Registry-based HCV Care Cascade Navigation at Atlanta's Grady Memorial Hospital

This study seeks to implement and evaluate a data-driven case navigation system for hepatitis C virus (HCV) treatment among persons who are either actively injecting drugs or who are receiving opioid substitution therapy (OST). The study will use data from a previously developed patient registry system to identify patients for study recruitment, and use monthly updates of registry data to organize and direct patient navigation services for those individuals assigned to the treatment group. Patients assigned to the control group will also be eligible to receive HCV treatment, but will otherwise receive usual care. This study has a parallel, randomized unblinded, case/control design in which eligible patients are assigned at baseline to either a registry-directed patient navigation system (case) or to usual care (control), characterized in terms of demographic and sub-population variables, and then compared after 12 months on two categories of outcomes; (1) attainment of care cascade milestones; and (2) treatment initiation, adherence, and virologic response. The study is designed and powered to answer two primary hypotheses (H1 \& H2): * H1: As compared to those randomized to usual care (control), those randomized to the registry directed patient navigation arm (case) will be more likely to complete all pretreatment HCV care milestones as defined by a higher proportion completing all four pre-treatment care cascade outcomes. * H2: As compared to the control group, a significantly higher proportion of those randomized to the case group will achieve a sustained viral response.