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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2030-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV Infections Opioid Use Disorder Incarceration; Lens

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Daily Oral Pill Arm

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

Group Type ACTIVE_COMPARATOR

Cabotegravir Pill

Intervention Type DRUG

Oral PrEP + SL-B treatment initiated in jail or prison.

Buprenorphine Pill

Intervention Type DRUG

Oral PrEP + SL-B treatment initiated in jail or prison.

Long Acting Injectable Arm

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.

Group Type EXPERIMENTAL

Cabotegravir Injection

Intervention Type DRUG

Long-acting injection (LAI) Prep + X-RB treatment initiated in jail or prison.

Buprenorphine injection

Intervention Type DRUG

Long-acting injection (LAI) Prep + X-RB treatment initiated in jail or prison.

Interventions

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Cabotegravir Injection

Long-acting injection (LAI) Prep + X-RB treatment initiated in jail or prison.

Intervention Type DRUG

Cabotegravir Pill

Oral PrEP + SL-B treatment initiated in jail or prison.

Intervention Type DRUG

Buprenorphine injection

Long-acting injection (LAI) Prep + X-RB treatment initiated in jail or prison.

Intervention Type DRUG

Buprenorphine Pill

Oral PrEP + SL-B treatment initiated in jail or prison.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes