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

Hepatitis C Clinical Trial

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 - HCV Antibody Testing Minimal Dataset

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05713136
• Other study ID #: VHCRP2203
• Status: Recruiting
• Start date: January 25, 2023
• Est. completion date: January 2027

Study information

• Verified date: June 2024
• Source: Kirby Institute
• Contact: David Silk, BSc
• Phone: +61293850900
• Email: dsilk[@]kirby.unsw.edu.au
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40000
• Est. completion date: January 2027
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Provide informed consent

• = 18 years of age.

Exclusion Criteria:

• Is unable or unwilling to provide informed consent

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

Intervention

Device:
• Diagnostic Test: Point-of-Care Testing
Participants will be offered finger-stick point-of-care testing for HCV

Locations

Country	Name	City	State
Australia	South Australian Prison Health Service	Adelaide	South Australia
Australia	Queensland Injectors Health Network Ltd	Bowen Hills	Queensland
Australia	West Moreton Hospital and Health Service	Brisbane	Queensland
Australia	Lotus Glen Correctional Centre	Cairns	Queensland
Australia	ACT Justice Health	Canberra	Australian Capital Territory
Australia	Hepatitis South Australia	Hackney	South Australia
Australia	Tasmanian Prison Service	Hobart	Tasmania
Australia	St Vincent's Hospital (Melbourne)	Melbourne	Victoria
Australia	WA Department of Justice	Perth	Western Australia
Australia	Justice Health and Forensic Mental Health Network	Sydney	New South Wales
Australia	Townsville Correctional Centre	Townsville	Queensland
Australia	Woodford Correctional Centre	Woodford	Queensland

Sponsors (2)

Lead Sponsor	Collaborator
Kirby Institute	Flinders University

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	HCV treatment	12 weeks from enrolment
Secondary	To evaluate the proportion of people who accept point-of-care testing among those offered testing.	Accepting testing	Recruitment phase
Secondary	To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested.	Prevalence	Recruitment phase
Secondary	To evaluate the HCV antibody prevalence among people tested.	Prevalence	Recruitment phase
Secondary	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 to treatment	52 weeks
Secondary	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.	Initiation of treatment	52 weeks
Secondary	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;	Completion of treatment	52 weeks
Secondary	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	SVR	52 weeks
Secondary	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.	HCV negative	52 weeks
Secondary	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.	Cost-effectiveness	52 weeks