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  • Research & Results
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  • Comparing Ways to Provide Hepatitis C...

Comparing Ways to Provide Hepatitis C Treatment for People Who Take Methadone

Sign Up for Updates to This Study  

Project Summary  

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Hepatitis C virus affects almost 5 million people in the United States. It’s a major cause of chronic liver disease, liver scarring, cirrhosis, liver failure, liver cancer, and death. Hepatitis C infects 30–70 percent of people with opioid addiction.

People with opioid drug addiction often don’t get treatment for hepatitis C. This may be because they don’t know much about hepatitis C. Or they may have a hard time finding and scheduling the care they need. People with opioid addiction also may not trust doctors.

Methadone clinics help people reduce or stop their dependence on heroin or other opioids. However, only a small number of methadone clinics also treat patients for hepatitis C. Many methadone clinics refer patients with hepatitis C to liver specialists outside the clinics.

In this study, researchers are comparing two ways to treat hepatitis C in patients who are getting methadone treatment. With the first way, patients get treatment through telemedicine while they are at a methadone clinic. In telemedicine, a doctor uses videoconferencing from another location to meet with the patient. With the second way, which is usual care, patients get in-person treatment from a liver specialist who is not at the clinic.

Who can this research help?

Health administrators, liver specialists, and methadone clinics can use information from this study to make decisions about how to care for people with hepatitis C who also have opioid addiction. People with opioid addiction who have hepatitis C can use information from this study to decide whether getting treatment via telemedicine is right for them.

What is the research team doing?

The research team is enrolling patients with hepatitis C from 12 methadone clinics. The team is selecting clinics in rural and urban areas in New York State. Researchers are working to make sure the study includes a mix of patients.  

Patients who have hepatitis C and aren’t getting treatment for it elsewhere can join the study. All methadone clinics are providing usual care for the first six months of the study. As part of usual care, these clinics refer patients to liver specialists outside of the clinic. After six months, the research team is selecting several clinics by chance to switch to using telemedicine to treat patients.  Every nine months more clinics switch until all of the clinics are using telemedicine to treat patients’ hepatitis C. Patients getting telemedicine receive their hepatitis C medicine at the same time they get methadone.

The research team is looking at both telemedicine and usual care to see:

  • How many patients with hepatitis C are cured, which means the virus can’t be found in the patient’s blood 12 weeks after treatment ends
  • How many patients started and finished their treatment
  • How satisfied patients are with the care they received, based on a questionnaire
  • How many patients get reinfected with the virus after being cured

One or two patients from each clinic are part of a patient advisory committee for this study. Local and federal government agencies, community organizations, and other organizations interested in hepatitis C are participating as study partners. Experts in hepatitis C treatment and medical specialists from a variety of disciplines have worked with the research team to plan the study.

Research methods at a glance

Design Element Description
Study Design Randomized controlled trial
Population Adults 18 years and older who have hepatitis C and have been enrolled in an opioid treatment program for at least 6 months
Interventions/
Comparators
  • Telemedicine
  • Usual care, which is usually referral to a liver specialist off-site
Outcomes

Primary: percentage of patients who do not have hepatitis C in their system after treatment ends

Secondary: patient satisfaction with the delivery of care by telemedicine, patient satisfaction with the delivery of care by a liver specialist, differences in how many patients start and complete treatment, how many patients become reinfected with hepatitis C or relapse after treatment

Timeframe 12-week follow-up after treatment ends for primary outcome

More on This Project

Related Articles

Journal of Viral Hepatitis

Age- and risk factor-based serologic screening for Hepatitis C virus among an Urban, high-risk population

PLoS One

Assessing routes of hepatitis C transmission in HIV-infected men who have sex with men using single genome sequencing

Journal of Substance Abuse Treatment

Influence of social determinants of health and substance use characteristics on persons who use drugs pursuit of care for hepatitis C virus infection

Clinical Infectious Diseases

Integrated, Co-located, Telemedicine-based Treatment Approaches for Hepatitis C Virus (HCV) Management in Opioid Use Disorder Patients on Methadone

