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.
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. Patient preference trial for 450 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
450
Long-acting injection (LAI) Prep + X-RB treatment initiated in jail or prison.
Oral PrEP + SL-B treatment initiated in jail or prison.
Long-acting injection (LAI) Prep + X-RB treatment initiated in jail or prison.
Oral PrEP + SL-B treatment initiated in jail or prison.
Duke University Medical System
Durham, North Carolina, United States
PrEP adherence, time to dropout
Dropout is defined as missing treatment for 7 consecutive days.
Time frame: up to 12 months
Buprenorphine adherence, time to dropout
Dropout is defined as missing treatment for 7 consecutive days.
Time frame: up to 12 months
Substance use as measured by number of participants with positive Urine Drug Test (UDT)
Time frame: up to 12 months
Number of participants with a fatal or non-fatal overdose
Time frame: up to 12 months
Number of participants engaging in HIV risk behaviors
Time frame: up to 12 months
Number of participants with past criminal system engagement
Time frame: Baseline
Number of participants with HIV acquisition
Time frame: up to 12 months
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