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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
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
Secondary ID [1] 0 0
VHCRP2203
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
12 weeks from enrolment
Secondary outcome [1] 0 0
To evaluate the proportion of people who accept point-of-care testing among those offered testing.
Timepoint [1] 0 0
Recruitment phase
Secondary outcome [2] 0 0
To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested.
Timepoint [2] 0 0
Recruitment phase
Secondary outcome [3] 0 0
To evaluate the HCV antibody prevalence among people tested.
Timepoint [3] 0 0
Recruitment phase
Secondary outcome [4] 0 0
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;
Timepoint [4] 0 0
52 weeks
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
52 weeks
Secondary outcome [6] 0 0
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;
Timepoint [6] 0 0
52 weeks
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
52 weeks
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
52 weeks
Secondary outcome [9] 0 0
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.
Timepoint [9] 0 0
52 weeks

Eligibility
Key inclusion criteria
- Provide informed consent

- = 18 years of age.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Is unable or unwilling to provide informed consent

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
14/08/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
40000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
ACT Justice Health - Canberra
Recruitment hospital [2] 0 0
Justice Health and Forensic Mental Health Network - Sydney
Recruitment hospital [3] 0 0
West Moreton Hospital and Health Service - Brisbane
Recruitment hospital [4] 0 0
Lotus Glen Correctional Centre - Cairns
Recruitment hospital [5] 0 0
Woodford Correctional Centre - Woodford
Recruitment hospital [6] 0 0
South Australian Prison Health Service - Adelaide
Recruitment hospital [7] 0 0
St Vincent's Hospital (Melbourne) - Melbourne
Recruitment postcode(s) [1] 0 0
- Canberra
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment postcode(s) [3] 0 0
- Brisbane
Recruitment postcode(s) [4] 0 0
- Cairns
Recruitment postcode(s) [5] 0 0
- Woodford
Recruitment postcode(s) [6] 0 0
- Adelaide
Recruitment postcode(s) [7] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Kirby Institute
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05713136
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
David Silk, BSc
Address 0 0
Country 0 0
Phone 0 0
+61293850900
Fax 0 0
Email 0 0
dsilk@kirby.unsw.edu.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05713136