This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final. In the meantime, results have been published in peer-reviewed journals, as listed below.
PCORI has identified hepatitis C as an important research topic. Patients, clinicians, and others want to learn: What treatments work best for hard-to-treat patients with hepatitis C? To help answer this question, PCORI launched a funding initiative in 2015 on Clinical Management of Hepatitis C Infection. This research project is one of the studies PCORI awarded as part of this program.
What is the research about?
Hepatitis C is a virus that causes damage and swelling in the liver. About 3 to 4 million people in the United States have chronic hepatitis C. The most common way to get hepatitis C is through sharing needles to inject illegal drugs. People who inject drugs have higher rates of hepatitis C infection than other groups. Recent surveys show that almost half of active injection-drug users who are 18 to 30 years old have hepatitis C. Up to 90% of patients in treatment programs for opioid addiction have hepatitis C.
Doctors treat hepatitis C with medicines called direct-acting antiviral agents. These medicines attack the virus and can cure the disease in most cases. However, people who inject drugs rarely get these treatments. One reason is that the treatments are expensive, and some insurance companies may not cover their cost. Also, doctors may not want to prescribe these treatments to people who inject drugs, because they worry that injection drug users may not take the medicine properly. Doctors may also worry that these patients could get infected with hepatitis C again.
This study compares two ways to provide treatment for people with hepatitis C who inject drugs:
- Patients take medicine in front of a clinic staff member. This is called directly observed treatment. In directly observed treatment, patients may instead use a smartphone app to take videos of themselves taking medicine.
- Patient navigators—trained staff who provide support to patients—educate patients to help them overcome barriers to taking their medicine.
Who can this research help?
This research can help care providers, payers and policy makers choose how to treat hepatitis C.
What is the research team doing?
At eight sites around the country, the research team is enrolling up to 750 people with hepatitis C who inject drugs. Patients in the study are 18 to 70 years old. Patients are assigned by chance to one of two groups: one group takes their medicine in front of a staff member in person or by video, and the other group gets help from a patient navigator. The research team wants to know how many people in each group
- Start their treatment
- Take at least 80 percent of their medicine
- Finish their treatment
- Become resistant to the medicine
- Become infected with hepatitis C again
The research team is looking at whether issues such as homelessness, mental illness, and lack of knowledge about hepatitis C affect treatment outcomes. The research team is interviewing patients to learn about their experiences taking the medicine. The researchers are also interviewing clinic leaders and staff, patient navigators, and research staff to see what they think about the program.
The Centers for Disease Control and Prevention is leading a group of organizations with an interest in hepatitis C and its treatment that are providing advice and resources to the project. The group also includes
- State and local government officials (New York City Department of Health and Mental Hygiene, New York State Department of Health, state Medicaid directors from West Virginia, New York, and Washington)
- Patient and drug treatment groups (American Association for the Treatment of Opioid Dependence, Harm Reduction Coalition, Hepatitis C Mentor and Support Group, Hepatitis Education Project, National AIDS Treatment Advocacy Project, National Alliance for Medication Assisted Recovery, National Viral Hepatitis Roundtable, Project Inform, Treatment Action Group)
- Drug abuse treatment groups (Medication-Assisted Recovery Services)
- Insurers (Healthfirst)
- Laboratories (Monogram Biosciences, OraSure Technologies, Quest Diagnostics)
- Pharmaceutical companies (Gilead Sciences)
Research methods at a glance
|Study Design||Randomized controlled trial|
|Population||Adults 18 to 70 years old who have hepatitis C, are actively injecting drugs, and have not been previously treated with direct-acting antiviral medications|
Primary: hepatitis C viral load not detected 12 weeks after treatment is complete
Secondary: hepatitis C treatment initiation, treatment adherence, treatment completion, and becoming infected with hepatitis C again
|Timeframe||12-week follow-up for primary outcome|
Results of This Project
Related Journal Citations
Study Registration Information
^Montefiore Medical Center was the orginal organization associated with this project.
- Has Results