Care Facilitation Advances Movement Along The Hepatitis C Care Continuum For Persons With Hiv, Hepatitis C And Substance Use: A Randomized Clinical Trial (Ctn-0064)
Abstract Background Direct-acting antivirals can cure HCV. Persons with HCV/HIV and living with substance use are disadvantaged in benefitting from advances in HCV treatment. Methods In this randomized controlled trial, participants with HCV/HIV were randomized between February 2016 and January 2017 to either care facilitation or control. Twelve-month follow-up assessments completed in January 2018. Care facilitation group participants received motivation and strengths-based case-management addressing retrieval of HCV load results, engagement in HCV/HIV care and medication adherence. Control group participants received referral to HCV evaluation and an offer of assistance in making care appointments. Primary outcome was number of steps achieved along a series of 8 clinical steps (e.g., receiving HCV results, initiating treatment, sustained viral response) of the HCV/HIV care continuum over 12 months post-randomization. Results Three hundred and eighty-one individuals were screened and 113 randomized. Median age was 51 years; 58.4% male and 72.6% Black/African American. Median HIV-1 viral load was 27,209 copies/ml with 69% having a detectable viral load. Mean number of steps completed was statistically significantly higher in the intervention (2.44 steps) vs. control group (1.68 steps) [χ 2(1)=7.36, p=0.0067]. Men in the intervention (vs. control) group completed a statistically significantly higher number of steps. Eleven participants achieved sustained viral response with no difference by treatment group. Conclusions The care facilitation intervention increased progress along the HCV/HIV care continuum, as observed for men and not women. Study findings also highlight the continued challenges to achieve individual patient sustained viral responses and population level HCV elimination.