Clinical trial NCT04914611: Real World Assessment of People Living With Chronic Hepatitis B in Australia
Official title: Real World Assessment of People Living With Chronic Hepatitis B in Australia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis B
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
First posted: 2021-06-04
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Characterisation of HBV
timeFrame: July 2027
Secondary outcomes:
measure: Socio-demographics of HBV infected population
timeFrame: July 2027
measure: HBV Disease staging
timeFrame: July 2027
measure: HBV Care Cascade
timeFrame: July 2027
measure: HBV Treatment and Care
timeFrame: July 2027
measure: HBV Care and treatment adherence
timeFrame: July 2027
measure: HCC Surveillance
timeFrame: July 2027
measure: HBV Disease Progression
timeFrame: July 2027
measure: Liver fibrosis progression
timeFrame: July 2027
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM)
state: New South Wales
city: Sydney
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Justice Health and Forensic Mental Health Network
state: New South Wales
city: Sydney
country: Australia
facility: Blacktown Mount Druitt Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Darwin
country: Australia
facility: Menzies School of Health Research (Royal Darwin & Alice Springs Hospitals)
state: Northern Territory
city: Darwin
country: Australia
facility: Top End Medical Centre
state: Northern Territory
city: Birtinya
country: Australia
facility: Sunshine Coast University Hospital
state: Queensland
city: Cairns
country: Australia
facility: Cairns and Hinterland Hospital Health Service
state: Queensland
city: Cairns
country: Australia
facility: Torres and Cape Hospital and Health Service
state: Queensland
city: Adelaide
country: Australia
facility: Central Adelaide Local Health Network (Royal Adelaide & The Queen Elizabeth Hospitals)
state: South Australia
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Cohealth
state: Victoria
city: Melbourne
country: Australia
facility: Utopia Refugee and Asylum Seeker Health
state: Victoria
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Melbourne
country: Australia
facility: St Vincent's Hospital
state: Victoria
city: Albany
country: Australia
facility: Albany Health Campus, WACHS Great Southern
state: Western Australia
city: Broome
country: Australia
facility: Broome Regional Hospital, WACHS Kimberley
state: Western Australia
city: Kalgoorlie
country: Australia
facility: Kalgoorlie Health Campus, WACHS Goldfields
state: Western Australia
Study officials:
affiliation: Kirby Insitute, UNSW
name: Gail Matthews, PhD MBBS
role: PRINCIPAL_INVESTIGATOR
References: