Real World Assessment of People Living With Chronic Hepatitis B in Australia (REACH-B)

May 18, 2026 updated by: Kirby Institute
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2145
        • Recruiting
        • Westmead Hospital
        • Contact:
        • Principal Investigator:
          • Jacob George, MBBS
      • Sydney, New South Wales, Australia, 2010
      • Sydney, New South Wales, Australia, 2000
        • Active, not recruiting
        • Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM)
      • Sydney, New South Wales, Australia, 2036
        • Recruiting
        • Justice Health and Forensic Mental Health Network
        • Contact:
        • Principal Investigator:
          • Marianne Martinello, MBBS FRACP PhD
      • Sydney, New South Wales, Australia, 2143
        • Recruiting
        • Blacktown Mount Druitt Hospital
        • Contact:
        • Principal Investigator:
          • Tasnim Hasan, MBBS
        • Sub-Investigator:
          • Golo Ahlenstiel, MBBS
        • Principal Investigator:
          • Ian Wong, MBBS
    • Northern Territory
      • Darwin, Northern Territory, Australia, 0810
      • Darwin, Northern Territory, Australia, 0810
        • Recruiting
        • Menzies School of Health Research (Royal Darwin & Alice Springs Hospitals)
        • Contact:
        • Principal Investigator:
          • Jane Davies, MBBS
        • Sub-Investigator:
          • Robert Batey, MBBS
    • Queensland
      • Birtinya, Queensland, Australia, 4575
        • Recruiting
        • Sunshine Coast University Hospital
        • Contact:
        • Principal Investigator:
          • James P O'Beirne, MBBS FRACP
      • Cairns, Queensland, Australia, 4870
        • Recruiting
        • Cairns and Hinterland Hospital Health Service
        • Contact:
        • Principal Investigator:
          • Joshua P Hanson, MBBS
      • Cairns, Queensland, Australia, 4870
        • Recruiting
        • Torres and Cape Hospital and Health Service
        • Contact:
        • Principal Investigator:
          • Joshua S Hanson, MBBS
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Central Adelaide Local Health Network (Royal Adelaide & The Queen Elizabeth Hospitals)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Renjy Nelson, MD Gen Med FRACP
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Not yet recruiting
        • The Alfred Hospital
        • Contact:
        • Principal Investigator:
          • Joseph S Doyle, MBBS FRACP MSc
      • Melbourne, Victoria, Australia, 3050
        • Recruiting
        • Royal Melbourne Hospital
        • Contact:
        • Principal Investigator:
          • Benjamin C Cowie, MBBS
      • Melbourne, Victoria, Australia, 3065
        • Not yet recruiting
        • St Vincent's Hospital
        • Principal Investigator:
          • Alexander Thompson, MBBS
        • Contact:
      • Melbourne, Victoria, Australia, 3011
        • Not yet recruiting
        • Cohealth
        • Contact:
        • Principal Investigator:
          • Nicole Allard, MBBS MPH PhD
      • Melbourne, Victoria, Australia, 3029
        • Recruiting
        • Utopia Refugee and Asylum Seeker Health
        • Contact:
        • Principal Investigator:
          • Lester Mascarenhas, MBChB
    • Western Australia
      • Albany, Western Australia, Australia, 6330
        • Recruiting
        • Albany Health Campus, WACHS Great Southern
        • Contact:
        • Principal Investigator:
          • Lloyd Nash, MBBS FRACP MPH
      • Broome, Western Australia, Australia, 6725
        • Recruiting
        • Broome Regional Hospital, WACHS Kimberley
        • Contact:
        • Principal Investigator:
          • Sarah C Straw, MBBS FRACP
      • Kalgoorlie-Boulder, Western Australia, Australia, 6164
        • Recruiting
        • Kalgoorlie Health Campus, WACHS Goldfields
        • Contact:
        • Principal Investigator:
          • Georgina Trotter, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adults diagnosed with chronic HBV as defined by a positive HBsAg result at participating sites will be enrolled in the cohort. Participants can be newly diagnosed or existing patients of the service. Data on HBV disease status, liver disease status, HBV monitoring and treatment will be collected six monthly from enrolment.

Description

Inclusion Criteria:

  1. 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).
  2. 16 years of age or older.
  3. 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:

1. Nil

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HBsAg Positive
Patients with chronic hepatitis B infection as defined by HBV surface antigen positive
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterisation of HBV
Time Frame: July 2027
To characterise and monitor hepatitis B linkage to care and treatment requirements amongst people living with chronic hepatitis B
July 2027

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Socio-demographics of HBV infected population
Time Frame: July 2027
To characterise the socio-demographic spectrum of people living with chronic HBV
July 2027
HBV Disease staging
Time Frame: July 2027
To assess the proportion of individuals in each phase of the disease, based on the natural history of hepatitis B infection
July 2027
HBV Care Cascade
Time Frame: July 2027
To assess the proportion of individuals who are eligible for each recommended hepatitis B clinical care level
July 2027
HBV Treatment and Care
Time Frame: July 2027
To monitor the uptake of recommended hepatitis B clinical care, including antiviral treatment
July 2027
HBV Care and treatment adherence
Time Frame: July 2027
To monitor the adherence to recommended hepatitis B care, including the patterns of antiviral use and cessation
July 2027
HCC Surveillance
Time Frame: July 2027
To assess the rate of surveillance for hepatocellular carcinoma
July 2027
HBV Disease Progression
Time Frame: July 2027
To assess the rate of progression from each phase to the subsequent phase of hepatitis B
July 2027
Liver fibrosis progression
Time Frame: July 2027
To assess the rate of liver fibrosis progression, including the development of cirrhosis, decompensated cirrhosis, and hepatocellular carcinoma
July 2027

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kirby Institute

Investigators

  • Principal Investigator: Gail Matthews, PhD MBBS, Kirby Insitute, UNSW

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2022

Primary Completion (Estimated)

July 31, 2030

Study Completion (Estimated)

July 31, 2030

Study Registration Dates

First Submitted

May 30, 2021

First Submitted That Met QC Criteria

May 30, 2021

First Posted (Actual)

June 4, 2021

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VHCRP2008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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