1 Clemson University School of Health Research, Clemson, SC, USA; Department of Medicine, University of South Carolina School of Medicine, Greenville, SC, USA; Department of Medicine, Prisma Health, Greenville, SC, USA. Electronic address: Alain.Litwin@prismahealth.org.
2 Department of Medicine, Montefiore Medical Center, Bronx, NY, USA.
3 Department of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque, NM, USA.
4 Department of Public Health Sciences, College of Behavioral, Social, and Health Sciences, Clemson University Clemson, SC, USA.
5 Einstein College of Medicine, Bronx, NY, USA.
6 Department of Behavioral Medicine & Psychiatry and Department of Medicine, West Virginia University, Morgantown, WV, USA.
7 Department of Infectious Diseases, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
8 Department of Medicine, University of California San Francisco, San Francisco, CA, USA.
9 Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
10 College of Pharmacy, University of Rhode Island, CODAC Behavioral Health, Providence, RI, USA.
11 Department of Medicine, University of Washington, Seattle, WA, USA.
12 Clemson University School of Health Research, Clemson, SC, USA; Department of Medicine, Prisma Health, Greenville, SC, USA.
BACKGROUND: Although people who inject drugs (PWID) having the highest incidence and prevalence of hepatitis C virus (HCV) in the US, HCV treatment is rarely provided to PWID due to assumptions about poor adherence and reinfection risk. As direct-acting antiviral agents (DAAs) have achieved sustained virologic response (SVR) rates of 95% or more, evidence-based strategies are urgently needed to demonstrate real-world effectiveness in marginalized patient populations such as PWID. The objectives of this study are: 1) to determine whether either of two patient-centered treatment models - patient navigation (PN) or modified directly observed therapy (mDOT) - results in more forward movement along the HCV care cascade including treatment initiation, adherence, and SVR; 2) using quantitative and qualitative methods, to understand factors associated with lack of treatment uptake, poor adherence (<80%), failure to achieve SVR, DAA resistance, and HCV reinfection.
METHODS: The HERO study is a multi-site, pragmatic randomized clinical trial conducted in eight states where 754 HCV-infected PWID were randomly assigned to either PN or mDOT.
CONCLUSIONS: This study addresses an urgent need for timely and accurate information on optimal models of care to promote HCV treatment initiation, adherence, treatment completion and SVR among PWID, as well as rates and factors associated with reinfection and resistance after treatment. This clinical trial has the potential to provide valuable information on how to reduce the burden of the HCV epidemic in PWID.