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

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.

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	2026-07-01
Primary Completion	2029-12-01 (estimated)
Study Completion	2030-06-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-04