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NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
Sponsor: Duke University
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.
Official title: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2026-06
Completion Date
2030-06
Last Updated
2026-02-17
Healthy Volunteers
Yes
Interventions
Cabotegravir Injection
Long-acting injection (LAI) Prep + X-RB treatment initiated in jail or prison.
Cabotegravir Pill
Oral PrEP + SL-B treatment initiated in jail or prison.
Buprenorphine injection
Long-acting injection (LAI) Prep + X-RB treatment initiated in jail or prison.
Buprenorphine Pill
Oral PrEP + SL-B treatment initiated in jail or prison.
Locations (1)
Duke University Medical System
Durham, North Carolina, United States