HIV InfectionsPhase 4NOTRENCT06854029

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

A Phase 4 study testing Cabotegravir Injection, Cabotegravir Pill and Buprenorphine injection in people with HIV Infections and Opioid Use Disorder, run by Duke University at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: HIV Infections, Opioid Use Disorder, Incarceration; Lens
What is being tested?: Cabotegravir Injection, Cabotegravir Pill and Buprenorphine injection
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 450 participants
Where: 1 siteUnited States
Study dates: 1 Sep 2026to 1 Jun 2030
Phase: Phase 4
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hannah Camp, MPH, MSW contact

9193600692

hannah.camp@duke.edu

United States1 site

Duke University Medical System
Durham, North Carolina, 27710
Hannah Camp, MPH, MSW, 9193600692, hannah.camp@duke.edu
Lauren Brinkley-Rubinstein, PhD, 919 668 1753, lauren.br@duke.edu

Other trials in United States

About this study

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

Read the 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.

Conditions: HIV Infections, Opioid Use Disorder, Incarceration; Lens
Being tested: Cabotegravir Injection, Cabotegravir Pill, Buprenorphine injection, Buprenorphine Pill
Medical subject headings: HIV Infections, Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cabotegravir InjectionDrug
Long-acting injection (LAI) Prep + X-RB treatment initiated in jail or prison.
Cabotegravir PillDrug
Oral PrEP + SL-B treatment initiated in jail or prison.
Buprenorphine injectionDrug
Long-acting injection (LAI) Prep + X-RB treatment initiated in jail or prison.
Buprenorphine PillDrug
Oral PrEP + SL-B treatment initiated in jail or prison.

Study groups in NCT06854029
Study group	Role	What they receive
Daily Oral Pill Arm	Active comparator	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 Receives: Drug: Cabotegravir Pill; Drug: Buprenorphine Pill
Long Acting Injectable Arm	Experimental	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. Receives: Drug: Cabotegravir Injection; Drug: Buprenorphine injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20261 Jun 2030

First posted3 Mar 2025
Study start1 Sep 2026 (estimated)
Primary completion1 Dec 2029 (estimated)
Study completion1 Jun 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Participants choose one of two groups; 1) Daily oral medications for HIV prevention and MOUD treatment, and 2) Long-acting injectable HIV prevention and MOUD treatment
Masking: Single blind
Who is masked: Participant
Enrolment: 450 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06854029
Sponsor's protocol ID: Pro00117590
Other IDs: R61DA060583
Acronym: NOTRE
Status last verified: Aug 2026
First submitted: 25 Feb 2025
Last updated: 26 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Interested in taking part?

Hannah Camp, MPH, MSW

9193600692

hannah.camp@duke.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
ClinicalTrials.gov ID: NCT06854029
Acronym / sponsor ID: NOTRE / Pro00117590
Conditions: HIV Infections, Opioid Use Disorder, Incarceration; Lens
Phase: Phase 4
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 450 participants (estimated)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: Friends Research Institute, Inc., The Miriam Hospital, University of Arkansas, National Institute on Drug Abuse (NIDA)
Study start: 1 Sep 2026 (estimated)
Primary completion: 1 Dec 2029 (estimated)
Study completion: 1 Jun 2030 (estimated)
First posted: 3 Mar 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Participants choose one of two groups; 1) Daily oral medications for HIV prevention and MOUD treatment, and 2) Long-acting injectable HIV prevention and MOUD treatment

Arm	Type	Receives
Daily Oral Pill Arm	Active comparator	Drug: Cabotegravir Pill, Drug: Buprenorphine PillParticipants 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	Experimental	Drug: Cabotegravir Injection, Drug: Buprenorphine injectionParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cabotegravir InjectionLong-acting injection (LAI) Prep + X-RB treatment initiated in jail or prison.	Drug	Long Acting Injectable Arm
Cabotegravir PillOral PrEP + SL-B treatment initiated in jail or prison.	Drug	Daily Oral Pill Arm
Buprenorphine injectionLong-acting injection (LAI) Prep + X-RB treatment initiated in jail or prison.	Drug	Long Acting Injectable Arm
Buprenorphine PillOral PrEP + SL-B treatment initiated in jail or prison.	Drug	Daily Oral Pill Arm

Primary outcome

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

5 secondary outcomes

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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
Individual participant dataSharing planned: Yes. 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.

Related trials for HIV Infections

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Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
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Multiple Interventions With Distinct Anti-reservoir Activities in People on Antiretroviral Treatment
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Hannah Camp, MPH, MSW contact

9193600692

hannah.camp@duke.edu

Lauren Brinkley-Rubinstein, PhD principal investigator

Duke University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cabotegravir Injection, Cabotegravir Pill and Buprenorphine injection in people with HIV Infections and Opioid Use Disorder, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hannah Camp, MPH, MSW (9193600692, hannah.camp@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PrEP adherence, time to dropout (time frame: up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06854029.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.