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Not Yet Recruiting
NCT06854029
NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
Conditions: HIV Infections, Opioid Use Disorder, Incarceration; Lens
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: PHASE4
Enrollment: 450
Sponsor: Duke University
Location: Duke University Medical System Durham North Carolina
Summary
The investigators plan to conduct an R61/33 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.
Eligibility Criteria
Inclusion Criteria:
1. Adults (age 18) at a participating carceral site;
2. Eligible for release within 120 days (sentenced and/or pretrial). Individuals who might be sentenced to federal prison will be excluded;
3. 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);
4. HIV negative (as confirmed by a HIV rapid test);
5. Clinically indicated for PrEP based on CDC guidelines during incarceration and/or the year prior to incarceration;
6. Willing to enroll in buprenorphine treatment and PrEP and be randomized to either study arm; and
7. Report that, during community re-entry they will reside in the geographic locations of the study.
Exclusion Criteria:
1. 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);
2. Active medical illness that may make participation hazardous (e.g., unstable diabetes, heart disease; renal impairment, Hepatitis B);
3. 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);
4. Untreated psychiatric disorder that may make participation hazardous (e.g., untreated psychosis, treated psychiatric disorders will be allowed);
5. Known allergic reaction to PrEP or buprenorphine; and
6. Suicidal ideation.
Source: ClinicalTrials.gov (NCT06854029). StuddyBuddy aggregates publicly available trial information.