Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05248555
Registration number
NCT05248555
Ethics application status
Date submitted
12/12/2021
Date registered
21/02/2022
Date last updated
13/06/2024
Titles & IDs
Public title
The National Australian HCV Point-of-Care Testing Program - Minimal Dataset
Query!
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 - Minimal Dataset
Query!
Secondary ID [1]
0
0
VHCRP2104
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Hepatitis C
0
0
Query!
Condition category
Condition code
Infection
0
0
0
0
Query!
Other infectious diseases
Query!
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
Description of intervention(s) / exposure
Diagnosis / Prognosis - 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.
Diagnosis / Prognosis: Point-of-Care Testing
Participants will be offered finger-stick point-of-care testing for HCV
Query!
Intervention code [1]
0
0
Diagnosis / Prognosis
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
The proportion of HCV infected participants who initiate HCV treatment at 12 weeks
Query!
Assessment method [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.
Query!
Timepoint [1]
0
0
12 Weeks from enrolment
Query!
Secondary outcome [1]
0
0
The proportion of participants who accept point-of-care testing
Query!
Assessment method [1]
0
0
To evaluate the proportion of people who accept point-of-care testing among those offered testing.
Query!
Timepoint [1]
0
0
2 years from recruitment commencement
Query!
Secondary outcome [2]
0
0
The prevalence of HCV infection amongst study participants tested
Query!
Assessment method [2]
0
0
To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested.
Query!
Timepoint [2]
0
0
2 years from recruitment commencement
Query!
Secondary outcome [3]
0
0
To evaluate the time to HCV treatment uptake among HCV RNA positive participants
Query!
Assessment method [3]
0
0
To evaluate the length of time participants take to initiate HCV treatment after diagnosis
Query!
Timepoint [3]
0
0
52 weeks
Query!
Secondary outcome [4]
0
0
To evaluate proportion of HCV RNA positive participants who initiate HCV treatment
Query!
Assessment method [4]
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.
Query!
Timepoint [4]
0
0
52 weeks
Query!
Secondary outcome [5]
0
0
To evaluate the proportion of participants who complete HCV (DAA) treatment
Query!
Assessment method [5]
0
0
To evaluate the proportion of participants who complete HCV direct-acting antiviral (DAA) treatment.
Query!
Timepoint [5]
0
0
52 weeks
Query!
Secondary outcome [6]
0
0
To evaluate the proportion of participants who achieve an SVR
Query!
Assessment method [6]
0
0
To evaluate the proportion of participants who achieve an SVR (defined as HCV RNA below the lower limit of quantitation at post treatment week 12).
Query!
Timepoint [6]
0
0
12 weeks
Query!
Secondary outcome [7]
0
0
To evaluate the proportion of participants who are HCV RNA negative at 12 months
Query!
Assessment method [7]
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.
Query!
Timepoint [7]
0
0
52 weeks
Query!
Eligibility
Key inclusion criteria
* = 18 years of age.
* Received point-of-care HCV testing.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
* Nil
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/12/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/12/2026
Query!
Actual
Query!
Sample size
Target
40000
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Query!
Recruitment hospital [1]
0
0
Justice Health and Forensic Mental Health Network - Sydney
Query!
Recruitment hospital [2]
0
0
Lotus Glen Correctional Centre - Cairns
Query!
Recruitment hospital [3]
0
0
Hepatitis Queensland - Coorparoo
Query!
Recruitment hospital [4]
0
0
West Moreton Hospital and Health Service - Ipswich
Query!
Recruitment hospital [5]
0
0
Townsville Correctional Centre - Townsville
Query!
Recruitment hospital [6]
0
0
Woodford Correctional Centre - Woodford
Query!
Recruitment hospital [7]
0
0
South Australian Prison Health Service - Marden
Query!
Recruitment hospital [8]
0
0
Mount Gambier Priosn - Mount Gambier
Query!
Recruitment hospital [9]
0
0
St Vincent's Correctional Health Services - Fitzroy
Query!
Recruitment hospital [10]
0
0
Medically Supervised Injecting Room - Melbourne
Query!
Recruitment hospital [11]
0
0
Geo Healthcare - The Geo Group Australia Pty Ltd - Ravenhall
Query!
Recruitment postcode(s) [1]
0
0
- Sydney
Query!
Recruitment postcode(s) [2]
0
0
- Cairns
Query!
Recruitment postcode(s) [3]
0
0
4151 - Coorparoo
Query!
Recruitment postcode(s) [4]
0
0
- Ipswich
Query!
Recruitment postcode(s) [5]
0
0
- Townsville
Query!
Recruitment postcode(s) [6]
0
0
- Woodford
Query!
Recruitment postcode(s) [7]
0
0
5070 - Marden
Query!
Recruitment postcode(s) [8]
0
0
5290 - Mount Gambier
Query!
Recruitment postcode(s) [9]
0
0
3065 - Fitzroy
Query!
Recruitment postcode(s) [10]
0
0
3000 - Melbourne
Query!
Recruitment postcode(s) [11]
0
0
3023 - Ravenhall
Query!
Funding & Sponsors
Primary sponsor type
Government body
Query!
Name
Kirby Institute
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Flinders University
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The National Australian HCV Point-of-Care Testing Program will establish an observational cohort to evaluate whether scale-up of finger-stick point-of-care HCV testing increases diagnosis and treatment for HCV infection. Participants will be recruited from settings providing services to people with a risk factor for the acquisition of HCV infection (including drug treatment clinics, needle and syringe programs, homelessness settings, mental health services, prisons, and mobile outreach). All participants who undergo HCV point-of-care testing at the study site will be included in the data collection. Participants will not receive treatment as a part of this study. Participants who are HCV RNA positive will be linked to standard of care.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05248555
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
David Silk, BSc
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
+61293850900
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05248555
Download to PDF