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

doi:10.1093/ofid/ofab334

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.

Authors

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

Affiliations

¹ Department of Sociomedical Sciences, Columbia University, New York, New York, USA.
² Department of Public Health Sciences, University of Miami, Miami, Florida, USA.
³ Department of Psychiatry and Behavioral Sciences, University of California, San Francisco, San Francisco, California, USA.
⁴ Division of Infectious Diseases, Mount Sinai Health System, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
⁵ Division of Infectious Diseases, University of Texas Southwestern Medical Center and Parkland Health & Hospital System, Dallas, Texas, USA.
⁶ Center on Substance Use and Health, San Francisco Department of Public Health, San Francisco, California, USA.
⁷ Center for Clinical Trials Network, National Institute on Drug Abuse, Rockville, Maryland, USA.
⁸ Department of Psychiatry, Columbia University, New York, New York, USA.
⁹ College of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.
¹⁰ Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
¹¹ Division of Infectious Diseases, Emory University, Atlanta, Georgia, USA.
¹² Infectious Disease, University of Miami, Miami, Florida, USA.
¹³ Section of Infectious Diseases, Department of Medicine, Boston University School of Medicine, Boston, Massachusetts, USA.
¹⁴ Division of Infectious Diseases and HIV Medicine, Case Western Reserve University, Cleveland, Ohio, USA.
¹⁵ HIV/AIDS Prevention Research Division, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
¹⁶ Mental Health and Substance Abuse Division, John H. Stroger, Jr Hospital of Cook County, Chicago, Illinois, USA.
¹⁷ Infectious Diseases, John H. Stroger, Jr Hospital of Cook County, Chicago, Illinois, USA.
¹⁸ Data Statistical Center, The Emmes Company, LLC, Rockville, Maryland, USA.
¹⁹ Clinical Coordinating Center, The Emmes Company, LLC, Rockville, Maryland, USA.
²⁰ Clinical/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.

Clinical trials registration: NCT02641158.

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

Associated data

ClinicalTrials.gov/NCT02641158

Abstract

Associated data

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