NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
NOTRE
Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
2 other identifiers
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 hiv-infections
Started Jun 2026
Longer than P75 for phase_4 hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2025
CompletedFirst Posted
Study publicly available on registry
March 3, 2025
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2029
Study Completion
Last participant's last visit for all outcomes
June 1, 2030
February 17, 2026
February 1, 2026
3.5 years
February 25, 2025
February 12, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
PrEP adherence, time to dropout
Dropout is defined as missing treatment for 7 consecutive days.
up to 12 months
Buprenorphine adherence, time to dropout
Dropout is defined as missing treatment for 7 consecutive days.
up to 12 months
Secondary Outcomes (5)
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
Study Arms (2)
Daily Oral Pill Arm
ACTIVE COMPARATORParticipants 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
EXPERIMENTALParticipants 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.
Interventions
Long-acting injection (LAI) Prep + X-RB treatment initiated in jail or prison.
Long-acting injection (LAI) Prep + X-RB treatment initiated in jail or prison.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- Friends Research Institute, Inc.collaborator
- The Miriam Hospitalcollaborator
- University of Arkansascollaborator
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
Duke University Medical System
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lauren Brinkley-Rubinstein, PhD
Duke University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2025
First Posted
March 3, 2025
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
December 1, 2029
Study Completion (Estimated)
June 1, 2030
Last Updated
February 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Scientific data will be made available after all longitudinal data is collected (baseline, follow-up data) and has undergone rigorous quality control. In addition, data will be made available after the primary outcome papers are accepted for publication. An exception to this will be sharing more routinely with the HIV/Justice Research Network Data Coordination Center.
Our data and research findings will be shared with other researchers through the customary means of peer-reviewed publications and at national and international conferences and symposia, such as the annual meeting of the Academic Consortium on Criminal Justice Health, the American Public Health Association. We will ensure that publications reporting on study data and results will be made available to interested scientists by submitting an electronic version of all papers, upon acceptance for publication, to the National Library of Medicine's PubMed Central. In addition, we will cite this grant in any products emanating from this research study. Whenever possible, we will make resulting publications open access. In addition, our team, whenever possible, will make the data underlying the conclusions of peer-reviewed scientific research publications freely available in public repositories at the time of initial publication.