Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000256471
Ethics application status
Approved
Date submitted
6/02/2025
Date registered
8/04/2025
Date last updated
8/04/2025
Date data sharing statement initially provided
8/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
An alternative model of care for liver health care for First Nations patients living in remote communities
Scientific title
Assessing adherence of screening and surveillance models of care for liver disease in remote Indigenous Australian communities
Secondary ID [1] 313898 0
Nil
Universal Trial Number (UTN)
Trial acronym
SSOLID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liver Disease 336579 0
Condition category
Condition code
Oral and Gastrointestinal 333090 333090 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Public Health 333091 333091 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is divided into three parts: (1) the site engagement phase, (2) the liver check (screening) phase and (3) the liver monitoring (surveillance) phase. In Phase 1 (duration: 12mths, concurrently with Phase 2), the study will focus on engaging with sites about the project, establishing a Community Leadership Group, providing training to the local study team (Principal Investigator and Indigenous Project Officer), and providing community awareness and education. A CLG will be established at each study site and may include local primary healthcare staff, community Elders and local community members, who will be the primary mechanism for community liaison with support from site Principal Investigator (PI) and Indigenous Project Officer (IPO), and project team. The CLG will have up to five members as chosen by the community. The CLG, with the support of the project team, will provide feedback on the project training and resources relevant to their site (including language translation, diagrams and visual representation of service pathways).
Training for the local study team will focus on liver disease and the research project and will be provided by two of the study investigators over 2 sessions at 2hrs each within a month of starting Phase 2.
Community awareness and education will be an ongoing process, and can vary from one-to-one sessions during a clinic visit to a yarn at the local community centre. This will be determine by each local CLG.

In the liver check phase (duration: 12mths, concurrently with Phase 1), members in the community meeting study inclusion criteria will be eligible to have a liver health assessment alongside their routine annual health check. This phase will include simple fibrosis tests that will help identify anyone at potential risk of liver disease complications. This risk will be confirmed by an On-Country scan (using a FibroScan) that will enable diagnosis of advanced liver disease. The liver health check will require one appointment at your local medical health service, and you may need to come in for another appointment for the FibroScan appointment. These appointments will take approximately 20mins each.

Participants identified to be at risk of liver cancer in Phase 2 will be invited to take part in Phase 3, the liver monitoring phase (duration: 24mths). This phase of the project will be a stepped-wedge randomised trial to compare two models of liver cancer surveillance — the current model of care and the study On-Country model of care. The new model of care will allow participants to have 6 monthly ultrasounds On-Country (performed by an experienced ultrasonographer) in conjunction with serum biomarker tests for liver cancer. The blood test will take approximately 10-15mins and the liver scan approximately 20mins. Adherence to the intervention will be assessed through collecting information on how many of the 6mthly reviews are attended.

Yarning circles will be incorporated at the end of Phase 2 and Phase 3 to explore participant experiences in the study, their knowledge of liver disease and views on the different models of care. Each yarning circle is anticipated to take 1hr.
Intervention code [1] 330486 0
Early detection / Screening
Comparator / control treatment
Active control - standard of care control
Standard of care is defined as the current local method for liver cancer surveillance at each site. For most sites, this involves travelling off-country to a big city to access radiology services.
Control group
Active

Outcomes
Primary outcome [1] 340627 0
Adherence of eligible participants to On-Country HCC monitoring (using both liver ultrasound and serum biomarkers) compared to usual care.
Timepoint [1] 340627 0
Baseline, 6, 12, 18, and 24 after the start of phase 3
Secondary outcome [1] 444642 0
Cost effectiveness of On-Country HCC monitoring and usual care monitoring.
Timepoint [1] 444642 0
End of liver monitoring phase (36 months post start of phase 2)
Secondary outcome [2] 444644 0
Acceptance and feasibility of On-Country model of liver health care (composite outcome)
Timepoint [2] 444644 0
End of liver check phase (12mths) and end of liver monitoring phase (36mths)
Secondary outcome [3] 444643 0
Adequacy of liver ultrasound examination
Timepoint [3] 444643 0
End of liver monitoring phase (24 months post start of phase 3)

