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NCT Number: NCT05713136

The National Australian HCV Point-of-Care Testing Program - HCV Antibody Testing Minimal Dataset

The goal of this observational study is to learn if offering a point-of-care screening test for exposure to the Hepatitis C virus, before providing a diagnostic test for Hepatitis C infection can increase testing, diagnosis and treatment in Adults. Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of Hepatitis C viral infection. The main question it aims to answer is:

What proportion of the participants that have been diagnosed with HCV infection have started treatment when their records are reviewed 12 weeks after diagnosis?

Participants will have one in-person visit where they will provide informed consent and receive a finger-prick rapid result test for Hepatitis C infection. Participants with no previous Hepatitis C infection will have a screening test to see if they have an immune reaction to Hepatitis C. Participants who know they have been infected with Hepatitis C in the past, and all participants with a positive screening test result will then be given a Hepatitis C diagnostic test at this visit.

No treatment is provided as a part of this study, participants who are diagnosed with Hepatitis C infection will be referred to testing locations standard of care for any additional clinical assessments and treatment initiation. A review of the participant's records will be made 12 weeks after their Hepatitis C result and their treatment data are gathered.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ACT Justice Health, Canberra, Australian Capital Territory, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provide informed consent
  • ≥ 18 years of age.

Exclusion criteria

  • Is unable or unwilling to provide informed consent

Treatment and study plan

Diagnostic Test: Point-of-Care Testing

Device

Participants will be offered finger-stick point-of-care testing for HCV

Primary outcomes

  1. To evaluate the proportion of HCV infected (HCV RNA quantifiable) participants who initiate HCV treatment at 12 weeks following finger-stick point-of-care HCV RNA testing.

    Time frame: 12 weeks from enrolment

    HCV treatment

Secondary outcomes

  1. To evaluate the proportion of people who accept point-of-care testing among those offered testing.

    Time frame: Recruitment phase

    Accepting testing

  2. To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested.

    Time frame: Recruitment phase

    Prevalence

  3. To evaluate the HCV antibody prevalence among people tested.

    Time frame: Recruitment phase

    Prevalence

  4. To evaluate the time to treatment uptake among people receiving point-of-care HCV antibody testing with reflex HCV RNA testing in those who are HCV antibody detectable who received HCV treatment;

    Time frame: 52 weeks

    Time to treatment

  5. To evaluate the proportion of HCV RNA positive participants who initiate HCV treatment at 12 months (52 weeks) following finger-stick point-of-care HCV RNA testing.

    Time frame: 52 weeks

    Initiation of treatment

  6. To evaluate the proportion of participants who complete HCV direct-acting antiviral (DAA) treatment following point-of-care HCV antibody testing with reflex HCV RNA testing in those who are HCV antibody detectable who received HCV treatment;

    Time frame: 52 weeks

    Completion of treatment

  7. To evaluate the proportion of participants who achieve an SVR following point-of-care HCV antibody testing with reflex HCV RNA testing in those who are HCV antibody detectable who received HCV treatment

    Time frame: 52 weeks

    SVR

  8. To evaluate the proportion of participants who are HCV RNA negative at 12 months (52 weeks) following finger-stick point-of-care HCV RNA testing.

    Time frame: 52 weeks

    HCV negative

  9. To evaluate the cost of point-of-care HCV antibody testing prior to reflex HCV RNA testing compared to direct point-of-care HCV RNA testing and standard of care.

    Time frame: 52 weeks

    Cost-effectiveness

Study contacts

Contact information is provided by the study sponsor or research team.

David Silk, BSc

CONTACT

[email protected]

+61293850900

Stephanie Davey, BSc

CONTACT

[email protected]

+61293481404

Sponsors and collaborators

Lead sponsor

Kirby Institute

Other Gov

Collaborators

  • Flinders University

Registry information

Official study title

The National Australian HCV Point-of-Care Testing Program: An Observational Cohort Study to Evaluate the Use of Finger-stick Point-of-care Hepatitis C Testing to Enhance Diagnosis and Treatment of HCV Infection - HCV Antibody Testing Minimal Dataset

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Feb 6, 2023
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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