Care Facilitation Advances Movement Along the Hepatitis C Care Continuum for Persons With Human Immunodeficiency Virus, Hepatitis C, and Substance Use: A Randomized Clinical Trial (CTN-0064)
Lisa R. Metsch, Daniel J. Feaster, Lauren Gooden, Carmen L. Masson, David C. Perlman, Mamta K. Jain, Tim Matheson, C. Mindy Nelson, Petra Jacobs, Susan Tross, Louise Haynes, Gregory M. Lucas, Jonathan Colasanti, Allan Rodríguez, Mari‐Lynn Drainoni, Georgina Osorio, Ank E. Nijhawan, Jeffrey M. Jacobson, Meg Sullivan, David S. Metzger, Pamela Vergara‐Rodriguez, Ronald Lubelchek, Rui Duan, Jacob N. Batycki, Abigail G. Matthews, F Vasconez Muñoz, Eve Jelstrom, Raúl N. Mandler, Carlos del Rı́o
Abstract
Abstract Background Direct-acting antivirals can cure hepatitis C virus (HCV). Persons with HCV/HIV and living with substance use are disadvantaged in benefiting 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 were completed in January 2018. Care facilitation group participants received motivation and strengths-based case management addressing retrieval of HCV viral 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 (eg, receiving HCV results, initiating treatment, sustained virologic response [SVR]) of the HCV/HIV care continuum over 12 months postrandomization. Results Three hundred eighty-one individuals were screened and 113 randomized. Median age was 51 years; 58.4% of participants were male and 72.6% were 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 group vs controls (2.44 vs 1.68 steps; χ 2 [1] = 7.36, P = .0067). Men in the intervention group completed a statistically significantly higher number of steps than controls. Eleven participants achieved SVR 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 continued challenges to achieve individual-patient SVR and population-level HCV elimination. Clinical Trials Registration NCT02641158.