Clinical trial NCT02833298: Post Sustained Virological Response (SVR) Hepatocellular Carcinoma (HCC) Screening
Official title: Post Sustained Virological Response (SVR) Hepatocellular Carcinoma (HCC) Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
HCC
Hepatitis C
HCV
Keywords: Sustained Virological Response
SVR
patient navigation
screening
HCC
HCV
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2016-07-14
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: HCC screening rates
timeFrame: every 6 months until death - average of 5 years
Secondary outcomes:
measure: Adherence to HCC Surveillance
timeFrame: every 6 months until death - average of 5 years
measure: Rates of HCC
timeFrame: every 6 months until death - average of 5 years
measure: Incidence of Death
timeFrame: every 6 months until death - average of 5 years
measure: Incidence of liver transplant
timeFrame: every 6 months until death - average of 5 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Ponni Perumalswami, MD
role: PRINCIPAL_INVESTIGATOR
References: