[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581724":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":39,"centralContacts":43,"locations":49,"responsibleParty":73,"collaborators":75,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":94,"minAge":95,"maxAge":28,"enrollmentInfo":96,"targetDuration":28,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":28,"overallStatus":107,"whyStopped":28,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Duke University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Daily Oral Pill Arm","ACTIVE_COMPARATOR","Participants assigned to this arm will be administered daily oral pre-exposure prophylaxis for HIV prevention, as well as daily oral buprenorphine for opioid use disorder",[13,14],"Drug: Cabotegravir Pill","Drug: Buprenorphine Pill",{"label":16,"type":17,"description":18,"interventionNames":19},"Long Acting Injectable Arm","EXPERIMENTAL","Participants assigned to this arm will be administered the-long acting injectable formulation of pre-exposure prophylaxis every 1-2 months, as well as the long-acting injectable formulation of buprenorphine, at the same clinic visit.",[20,21],"Drug: Cabotegravir Injection","Drug: Buprenorphine injection",[23,29,33,36],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Cabotegravir Injection","Long-acting injection (LAI) Prep + X-RB treatment initiated in jail or prison.",[16],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Cabotegravir Pill","Oral PrEP + SL-B treatment initiated in jail or prison.",[9],{"type":24,"name":34,"description":26,"armGroupLabels":35,"otherNames":28},"Buprenorphine injection",[16],{"type":24,"name":37,"description":31,"armGroupLabels":38,"otherNames":28},"Buprenorphine Pill",[9],[40],{"name":41,"affiliation":5,"role":42},"Lauren Brinkley-Rubinstein, PhD","PRINCIPAL_INVESTIGATOR",[44],{"name":45,"role":46,"phone":47,"phoneExt":28,"email":48},"Hannah Camp, MPH, MSW","CONTACT","9193600692","hannah.camp@duke.edu",[50],{"facility":51,"status":28,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Duke University Medical System","Durham","North Carolina","27710","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-78.89862,35.99403,{"lat":61,"lon":60},[64,65,68,69,71],{"name":45,"role":46,"phone":47,"phoneExt":28,"email":48},{"name":41,"role":46,"phone":66,"phoneExt":28,"email":67},"919 668 1753","lauren.br@duke.edu",{"name":41,"role":42,"phone":28,"phoneExt":28,"email":28},{"name":70,"role":42,"phone":28,"phoneExt":28,"email":28},"Michael Gordon, DPA",{"name":72,"role":42,"phone":28,"phoneExt":28,"email":28},"Curt Beckwith, MD, FIDSA, FACP",{"type":74,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[76,78,80,82],{"name":77,"class":6},"Friends Research Institute, Inc.",{"name":79,"class":6},"The Miriam Hospital",{"name":81,"class":6},"University of Arkansas",{"name":83,"class":84},"National Institute on Drug Abuse (NIDA)","NIH","100581724","phase-4-notre-optimizing-long-acting-pre-exposure-prophylaxis-and-medications-for-opioid-use-disorder-interventions-in-carceral-settings-100581724",false,"NCT06854029","NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings","Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings","NOTRE","Inclusion Criteria:\n\n1. Adults (age 18) at a participating carceral site;\n2. Eligible for release within 120 days (sentenced and\u002For pretrial). Individuals who might be sentenced to federal prison will be excluded;\n3. History of OUD (meeting DSM-5 criteria of moderate or severe opioid use disorder at the time of incarceration; individuals not meeting the opioid-disorder criterion will be eligible if they were treated in an opioid agonist treatment program during the year before incarceration or met OUD criteria in the year prior to incarceration);\n4. HIV negative (as confirmed by a HIV rapid test);\n5. Clinically indicated for PrEP based on CDC guidelines during incarceration and\u002For the year prior to incarceration;\n6. Willing to enroll in buprenorphine treatment and PrEP and be randomized to either study arm; and\n7. Report that, during community re-entry they will reside in the geographic locations of the study.\n\nExclusion Criteria:\n\n1. Liver function test levels greater than four times normal (if we are unable to obtain labs, a determination by our site partner physicians will be made to allow inclusion);\n2. Active medical illness that may make participation hazardous (e.g., unstable diabetes, heart disease; renal impairment, Hepatitis B);\n3. Conditions or medications that may predispose to QTc prolongation (personal or family history of long QT syndrome, hypokalemia, medications that prolong QTc interval, e.g., macrolide antibiotics, azole antifungal compounds, anti-arrhythmics, antipsychotics and antidepressants);\n4. Untreated psychiatric disorder that may make participation hazardous (e.g., untreated psychosis, treated psychiatric disorders will be allowed);\n5. Known allergic reaction to PrEP or buprenorphine; and\n6. Suicidal ideation.",true,"ALL","18 Years",{"count":97,"type":98},450,"ESTIMATED","INTERVENTIONAL",[101],"PHASE4","The investigators plan to conduct an R61\u002F33 hybrid type 2 implementation-effectiveness trial that includes 1) a one-year exploratory R61 phase that will enable the development of the intervention protocol needed for the R33 trial phase including concrete R61 phase milestones; 2) a four-year R33 phase that will include a concurrent implementation evaluation and a randomized control trial.",[104,105,106],"HIV Infections","Opioid Use Disorder","Incarceration; Lens","NOT_YET_RECRUITING","2026-06-03",{"date":110,"type":111},"2026-06-04","ACTUAL",{"date":113,"type":98},"2026-07-01",{"date":115,"type":98},"2030-06-01",{"name":5,"class":6},1]