Clinical trial NCT06854029: NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
Official title: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: HIV Infections
Opioid Use Disorder
Incarceration; Lens
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Friends Research Institute, Inc.
name: The Miriam Hospital
name: University of Arkansas
name: National Institute on Drug Abuse (NIDA)
First posted: 2025-03-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two groups; 1) Daily oral medications for HIV prevention and MOUD treatment, and 2) Long-acting injectable HIV prevention and MOUD treatment
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: PrEP adherence, time to dropout
timeFrame: up to 12 months
measure: Buprenorphine adherence, time to dropout
timeFrame: up to 12 months
Secondary outcomes:
measure: Substance use as measured by number of participants with positive Urine Drug Test (UDT)
timeFrame: up to 12 months
measure: Number of participants with a fatal or non-fatal overdose
timeFrame: up to 12 months
measure: Number of participants engaging in HIV risk behaviors
timeFrame: up to 12 months
measure: Number of participants with past criminal system engagement
timeFrame: Baseline
measure: Number of participants with HIV acquisition
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical System
state: North Carolina
Study officials:
affiliation: Duke University
name: Lauren Brinkley-Rubinstein, PhD
role: PRINCIPAL_INVESTIGATOR
References: