Point of Care Hepatitis C Pilot Initiative

Overview

National Australian Hepatitis C Point of Care Testing Program aims to establish 65-80 sites nationally, testing 50,000-60,000 people between July 2021 and July 2023. The Commonwealth Department of Health has invested $6.5 million, funding Kirby Institute (UNSW) and International Centre for Point of Care Testing (Flinders University) to lead this initiative toward hepatitis C elimination by 2030.

Why Point of Care Testing is Needed

• Both global WHO strategy and national hepatitis C strategy target elimination as major public health threat by 2030.
• Australia experiencing decline in both hepatitis C RNA testing and treatment initiation numbers since peak.
• Modeling shows need to increase RNA testing to maintain treatment numbers and achieve elimination targets.
• Traditional care cascade requires up to 5 visits for diagnosis, with multiple points where patients lost to follow-up.
• GeneXpert platform enables fingerstick blood test with 60-minute result at point of care, allowing single-visit testing, diagnosis, and treatment.
• Technology particularly beneficial for people who inject drugs with poor venous access; increased acceptability versus venipuncture.
• TGA-approved HCV viral load fingerstick assay provides "game changer" opportunity to address care cascade drop-off.

Evidence from Pilot Studies

TEMPO Pilot Study (Kirketon Road Centre, NUAA)

• 101 participants recruited from community-led NSP in Sydney (September 2019-April 2021).
• Model: Peers offered point of care RNA testing to clients collecting injecting equipment.
• Population: 100% injected in previous month; 18% had greater than daily injecting frequency.
• Results: 27 of 101 tested RNA positive; 78% initiated treatment (71% within study, 7% outside).
• 53% initiated treatment same visit; 100% initiated treatment within 3 days of receiving results.

PIVOT Study (Reception Prison, Mid-North Coast NSW)

• Control period (October 2019-May 2020): 240 enrolled; 26% of positives initiated treatment (~90 days).
• Intervention period (June 2020-April 2021): 301 enrolled; 93% of positives initiated treatment.
• Point of care testing increased from 18% to 99% of eligible participants.
• One-stop shop model dramatically improved treatment initiation rates in custodial settings.

Program Structure and Funding

Funding and Timeline

• $6.5 million Commonwealth Department of Health investment for July 2021-July 2023 period.
• First 25 sites from existing studies using point of care testing.
• Additional 40-60 sites to be established through expression of interest process.
• 40 machines purchased through program; 15 sites designated for prison settings.

Two-Stage Selection Process

• First 50% of sites selected through objective peer review ranking based on merit criteria.
• Equal distribution across states/territories based on hepatitis C burden in each jurisdiction.
• Remaining 50% selected collaboratively with state health departments to address geographic gaps.
• Strategy prevents concentration in cities or specific regions within states.

Site Selection Criteria

Program Support and Components

Provided by Program

• Standard operating procedures for point of care testing implementation.
• Mini-vats (blood collection devices) and test cartridges supplied.
• HCV antibody tests provided through research funding (TGA approval pending; consent required).
• GeneXpert laptops and devices configured with required software.
• Remote support for setup and troubleshooting.
• Participation in quality assurance and training programs.
• Two-year commitment per site (machine ownership to be determined after funding period).

IT Connectivity

• Middleware system enables test ordering, communicates with GeneXpert software, returns results to patient management system.
• Results transmitted to public health units for mandatory notification of infections.
• Hardware/software for IT connectivity planned but not guaranteed deliverable under current funding.

Machine Portability

• Four-module device weighs 11.8 kg; easily transportable with provided Pelican cases.
• Highly suitable for mobile outreach, rotating between multiple service locations.
• Can perform various tests: HCV, HIV, hepatitis B, syphilis, STIs, Group A/B strep, COVID-19, RSV, flu.

Quality Assurance and Training

Training Requirements

• Standardized remote training for all operators (medical qualifications not required).
• Task shifting encouraged: NSP workers, peer support workers, healthcare professionals eligible.
• Training covers sample collection, machine operation, error reduction, result interpretation.
• Training provided by either Flinders University or NSW Pathology depending on location.

