NCT06854029

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

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Study aims are: Aim 1 (R61): Develop the intervention protocol for delivery of LAI PrEP + XR-B. We will conduct interviews with stakeholders (staff at partner and other carceral and community sites, n=18:) and currently or recently incarcerated individuals (n=18). Interviews will focus on how to optimize intervention components for the R33 phase. Aim 2 (R33): Evaluate implementation facilitation as a strategy to support co-located LAI PrEP + XR-B in carceral and re-entry settings. Guided by the Consolidated Framework for Implementation Research (CFIR), implementation outcomes from Proctor et al.,including acceptability, appropriateness, adoption, feasibility, and sustainability will be assessed using surveys, interviews, and administrative records. Aim 3 (R33): Compare the effectiveness of co-located LAI PrEP + XR-B to oral PrEP + SL-B. An open-label design will randomly assign 300 adults who are clinically indicated for both PrEP and MOUD and soon-to-be-released from a carceral setting to either LAI Prep + X-RB (n=150) or oral PrEP + SL-B (n=150) treatment initiated in jail or prison. A baseline assessment will be conducted prior to release followed by monthly follow-up for 7 months and a final long-term follow-up visit at 12-months.

Conditions

• HIV Infections
• Opioid Use Disorder
• Incarceration; Lens

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-06-01
• Primary completion: 2029-12-01
• Completion: 2030-06-01
• First posted: 2025-03-03
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study