Patient-Centered Models of HCV Care for People Who Inject Drugs
Condition: Hepatitis C; Medication Adherence
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional

Summary: 
      People who inject drugs (PWID) have higher rates of hepatitis C virus (HCV) than do other
      groups. Effective, safe new treatments called direct-acting antiviral agents (DAAs) have been
      developed recently. Unfortunately, PWID rarely get these treatments. The drugs are expensive,
      so insurers often do not cover the cost of DAAs. Sometimes providers hesitate to prescribe
      DAAs because they are concerned that PWID won't take their medication or that these patients
      might become reinfected.

      Several good models for treating PWID exist. One of them is to provide directly observed
      treatment (DOT). Another model provides treatment to PWID with the support of patient
      navigators (PN), public health workers who offer support and education to patients. Though
      both the DOT and PN models have been successful, we still don't know which model works best.

      In this study, the investigators will study both DOT and PN models for treating HCV in PWID.
      The investigators' goal is to find out which model produces the best results and is preferred
      by patients. Up to 1,000 HCV-infected PWID will participate in the study in eight sites
      around the country. Patients will be randomized into either the PN or the DOT groups.
      Patients who end up in the PN group will get a biweekly blister pack of medication to take
      home. Their PN will provide education and support. The investigators will find out whether
      patients adhered to medication using an electronic adherence monitoring system. Patients who
      are randomly assigned to the DOT group will take their medication in front of a staff member.
    

Detailed description: 
      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.
    

Intervention name(s): Patient Navigation; modified Directly Observed Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The study will follow a PN model (Check Hep C) developed by NYCDOH in collaboration with Montefiore and the community. HCV PNs will provide the following interventions to those randomized to the PN arm: coordination of HCV treatment; health promotion; assisting patients to overcome barriers; and psychosocial support.; Subjects will be observed taking medications, a minimum of 5 times a week for those enrolled in the OAT setting, and a minimum of 3 times a week for those enrolled in the community health clinic setting.
Other intervention name(s): PN; mDOT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Addiction; Adherence; Adverse Effects; Direct Acting Antiviral Agent; Chronic Hepatitis C; Resistance Development; Methadone Clinic; Primary Care; Directly Observed Therapy; Randomized Controlled Trial; Resistance; Reinfection; Treatment Outcome; Patient Navigation; Multi-Site; Liver Disease; Intervention; Sustained Viral Response