[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06569667":3,"trial-entities:NCT06569667":100,"trial-summary:NCT06569667":103},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":48,"secondary_outcomes":53,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":67,"eligibility_criteria":68,"std_ages":72,"locations":75,"central_contacts":91,"overall_officials":95,"references":98,"see_also_links":99},"NCT06569667","R18HS029783","Using AI and Peer Coaching to Address Racial Disparities Among People Who Use Opioids","Leveraging Social Determinants Via Artificial Intelligence and Peer Coaching to Address Racial Disparities in Primary Care Among People Who Use Opioids","RECRUITING","2026-08-31","2024-09","2025-08-12","2025-03-28","Friends Research Institute, Inc.","OTHER",null,"Black and Latinx people who use opioids are disproportionately impacted by opioid overdose deaths. The proposed study assesses the efficacy of an open source, multimodal artificial intelligence-driven texting tool combined with peer recovery coach-supported text contact that delivers social services, stigma reduction, health habitus, and patient navigation content addressing social determinants of health to enhance receipt of buprenorphine in primary care among emergency department-enrolled Black \u002F Latinx people who use opioids.","The investigators have validated a theory-driven, artificial intelligence (AI)-driven texting tool using natural language processing to facilitate real-time text responses to patient queries combined with automated texts facilitating receipt of buprenorphine in office-based opioid treatment (OBOT) and social services that address social determinants of health (SDH). This open-source texting tool offers passive reminders, informational content, and interactive two-way response algorithms without personal staff contact. In addition, the investigators have adapted an efficacious cultural and structural humility training for PRCs that goes beyond SDH to also address stigma reduction, discrimination, health habitus, and patient navigation to enhance uptake of primary care and social services for PWUO.\n\nUsing a three-arm, comparative effectiveness trial design, the specific aims are to: (1) Assess the efficacy of PRC supported text-based care\u002Fservices coordination with PWUO + AI-driven SDH-enhanced text messaging (intervention arm-1) vs. AI-driven SDH-enhanced text messaging only (intervention arm-2) vs. Treatment as Usual (TAU) or printed social\u002Fmedical services referrals (control) to enhance the receipt of buprenorphine in OBOT among community and ED-enrolled Black \u002F Latinx PWUO (N=252); (2) Evaluate the implementation of the multimodal intervention (arm-1) guided by the RE-AIM and CFIR frameworks using in-depth interviews among 3 stakeholder groups: (a) frontline providers (n=10); (b) administrators (n=10); and (c) a subset of the Black and Latinx PWUO from the multimodal intervention arm-1 (n=30); and (3) Identify the resources and estimate the associated cost of implementing and sustaining the multimodal intervention and incorporate this information into a customizable budget-impact tool and conduct a comprehensive economic evaluation to calculate the relative economic value (e.g., cost-per quality-adjusted life years, cost-per OUD treatment days) of each study arm from the healthcare sector, state policymaker, and societal perspectives which will also inform implementation framed by RE-AIM.",[19],"Opioid Use Disorder",[19,21,22,23],"Peer Recovery Coach","AI-driven text tool","mobile health (mHealth)","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[27],"NA",{"count":29,"type":30},292,"ESTIMATED",[32,38,43],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BEHAVIORAL","PRC supported text + AI driven SDH-enhanced text","This interventional study evaluates an AI-driven texting tool combined with peer recovery coach support to deliver social services, reduce stigma, and provide patient navigation content. The goal is to enhance the receipt of buprenorphine in primary care among emergency department-enrolled Black and Latinx individuals who use opioids, addressing the disproportionate impact of opioid overdose deaths on these communities.",[37],"Intervention Arm-1: PRC supported text+ AI driven SDH-enhanced text",{"type":33,"name":39,"description":40,"armGroupLabels":41},"AI driven SDH-enhanced text only","This interventional study evaluates an AI-driven SDH-enhanced texting tool to deliver social services, reduce stigma, and provide patient