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 |
|
| 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 |
| 12-week follow-up after treatment ends for primary outcome |
Journal Citations
Related Journal Citations
Project Information
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