NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cabotegravir Injection, Cabotegravir Pill, Buprenorphine injection, Buprenorphine Pill.
- Who it may be relevant to
- Registry conditions: HIV Infections, Opioid Use Disorder, Incarceration; Lens. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
Overview
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. Patient preference trial for 450 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.
Interventions
- Drug Cabotegravir Injection
Long-acting injection (LAI) Prep + X-RB treatment initiated in jail or prison. - Drug Cabotegravir Pill
Oral PrEP + SL-B treatment initiated in jail or prison. - Drug Buprenorphine injection
Long-acting injection (LAI) Prep + X-RB treatment initiated in jail or prison. - Drug Buprenorphine Pill
Oral PrEP + SL-B treatment initiated in jail or prison.
Primary outcome measures
- PrEP adherence, time to dropout [Time frame: up to 12 months]
- Buprenorphine adherence, time to dropout [Time frame: up to 12 months]
Secondary outcome measures (5)
- Substance use as measured by number of participants with positive Urine Drug Test (UDT) [Time frame: up to 12 months]
- Number of participants with a fatal or non-fatal overdose [Time frame: up to 12 months]
- Number of participants engaging in HIV risk behaviors [Time frame: up to 12 months]
- Number of participants with past criminal system engagement [Time frame: Baseline]
- Number of participants with HIV acquisition [Time frame: up to 12 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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);
- Active medical illness that may make participation hazardous (e.g., unstable diabetes, heart disease; renal impairment, Hepatitis B);
- 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);
- 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
- Suicidal ideation.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Duke University Medical System — Durham
Identifiers
NCT: NCT06854029 · Pro00117590 · R61DA060583