Eligibility
Key inclusion criteria
For the liver check phase:
Inclusion criteria:
• Aboriginal and/or Torres Strait Islander person
• Aged greater than or equal to 25 years
• Able to provide informed consent
• Has at least one risk factor for liver disease (defined in Protocol)

For the liver monitoring phase:
Inclusion criteria:
• Patients with compensated advanced chronic liver disease/cirrhosis identified during the screening phase by any of the following:
o Clinically diagnosed on the basis of clinical and radiological features, or
o Liver stiffness score >12kPa, or
o Hepascore™ greater than or equal to 0.8 or liver outcome score for HCC of greater than or equal to 10% at 5 years, and
• Patients with chronic HBV infection, without cirrhosis, who are >50 years
Minimum age
25 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
For the liver check phase:
Exclusion criteria:
• Unable to provide informed consent
• <25 years of age
• No known risk factors for liver disease

For the liver monitoring phase:
Nil Exclusion Criteria for this phase.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Stepped wedge randomisation - no allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation of sites will be determined using automated computer-generated randomisation. Stratification of sites will not be feasible due to low site number.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Stepped wedge study design.
Once the liver check phase is completed and eligible participants have been identified and consented, the participating sties will be randomised into the stepped wedge phase of the trial. All sites will have a phase of usual care before commencing the On-Country HCC monitoring programme at different time intervals.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
1/03/2026
Actual
Date of last data collection
Anticipated
1/06/2028
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,WA

Funding & Sponsors
Funding source category [1] 318364 0
Government body
Name [1] 318364 0
Department of Health and Aged Care - MRFF Indigenous Health Research Fund - 2022 Indigenous Health Research – Stream 4
Country [1] 318364 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Country
Australia
Secondary sponsor category [1] 320767 0
None
Name [1] 320767 0
Address [1] 320767 0
Country [1] 320767 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317002 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [1] 317002 0
Ethics committee country [1] 317002 0
Australia
Date submitted for ethics approval [1] 317002 0
23/10/2024
Approval date [1] 317002 0
Ethics approval number [1] 317002 0
HREC1376
Ethics committee name [2] 316997 0
Australian Institute of Aboriginal and Torres Strait Islander Studies Research Ethics Committee
Ethics committee address [2] 316997 0
Ethics committee country [2] 316997 0
Australia
Date submitted for ethics approval [2] 316997 0
20/09/2024
Approval date [2] 316997 0
27/11/2024
Ethics approval number [2] 316997 0
REC-0387
Ethics committee name [3] 317001 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [3] 317001 0
Ethics committee country [3] 317001 0
Australia
Date submitted for ethics approval [3] 317001 0
26/09/2024
Approval date [3] 317001 0
Ethics approval number [3] 317001 0
2024/HRE00238
Ethics committee name [4] 317000 0
Aboriginal Health & Medical Research Council Ethics Committee
Ethics committee address [4] 317000 0
Ethics committee country [4] 317000 0
Australia
Date submitted for ethics approval [4] 317000 0
25/09/2024
Approval date [4] 317000 0
Ethics approval number [4] 317000 0
AHREC 04-24-1047

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139698 0
A/Prof Tamara Mackean
Address 139698 0
Flinders University, Sturt Rd, Bedford Park SA 5042
Country 139698 0
Australia
Phone 139698 0
+61 08 7221 8467
Fax 139698 0
Email 139698 0
[email protected]
Contact person for public queries
Name 139699 0
Dr Sumudu Narayana
Address 139699 0
Lvl 3, Department of Gastroenterology and Hepatology Flinders Medical Centre Flinders Drive, Bedford Park SA 5042
Country 139699 0
Australia
Phone 139699 0
+61 08 82046421
Fax 139699 0
Email 139699 0
[email protected]
Contact person for scientific queries
Name 139700 0
Prof Alan Wigg
Address 139700 0
Lvl 3, Department of Gastroenterology and Hepatology Flinders Medical Centre Flinders Drive, Bedford Park SA 5042
Country 139700 0
Australia
Phone 139700 0
+61 0882046421
Fax 139700 0
Email 139700 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.