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

Study acronym: NOTRE
StatusNot Yet Recruiting
PhasePhase 4
Started2026-09-01
View on ClinicalTrials.gov ↗

Amendment history

2026-08-24
minor
Study Status v4
Start date2026-07-01→2026-09-01
2026-06-03
minor
Study Status v3
Primary completion date2029-12→2029-12-01
Completion date2030-06→2030-06-01
Start date2026-06→2026-07-01
2026-05-12
notable
Study Status, Study Description, Study Design v2
Enrollment increased: 300 → 450 participants
Study description-13 characters
[...] tiveness of co-located LAI PrEP + XR-B to oral PrEP + SL-B. AnPatient open-labelpreference designtrial willfor randomly assign 300450 adults who are clinically indicated for both PrEP and MOUD [...]
2026-02-12
minor
Study Status v1
Start date2025-11→2026-06
2025-02-25
minor
Original filing
455 trials monitored
See 53 trials at risk
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 Details
NCT Number NCT06854029
Lead Sponsor Duke University
Collaborators: Friends Research Institute, Inc., The Miriam Hospital, University of Arkansas, National Institute on Drug Abuse (NIDA)
Conditions HIV Infections, Opioid Use Disorder, Incarceration; Lens
Enrollment 450 participants
Start Date 2026-09-01
Primary Completion 2029-12-01 (estimated)
Study Completion 2030-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-26