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

• ClinicalTrials.gov Identifier: NCT02824640
• Recruitment Status: Recruiting
• First Posted: July 7, 2016
• Last Update Posted: June 18, 2018
• Sponsor: Alain Litwin
• 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: June 23, 2016
• First Posted Date: July 7, 2016
• Last Update Posted Date: June 18, 2018
• Actual Study Start Date: October 1, 2016
• Estimated Primary Completion Date: October 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Patient-Centered Models of HCV Care for People Who Inject Drugs
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Hepatitis C
• Medication Adherence

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 14, 2018): 750
• Original Estimated Enrollment (submitted: July 1, 2016): 1000
• Estimated Study Completion Date: October 31, 2021
• Estimated Primary Completion Date: October 31, 2019 (Final data collection date for primary outcome measure)

Eligibility 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 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

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Linda Agyemang, MPH; 646-771-9536; lagyeman@montefiore.org

Contact: Kiara Lora, BS; 646-385-0649; kialora@montefiore.org

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02824640
• Other Study ID Numbers: 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

• Plan to Share IPD: Undecided

• Responsible Party: Alain Litwin, Prisma Health-Upstate
• Study Sponsor: Alain Litwin

Collaborators

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

Investigators

• Principal Investigator: Alain Litwin, MD, MPH; Prisma Health-Upstate

• PRS Account: Prisma Health-Upstate
• Verification Date: June 2018