.
- Conditions
- Substance Abuse, Substance Addiction, Substance Use Disorder (SUD), Substance Use (Drugs, Alcohol), Human Immunodeficiency Virus (HIV)
- Being tested
- The TLC Program
- Keywords
- Substance misuse, HIV risk, Stigma, Psychological distress, Gender affirmation
- Medical subject headings
- Substance-Related Disorders, Acquired Immunodeficiency Syndrome, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The TLC ProgramBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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." Receives: Behavioral: The TLC Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gender Minority Stress and Resilience Scale Internalized Transphobia
Minimum value = 0, Maximum value = 1, Higher score = worse outcome
Measured: 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
Measured: 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
Measured: 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
Measured: Reported at baseline assessment
The Acceptability of Intervention Measure (AIM)
Minimum value = 1, Maximum value = 5, Higher score = better outcome
Measured: Reported at post-assessment (12 weeks)
Intervention Appropriateness Measure
Minimum value = 1, Maximum value = 5, Higher score = better outcome
Measured: Reported at post-assessment (12 weeks)
Feasibility of Intervention Measure (FIM)
Minimum value = 1, Maximum value = 5, Higher score = better outcome
Measured: Reported at post-assessment (12 weeks)
Secondary outcomes (2)
Substance Use Timeline Followback Interview
Measured: 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
Measured: Reported at baseline assessment, post-assessment (12 weeks), and follow-up assessment (24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start14 Apr 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Illinois Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Arryn Guy, Illinois Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880705
- Sponsor's protocol ID
- R00DA055508
- Other IDs
- R00DA055508
- Acronym
- TLC
- Status last verified
- Jul 2026
- First submitted
- 26 Feb 2025
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Gender-Affirming Stigma Intervention to Improve Substance Misuse and HIV Risk Among Transgender Women
- ClinicalTrials.gov ID
- NCT06880705
- Acronym / sponsor ID
- TLC / R00DA055508
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Illinois Institute of TechnologyUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: The TLC ProgramParticipants randomized to the TLC Program will receive TAU plus the telehealth, peer-delivered group intervention, "the TLC Program." |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The TLC ProgramParticipants 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. | Behavioural | The TLC Program |
Primary outcome
Gender Minority Stress and Resilience Scale Internalized Transphobia
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: Reported at baseline assessment
Minimum value = 1 (per subscale), Maximum value = 6 (per subscale), Higher score = worse outcome
The Acceptability of Intervention Measure (AIM)
Time frame: Reported at post-assessment (12 weeks)
Minimum value = 1, Maximum value = 5, Higher score = better outcome
Intervention Appropriateness Measure
Time frame: Reported at post-assessment (12 weeks)
Minimum value = 1, Maximum value = 5, Higher score = better outcome
Feasibility of Intervention Measure (FIM)
Time frame: Reported at post-assessment (12 weeks)
Minimum value = 1, Maximum value = 5, Higher score = better outcome
2 secondary outcomes
Substance Use Timeline Followback Interview
Time frame: Over the past 30 days
HIV Risk Questionnaire
Time frame: Reported at baseline assessment, post-assessment (12 weeks), and follow-up assessment (24 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The TLC Program in people with Substance Abuse and Substance Addiction, run by Illinois Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arryn Guy, PhD (312-567-6467, aguy1@iit.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.