REACH-B: Real World Assessment of People Living With Chronic Hepatitis B in Australia
Study Details
Study Description
Brief Summary
The REACH-B study establishes an observational cohort study of people living with chronic hepatitis B from a national network, including a diverse range of services, to characterise and monitor hepatitis B linkage to care and treatment requirements amongst this population.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Participants presenting to participating clinics for HBV care within the previous 12 months will be identified and enrolment data will be collected including demographics, laboratory parameters, liver disease assessment, treatment history and clinical management. Follow-up data on HBV treatment and clinical management, liver disease stage and laboratory parameters will be collected at each subsequent visit or at minimum every 12 months.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| HBsAg Positive Patients with chronic hepatitis B infection as defined by HBV surface antigen positive |
Other: No intervention
No intervention
|
Outcome Measures
Primary Outcome Measures
- Characterisation of HBV [July 2027]
To characterise and monitor hepatitis B linkage to care and treatment requirements amongst people living with chronic hepatitis B
Secondary Outcome Measures
- Socio-demographics of HBV infected population [July 2027]
To characterise the socio-demographic spectrum of people living with chronic HBV
- HBV Disease staging [July 2027]
To assess the proportion of individuals in each phase of the disease, based on the natural history of hepatitis B infection
- HBV Care Cascade [July 2027]
To assess the proportion of individuals who are eligible for each recommended hepatitis B clinical care level
- HBV Treatment and Care [July 2027]
To monitor the uptake of recommended hepatitis B clinical care, including antiviral treatment
- HBV Care and treatment adherence [July 2027]
To monitor the adherence to recommended hepatitis B care, including the patterns of antiviral use and cessation
- HCC Surveillance [July 2027]
To assess the rate of surveillance for hepatocellular carcinoma
- HBV Disease Progression [July 2027]
To assess the rate of progression from each phase to the subsequent phase of hepatitis B
- Liver fibrosis progression [July 2027]
To assess the rate of liver fibrosis progression, including the development of cirrhosis, decompensated cirrhosis, and hepatocellular carcinoma
Eligibility Criteria
Criteria
Inclusion Criteria:
-
All individuals diagnosed with chronic hepatitis B in the participating study sites are eligible to be included (both newly diagnosed cases and those diagnosed in the past).
-
16 years of age or older.
-
Attended the health service for HBV care within the prior 12 months from study commencement (retrospective recruitment) OR Attending the health service for HBV care from study commencement (prospective recruitment)
Exclusion Criteria:
- Nil
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St Vincent's Hospital | Sydney | New South Wales | Australia | 2010 |
Sponsors and Collaborators
- Kirby Institute
Investigators
- Principal Investigator: Gail Matthews, PhD MBBS, Kirby Insitute, UNSW
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VHCRP2008