Quality Assurance Program

• External QA: Six-monthly panel testing (March/April and September/October).
• Five blinded samples per event: one negative, four positives (varying genotypes and viral loads).
• Monthly competency assessment: Two samples (one negative, one positive) known to operator.
• Aligns with national point of care testing guidelines requirements.
• Monitoring of error rates; target below 3% (current programs achieving this benchmark).

Technical Performance

• PCR-based lab-in-a-box technology with excellent sensitivity/specificity.
• Above/below limit of quantification: 100% sensitive and specific in studies.
• "Detectable but not quantifiable" results require confirmatory venipuncture draw.
• Errors related to sample volume, air bubbles; minimized through proper training.

Research Framework

NHMRC Partnership Project

• Submitted August 12; includes multiple investigators and partner organizations.
• Significant in-kind contributions from Cepheid (cartridges, machines), Gilead (funding), NSW Health.
• National observational cohort established to generate data for MSAC/MBS submissions.

Research Objectives

• Evaluate reach, effectiveness, adoption, implementation, maintenance using RE-AIM framework.
• Assess cost-effectiveness, affordability, long-term epidemiological impact of scaling point of care testing.
• Social science research examining perceptions, acceptability, barriers, facilitators (led by Carla Treloar, Alison Marshall).
• Develop implementation toolkit for rapid site deployment.
• Generate evidence for sustainable funding model through MBS item number revision.

Data Collection

• Brief patient survey (under 5 minutes): 10 questions covering demographics, risk factors, testing/treatment history.
• Case report form captures test results, treatment details for those initiating therapy.
• Electronic transmission of HCV results through GeneXpert system.
• Opt-out consent for data linkage to MBS/PBS for cost-effectiveness analyses.

Testing Strategies

One-Step Approach (High Prevalence Settings)

• Direct point of care RNA testing using fingerstick sample.
• Suitable for drug treatment clinics, needle and syringe programs, settings with >10% antibody prevalence.
• Enables same-visit diagnosis and treatment initiation.

Two-Step Approach (Lower Prevalence Settings)

• Initial rapid point of care antibody test; reflex to RNA testing if positive.
• More cost-effective in lower prevalence populations.
• Appropriate for Aboriginal Community Controlled Health Organizations, primary care settings.
• Requires consent as antibody tests not yet TGA approved.

Additional Applications

• SVR confirmation at end of treatment.
• Post-treatment monitoring for HCV reinfection.
• Simultaneous testing for HIV (Alere HIV Combo), hepatitis B surface antigen (if antibodies detected).
• FibroScan-based disease assessment to exclude decompensated liver disease before same-visit treatment.

Finding 50,000 Initiative

Five Pillars

• National hepatitis C awareness campaign.
• Enhancement of national hepatitis info line services.
• Primary care enhancement including case finding strategies.
• Point of care testing program (this initiative).
• Coordination through national time-limited working group of BBV/STI Standing Committee.

Goals and Equity

• Minister's commitment to find 50,000 people with hepatitis C by end of 2022.
• Focus on geographic equity ensuring all Australians with HCV have elimination opportunity.
• Coordinated effort to amplify existing activities, share information, work in concert.
• Addresses impacts of COVID-19 pandemic on testing and treatment numbers.

Implementation Timeline and Process

• Expression of interest submission deadline not specified in transcript; review by end of January/first week February.
• Site selection committee meeting February 2022; all sites selected by end February/March 2022.
• First 25 sites from existing studies prioritized for rapid deployment.
• Two-year operational period per site from machine installation date.
• Local ethics approval and site-specific assessment required.
• Provider number required for electronic ordering and result transmission (not for MBS reimbursement).

Action Items / Next Steps

• Submit expression of interest even if not meeting all criteria; second-phase selection addresses gaps.
• Collaborate with partner organizations to share machines or conduct joint outreach activities.
• Ensure minimum 250 annual client testing capacity before applying.
• Establish systems for quality assurance participation and electronic result reporting.
• Coordinate with state health departments and local PHNs for strategic placement.
• Contact Jason Grebley ([email protected]), Simon, or David with questions.
• Consider integration with other testing strategies: dry blood spot testing, reflex RNA testing from standard bloodwork.
• Maintain full spectrum response: prevention, harm reduction, testing, diagnosis, treatment, ongoing care.