[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583774":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":24,"locations":30,"responsibleParty":48,"collaborators":51,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":12,"enrollmentInfo":65,"targetDuration":12,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":78,"overallStatus":32,"whyStopped":12,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Illinois Institute of Technology","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"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\u002FHIV 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\u002FSTDs, HIV care, and\u002For substance use treatment).",null,{"label":14,"type":15,"description":16,"interventionNames":17},"The TLC Program","EXPERIMENTAL","Participants randomized to the TLC Program will receive TAU plus the telehealth, peer-delivered group intervention, \"the TLC Program.\"",[18],"Behavioral: The TLC Program",[20],{"type":21,"name":14,"description":22,"armGroupLabels":23,"otherNames":12},"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.",[14],[25],{"name":26,"role":27,"phone":28,"phoneExt":12,"email":29},"Arryn Guy, PhD","CONTACT","312-567-6467","aguy1@iit.edu",[31],{"facility":5,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Chicago","Illinois","60616","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-87.65005,41.85003,{"lat":42,"lon":41},[45,46],{"name":26,"role":27,"phone":28,"phoneExt":12,"email":29},{"name":26,"role":47,"phone":12,"phoneExt":12,"email":12},"PRINCIPAL_INVESTIGATOR",{"type":47,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Arryn Guy","Assistant Professor of Psychology",[52],{"name":53,"class":54},"National Institute on Drug Abuse (NIDA)","NIH","100583774","the-trans-led-care-study-100583774",false,"NCT06880705","The Trans-Led Care Study","A Gender-Affirming Stigma Intervention to Improve Substance Misuse and HIV Risk Among Transgender Women","TLC","Inclusion Criteria:\n\nEligible transgender adults must:\n\n1. be 18 years of age or older;\n2. speak primarily English;\n3. live in the U.S.;\n4. have a gender identity different from their assumed gender, or sex assigned, at birth;\n5. identify as a person of transgender experience;\n6. endorse having experienced two or more problem(s) related to alcohol or other drug use within the past 12 months.","ALL","18 Years",{"count":66,"type":67},124,"ESTIMATED","INTERVENTIONAL",[70],"NA","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.",[73,74,75,76,77],"Substance Abuse","Substance Addiction","Substance Use Disorder (SUD)","Substance Use (Drugs, Alcohol)","Human Immunodeficiency Virus (HIV)",[79,80,81,82,83],"Substance misuse","HIV risk","Stigma","Psychological distress","Gender affirmation","2026-03-23",{"date":86,"type":87},"2026-03-27","ACTUAL",{"date":89,"type":87},"2025-02-10",{"date":91,"type":67},"2027-07-31",{"name":5,"class":6},1]