NCT04914611

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
14mo left

Started Feb 2022

Longer than P75 for all trials

Geographic Reach
1 country

19 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Feb 2022Jul 2027

First Submitted

Initial submission to the registry

May 30, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 4, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

February 17, 2022

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

December 12, 2024

Status Verified

December 1, 2024

Enrollment Period

4.4 years

First QC Date

May 30, 2021

Last Update Submit

December 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Characterisation of HBV

    To characterise and monitor hepatitis B linkage to care and treatment requirements amongst people living with chronic hepatitis B

    July 2027

Secondary Outcomes (8)

  • Socio-demographics of HBV infected population

    July 2027

  • HBV Disease staging

    July 2027

  • HBV Care Cascade

    July 2027

  • HBV Treatment and Care

    July 2027

  • HBV Care and treatment adherence

    July 2027

  • +3 more secondary outcomes

Study Arms (1)

HBsAg Positive

Patients with chronic hepatitis B infection as defined by HBV surface antigen positive

Other: No intervention

Interventions

No intervention

HBsAg Positive

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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).
  • 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)

You may not qualify if:

  • \. Nil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM)

Sydney, New South Wales, 2000, Australia

ACTIVE NOT RECRUITING

St Vincent's Hospital

Sydney, New South Wales, 2010, Australia

RECRUITING

Justice Health and Forensic Mental Health Network

Sydney, New South Wales, 2036, Australia

RECRUITING

Blacktown Mount Druitt Hospital

Sydney, New South Wales, 2143, Australia

RECRUITING

Westmead Hospital

Sydney, New South Wales, 2145, Australia

RECRUITING

Menzies School of Health Research (Royal Darwin & Alice Springs Hospitals)

Darwin, Northern Territory, 0810, Australia

RECRUITING

Top End Medical Centre

Darwin, Northern Territory, 0810, Australia

RECRUITING

Sunshine Coast University Hospital

Birtinya, Queensland, 4575, Australia

RECRUITING

Cairns and Hinterland Hospital Health Service

Cairns, Queensland, 4870, Australia

RECRUITING

Torres and Cape Hospital and Health Service

Cairns, Queensland, 4870, Australia

RECRUITING

Central Adelaide Local Health Network (Royal Adelaide & The Queen Elizabeth Hospitals)

Adelaide, South Australia, 5000, Australia

RECRUITING

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

NOT YET RECRUITING

Cohealth

Melbourne, Victoria, 3011, Australia

NOT YET RECRUITING

Utopia Refugee and Asylum Seeker Health

Melbourne, Victoria, 3029, Australia

RECRUITING

Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

NOT YET RECRUITING

St Vincent's Hospital

Melbourne, Victoria, 3065, Australia

NOT YET RECRUITING

Albany Health Campus, WACHS Great Southern

Albany, Western Australia, 6330, Australia

RECRUITING

Broome Regional Hospital, WACHS Kimberley

Broome, Western Australia, 6725, Australia

RECRUITING

Kalgoorlie Health Campus, WACHS Goldfields

Kalgoorlie-Boulder, Western Australia, 6164, Australia

RECRUITING

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Gail Matthews, PhD MBBS

    Kirby Insitute, UNSW

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2021

First Posted

June 4, 2021

Study Start

February 17, 2022

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

December 12, 2024

Record last verified: 2024-12

Locations