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 K Gooden, Carmen Masson, David C Perlman, Mamta K Jain, Tim Matheson, C Mindy Nelson, Petra Jacobs, Susan Tross, Louise Haynes, Gregory M Lucas, Jonathan A Colasanti, Allan Rodriguez, Mari-Lynn Drainoni, Georgina Osorio, Ank E Nijhawan, Jeffrey M Jacobson, Meg Sullivan, David Metzger, Pamela Vergara-Rodriguez, Ronald Lubelchek, Rui Duan, Jacob N Batycki, Abigail G Matthews, Felipe Munoz, Eve Jelstrom, Raul Mandler, Carlos Del Rio, Lisa R Metsch, Daniel J Feaster, Lauren K Gooden, Carmen Masson, David C Perlman, Mamta K Jain, Tim Matheson, C Mindy Nelson, Petra Jacobs, Susan Tross, Louise Haynes, Gregory M Lucas, Jonathan A Colasanti, Allan Rodriguez, Mari-Lynn Drainoni, Georgina Osorio, Ank E Nijhawan, Jeffrey M Jacobson, Meg Sullivan, David Metzger, Pamela Vergara-Rodriguez, Ronald Lubelchek, Rui Duan, Jacob N Batycki, Abigail G Matthews, Felipe Munoz, Eve Jelstrom, Raul Mandler, Carlos Del Rio

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.

Keywords: HIV; cascade; hepatitis C; patient navigation; substance use.

© The Author(s) 2021. Published by Oxford University Press on behalf of Infectious Diseases Society of America.

Figures

Figure 1.
Figure 1.
Consolidated Standards of Reporting Trials (CONSORT) flow diagram. Abbreviations: HCV, hepatitis C virus; PI, principal investigator; RCT, randomized controlled trial.
Figure 2.
Figure 2.
Sum of steps completed on hepatitis C virus care continuum by treatment group. Abbreviations: CF, care facilitator; HCV, hepatitis C virus.

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Source: PubMed

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