UHN Inpatient Hepatitis C & B Screening

Jordan Feld

Status and phase: Enrolling; Phase 4

Conditions: Hepatitis C; Hepatitis B

Treatments: Other: Quality Improvement

Study type: Interventional

Funder types: Other

Identifiers

NCT04620226

UHN Inpatient HCV & HBV Screen

Details and patient eligibility

About

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.

Enrollment: 2,920 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2,920 participants in 2 patient groups

Conventional Serum Testing

No Intervention group

Description:

Participants will be screened by conventional HCV antibody (anti-HCV) serology and if screen positive, a second sample will be collected and tested for HCV RNA using a standard commercial assay.

Rapid Point-of-Care Testing

Experimental group

Description:

Participants will be screened using the OraQuick® Rapid Anti-HCV Point-of-Care Test (OraSure) and if screen positive, an additional whole blood sample will be collected and tested for HCV RNA using Xpert® HCV RNA (Cepheid) point-of-care testing and confirmed using a standard commercial assay.

Treatment:

Other: Quality Improvement