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NCT06854029Not yet recruitingPhase 4

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

Source: ClinicalTrials.gov · Last updated 26 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
450 (estimated)
First submitted
25 Feb 2025
Start date
1 Sept 2026
Primary completion date
1 Dec 2029
Lead sponsor
Duke University
Diseases
HIV
NCT number
NCT06854029

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 450
  • From 1 Sept 2026 to the primary completion date, 1 Dec 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Active medical illness that may make participation hazardous (e.g., unstable diabetes, heart disease; renal impairment, Hepatitis B);
  • Untreated psychiatric disorder that may make participation hazardous (e.g., untreated psychosis, treated psychiatric disorders will be allowed);
  • Known allergic reaction to PrEP or buprenorphine; and

Lab values

  • 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);

Other

  • 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);
  • Suicidal ideation.

Who the study is looking for

  • Adults (age 18) at a participating carceral site;
  • Eligible for release within 120 days (sentenced and/or pretrial). Individuals who might be sentenced to federal prison will be excluded;
  • 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);
  • HIV negative (as confirmed by a HIV rapid test);
  • Clinically indicated for PrEP based on CDC guidelines during incarceration and/or the year prior to incarceration;
  • Willing to enroll in buprenorphine treatment and PrEP and be randomized to either study arm; and
  • Report that, during community re-entry they will reside in the geographic locations of the study.

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Duke University Medical System
Coordinator of this site? Confirm its status
DurhamUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.