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Hepatitis D: Epidemiology, screening practices and linkage to care using universal HDV screening in South Australia (HIDE-SA study).

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)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000916448
Enrollment
100
Registered
2025-08-22
Start date
2025-09-01
Completion date
2026-09-01
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

HIDE-SA is a state-wide multi-centre interventional prospective study with a historical control arm. Clinicians will be prompted and reminded during clinics to adopt universal HDV screening of all chronic hepatitis B (CHB) patients. This will be combined with the concurrent introduction of an electronic prompt within the centralised laboratory testing system to remind clinicians to perform reflexive HDV RNA testing on all HDV seropositive patients.. This intervention will run for a 12-month period aiming to increase HDV testing and linkage to care in South Australia. Testing results will be compared to a historical control arm, that will audit HDV testing data during the the preceding 12 month period of standard of care.

Interventions

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 chron

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.

Sponsors

Royal Adelaide Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

Exclusion criteria

nil

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026