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

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.

Study Overview

• Status: Completed
• Conditions: HCC; Hepatocellular Carcinoma; Hepatitis C; HCV
• Intervention / Treatment: Behavioral: Automated reminders; Behavioral: Patient navigation

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Automated reminders; 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; 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)
Experimental: Patient navigation; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Ponni Perumalswami, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: July 12, 2016
• First Submitted That Met QC Criteria: July 12, 2016
• First Posted (Estimate): July 14, 2016

Study Record Updates

• Last Update Posted (Actual): October 12, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: HCC; HCV; screening; patient navigation; SVR; Sustained Virological Response
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Liver Neoplasms; Hepatitis; Carcinoma; Carcinoma, Hepatocellular; Hepatitis C
• Other Study ID Numbers: GCO 16-1542

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO