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
Conditions: Hepatitis C
Sponsor: Kirby Institute

National Australian HCV POCT Program, HCV antibody minimal dataset Protocol  
V4.0, 13 Jul 2023  
Page 1 of 19 
 
 
 
 
 
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 
  
Protocol version: 4.0 
 
Protocol date: 13 July 2023  
 
 
Name and address of sponsor: 
Kirby Institute 
UNSW Sydney 
Wallace Wurth Building (C27) 
Sydney NSW 2052 
Australia 
 
 
 
Coordinating Principal Investigator (CPI):  
Medical Monitor: 
Professor Jason Grebely 
 
The Kirby Institute 
UNSW Sydney 
Wallace Wurth Building (C27) 
Sydney NSW 2052 
Australia 
E: jgrebely@kirby.unsw.edu.au 
P: +61 2 9385 0900 
F: +61 2 9385 9214 
Dr Marianne Martinello 
The Kirby Institute 
UNSW Sydney 
Wallace Wurth Building (C27) 
Sydney NSW 2052 
Australia 
E: mmartinello@kirby.unsw.edu.au 
P: +61 2 9385 0900 
F: +61 2 9385 9214 
 
Signature 
 
 
 
 
Print name 
Prof Jason Grebely 
Date:  
 
 
 
 

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Table of contents 
 
Protocol Synopsis ......................................................................................................................... 3 
Primary outcome ........................................................................................................................... 7 
Sample size .................................................................................................................................. 7 
1. Background and rationale ......................................................................................................... 8 
2. Hypotheses ............................................................................................................................... 9 
3. Study objectives ........................................................................................................................ 9 
4. Participant population.............................................................................................................. 10 
5. Study design ........................................................................................................................... 10 
6. Treatment of participants ........................................................................................................ 11 
7. Study procedures .................................................................................................................... 11 
7.1 Visits and Procedures ........................................................................................................... 11 
7.2 Study case report forms (CRFs) ............................................................................................ 12 
7.3 Process evaluation ................................................................................................................ 12 
8. Statistics ................................................................................................................................. 13 
8.1 Primary outcome ................................................................................................................... 13 
8.2 Sample size .......................................................................................................................... 13 
9. Data collection, source documents and record retention ......................................................... 14 
10.1 Submission of data.............................................................................................................. 14 
10.2 Archiving ............................................................................................................................. 15 
11. Ethics committee/regulatory approval ................................................................................... 15 
12. Confidentiality of data ............................................................................................................ 16 
13. Governance .......................................................................................................................... 17 
14. Quality Control (QC) and Quality Assurance (QA) ................................................................. 17 
15. Publication Policy .................................................................................................................. 17 
17. List of References ................................................................................................................. 18 
18. Abbreviations List .................................................................................................................. 19 
 
 
 

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Protocol Synopsis 
 
Title 
The National Australian HCV Point-of-Care Testing Program: An 
observational cohort study to evaluate the use of finger-stick 
point-of-care HCV testing to enhance diagnosis and treatment 
of HCV infection – HCV antibody testing minimal dataset 
Protocol 
registration 
no. 
 
NCT05713136 
Background 
and 
rationale 
 
 
The advent of simple direct-acting antiviral hepatitis C (HCV) 
therapies with cure rates >95% is one of the greatest medical 
advances in decades, having led to a reversal in liver-related 
mortality. In Australia, treatment uptake has declined between 2016 
(32,000 treated) and 2019/20 (2019: 11,500; 2020: 8,500).1 
Progress towards HCV elimination has been impeded by COVID-19, 
affecting the delivery of national and state-based HCV strategies. 
Improving HCV treatment uptake to reduce disease burden is a key 
aim of global, national and state-based HCV strategies.2-4 
  
Scale-up of HCV testing and treatment will be required to achieve 
elimination by 2030. Increasing HCV testing is hampered by 
diagnostic pathways requiring multiple visits and loss to follow-up, 
amplified in key populations, such as people who inject drugs. In 
Australia, 81% of people have had HCV antibody testing (indicates 
exposure), but only 47% have been HCV RNA tested (indicates 
active infection and the need for HCV treatment).5 Mathematical 
modelling suggests that HCV RNA testing needs to increase by at 
least 50% annually to achieve elimination in Australia by 2030.6 
 
The approval of the Xpert® HCV Viral Load Fingerstick test for 
detection of active HCV infection in one hour at the point-of-care by 
the Therapeutic Goods Administration is a ‘game-changer’. This 
HCV point-of-care test enables diagnosis and treatment in a single-
visit, increases testing acceptability, and reduces loss to follow-up, 
addressing the drop-off in the HCV care cascade.  
 
