Clinical trial NCT04620226: UHN Inpatient Hepatitis C & B Screening
Official title: Screening for Hepatitis C and Hepatitis B in Inpatients: A Toronto Viral Hepatitis Care Network (VIRCAN) Collaboration
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hepatitis C
Hepatitis B
Keywords: Hepatitis C
Hepatitis B
Screening
Inpatient
Hospital
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2020-11-06
Enrollment: 2920
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Currently, there is a lack of literature on programs evaluating rapid screening methods to traditional venipuncture methods for sample collection during screening for viral hepatitis. Due to the relatively low diagnosis and linkage to care rate, screening programs that provide same day results for viral hepatitis infection may improve both diagnosis and enable providers to engage patients shortly after diagnosis. This stands in contrast to the multi-visit, weeks long process that normally accompanies serum testing for hepatitis C virus (HCV) and hepatitis B virus (HBV). A few American studies have examined the implementation of HCV inpatient screening programs; however, they are focused specifically on high-risk patient populations, the barriers to accessing care experienced by study participants are not relevant to the Canadian healthcare system context, and do not use rapid testing. Furthermore, there are few, if any, data on HBV inpatient screening programs and the diagnosis rate remains low. This project will provide key data on a rapid inpatient screening and linkage to care strategy as well as the prevalence of these viruses across different age bands within the population. Finally, the study will help determine whether rapid inpatient screening is a feasible and acceptable approach for screening and linkage to care.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years or older at time of consent
* Patients admitted to GIMIUs at TGH or TWH

Exclusion Criteria:

* Patients whose end of life is expected to be less than 6 months
* Patients who are unable or decline to provide informed consent
* Patients with confirmed, active COVID-19 infections
* Patients with immediate life-threatening conditions where screening for chronic HCV and HBV infection may delay urgent care

Primary outcomes:
measure: Number of HCV antibody positive participants who complete an HCV RNA PCR.
timeFrame: 2 year
measure: Number of HCV RNA positive participants who attend their first hepatology appointment.
timeFrame: 2 year
measure: Number of HCV RNA positive participants who achieve a Sustained Virological Response at 12 weeks (SVR12) after treatment completion.
timeFrame: 2 year
Secondary outcomes:
measure: Number of chronic hepatitis C and hepatitis B infection in the general internal medicine inpatient units.
timeFrame: 1 year
measure: Number of patients willing to participate in hepatitis C and hepatitis B screening in general internal medicine inpatient units.
timeFrame: 1 year
measure: Percentage of physicians, residents, and nurses who believe that hepatitis C and hepatitis B screening can be incorporated into the general internal medicine inpatient units' workflow.
timeFrame: 1 year
measure: Proportion of Cepheid Xpert® HCV Viral Load test results matching test results from the standard commercial assay for HCV RNA PCR.
timeFrame: 1 year
measure: Retrospective rates of HCV testing, HCV antibody positive results, and HCV RNA positive results in general internal medicine inpatient units.
timeFrame: 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
References: