[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07223398":3,"trial-entities:NCT07223398":187,"trial-summary:NCT07223398":192},{"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":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":40,"secondary_outcomes":48,"sex":108,"minimum_age":109,"maximum_age":15,"healthy_volunteers":110,"eligibility_criteria":111,"std_ages":124,"locations":127,"central_contacts":173,"overall_officials":183,"references":185,"see_also_links":186},"NCT07223398","2000037052_a","Shared Decision Making to Treat Or Prevent (STOP) HIV in Criminal Legal Involved Populations (R33)","STOP (Shared Decision Making to Treat Or Prevent) HIV in Criminal Legal Involved Populations","RECRUITING","2028-06","2026-06","2026-06-25","2025-11-24","Yale University","OTHER",null,"This study seeks to compare the effectiveness of two Patient Navigation models of care to evaluate the proportion who initiate PrEP\u002FART and substance use\u002Fsubstance use disorder (SU\u002FSUD) treatment. A standardized Patient Navigation (PN) arm will be compared with a shared decision-making model in the form of Patient Choice (PC) through the offer of a menu of existing community-based health service delivery options. This design will offer providers, correctional and public health authorities, payers and policy makers' timely and relevant data to assess the effectiveness of Patient Navigation and Patient Choice models of care as potentially useful re-entry and relapse prevention treatment options.","This study will be done in two phases. Aim 1, the R61 portion of the project will be a Pilot Study, and Aim 2, the R33 portion of the project will be a Randomized Controlled Trail informed by the pilot.\n\nThe focus of this registration is Aim 2, the randomized controlled trial. The Aim 1 (R61) portion is registered with NCT06439329. In Aim 2 (R33), investigators will evaluate standard PN compared to PN+PC on participant outcomes, implementation outcomes and costs associated with implementing the study.",[19],"Substance Use Disorders",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},400,"ESTIMATED",[29,36],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BEHAVIORAL","Standard PN","Standard of care",[34,35],"PN + Patient Choice (PC) (PN+PC)","Standard Patient Navigation (PN)",{"type":30,"name":37,"description":38,"armGroupLabels":39},"Patient Choice","Participants can select from a menu of options including brick and mortar services, Mobile Health Unit (MHU) or telehealth services.",[34],[41,45],{"measure":42,"description":43,"timeFrame":44},"Percentage of participants who initiate or re-initiate PrEP","Percentage of participants not living with HIV who initiate or re-initiate PrEP within the 6-month intervention period by self report","6 months",{"measure":46,"description":47,"timeFrame":44},"Percentage of participants who initiate or re-initiate ART","Percentage of participants living with HIV who initiate or re-initiate ART within the 6-month intervention period by self report",[49,52,54,57,59,62,65,68,71,74,77,80,83,86,89,92,95,98,101,104],{"measure":50,"description":50,"timeFrame":51},"Percentage of participants that adhere to PrEP","6 and 12 months",{"measure":53,"description":53,"timeFrame":51},"Percentage of participants retaining on PrEP",{"measure":55,"description":56,"timeFrame":51},"HIV incidence","HIV incidence \\[binary\\] for those testing negative using rapid point of care (POC) test over time",{"measure":58,"description":58,"timeFrame":51},"Percentage of participants that adhere to ART",{"measure":60,"description":61,"timeFrame":51},"ART retention","For persons living with HIV (PLH), ART retention \\[binary\\]",{"measure":63,"description":64,"timeFrame":51},"Substance use treatment","Percentage of participants engaged in substance use disorder (SUD) treatment",{"measure":66,"description":67,"timeFrame":44},"HIV viral suppression","For PLH, HIV viral suppression, for those with HIV at time of randomization: the percent who maintain or achieve HIV viral load \\\u003C 200 copies\u002FmL at 6 months",{"measure":69,"description":70,"timeFrame":44},"Retention in HIV PrEP\u002FART","Retention in HIV PrEP\u002FART care \\[binary\\]: defined as attending 2 or more visits in 6-months",{"measure":72,"description":73,"timeFrame":51},"Number of Participants Who Had Any Needle Sharing Activity to Assess HIV Risk Behavior","Number of Participants Who Had Any Needle Sharing Activity",{"measure":75,"description":76,"timeFrame":51},"Number of Participants Who Had Sex Without a Condom to assess HIV Risk Behavior","Number of Participants Who Had Vaginal or Anal Sex Without a Condom",{"measure":78,"description":79,"timeFrame":51},"Days of using opioids","Measured by Timeline Followback, which assesses self-reported alcohol and other drug use including opioid use",{"measure":81,"description":82,"timeFrame":51},"Number of participants with with overdose events","Number of participants with non-fatal and fatal overdose events",{"measure":84,"description":85,"timeFrame":51},"Percentage of participants with retention in SUD treatment","Retention in SUD treatment including but not exclusive to Medication for Opioid Use Disorder (MOUD) for Opioid Use Disorder (OUD)",{"measure":87,"description":88,"timeFrame":51},"Quality of Life assessed using PROMIS-PROPr","PROMIS-PROPr assesses general societal health. Total summary score ranges from -0.022, worse than dead, to 1, perfect health.",{"measure":90,"description":91,"timeFrame":51},"Change in Depression assessed using Patient Health Questionnaire-9 (PHQ-9)","Depression will be assessed using the PHQ-9. PHQ-9 is a 9-item validated questionnaire used to screen for depression with a range of scores from 0-45. A cumulative score of ≥10 is considered positive with lower scores indicating no or mild anxiety.",{"measure":93,"description":94,"timeFrame":51},"Recidivism: Reasons","Number of participants per reason for arrest\u002F