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NOT YET RECRUITING
NCT06854029
PHASE4

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

Sponsor: Duke University

View on ClinicalTrials.gov

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

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.

Locations (1)

Duke University Medical System

Durham, North Carolina, United States