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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02824640
Recruitment Status : Recruiting
First Posted : July 7, 2016
Last Update Posted : June 18, 2018
Sponsor:
Collaborators:
Massachusetts General Hospital
University of Rhode Island
Johns Hopkins University
West Virginia University
University of New Mexico
University of California
University of Washington
Information provided by (Responsible Party):
Alain Litwin, Prisma Health-Upstate

Tracking Information
First Submitted Date  ICMJE June 23, 2016
First Posted Date  ICMJE July 7, 2016
Last Update Posted Date June 18, 2018
Actual Study Start Date  ICMJE October 1, 2016
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2016)
Sustained Viral Response (SVR) [ Time Frame: 12 weeks after treatment completion ]
HCV viral load undetectable 12 weeks after treatment completion.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2016)
  • HCV 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.
  • Adherence (by electronic monitors) [ Time Frame: During 12 weeks of treatment ]
    Adherence will be measured by electronic blister packs. Adherence will also be measured by pill counts and self-report..
  • Treatment Completion measured by the # of weeks of treatment [ Time Frame: After 12 weeks of treatment ]
    (Yes/No) Patients who received HCV treatment for 12 out of 12 planned treatment weeks will be considered to have completed treatment.
  • Resistance (to NS5A) [ Time Frame: At weeks 12 or 24 ]
    NS5A resistance by Monogram assays.
  • Resistance (to NS5B) [ Time Frame: At weeks 12 or 24 ]
    NS5B resistance by Monogram assays
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Patient-Centered Models of HCV Care for People Who Inject Drugs
Official Title  ICMJE Patient-Centered Models of HCV Care for People Who Inject Drugs
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatitis C
  • Medication Adherence
Intervention  ICMJE
  • Behavioral: Patient Navigation
    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 Name: PN
  • Behavioral: modified Directly Observed Therapy
    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 Name: mDOT
Study Arms  ICMJE
  • Active Comparator: Patient Navigation

    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.

    Health Promotion Sessions: PNs will deliver 4 standardized health promotion sessions to all patients either individually or within a group.

    Optional Weekly Support Groups: Subjects randomized to the PN arm will be offered weekly support groups led by Peers.

    Intervention: Behavioral: Patient Navigation
  • Active Comparator: modified Directly Observed Therapy

    OAT clinic setting: Observation of HCV medications will be linked to methadone visits among patients receiving methadone. Patients will be receiving methadone as part of routine clinical care for opioid addiction and not as an intervention related to this study. The schedule of five days per week will be considered modified DOT (mDOT). Subjects will initiate HCV treatment on Mondays if feasible. Take home medications will be packed in a weekly electronic blister pack.

    Community health clinic setting: This intervention is considered modified DOT (mDOT) since between 3-5 weekly doses will be directly observed. A minimum of one dose will be observed in person by clinic/study staff. For the remaining observed doses, the research staff and provider will present the participant with a menu of options and determine what will work best for that participant.

    Intervention: Behavioral: modified Directly Observed Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 14, 2018)
750
Original Estimated Enrollment  ICMJE
 (submitted: July 1, 2016)
1000
Estimated Study Completion Date  ICMJE October 31, 2021
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Linda Agyemang, MPH 646-771-9536 lagyeman@montefiore.org
Contact: Kiara Lora, BS 646-385-0649 kialora@montefiore.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02824640
Other Study ID Numbers  ICMJE 2015-5723
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Alain Litwin, Prisma Health-Upstate
Study Sponsor  ICMJE Alain Litwin
Collaborators  ICMJE
  • Massachusetts General Hospital
  • University of Rhode Island
  • Johns Hopkins University
  • West Virginia University
  • University of New Mexico
  • University of California
  • University of Washington
Investigators  ICMJE
Principal Investigator: Alain Litwin, MD, MPH Prisma Health-Upstate
PRS Account Prisma Health-Upstate
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP