Post Sustained Virological Response (SVR) Hepatocellular Carcinoma (HCC) Screening

Study Overview
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Brief Summary
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Approximately half of the patients receiving treatment for chronic hepatitis C virus (HCV) infection in the United States have advanced liver disease. Patients with advanced fibrosis/cirrhosis who achieve a sustained virological response (SVR) to treatment and are clinically cured of HCV continue to have an elevated risk of developing hepatocellular carcinoma (HCC). According to guidelines from several professional societies and from the American Association for the Study of Liver Diseases (AASLD), in particular, patients with advanced fibrosis/cirrhosis should undergo life-long bi-annual screening for incident HCC whether they achieve an SVR, or not. The number of patients who need post-SVR HCC screening has risen dramatically in recent years due to the confluence of three factors: Increased screening for HCV, which has allowed more people to realize that they have this often silent infection; the availability of safe and highly effective direct acting antiviral drugs (DAAs) for HCV, which has allowed a much higher percentage of treated patients to achieve an SVR; and the long duration of HCV infection in many patients, which has allowed enough time for advanced fibrosis/cirrhosis to develop. To investigate post-SVR patients in the era of DAAs and to promote HCC screening, the objective of this study is to conduct a randomized, unblinded, two-arm prospective intervention trial comparing rates of HCC screening between patients randomized to either personalized patient navigation or automated reminders (e.g. electronic or mailed). Both interventions represent improved care over current standard of care (no patient navigation or automated reminders). There is no evidence to suggest one intervention is better than the other. Healthcare providers who agree to participate in the study will be contacted to confirm the liver disease status of their patients and during the clinical trial the providers of patients in both arms of the trial will be sent reminders about the need to schedule patients for screening visits.

Official Title
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Post Sustained Virological Response (SVR) Hepatocellular Carcinoma (HCC) Screening

Conditions
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Hepatocellular Carcinoma, HCC, Hepatitis C, HCV

Intervention / Treatment
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* Behavioral: Automated reminders
* Behavioral: Patient navigation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥21 years old history of HCV infection treated in 2011 or after with direct acting antiviral therapy achieved ≥SVR-12 as defined as no detectable virus 12 weeks or longer after the cessation of therapy FIB-4 ≥3.25 no history of HCC prior to treatment HCV provider deems a subject eligible for HCC surveillance according to AASLD criteria able to understand and speak English willing to sign the informed consent have a working phone number or e-mail to reach them no history of liver transplantation.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Automated reminders<br>Patient will be contacted for automated reminders within one month before the six-month interval indicating they are due for HCC screening. | Behavioral: Automated reminders<br>* At the time consent is obtained, members of the research team will collect data about how a subject prefers to be contacted for automated reminders (i.e. text messages, postcard, email, MyChart)<br>|
| Experimental: Patient navigation<br>The patient navigator will coordinate with the provider and subject to schedule the appropriate office visit and imaging for HCC screening as needed within one month before the test is due. | Behavioral: Patient navigation<br>* The patient navigator will attempt to provide a reminder to the subject one to three days before the scheduled imaging and also offer to accompany the subject to the test.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCC screening rates | Ratio of Number of on-time screening visits to number of missed screening visits | every 6 months until death - average of 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to HCC Surveillance | Percentage for patients completing timely screening visit | every 6 months until death - average of 5 years | 
| Rates of HCC | New incidences of HCC | every 6 months until death - average of 5 years | 
| Incidence of Death | Incidence of death | every 6 months until death - average of 5 years | 
| Incidence of liver transplant |  | every 6 months until death - average of 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sustained Virological Response, SVR, patient navigation, screening, HCC, HCV