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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04914611
Registration number
NCT04914611
Ethics application status
Date submitted
30/05/2021
Date registered
4/06/2021
Titles & IDs
Public title
Real World Assessment of People Living With Chronic Hepatitis B in Australia
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Scientific title
Real World Assessment of People Living With Chronic Hepatitis B in Australia
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Secondary ID [1]
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VHCRP2008
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Universal Trial Number (UTN)
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Trial acronym
REACH-B
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis B
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - No intervention
HBsAg Positive - Patients with chronic hepatitis B infection as defined by HBV surface antigen positive
Other interventions: No intervention
No intervention
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Characterisation of HBV
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Assessment method [1]
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To characterise and monitor hepatitis B linkage to care and treatment requirements amongst people living with chronic hepatitis B
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Timepoint [1]
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July 2027
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Secondary outcome [1]
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Socio-demographics of HBV infected population
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Assessment method [1]
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To characterise the socio-demographic spectrum of people living with chronic HBV
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Timepoint [1]
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July 2027
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Secondary outcome [2]
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HBV Disease staging
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Assessment method [2]
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To assess the proportion of individuals in each phase of the disease, based on the natural history of hepatitis B infection
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Timepoint [2]
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July 2027
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Secondary outcome [3]
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HBV Care Cascade
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Assessment method [3]
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To assess the proportion of individuals who are eligible for each recommended hepatitis B clinical care level
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Timepoint [3]
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July 2027
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Secondary outcome [4]
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HBV Treatment and Care
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Assessment method [4]
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To monitor the uptake of recommended hepatitis B clinical care, including antiviral treatment
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Timepoint [4]
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July 2027
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Secondary outcome [5]
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HBV Care and treatment adherence
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Assessment method [5]
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To monitor the adherence to recommended hepatitis B care, including the patterns of antiviral use and cessation
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Timepoint [5]
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July 2027
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Secondary outcome [6]
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HCC Surveillance
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Assessment method [6]
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To assess the rate of surveillance for hepatocellular carcinoma
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Timepoint [6]
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July 2027
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Secondary outcome [7]
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HBV Disease Progression
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Assessment method [7]
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To assess the rate of progression from each phase to the subsequent phase of hepatitis B
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Timepoint [7]
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July 2027
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Secondary outcome [8]
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Liver fibrosis progression
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Assessment method [8]
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To assess the rate of liver fibrosis progression, including the development of cirrhosis, decompensated cirrhosis, and hepatocellular carcinoma
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Timepoint [8]
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July 2027
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Eligibility
Key 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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Nil
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/02/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2027
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Actual
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Sample size
Target
10000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM) - Sydney
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Recruitment hospital [2]
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St Vincent's Hospital - Sydney
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Recruitment hospital [3]
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Justice Health and Forensic Mental Health Network - Sydney
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Recruitment hospital [4]
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Blacktown Mount Druitt Hospital - Sydney
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Recruitment hospital [5]
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Westmead Hospital - Sydney
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Recruitment hospital [6]
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Menzies School of Health Research (Royal Darwin & Alice Springs Hospitals) - Darwin
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Recruitment hospital [7]
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Top End Medical Centre - Darwin
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Recruitment hospital [8]
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Sunshine Coast University Hospital - Birtinya
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Recruitment hospital [9]
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Cairns and Hinterland Hospital Health Service - Cairns
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Recruitment hospital [10]
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Torres and Cape Hospital and Health Service - Cairns
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Recruitment hospital [11]
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Central Adelaide Local Health Network (Royal Adelaide & The Queen Elizabeth Hospitals) - Adelaide
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Recruitment hospital [12]
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The Alfred Hospital - Melbourne
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Recruitment hospital [13]
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Cohealth - Melbourne
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Recruitment hospital [14]
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Utopia Refugee and Asylum Seeker Health - Melbourne
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Recruitment hospital [15]
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Royal Melbourne Hospital - Melbourne
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Recruitment hospital [16]
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St Vincent's Hospital - Melbourne
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Recruitment hospital [17]
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Albany Health Campus, WACHS Great Southern - Albany
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Recruitment hospital [18]
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Broome Regional Hospital, WACHS Kimberley - Broome
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Recruitment hospital [19]
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Kalgoorlie Health Campus, WACHS Goldfields - Kalgoorlie
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Recruitment postcode(s) [1]
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2000 - Sydney
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Recruitment postcode(s) [2]
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2010 - Sydney
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Recruitment postcode(s) [3]
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2036 - Sydney
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Recruitment postcode(s) [4]
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2143 - Sydney
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Recruitment postcode(s) [5]
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2145 - Sydney
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Recruitment postcode(s) [6]
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0810 - Darwin
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Recruitment postcode(s) [7]
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4575 - Birtinya
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Recruitment postcode(s) [8]
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4870 - Cairns
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Recruitment postcode(s) [9]
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5000 - Adelaide
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Recruitment postcode(s) [10]
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3004 - Melbourne
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Recruitment postcode(s) [11]
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3011 - Melbourne
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Recruitment postcode(s) [12]
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3029 - Melbourne
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Recruitment postcode(s) [13]
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3050 - Melbourne
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Recruitment postcode(s) [14]
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3065 - Melbourne
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Recruitment postcode(s) [15]
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6330 - Albany
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Recruitment postcode(s) [16]
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6725 - Broome
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Recruitment postcode(s) [17]
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6164 - Kalgoorlie
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Funding & Sponsors
Primary sponsor type
Government body
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Name
Kirby Institute
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT04914611
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Gail Matthews, PhD MBBS
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Address
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Kirby Insitute, UNSW
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Jessica Carter
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Address
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Country
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Phone
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+61290654212
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04914611