Contemporary clinical trials · 2025
Rationale, design, and methodology of a randomized controlled trial evaluating the impact of peer-enhanced care coordination on linkage to HCV care among formerly incarcerated individuals.
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Riback Lindsey R, Davis Morgan, King Ashley, Boswell Kristine, Moore Caitlin, Dendy Barbara, Hoeflich Carolin, Heo Moonseong, Litwin Alain H, Akiyama Matthew J
Аннотация
BACKGROUND: Hepatitis C Virus (HCV) disproportionately affects criminal legal-involved individuals (CLI), yet low treatment availability and high turnover in U.S. jails limits the number of individuals treated while incarcerated. HCV care coordination upon release is also an unmet need requiring improved models of care. This study will assess the feasibility and preliminary effectiveness of a peer-enhanced HCV care coordination intervention among individuals leaving jail.
METHODS/DESIGN: We aim to enroll 80 current or formerly incarcerated CLI with current HCV infection. Participants will be 1:1 randomized to the enhanced linkage and retention intervention (HCV-ACCELERATE) intervention or advanced standard of care (SOC) coordination. HCV-ACCELERATE participants will receive peer mentorship to support community reentry, HCV treatment and other ancillary needs such as mental health or substance use disorder treatment, as well as scheduling and accompaniment to their first community-based HCV appointment. SOC participants will receive a community resource flyer to schedule their first community-based HCV appointment. Participants will complete five research visits over six months and medical records will be reviewed. The primary outcome will be linkage to HCV care after release. Secondary outcomes include HCV treatment initiation and completion, sustained virologic response, and HCV re-infection.
DISCUSSION: The evaluation of this intervention will be critical in understanding the feasibility of a peer-enhanced care coordination intervention among CLI to promote linkage to and retention in the HCV care continuum. Moreover, the methodology discussed here can serve as a template for future programs and studies regarding treatment provision and outcomes among CLI with HCV.
TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov (NCT04701437). Trial registration was obtained prospectively February 19, 2021.
METHODS/DESIGN: We aim to enroll 80 current or formerly incarcerated CLI with current HCV infection. Participants will be 1:1 randomized to the enhanced linkage and retention intervention (HCV-ACCELERATE) intervention or advanced standard of care (SOC) coordination. HCV-ACCELERATE participants will receive peer mentorship to support community reentry, HCV treatment and other ancillary needs such as mental health or substance use disorder treatment, as well as scheduling and accompaniment to their first community-based HCV appointment. SOC participants will receive a community resource flyer to schedule their first community-based HCV appointment. Participants will complete five research visits over six months and medical records will be reviewed. The primary outcome will be linkage to HCV care after release. Secondary outcomes include HCV treatment initiation and completion, sustained virologic response, and HCV re-infection.
DISCUSSION: The evaluation of this intervention will be critical in understanding the feasibility of a peer-enhanced care coordination intervention among CLI to promote linkage to and retention in the HCV care continuum. Moreover, the methodology discussed here can serve as a template for future programs and studies regarding treatment provision and outcomes among CLI with HCV.
TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov (NCT04701437). Trial registration was obtained prospectively February 19, 2021.