navigation content. The goal is to enhance the receipt of buprenorphine in primary care among emergency department-enrolled Black and Latinx individuals who use opioids, addressing the disproportionate impact of opioid overdose deaths on these communities.",[42],"Intervention Arm-2: AI driven SDH-enhanced text only",{"type":33,"name":44,"description":45,"armGroupLabels":46},"Treatment as Usual (TAU)","Control Arm-3 will receive treatment as usual (i.e., verbal instructions, NYC Dept of Health pamphlets detailing access to OUD and social services, health system smartphone application EMR patient portal).",[47],"Control Arm 3- Treatment as Usual",[49],{"measure":50,"description":51,"timeFrame":52},"Rate of self-reported linkage to OUD services","The primary outcome for this efficacy study is self-reported linkage to OUD services (i.e., time to initial buprenorphine prescription that is prescribed in OBOT programs or other OUD treatment providers per the Non-study Medical and Other Services form.","1 year",[54,57,60],{"measure":55,"description":56,"timeFrame":52},"Number of Office-Based Opioid Treatment with buprenorphine.","Durability of treatment effect at 52 weeks. For example, continuous retention in Office-Based Opioid Treatment with buprenorphine.",{"measure":58,"description":59,"timeFrame":52},"Number of social services received","Total number of social services received and documented over 52 weeks.",{"measure":61,"description":62,"timeFrame":63},"Number of interactions and time spent (in minutes) engaged with the intervention","Total number of interactions and time spent (in minutes) engaged with the intervention over 26 weeks","26 weeks","ALL","18 Years","99 Years",false,{"inclusion":69,"exclusion":70,"raw_text":71},[],[],"Inclusion Criteria:\n\n1. ≥18 years of age;\n2. fluent in English and\u002For Spanish;\n3. self-reported non-prescription opioid use \\\u003C30 days prior to consent;\n4. provision of informed consent;\n5. planned stay in NYC ≥12 month;\n6. self-identified Black and\u002For Latinx race\u002Fethnicity;\n7. positive urine toxicology for opioids per EMR records;\n8. diagnosis of OUD per the Diagnostic and Statistical Manual of Mental Disorders-5\n9. self-reported interest in initiating buprenorphine in primary care\n10. must have a mobile phone data plan.\n\nExclusion Criteria:\n\n1. inability to comprehend text content written at a 3rd grade reading level;\n2. physical or visual disability preventing mobile phone use;\n3. self-reported receipt of medications for OUD in past 30 days.",[73,74],"ADULT","OLDER_ADULT",[76],{"facility":77,"status":8,"city":78,"state":79,"zip":80,"country":81,"contacts":82,"geoPoint":88},"NYC Health + Hospitals","The Bronx","New York","10451","United States",[83],{"name":84,"role":85,"phone":86,"email":87},"Babak Tofighi, MSc, MD","CONTACT","410-294-7477","btofighi@friendsresearch.org",{"lat":89,"lon":90},40.84985,-73.86641,[92],{"name":84,"role":85,"phone":93,"email":94},"4102947477","babak.tofighi@nki.rfmh.org",[96],{"name":84,"affiliation":13,"role":97},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":101,"biomarkers":102},[19],[],{"nct_id":4,"found":104,"summary":105,"prompt_version":115},true,{"design":106,"status":107,"heading":108,"summary":109,"follow_up":110,"word_count":111,"commitments":112,"compensation":113,"drugs_mentioned":114},"This study is an interventional trial designed to enroll 292 participants. It uses a three-arm comparative effectiveness design to compare different approaches.","completed","AI and Peer Coaching for Opioid Use Disorder in Black and Latinx Individuals","This study is testing different ways to help Black and Latinx individuals who use opioids get treatment. It compares an AI-driven texting tool combined with support from a peer recovery coach, an AI-driven texting tool alone, and standard care. The goal is to improve access to buprenorphine (a medication for opioid use disorder) and social services, reduce stigma, and help people navigate the healthcare system. You might be able to join if you are 18 or older, speak English or Spanish, have used non-prescription opioids recently, plan to stay in NYC for at least a year, and identify as Black and\u002For Latinx. The study will measure how many people connect with opioid use disorder services after one year. The current recruitment status is unclear.","Participants will be followed for one year to measure their self-reported linkage to opioid use disorder services.",124,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]