Telemedicine Journal and E-Health

Patient Reaction to Telemedicine for Clinical Management of Hepatitis C Virus Integrated into an Opioid Treatment Program

International Statistical Review

Distance Metrics and Clustering Methods for Mixed‐type Data

World Journal of Hepatology

Hepatitis C virus knowledge improves hepatitis C virus screening practices among primary care physicians

The Journal of Infectious Diseases

Improvements in Quality of Life: A New Hepatitis C Virus Treatment Indication in Persons with Substance Use Disorders

The Journal of Infectious Diseases

Improvements in Quality of Life: A New Hepatitis C Virus Treatment Indication in Persons with Substance Use Disorders

Addictive Disorders & Their Treatment

Medical and Behavioral Approaches to Engage People Who Inject Drugs Into Care for Hepatitis C Virus Infection

Annals of Internal Medicine

Toward Optimal Control of Hepatitis C Virus Infection in Persons With Substance Use Disorders

Journal of Substance Abuse Treatment

Hepatitis C virus core antigen: A potential alternative to HCV RNA testing among persons with substance use disorders

Statistical Methods in Medical Research

A comparative study of subgroup identification methods for differential treatment effect: Performance metrics and recommendations

Project Details

Principal Investigator
Andrew Talal, MD, MPH
Project Status
In progress; Enrollment complete
Project Title
Patient-Centered HCV Care via Telemedicine for Individuals on Opiate Substitution Therapy: A Stepped Wedge Cluster Randomized Controlled Trial
Board Approval Date
May 2016
Project End Date
May 2022
Organization
The Research Foundation for the State University of New York
Year Awarded
2016
State
New York
Project Type
Research Project
Health Conditions  
Liver Diseases
Hepatitis
Mental/Behavioral Health
Addiction/Substance Abuse
Intervention Strategies
Other Clinical Interventions
Care Coordination
Telemedicine
Other Health Services Interventions
Training and Education Interventions
Populations
Racial/Ethnic Minorities
Rural
Urban
Funding Announcement
Improving Healthcare Systems
Project Budget
$7,514,520
Study Registration Information
HSRP20163107
NCT02933970

Partners

Patient/Caregiver Partners

  • Carl Edwards, Patient partner
  • John Lundy, Patient partner
  • Clifford Doyle, Patient partner
  • Andrew Reynolds
  • Project Inform; Robert Gish, MD
  • National Viral Hepatitis Roundtable

Other Stakeholder Partners

  • Lisa Kaplowitz, MD, MSHA, Relevant Organizations: SAMHSA
  • Dan O'Connell, Relevant Organizations: NYS AIDS Institute
  • Fabienne Laraque, MD, PhD, Relevant Organizations: NYC HCV Coordinator
  • Ira Jacobson, MD, Medical Providers: Hepatology, Mount Sinai Beth Israel
  • Lawrence Brown, MD, MPH, Medical Providers: Addiction Medicine, START Treatment & Recovery Centers
  • Richard Blondell, MD, Medical Providers: Addiction Medicine, University at Buffalo
  • Lisa Pedicone, PhD, Provider Education Organizations: Chronic Liver Disease Foundation
  • Jerry Ernst, MD, Third Party Payers: Amidacar
  • Sandeep Krishnan, MS, Telemedicine Implementation Expert
  • George Burnite, HCV Pharmaceutical Supplier
  • Gavin Cloherty, PhD, Abbott Molecular
  • Eirum Chaudhri, MD, Merck and Company
  • Lorenzo Rossaro, MD, Gilead Sciences
Page Last Updated: 
December 8, 2020

Research & Results

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Meetings & Events

January 21
Cycle 1 2021 Broad PFA Applicant Town Hall
February 2
PCORI 2021 and Beyond: Opportunities for Funding and Involvement in Patient-Centered Research
February 9
Board of Governors Meeting: February 9, 2021

PCORI

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