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Abstract Details
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)
Open Forum Infect Dis. 2021 Jun 27;8(8):ofab334. doi: 10.1093/ofid/ofab334.eCollection 2021 Aug.
Lisa R Metsch1, Daniel J Feaster2, Lauren K Gooden1, Carmen Masson3, David C Perlman4, Mamta K Jain5, Tim Matheson6, C Mindy Nelson2, Petra Jacobs7, Susan Tross8, Louise Haynes9, Gregory M Lucas10, Jonathan A Colasanti11, Allan Rodriguez12, Mari-Lynn Drainoni13, Georgina Osorio4, Ank E Nijhawan5, Jeffrey M Jacobson14, Meg Sullivan13, David Metzger15, Pamela Vergara-Rodriguez16, Ronald Lubelchek17, Rui Duan2, Jacob N Batycki2, Abigail G Matthews18, Felipe Munoz18, Eve Jelstrom19, Raul Mandler20, Carlos Del Rio11
Author information
1Department of Sociomedical Sciences, Columbia University, New York, New York, USA.
2Department of Public Health Sciences, University of Miami, Miami, Florida, USA.
3Department of Psychiatry and Behavioral Sciences, University of California, San Francisco, San Francisco, California, USA.
4Division of Infectious Diseases, Mount Sinai Health System, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
5Division of Infectious Diseases, University of Texas Southwestern Medical Center and Parkland Health & Hospital System, Dallas, Texas, USA.
6Center on Substance Use and Health, San Francisco Department of Public Health, San Francisco, California, USA.
7Center for Clinical Trials Network, National Institute on Drug Abuse, Rockville, Maryland, USA.
8Department of Psychiatry, Columbia University, New York, New York, USA.
9College of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.
10Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
11Division of Infectious Diseases, Emory University, Atlanta, Georgia, USA.
12Infectious Disease, University of Miami, Miami, Florida, USA.
13Section of Infectious Diseases, Department of Medicine, Boston University School of Medicine, Boston, Massachusetts, USA.
14Division of Infectious Diseases and HIV Medicine, Case Western Reserve University, Cleveland, Ohio, USA.
15HIV/AIDS Prevention Research Division, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
16Mental Health and Substance Abuse Division, John H. Stroger, Jr Hospital of Cook County, Chicago, Illinois, USA.
17Infectious Diseases, John H. Stroger, Jr Hospital of Cook County, Chicago, Illinois, USA.
18Data Statistical Center, The Emmes Company, LLC, Rockville, Maryland, USA.
19Clinical Coordinating Center, The Emmes Company, LLC, Rockville, Maryland, USA.
20Clinical/Medical Branch, National Institute on Drug Abuse, Rockville, Maryland, USA.
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.