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The National Australian HCV Point-of-Care Testing Program

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ClinicalTrials.gov Identifier: NCT05042544
Recruitment Status : Not yet recruiting
First Posted : September 13, 2021
Last Update Posted : November 11, 2021
Sponsor:
Information provided by (Responsible Party):
Kirby Institute

Brief Summary:
The National Australian HCV Point-of-Care Testing Program will establish an observational cohort to evaluate whether scale-up of finger-stick point-of-care HCV testing increases diagnosis and treatment for HCV infection. Participants will be recruited from settings providing services to people with a risk factor for the acquisition of HCV infection (including drug treatment clinics, needle and syringe programs, homelessness settings, mental health services, prisons, and mobile outreach). Participants will attend a single visit to have their HCV RNA status tested and complete a self-administered survey. Participants will not receive treatment as a part of this study. Participants who are HCV RNA positive will be linked to standard of care.

Condition or disease Intervention/treatment
Hepatitis C Diagnostic Test: Point-of-Care Testing

Detailed Description:

The advent of simple direct-acting antiviral hepatitis C (HCV) therapies with cure rates >95% is one of the greatest medical advances in decades, having led to a reversal in liver-related mortality. In Australia, treatment uptake has declined between 2016 (32,000 treated) and 2019/20 (2019: 11,500; 2020: 8,500).1 Progress towards HCV elimination has been impeded by COVID-19, affecting the delivery of national and state-based HCV strategies. Improving HCV treatment uptake to reduce disease burden is a key aim of global, national and state-based HCV strategies.2-4

Scale-up of HCV testing and treatment will be required to achieve elimination by 2030. Current diagnostic pathways require multiple visits to a practitioner reducing the proportion who receive a diagnosis. In Australia, 81% of people have had HCV antibody testing (indicates exposure), but only 47% have been HCV RNA tested (indicates active infection and the need for HCV treatment).5 Mathematical modelling suggests that HCV RNA testing needs to increase by at least 50% annually to achieve elimination in Australia by 2030.6

The Kirby Institute is an international leader in research evaluating the Xpert HCV assay (Grebely Lancet Gastro Hep 2017), having built a large network of Xpert platforms for HCV testing in needle and syringe programs, prisons, drug treatment clinics, tertiary hospitals, and Aboriginal Community Controlled Health Service. In Kirby-led research, point-of-care HCV testing interventions in needle and syringe programs and prisons have resulted in high HCV treatment uptake (70-90%). The Kirby Institute and Flinders University also have a strong track record of implementing point-of-care testing for STIs and COVID-19, providing an ideal foundation to scale-up Xpert HCV testing in Australia.

The Kirby Institute and Flinders University will establish the Australian National HCV Point-of-care Testing Program for the scale-up of point-of-care HCV RNA testing in services with high prevalence of HCV infection, including community health centres, drug treatment clinics, needle and syringe programs, and prisons. This program will include the development of standard operating procedures, logistics/deployment, initial set-up, an operator training program, and quality assurance and competency assessment program.

An observational cohort study that will be established to evaluate HCV treatment uptake following scale-up of point-of-care HCV testing among people with a risk factor for acquisition of HCV infection or people attending a service caring for people with risk factors for the acquisition of HCV infection. This study will also include the linkage of survey data to a range of administrative datasets which will be used to evaluate the impact of HCV testing and treatment scale-up on a range of long-term health outcomes.

Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of HCV infection. Participants will attend a single visit to receive point-of-care HCV testing and complete a self-administered survey. In settings with high anticipated HCV antibody prevalence (>15%; e.g. drug treatment, prisons, needle and syringe programs), people who have previously been told they have HCV infection, or for people who have previously received HCV treatment, testing will be performed using point-of-care HCV RNA testing (results in one hour). In settings with a low anticipated HCV antibody prevalence (<15%; e.g. mental health, homelessness), testing will be performed using point-of-care HCV antibody testing (results in 20 minutes) and if positive, point-of-care HCV RNA testing will be performed. Participants will not receive treatment as a part of this study. Participants who are HCV RNA positive will be linked to standard of care for any other clinical assessments and treatment initiation.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 40000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official 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
Estimated Study Start Date : November 1, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
People at risk of HCV acquisition
Clinic staff will offer HCV point-of-care testing to participants as they access services. In settings with high anticipated HCV antibody prevalence (>15%; e.g. drug treatment, prisons, needle and syringe programs), people who have previously been told they have HCV infection, or people who have previously received HCV treatment, testing will be performed using point-of-care HCV RNA testing. In settings with a low anticipated HCV antibody prevalence (<15%; e.g. mental health, homelessness), testing will be performed using point-of-care HCV antibody testing and if positive, point-of-care HCV RNA testing will be performed.
Diagnostic Test: Point-of-Care Testing
Participants will be offered finger-stick point-of-care testing for HCV




Primary Outcome Measures :
  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 Outcome Measures :
  1. 1. To evaluate the proportion of people who accept point-of-care testing among those offered testing. [ Time Frame: Recruitment phase ]
    Accepting testing

  2. 2. To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested. [ Time Frame: Recruitment phase ]
    Prevalence

  3. 3. To evaluate the time to HCV treatment uptake among people who receive treatment. [ Time Frame: 52 weeks ]
    Time to treatment

  4. 4. 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

  5. 5. To evaluate the proportion of participants who complete HCV direct-acting antiviral (DAA) treatment. [ Time Frame: 52 weeks ]
    Completion of treatment

  6. 6. To evaluate the proportion of participants who achieve an SVR (defined as HCV RNA below the lower limit of quantitation at post treatment week 12). [ Time Frame: 12 weeks ]
    SVR

  7. 7. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of HCV infection, including drug treatment clinics, needle and syringe programs, prisons, mobile outreach services, community health services, mental health services, homelessness services, and other appropriate settings nationally. It is anticipated approximately 40,000 participants will be screened for HCV infection using point-of-care HCV testing.
Criteria

Inclusion Criteria:

  1. Provided informed consent.
  2. ≥ 18 years of age.
  3. Have a risk factor for the acquisition of HCV infection (including current or past injecting drug use, previous incarceration, HIV infection, receiving blood products prior to 1990, having a tattoo or piercing in an unregulated environment, a needle-stick injury, or a mother with HCV).

    OR:

  4. Are attending a service caring for people with risk factors for the acquisition of HCV infection (e.g. drug treatment clinics, needle and syringe programs, prisons, mobile outreach services, community health services, mental health services, and homelessness services).

Exclusion Criteria:

a. Is unable or unwilling to provide informed consent or abide by the requirements of the study.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05042544


Contacts
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Contact: David C Silk, BSc +61293850900 dsilk@kirby.unsw.edu.au

Locations
Show Show 22 study locations
Sponsors and Collaborators
Kirby Institute
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Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT05042544    
Other Study ID Numbers: VHCRP2101
First Posted: September 13, 2021    Key Record Dates
Last Update Posted: November 11, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kirby Institute:
Hepatitis C Virus
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections