Eliminating hepatitis C in a rural Appalachian county: protocol for the Kentucky Viral Hepatitis Treatment Study (KeY Treat), a phase IV, single-arm, open-label trial of sofosbuvir/velpatasvir for the treatment of hepatitis C

Havens, Jennifer R.; Schaninger, Takako; Fraser, Hannah; Lofwall, Michelle R.; Staton, Michele; Young, April M.; Hoven, Ardis; Walsh, Sharon; Vickerman, Peter

doi:10.1136/bmjopen-2020-041490

Cited by 2 publications

(1 citation statement)

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“…The county is considered economically distressed and is one of the most impoverished counties in the United States 33 . KeY Treat is a Phase 4, open‐label, single‐arm clinical trial using a 12‐week, once‐per‐day DAA (sofosbuvir/velpatasvir) (see Havens and colleagues 34 –for an extensive description of the protocol). Recruitment began in September 2019 and was completed in April 2023.…”

Section: Methodsmentioning

confidence: 99%

Predictors of engagement in screening for a hepatitis C virus (HCV) treatment trial in a rural Appalachian community

Havens,

Lofwall,

Young

et al. 2024

Journal of Viral Hepatitis

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An HCV treatment trial was initiated in September 2019 to address the opioid/hepatitis C virus (HCV) syndemic in rural Kentucky. The focus of the current analysis is on participation in diagnostic screening for the trial. Initial eligibility (≥18 years of age, county resident) was established by phone followed by in‐person HCV viremia testing. 900 rural residents met the inclusion criteria and comprised the analytic sample. Generalized linear models were specified to estimate the relative risk of non‐attendance at the in‐person visit determining HCV eligibility. Approximately one‐quarter (22.1%) of scheduled participants were no‐shows. People who inject drugs were no more likely than people not injecting drugs to be a no‐show; however, participants ≤35 years of age were significantly less likely to attend. While the median time between phone screening and scheduled in‐person screening was only 2 days, each additional day increased the odds of no‐show by 3% (95% confidence interval: 2%–3%). Finally, unknown HCV status predicted no‐show even after adjustment for age, gender, days between screenings and injection status. We found that drug injection did not predict no‐show, further justifying expanded access to HCV treatment among people who inject drugs. Those 35 years and younger were more likely to no‐show, suggesting that younger individuals may require targeted strategies for increasing testing and treatment uptake. Finally, streamlining the treatment cascade may also improve outcomes, as participants in the current study were more likely to attend if there were fewer days between phone screening and scheduled in‐person screening.

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Section: Methodsmentioning

confidence: 99%