Results Summary
What was the research about?
Hepatitis C virus, or HCV, causes liver damage. The most common way people get HCV is by sharing needles when they inject illegal drugs. Medicines are available to treat and cure HCV. People must take HCV medicine every day for three months. But people who inject drugs rarely get treatment due to costs or concerns about taking the medicine properly.
In this study, the research team compared two approaches to support treatment for people with HCV who inject drugs:
- Patient navigation. Trained peer patient navigators helped people get and take HCV medicine by overcoming barriers to treatment.
- Directly observed treatment. People took HCV medicine in front of a program or clinic staff member. Some people took the medicine at in-person visits five days per week and then on their own the other two days. Other people received medicine from their health center each week and used a smartphone app to take videos of themselves taking the medicine.
What were the results?
Across both approaches, 83 percent of people started treatment, and 74 percent took their medicine every day. More people in directly observed treatment took their medicine every day than did people in patient navigation.
Of those who started treatment, 74 percent were cured of HCV. Among those who had a follow-up blood test, 92 percent were cured of HCV.
The two approaches didn’t differ in the percentage of people who:
- Were cured of HCV
- Started or completed treatment
- Became infected with HCV again
Who was in the study?
The study included 755 adults with HCV who had injected illegal drugs in the last three months. Of these, 65 percent were White, 14 percent were Black, and 15 percent selected other as their race; 22 percent were Hispanic or Latino. The average age was 43, and 70 percent were men. All received care from one of 8 opioid treatment programs or one of 15 community clinics in eight cities.
What did the research team do?
The research team assigned people by chance to one of the two approaches. All received the same dose of HCV medicine to take daily for three months.
People completed interviews and surveys at the start of the study, every month during treatment, and then every three months for 3.5 years. The research team also collected lab and imaging results from medical records, blood and urine tests, and data from electronic monitors that tracked when people took their medicine.
Patients, clinicians, public health agencies, and community advocates provided input during the study.
What were the limits of the study?
The study didn’t compare the two approaches to HCV treatment without support. As a result, the research team doesn’t know if the changes happened because of the two approaches or something else.
Future research could combine the two approaches. Studies could also include a group that starts treatment without support.
How can people use the results?
Programs and clinics can use the results to support HCV treatment for people who inject drugs.
| PCORI identified hepatitis C as an important research topic. Patients, clinicians, and others wanted to learn: What approaches work best to diagnose, treat, and manage hepatitis C, especially for people who are at high risk of infection? To help answer this question, PCORI launched an initiative in 2015 on Clinical Management of Hepatitis C Infection. The initiative funded this research project and one other. |
Professional Abstract
Objective
To compare the effectiveness of patient navigation versus modified directly observed therapy (mDOT) in achieving sustained virological response (SVR) among people with hepatitis C virus (HCV) who inject illicit drugs
Study Design
| Design Element | Description |
|---|---|
| Design | Pragmatic randomized controlled trial |
| Population | 755 adults with a current HCV infection who currently inject illicit drugs or who reported injecting drugs in the last 90 days before study participation |
| Interventions/ Comparators |
|
| Outcomes | Primary: SVR Secondary: treatment initiation, medication adherence, treatment completion, HCV reinfection for up to 3.5 years |
| Timeframe | 12-week follow-up for primary outcome |
This pragmatic randomized controlled trial compared the effectiveness of two approaches for supporting treatment of HCV in achieving SVR among people who inject drugs. Researchers also examined treatment initiation, medication adherence, treatment completion, drug resistance, and HCV reinfection.
Researchers randomly assigned participants to one of two approaches:
- Patient navigation. Trained peer patient navigators coordinated treatment, provided support for medication adherence, and helped participants overcome personal and structural barriers to treatment.
- mDOT. Participants took HCV medicine in front of a program or clinic staff member. Some participants took the medicine at in-person visits five days per week and then on their own for the other two days. Other participants received medicine from their health center each week and used a smartphone app to take videos of themselves taking the medicine.
The study included 755 adults with HCV who had injected illicit drugs in the last 90 days. All received the same fixed-dose combination of direct-acting antiviral medication intended as a daily dose for 12 weeks. They received care from one of 8 opioid treatment programs or one of 15 community health clinics in eight cities. Among participants, 65% were White, 14% were Black, and 15% selected other as their race; 22% were Hispanic or Latino. The average age was 43, and 70% were male.
Participants completed interviews and questionnaires at baseline, every 4 weeks during the 12-week treatment period, and every 12 weeks post-treatment for 3.5 years. Researchers also assessed outcomes using clinical lab and imaging results from medical records, blood tests, urine toxicology, and electronic monitors for assessing medication adherence.
Patients, clinicians, public health agencies, and community advocates provided input during the study.
Results
Across both approaches, 83% of participants initiated treatment, and 74% of participants adhered to the daily medication. Participants in mDOT had higher daily medication adherence than participants who received patient navigation (78% versus 73%; p=0.001). Among those who initiated treatment, 74% achieved SVR. Among those who had a follow-up viral load test, 92% had achieved SVR. The two approaches did not differ significantly in:
- SVR
- Treatment initiation
- Treatment completion
- HCV reinfection
Of the 415 participants eligible for assessment, 59 had demonstrated reinfection.
Limitations
Without a comparison group of HCV treatment with no support, this study cannot establish with certainty that the changes from before to after HCV treatment were a result of these supportive approaches.
Conclusions and Relevance
In this study, both patient navigation and mDOT were effective in supporting HCV treatment among people who inject drugs.
Future Research Needs
Future research could test a combined patient navigation and mDOT intervention or include a comparison group for people with HCV who inject drugs and initiate treatment without this kind of support.
| PCORI identified hepatitis C as an important research topic. Patients, clinicians, and others wanted to learn: What approaches work best to diagnose, treat, and manage hepatitis C, especially for people who are at high risk of infection? To help answer this question, PCORI launched an initiative in 2015 on Clinical Management of Hepatitis C Infection. The initiative funded this research project and one other. |
Final Research Report
This project's final research report is expected to be available by October 2024.
Journal Citations
Results of This Project
Related Journal Citations
Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers noted that the qualitative results did not include direct quotations to demonstrate the themes researchers identified. They pointed out that the lack of quotations could weaken the credibility of the researchers’ conclusions based on the qualitative work. The researchers added examples of quotations from their qualitative analyses.
- The reviewers asked the researchers to explain their decision to exclude baseline covariates associated with the outcome measures in the intent-to-treat analyses, stating that adjusting for unbalanced covariates could improve the precision of the analyses. The researchers explained that they did not adjust for covariates in the intent to treat analyses because randomization diminished the need for such adjustment, but they did make these adjustments in their modified intent-to-treat analyses and per-protocol analyses, since these samples breached randomization and they found a significant unbalance for participant race between the intervention arms.
- The reviewers did not feel that there was sufficient information about how the researchers dealt with missing data and loss to follow up. The researchers added a table comparing baseline characteristics between the study participants who were lost to follow up and those who were included in the analyses.
Conflict of Interest Disclosures
Project Information
Key Dates
Study Registration Information
^Montefiore Medical Center was the orginal organization associated with this project.