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

NCT06854029 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2026-05-14

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Friends Research Institute, Inc.

    collaborator OTHER

  • The Miriam Hospital

    collaborator OTHER

  • University of Arkansas

    collaborator OTHER

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • Lauren Brinkley-Rubinstein, PhD · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2029-12-31
Completion
2030-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06854029 on ClinicalTrials.gov