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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT06854029
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Cabotegravir Injection — DRUG
    Long-acting injection (LAI) Prep + X-RB treatment initiated in jail or prison.
  • Cabotegravir Pill — DRUG
    Oral PrEP + SL-B treatment initiated in jail or prison.
  • Buprenorphine injection — DRUG
    Long-acting injection (LAI) Prep + X-RB treatment initiated in jail or prison.
  • Buprenorphine Pill — DRUG
    Oral PrEP + SL-B treatment initiated in jail or prison.

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
May 2026
Primary completion
Dec 1, 2029
Completion
Jun 1, 2030

Study Design

Enrollment
450 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Daily Oral Pill Arm
    Participants assigned to this arm will be administered daily oral pre-exposure prophylaxis for HIV prevention, as well as daily oral buprenorphine for opioid use disorder
  • Experimental: Long Acting Injectable Arm
    Participants assigned to this arm will be administered the-long acting injectable formulation of pre-exposure prophylaxis every 1-2 months, as well as the long-acting injectable formulation of buprenorphine, at the same clinic visit.

Primary Outcome Measure

PrEP adherence, time to dropout [ Time Frame: up to 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical SystemDurhamNorth Carolina27710
Hannah Camp, MPH, MSW
[email protected]
9193600692
Lauren Brinkley-Rubinstein, PhD
[email protected]
919 668 1753
Lauren Brinkley-Rubinstein, PhD (PRINCIPAL_INVESTIGATOR)
Michael Gordon, DPA (PRINCIPAL_INVESTIGATOR)
Curt Beckwith, MD, FIDSA, FACP (PRINCIPAL_INVESTIGATOR)

Find similar trials in Durham, NC

By condition
HIV
By specialty
Infectious disease
By research site
Duke University Medical System· Durham, NC

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