[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"incarceration-lens\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:incarceration-lens":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"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":21,"type":22},450,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30],"HIV Infections","Opioid Use Disorder","Incarceration; Lens","NOT_YET_RECRUITING","2026-06-03",{"date":34,"type":35},"2026-06-04","ACTUAL",{"date":37,"type":22},"2026-07-01",{"date":39,"type":22},"2030-06-01",{"name":41,"class":42},"Duke University","OTHER"]