Patient-Centered Models of HCV Care for People Who Inject Drugs

This is a multi-site national study (8 U.S. cities), where up to 1000 HCV-infected PWIDs (injecting illicit substances within the last 3 months) will be randomized to either PN plus biweekly blister pack dispensation versus mDOT. Among patients who go on to initiate HCV treatment (n=600 targeted) with a once-daily combination regimen, a comparison will be conducted of the proportion of patients in each arm who: (a) optimally adhere (\>=80%), (b) complete treatment, (c) achieve SVR, and (d) develop resistance. The primary outcome will be SVR. The 8 sites offer geographic and policy diversity: New York City, Baltimore, Providence, Boston, Morgantown, Seattle, San Francisco, and Albuquerque. Participants will be recruited from diverse venues: OAT clinics, community health centers, syringe exchange programs, community-based organizations, homeless programs, and cohorts established by research studies. The clinical sites will determine eligibility based on clinical records, or on-site testing including for HCV tests (anti-HCV and HCV viremia) and drug toxicology testing as needed. Study participants will be screened, consented and enrolled on-site at OAT and non-OAT clinic settings. Patients will be randomized to one of two models of care: patient navigation (PN) vs. modified directly observed treatment (mDOT). Patients enrolled from OAT clinics who are receiving methadone and randomized to mDOT will receive doses of once daily medication at the same time as they receive methadone. Patients enrolled from community health settings and randomized to mDOT may receive observed doses in a range of settings including: at their clinic, at home, a community site (e.g. at a coffee shop or other gathering place), or using a mobile health app on a smartphone. Subjects randomized to PN will receive a standardized PN intervention and additional support through a peer-led support group. Participants will be followed for up to 140 weeks: 12 weeks of pre-treatment evaluation, 12 weeks of treatment, 12 weeks of follow-up to determine SVR12, and 104 weeks of follow-up to determine long-term SVR and reinfection. Data sources will include clinical lab and imaging results from medical records, blood tests (HCV viral load during long-term follow-up and resistance assays), urine toxicology, questionnaires, electronic monitors for assessing adherence, and interview.