[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06962033":3,"trial-entities:NCT06962033":118,"trial-summary:NCT06962033":123},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":36,"secondary_outcomes":41,"sex":45,"minimum_age":46,"maximum_age":14,"healthy_volunteers":47,"eligibility_criteria":48,"std_ages":62,"locations":65,"central_contacts":103,"overall_officials":112,"references":116,"see_also_links":117},"NCT06962033","2000037393","PRIDE III Prison Interventions and HIV Prevention Collaboration","RECRUITING","2028-12","2025-05","2025-05-11","2024-11-05","Yale University","OTHER",null,"The primary objective of this research project is to identify barriers to scale-up of Opioid Agonist Therapy (OAT) in the justice systems (prisons and probation) in Tajikistan, Kyrgyzstan, Moldova, and Georgia, and establish a NIATx learning collaborative to scale-up OAT, and analyze scale-up utilizing latent class growth analyses in people who inject drugs (PWID).","Aim 1 consists of the development of NIATx learning collaboratives with prison OAT providers (addiction care specialists or primary care doctors). This aim is an implementation science aim involving the collection of OAT scale-up data from each country's national OAT database, as well as administration of survey to prison narcologists every 6 months.\n\nAim 2 consists of the development of NIATx learning collaboratives with probation and prison officers in Kyrgyzstan, Tajikistan, Moldova, and Georgia. Investigators will collect OAT scale-up data from each member country's national OAT database, and administer a survey to probation officers every 6 months. Investigators will also observe and interview probation clients and staff using ethnographic methods.",[18,19],"Hiv","Opioid Use",[],"INTERVENTIONAL","PREVENTION",[24],"NA",{"count":26,"type":27},300,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BEHAVIORAL","Opioid Agonist Therapy","Opioid Agonist Therapy (OAT) as HIV prevention",[34,35],"Aim 1- Implementation","Aim 2- Scale-Up",[37],{"measure":38,"description":39,"timeFrame":40},"Number of participants receiving opioid agonist therapy (OAT)","Number of patients receiving opioid agonist therapy (OAT) per OAT site.","baseline up to 4 years",[42],{"measure":43,"description":44,"timeFrame":40},"Adherence to NIATx protocol","Adherence to NIATx protocol: using the NIATx fidelity scale, a 19-item assesment to measure adherence to the NIATx model on a 5-point scale from 1 (No evidence) to 5 (Extensive evidence).","ALL","18 Years",false,{"inclusion":49,"exclusion":60,"raw_text":61},[50,51,50,52,53,50,54,50,55,56,50,57,58,59],"Being 18 years or older","Being currently assigned and working as a probation OAT provider for a probation site 2. ECHO procedures","Screen yes to opioid injection on the online screener questionnaire","Currently in probation 2. Quantitative surveys for probation and prison officers","Being currently assigned and working as a probation or prison officer at a probation site 3. Focus Groups (People in probation)","Screen yes to opioid injection criteria on the online screener","Currently in probation 4. Focus Groups (Probation and prison officers)","Being currently assigned and working as a probation or prison officer at a probation","Has more than 3 months of field experience","Works at a probation site within 25 kilometers of an OAT site",[],"Inclusion Criteria:\n\nAim 1:\n\n1. Quantitative surveys for prison OAT providers\n\n   * Being 18 years or older\n   * Being currently assigned and working as a probation OAT provider for a probation site\n2. ECHO procedures\n\nAim 2:\n\n1. Quantitative surveys for people in probation\n\n   * Being 18 years or older\n   * Screen yes to opioid injection on the online screener questionnaire\n   * Currently in probation\n2. Quantitative surveys for probation and prison officers\n\n   * Being 18 years or older\n   * Being currently assigned and working as a probation or prison officer at a probation site\n3. Focus Groups (People in probation)\n\n   * Being 18 years or older\n   * Screen yes to opioid injection criteria on the online screener\n   * Currently in probation\n4. Focus Groups (Probation and prison officers)\n\n   * Being 18 years or older\n   * Being currently assigned and working as a probation or prison officer at a probation\n   * Has more than 3 months of field experience\n   * Works at a probation site within 25 kilometers of an OAT site\n\nExclusion Criteria:\n\n\\-",[63,64],"ADULT","OLDER_ADULT",[66,75,82,89,96],{"facility":12,"status":67,"city":68,"state":69,"zip":70,"country":71,"geoPoint":72},"NOT_YET_RECRUITING","New Haven","Connecticut","06520","United States",{"lat":73,"lon":74},41.30815,-72.92816,{"facility":76,"status":7,"city":77,"country":78,"geoPoint":79},"Alternative Georgia","Tbilisi","Georgia",{"lat":80,"lon":81},41.69143,44.83412,{"facility":83,"status":7,"city":84,"country":85,"geoPoint":86},"AIDS Foundation East-West (AFEW)","Bishkek","Kyrgyzstan",{"lat":87,"lon":88},42.87,74.59,{"facility":90,"status":7,"city":91,"country":92,"geoPoint":93},"NGO AFI","Chisinau","Moldova",{"lat":94,"lon":95},47.00902,28.85938,{"facility":97,"status":7,"city":98,"country":99,"geoPoint":100},"Institute for International Health and Education (IIHE)","Dushanbe","Tajikistan",{"lat":101,"lon":102},38.53575,68.77905,[104,109],{"name":105,"role":106,"phone":107,"email":108},"David Oliveros, MPH","CONTACT","202-805-8118","david.oliveros@yale.edu",{"name":110,"role":106,"email":111},"Jin Hee Kim, MPH","jinhee.kim@yale.edu",[113],{"name":114,"affiliation":12,"role":115},"Frederick L Altice, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":119,"biomarkers":122},[120,121],"HIV Infection","Opioid Use Disorder",[],{"nct_id":4,"found":124,"summary":125,"prompt_version":134},true,{"design":126,"status":127,"heading":6,"summary":128,"follow_up":129,"word_count":130,"commitments":131,"compensation":132,"drugs_mentioned":133},"This is an interventional study planning to enroll 300 participants. The study does not specify if it is randomized or blinded.","completed","This study is looking at ways to improve the use of Opioid Agonist Therapy (OAT) in prisons and probation systems in Tajikistan, Kyrgyzstan, Moldova, and Georgia. OAT is a treatment that can help prevent HIV in people who use opioids. The study aims to understand what makes it hard to offer OAT more widely and to help these countries expand their OAT programs. Researchers will survey OAT providers and people on probation, and also observe and interview probation clients and staff. The main goal is to see how many people receive OAT over a period of up to four years. You might be able to join if you are 18 or older and are either an OAT provider in a prison setting or a person on probation who has reported injecting opioids.","Participants receiving Opioid Agonist Therapy (OAT) will be measured at baseline and up to 4 years.",132,"Not specified in the trial record.","Not stated in the trial record.",[31],"v2"]