Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05713136




Registration number
NCT05713136
Ethics application status
Date submitted
17/01/2023
Date registered
6/02/2023
Date last updated
3/07/2024

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2027
Actual
Sample size
Target
40000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
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
Queensland Injectors Health Network Ltd - Bowen Hills
Recruitment hospital [4] 0 0
West Moreton Hospital and Health Service - Brisbane
Recruitment hospital [5] 0 0
Lotus Glen Correctional Centre - Cairns
Recruitment hospital [6] 0 0
Townsville Correctional Centre - Townsville
Recruitment hospital [7] 0 0
Woodford Correctional Centre - Woodford
Recruitment hospital [8] 0 0
South Australian Prison Health Service - Adelaide
Recruitment hospital [9] 0 0
Hepatitis South Australia - Hackney
Recruitment hospital [10] 0 0
Tasmanian Prison Service - Hobart
Recruitment hospital [11] 0 0
St Vincent's Hospital (Melbourne) - Melbourne
Recruitment hospital [12] 0 0
WA Department of Justice - Perth
Recruitment postcode(s) [1] 0 0
- Canberra
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment postcode(s) [3] 0 0
4006 - Bowen Hills
Recruitment postcode(s) [4] 0 0
- Brisbane
Recruitment postcode(s) [5] 0 0
- Cairns
Recruitment postcode(s) [6] 0 0
4810 - Townsville
Recruitment postcode(s) [7] 0 0
- Woodford
Recruitment postcode(s) [8] 0 0
- Adelaide
Recruitment postcode(s) [9] 0 0
5069 - Hackney
Recruitment postcode(s) [10] 0 0
- Hobart
Recruitment postcode(s) [11] 0 0
- Melbourne
Recruitment postcode(s) [12] 0 0
6000 - Perth

Funding & Sponsors
Primary sponsor type
Government body
Name
Kirby Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Flinders University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05713136