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

NCT ID: NCT05713136

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-25

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis C

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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People at risk of HCV acquisition

Clinic staff will offer HCV point-of-care testing to participants as they access services. Testing will be performed using point-of-care HCV RNA testing

Diagnostic Test: Point-of-Care Testing

Intervention Type DEVICE

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

Interventions

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Diagnostic Test: Point-of-Care Testing

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Provide informed consent
* ≥ 18 years of age.

Exclusion Criteria

* Is unable or unwilling to provide informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Flinders University

OTHER

Sponsor Role collaborator

Kirby Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ACT Justice Health

Canberra, Australian Capital Territory, Australia

Site Status NOT_YET_RECRUITING

Justice Health and Forensic Mental Health Network

Sydney, New South Wales, Australia

Site Status RECRUITING

Queensland Injectors Health Network Ltd

Bowen Hills, Queensland, Australia

Site Status RECRUITING

West Moreton Hospital and Health Service

Brisbane, Queensland, Australia

Site Status RECRUITING

Lotus Glen Correctional Centre

Cairns, Queensland, Australia

Site Status RECRUITING

Townsville Correctional Centre

Townsville, Queensland, Australia

Site Status NOT_YET_RECRUITING

Woodford Correctional Centre

Woodford, Queensland, Australia

Site Status RECRUITING

South Australian Prison Health Service

Adelaide, South Australia, Australia

Site Status NOT_YET_RECRUITING

Hepatitis South Australia

Hackney, South Australia, Australia

Site Status NOT_YET_RECRUITING

Tasmanian Prison Service

Hobart, Tasmania, Australia

Site Status NOT_YET_RECRUITING

St Vincent's Hospital (Melbourne)

Melbourne, Victoria, Australia

Site Status RECRUITING

WA Department of Justice

Perth, Western Australia, Australia

Site Status NOT_YET_RECRUITING

Countries

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Australia

Central Contacts

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David Silk, BSc

Role: CONTACT

+61293850900

Stephanie Davey, BSc

Role: CONTACT

+61293481404

Facility Contacts

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Alex Misev

Role: primary

Tracey Brown

Role: primary

Nik Alexander

Role: primary

Blake Ponting

Role: primary

Darren Russell

Role: primary

John Morey

Role: primary

Rajendra Prakash

Role: primary

Tom Turnbull

Role: primary

Lisa Carter

Role: primary

Deborah Siddell

Role: primary

Alex Thompson

Role: primary

Holly Beasley

Role: primary

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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VHCRP2203

Identifier Type: -

Identifier Source: org_study_id

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