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Completed

NCT Number: NCT02824640

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

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.

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Key information

Conditions

Hepatitis C Behavior Behavior, Addictive Blood-Borne Infections Chronic Disease Communicable Diseases Compulsive Behavior Digestive System Diseases Directly Observed Therapy Disease Attributes Flaviviridae Infections Health Behavior Hepatitis Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Impulsive Behavior Infections Liver Diseases Medication Adherence Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance RNA Virus Infections Recurrence Reinfection Treatment Adherence and Compliance Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alain Litwin

The Bronx, New York, 10467, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HCV infection
  • Actively injecting drugs (any substance within 3 months)
  • Not previously treated with HCV direct-acting antiviral medications
  • Age 18 - 70
  • Willing to receive HCV treatment with sofosbuvir/velpatasvir
  • Willing to be randomized to either PN vs mDOT
  • If receiving methadone, be attending methadone clinic a minimum of 5 times per week
  • Able to provide informed consent
  • English or Spanish fluency

Exclusion criteria

  • Pregnant or breast feeding
  • Hepatocellular carcinoma

Treatment and study plan

Patient Navigation

Behavioral

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.

Other names: PN

modified Directly Observed Therapy

Behavioral

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 names: mDOT

Primary outcomes

  1. Sustained Viral Response (SVR)

    Time frame: 12 weeks after treatment completion

    HCV viral load undetectable 12 weeks after treatment completion.

Secondary outcomes

  1. HCV DAA Treatment Initiation

    Time frame: Up to 12 weeks after study enrollment

    (Yes/No). Subject who receive at least one dose of HCV medication (sofosbuvir + velpatasvir) will be considered to have initiated HCV treatment. Those who do not receive one dose within 12 weeks of study enrollment will have been considered not to have initiated HCV treatment.

  2. Adherence (by Electronic Monitors)

    Time frame: During 12 weeks of treatment

    Electronic blister pack data were used to estimate daily adherence, calculated as a binary measure indicating whether one or more doses was taken per day. Weekly adherence levels were then computed in terms of percentages, that is, the number of adherent days out of 7 days for each participant.

  3. HCV DAA Treatment Completion

    Time frame: After 12 weeks of treatment

    (Yes/No) Treatment completion was declared if there were ≥84 days between the treatment initiation and completion.

  4. Resistance (to NS5A)

    Time frame: At weeks 12 or 24

    NS5A resistance by Monogram assays.

  5. Resistance (to NS5B)

    Time frame: At weeks 12 or 24

    NS5B resistance by Monogram assays

Sponsors and collaborators

Lead sponsor

Prisma Health-Upstate

Other

Collaborators

  • Johns Hopkins University
  • Massachusetts General Hospital
  • Montefiore Medical Center
  • University of California
  • University of New Mexico
  • University of Rhode Island
  • University of Washington
  • West Virginia University

Registry information

Acronym: HERO

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Jul 7, 2016
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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