Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000916448
Ethics application status
Approved
Date submitted
2/07/2025
Date registered
22/08/2025
Date last updated
22/08/2025
Date data sharing statement initially provided
22/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Hepatitis D: Epidemiology, screening practices and linkage to care using universal HDV screening in South Australia (HIDE-SA study).
Scientific title
Hepatitis D: Investigating the effect of clinical education and electronic medical record prompts on Hepatitis D Virus screening practices in South Australia (HIDE-SA study)
Secondary ID [1] 314801 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B 338047 0
Hepatitis D Virus 338048 0
Hepatitis D Virus screening and testing 338049 0
Condition category
Condition code
Infection 334344 334344 0 0
Other infectious diseases
Public Health 334345 334345 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Over a 12-month period, clinical staff at each site will be prompted by participating viral hepatitis nurses/nurses/investigators at the start of each clinic session to adopt a universal screening approach of all new and existing CHB patients for HDV infection. This approach will be supported by the provision of written educational material that will be placed in clinic rooms and clinician folders.

Written prompt :
FOR ALL PHYSCICIANS – Double Reflex Testing for Hepatitis D
Patients with chronic hepatitis B should be screened at least once for hepatitis D co-infection.
Current recommendations:
- Test all HbsAg positive individuals for HDV antibody at least once
- Test HDV RNA in all HDV antibody positive individuals

An electronic prompt within the centralised laboratory testing system will also encourage clinicians to adopt this universal screening approach and perform HDV RNA testing on all HDV seropositive participants. All new CHB patients entering tertiary care at each site will be issued blood forms for HDV testing prior to their initial clinic appointments.

EMR prompt :
Consistent with an acute or chronic infection with hepatitis D virus (HDV). To assess for active infection, HDV NAT testing is recommended. Please send a dedicated 10mL EDTA (lavender top) sample requesting HDV NAT.
Intervention code [1] 331397 0
Diagnosis / Prognosis
Intervention code [2] 331398 0
Early detection / Screening
Comparator / control treatment
HDV testing data and results will be collected via an audit of SA Pathology for the preceding 12 month period before the implementation of the interventional prompt.
1/9/2024 - 31/8/2025.
Control group
Historical

Outcomes
Primary outcome [1] 342030 0
Number of Chronic HBV patients undergoing HDV antibody testing and results
Timepoint [1] 342030 0
HDV antibody testing data and results will be obtained via an audit of statewide testing data at SA Pathology at the end of the 12 month intervention period - 1/9/2025 - 31/8/2026.
Primary outcome [2] 342472 0
Number of Chronic HBV patients and HDV antibody positives patients undergoing HDV RNA testing and results
Timepoint [2] 342472 0
HDV RNA testing data and results will be obtained via an audit of statewide testing data at SA Pathology at the end of the 12 month intervention period. 1/9/2025 - 31/8/2026.
Secondary outcome [1] 450377 0
Number of HDV positive patients linked to care
Timepoint [1] 450377 0
Assessed at 12 months post introduction of the interventional prompt

Eligibility
Key inclusion criteria
Inclusion criteria: patients aged 18+ years with chronic hepatitis B infection, entering into or receiving care at one of the participating study sites
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
nil

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This is a pre-post study that will compare historical data to the prospectively collected post-intervention implementation data.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
HDV patient baseline characteristics and demographics will be obtained from medical records -
• ethnicity, country of birth, age and sex
• Medical history
• Laboratory parameters (HBV and HDV serology, liver and renal function, platelets, AFP)
• Structural liver and fibrosis assessments (eg liver ultrasound and Fibroscan)
• Treatment (HBV and/or HDV)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
1/09/2026
Actual
Date of last data collection
Anticipated
1/01/2027
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 319354 0
Commercial sector/Industry
Name [1] 319354 0
Gilead International
Country [1] 319354 0
United States of America
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Country
Australia
Secondary sponsor category [1] 321842 0
None
Name [1] 321842 0
Address [1] 321842 0
Country [1] 321842 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317933 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 317933 0
Ethics committee country [1] 317933 0
Australia
Date submitted for ethics approval [1] 317933 0
Approval date [1] 317933 0
21/11/2024
Ethics approval number [1] 317933 0
19971

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

Contacts
Principal investigator
Name 142610 0
Dr Anushia Ashokan
Address 142610 0
Royal Adelaide Hospital Port Road Adelaide 5000 SA
Country 142610 0
Australia
Phone 142610 0
+61 422983939
Fax 142610 0
Email 142610 0
[email protected]
Contact person for public queries
Name 142611 0
Erin McCartney
Address 142611 0
Royal Adelaide Hospital Port Road Adelaide 5000 SA
Country 142611 0
Australia
Phone 142611 0
+61 422983939
Fax 142611 0
Email 142611 0
[email protected]
Contact person for scientific queries
Name 142612 0
Erin McCartney
Address 142612 0
Royal Adelaide Hospital Port Road Adelaide 5000 SA
Country 142612 0
Australia
Phone 142612 0
+61 422983939
Fax 142612 0
Email 142612 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.