NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings

Launched by DUKE UNIVERSITY · Feb 25, 2025

Keywords

ClinConnect Summary

The NOTRE trial is studying ways to improve prevention and treatment for HIV and opioid use disorder in people who are incarcerated. This important research aims to find out how effective certain medications can be for protecting against HIV (called PrEP) and for treating opioid addiction while individuals are in jail or prison. The trial will first spend a year developing the best methods to deliver these treatments, followed by four years of testing these methods with participants to see how well they work.

To be eligible for this trial, participants must be adults (at least 18 years old) currently in a participating correctional facility and set to be released within 120 days. They should have a history of opioid use disorder and be willing to take part in treatment for both opioid use and HIV prevention. Participants will receive care that includes a medication called buprenorphine for opioid treatment and PrEP for HIV prevention, and they will be randomly assigned to different treatment groups. It’s important to note that certain health conditions may prevent someone from participating, such as severe liver problems or untreated mental health issues. Overall, this trial represents a significant step towards better health support for individuals transitioning back into the community after incarceration.

Gender

ALL

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.