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

Phase 4

Not yet recruiting

• Conditions: HIV Infections; Opioid Use Disorder; Incarceration; Lens
• Interventions: Drug: Cabotegravir Pill; Drug: Cabotegravir Injection; Drug: Buprenorphine Pill; Drug: Buprenorphine injection

• Registration Number: NCT06854029
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Study aims are: Aim 1 (R61): Develop the intervention protocol for delivery of LAI PrEP + XR-B. We will conduct interviews with stakeholders (staff at partner and other carceral and community sites, n=18:) and currently or recently incarcerated individuals (n=18). Interviews will focus on how to optimize intervention components for the R33 phase. Aim 2 (R33): Evaluate implementation facilitation as a strategy to support co-located LAI PrEP + XR-B in carceral and re-entry settings. Guided by the Consolidated Framework for Implementation Research (CFIR), implementation outcomes from Proctor et al.,including acceptability, appropriateness, adoption, feasibility, and sustainability will be assessed using surveys, interviews, and administrative records. Aim 3 (R33): Compare the effectiveness of co-located LAI PrEP + XR-B to oral PrEP + SL-B. An open-label design will randomly assign 300 adults who are clinically indicated for both PrEP and MOUD and soon-to-be-released from a carceral setting to either LAI Prep + X-RB (n=150) or oral PrEP + SL-B (n=150) treatment initiated in jail or prison. A baseline assessment will be conducted prior to release followed by monthly follow-up for 7 months and a final long-term follow-up visit at 12-months.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-25
• Study First Submitted QC: 2025-02-25
• Last Update Submitted: 2025-02-25
• Study First Posted: 2025-03-03
• Last Update Posted: 2025-03-03
• Study Start: 2025-11
• Primary Completion: 2029-12
• Study Completion: 2030-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Daily Oral Pill Arm	Cabotegravir Pill	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
Daily Oral Pill Arm	Buprenorphine Pill	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
Long Acting Injectable Arm	Cabotegravir Injection	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.
Long Acting Injectable Arm	Buprenorphine injection	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.

Primary Outcome Measures

Name	Time	Method
PrEP adherence, time to dropout	up to 12 months	Dropout is defined as missing treatment for 7 consecutive days.
Buprenorphine adherence, time to dropout	up to 12 months	Dropout is defined as missing treatment for 7 consecutive days.

Secondary Outcome Measures

Name	Time	Method
Substance use as measured by number of participants with positive Urine Drug Test (UDT)	up to 12 months
Number of participants with a fatal or non-fatal overdose	up to 12 months
Number of participants engaging in HIV risk behaviors	up to 12 months
Number of participants with past criminal system engagement	Baseline
Number of participants with HIV acquisition	up to 12 months

Trial Locations

Locations (1)

Duke University Medical System; 🇺🇸 Durham, North Carolina, United States