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History of Changes for Study: NCT02824640
Patient-Centered Models of HCV Care for People Who Inject Drugs (HERO)
Latest version (submitted March 19, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 1, 2016 None (earliest Version on record)
2 June 14, 2018 Recruitment Status, Contacts/Locations, Study Status, Eligibility, Oversight, Sponsor/Collaborators, Study Identification and Study Design
3 March 19, 2021 Recruitment Status, Study Status, Sponsor/Collaborators, Contacts/Locations, Study Design and Study Identification
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Study NCT02824640
Submitted Date:  July 1, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2015-5723
Brief Title: Patient-Centered Models of HCV Care for People Who Inject Drugs (HERO)
Official Title: Patient-Centered Models of HCV Care for People Who Inject Drugs
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2016
Overall Status: Not yet recruiting
Study Start: August 2016
Primary Completion: March 2021 [Anticipated]
Study Completion: March 2021 [Anticipated]
First Submitted: June 23, 2016
First Submitted that
Met QC Criteria:
July 1, 2016
First Posted: July 7, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 1, 2016
Last Update Posted: July 7, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Alain Litwin
Responsible Party: Sponsor-Investigator
Investigator: Alain Litwin
Official Title: Principal Investigator
Affiliation: Albert Einstein College of Medicine
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: Hepatitis C
Medication Adherence
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
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 1000 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.

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 Names:
  • PN
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.

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 Names:
  • mDOT
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Sustained Viral Response (SVR)
[ Time Frame: 12 weeks after treatment completion ]

HCV viral load undetectable 12 weeks after treatment completion.
Secondary Outcome Measures:
1. 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.
2. 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..
3. 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.
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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 70 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

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 OAT 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
Open or close this module Contacts/Locations
Central Contact Person: Hiral Patel, MPH
Telephone: 347-491-8687
Email: hpatel1@montefiore.org
Central Contact Backup: Linda Agyemang, MPH
Telephone: 347-307-0960
Email: lagyeman@montefiore.org
Study Officials: Alain Litwin, MD, MPH
Principal Investigator
Montefiore Medical Center
Locations: United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10472
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Citations:
Links:
Available IPD/Information:

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