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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05713136
Registration number
NCT05713136
Ethics application status
Date submitted
17/01/2023
Date registered
6/02/2023
Date last updated
3/08/2023
Titles & IDs
Public title
The National Australian HCV Point-of-Care Testing Program - HCV Antibody Testing Minimal Dataset
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Scientific 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
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Secondary ID [1]
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VHCRP2203
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis C
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - Diagnostic Test: Point-of-Care Testing
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
Treatment: Devices: Diagnostic Test: Point-of-Care Testing
Participants will be offered finger-stick point-of-care testing for HCV
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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HCV treatment
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Timepoint [1]
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12 weeks from enrolment
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Secondary outcome [1]
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To evaluate the proportion of people who accept point-of-care testing among those offered testing.
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Assessment method [1]
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Accepting testing
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Timepoint [1]
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Recruitment phase
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Secondary outcome [2]
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To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested.
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Assessment method [2]
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Prevalence
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Timepoint [2]
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Recruitment phase
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Secondary outcome [3]
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To evaluate the HCV antibody prevalence among people tested.
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Assessment method [3]
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Prevalence
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Timepoint [3]
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Recruitment phase
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Secondary outcome [4]
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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;
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Assessment method [4]
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Time to treatment
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Timepoint [4]
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52 weeks
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Secondary outcome [5]
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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.
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Assessment method [5]
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Initiation of treatment
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Timepoint [5]
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52 weeks
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Secondary outcome [6]
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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;
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Assessment method [6]
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Completion of treatment
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Timepoint [6]
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52 weeks
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Secondary outcome [7]
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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
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Assessment method [7]
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SVR
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Timepoint [7]
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52 weeks
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Secondary outcome [8]
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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.
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Assessment method [8]
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HCV negative
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Timepoint [8]
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52 weeks
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Secondary outcome [9]
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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.
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Assessment method [9]
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Cost-effectiveness
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Timepoint [9]
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52 weeks
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Eligibility
Key inclusion criteria
- Provide informed consent
- = 18 years of age.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Is unable or unwilling to provide informed consent
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
14/08/2023
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2025
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Actual
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Sample size
Target
40000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
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Recruitment hospital [1]
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ACT Justice Health - Canberra
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Recruitment hospital [2]
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Justice Health and Forensic Mental Health Network - Sydney
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Recruitment hospital [3]
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West Moreton Hospital and Health Service - Brisbane
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Recruitment hospital [4]
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Lotus Glen Correctional Centre - Cairns
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Recruitment hospital [5]
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Woodford Correctional Centre - Woodford
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Recruitment hospital [6]
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South Australian Prison Health Service - Adelaide
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Recruitment hospital [7]
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St Vincent's Hospital (Melbourne) - Melbourne
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Recruitment postcode(s) [1]
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- Canberra
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Recruitment postcode(s) [2]
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- Sydney
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Recruitment postcode(s) [3]
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- Brisbane
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Recruitment postcode(s) [4]
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- Cairns
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Recruitment postcode(s) [5]
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- Woodford
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Recruitment postcode(s) [6]
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- Adelaide
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Recruitment postcode(s) [7]
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- Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Kirby Institute
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is an observational cohort study. 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 have HCV point-of-care testing. Participants who
have not previously received HCV treatment will have a point-of-care HCV antibody test,
followed by reflex point-of-care HCV RNA test if positive. Those who have a history of HCV
treatment will proceed straight to point-of-care HCV RNA testing. Participants will not
receive treatment as a part of this study. Participants who are HCV RNA positive will receive
treatment via standard of care. The purpose of this study is to look at the effect of
finger-stick point-of-care hepatitis C testing, to see if it increases the number of tests,
diagnoses, and treatments for people with a risk factor of having hepatitis C in Australia.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05713136
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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David Silk, BSc
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Address
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Country
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Phone
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+61293850900
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05713136
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