incarceration\u002Freturn-to-custody",{"measure":96,"description":97,"timeFrame":51},"Recidivism: Mean days in custody\u002Fincarcerated","Mean days in custody\u002Fincarcerated",{"measure":99,"description":100,"timeFrame":51},"Recidivism: Mean days to return","Mean days to return to custody\u002Fincarcerated",{"measure":102,"description":103,"timeFrame":51},"HIV and SU Stigma assessed using Substance Use Stigma Mechanisms Scale (SU-SMS)","Mean score for Enacted (6 items), Anticipated (6 items), and Internalized (6 items) scales. Each scale is scored 1-5, with higher scores indicating greater endorsement of substance use stigma",{"measure":105,"description":106,"timeFrame":107},"Percentage of participants diagnosed with SUD","Percentage of participants diagnosed with SUD using DSM-5","Baseline and 12 months","ALL","18 Years",false,{"inclusion":112,"exclusion":119,"raw_text":123},[113,114,115,116,117,118],"able to provide written informed consent in English or Spanish;","living in the community of Western, CT, Dallas and Tarrant Counties in TX and Madison County, KY (potential for Fayette county as well);","Those with current justice involvement (with in the past 12 months) (e.g., prison, jail, community supervision);","willing to have HIV testing to determine negative or positive status;","persons with HIV who report not currently taking ART in past 6 months OR persons who test negative for HIV who report not taking PrEP that have a PrEP indication in past 12 months, including (i) condomless sexual intercourse; and\u002For (ii) sharing IDU equipment with HIV positive or unknown status partner; and\u002For (iii) bacterial STI and;","Having a history of opioid and\u002For stimulant use in the last 12 months within the community.",[120,121,122],"severe medical or psychiatric disability making participation unsafe;","unable to provide consent.","persons self-reporting pregnancy","Inclusion Criteria:\n\n* able to provide written informed consent in English or Spanish;\n* living in the community of Western, CT, Dallas and Tarrant Counties in TX and Madison County, KY (potential for Fayette county as well);\n* Those with current justice involvement (with in the past 12 months) (e.g., prison, jail, community supervision);\n* willing to have HIV testing to determine negative or positive status;\n* persons with HIV who report not currently taking ART in past 6 months OR persons who test negative for HIV who report not taking PrEP that have a PrEP indication in past 12 months, including (i) condomless sexual intercourse; and\u002For (ii) sharing IDU equipment with HIV positive or unknown status partner; and\u002For (iii) bacterial STI and;\n* Having a history of opioid and\u002For stimulant use in the last 12 months within the community.\n\nExclusion Criteria:\n\n* severe medical or psychiatric disability making participation unsafe;\n* unable to provide consent.\n* persons self-reporting pregnancy",[125,126],"ADULT","OLDER_ADULT",[128,141,152,163],{"facility":129,"status":8,"city":130,"state":131,"zip":132,"country":133,"contacts":134,"geoPoint":138},"Yale School of Medicine","New Haven","Connecticut","06510","United States",[135],{"name":136,"role":137},"Sandy Springer, MD","PRINCIPAL_INVESTIGATOR",{"lat":139,"lon":140},41.30815,-72.92816,{"facility":142,"status":8,"city":143,"state":144,"zip":145,"country":133,"contacts":146,"geoPoint":149},"College of Medicine at the University of Kentucky","Lexington","Kentucky","40506",[147],{"name":148,"role":137},"Michele Staton, PhD, MSW",{"lat":150,"lon":151},37.98869,-84.47772,{"facility":153,"status":8,"city":154,"state":155,"zip":156,"country":133,"contacts":157,"geoPoint":160},"University of Texas Southwestern Medical Center (UTSW)","Dallas","Texas","75390",[158],{"name":159,"role":137},"Ank Nijhawan, MD, MPH",{"lat":161,"lon":162},32.78306,-96.80667,{"facility":164,"status":8,"city":165,"state":155,"zip":166,"country":133,"contacts":167,"geoPoint":170},"Texas Christian University's (TCU) School of Medicine","Fort Worth","76109",[168],{"name":169,"role":137},"Kevin Knight,, PhD",{"lat":171,"lon":172},32.72541,-97.32085,[174,179],{"name":175,"role":176,"phone":177,"email":178},"Sandra Springer, MD","CONTACT","203-687-6680","Sandra.springer@yale.edu",{"name":180,"role":176,"phone":181,"email":182},"Alysse Schultheis, MA","203-231-2454","alysse.schultheis@yale.edu",[184],{"name":175,"affiliation":13,"role":137},[],[],{"nct_id":4,"conditions":188,"biomarkers":191},[189,190],"HIV Infection","Substance use disorder",[189],{"nct_id":4,"found":193,"summary":194,"prompt_version":204},true,{"design":195,"status":196,"heading":197,"summary":198,"follow_up":199,"word_count":200,"commitments":201,"compensation":202,"drugs_mentioned":203},"This is an interventional study comparing two different approaches to patient navigation. It plans to enroll 400 participants.","completed","Shared Decision Making to Treat Or Prevent (STOP) HIV in Criminal Legal Involved Populations","This study is looking at two ways to help people with substance use disorders who have been involved with the criminal justice system to prevent or treat HIV. We are comparing \"Standard PN\" (Patient Navigation), which is the usual care, with \"Patient Choice.\" Patient Choice lets you pick from different services like in-person clinics, a Mobile Health Unit, or telehealth. The goal is to see how many people start or restart PrEP (medication to prevent HIV) or ART (medication to treat HIV) within 6 months. We are also looking at how many people get treatment for substance use. You can join if you are 18 or older, live in specific areas of Connecticut, Texas, or Kentucky, and have been involved with the justice system in the last year. The study is currently recruiting 400 participants.","The main outcomes are measured at 6 months after starting the study interventions.",135,"Not specified in the trial record.","Not stated in the trial record.",[31,37],"v2"]