The Kirby Institute is an international leader in research evaluating 
the Xpert HCV assay (Grebely Lancet Gastro Hep 2017), having built 
a large network of Xpert platforms for HCV testing in needle and 
syringe programs, prisons, drug treatment clinics, tertiary hospitals, 

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and Aboriginal Community Controlled Health Service. In Kirby-led 
research, point-of-care HCV testing interventions in needle and 
syringe programs and prisons have resulted in high HCV treatment 
uptake (70-90%).  
 
The Kirby Institute and Flinders University will establish the 
Australian National HCV Point-of-care Testing Program for the 
scale-up of point-of-care HCV RNA testing in services with high 
prevalence of HCV infection, including community health centres, 
drug treatment clinics, needle and syringe programs, and prisons. 
This program will include the development of standard operating 
procedures, logistics/deployment, initial set-up, an operator training 
program, and quality assurance and competency assessment 
program.  
 
In settings with lower HCV antibody prevalence, immediate point-of-
care HCV RNA testing may not be cost-effective ($60/test), and a 
screening strategy using a point-of-care HCV antibody test 
(approximately $10/test) followed by a HCV RNA test in people who 
are HCV antibody positive may be more cost-effective and time 
efficient. However, although there are HCV antibody tests available 
for use in Australia, there are none currently approved by the 
Therapeutics Goods Administration. It is critical to evaluate the cost 
and time effectiveness of different testing strategies to optimise 
testing and government funding and to inform clinical utility. 
Understanding and addressing implementation challenges is critical 
to rapidly translate HCV point-of-care testing into practice and policy. 
 
This protocol describes an observational cohort study that will be 
established to evaluate initial point-of-care antibody testing before 
reflex HCV RNA testing. There are currently no TGA approved HCV 
antibody tests, so testing can only be evaluated within a research 
study with appropriate informed consent.  An evaluation of the HCV 
treatment uptake following scale-up of point-of-care HCV antibody 
testing followed by HCV RNA testing is therefore needed. 
 
Study objectives 
Primary Objective 
To evaluate the proportion of HCV infected (HCV RNA quantifiable) 
participants who initiate HCV treatment at 12 weeks following HCV 
RNA testing.  

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Secondary Objectives 
1. To evaluate the proportion of people who accept point-of-
care testing among those offered testing. 
2. To evaluate the prevalence of current HCV infection (HCV 
RNA quantifiable) among people tested. 
3. To evaluate the HCV antibody prevalence among people 
tested. 
4. 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; 
5. To evaluate the proportion of HCV RNA positive participants 
who initiate HCV treatment at 12 months (52 weeks) 
following HCV RNA testing. 
6. 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;   
7. 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) following point-of-
care HCV antibody testing with reflex HCV RNA testing in 
those who are HCV antibody detectable who received HCV 
treatment. 
8. To evaluate the proportion of participants who are HCV RNA 
negative at 12 months (52 weeks) following HCV RNA 
testing. 
9. To evaluate the cost-effectiveness of this testing strategy. 
 
Participant population  Participants will be included from settings that provide services to 
people with a risk factor for the acquisition of HCV infection, including 
drug treatment clinics, needle and syringe programs, prisons, mobile 
outreach services, community health services, mental health 
services, homelessness services, and other appropriate settings 
nationally. It is anticipated that approximately 40,000 participants will 
be screened for HCV infection using point-of-care HCV testing.   
 
Inclusion criteria 

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Participants are eligible for inclusion if the following criteria are met: 
a. Provide informed consent 
b. ≥ 18 years of age. 
 
Exclusion criteria 
a. Is unable or unwilling to provide informed consent  
 
Study design 
This is an observational cohort study. Participants will attend a single 
visit where they will provide informed consent and receive point-of-
care HCV testing. All other study procedures will comprise data 
collection only. 
 
Treatment of 
participants 
No treatment will be prescribed as a part of this study. Participants 
who are HCV RNA detectable will be linked to standard of care for 
any other clinical assessments and treatment initiation. 
 
Study procedures 
All participants receiving HCV testing at sites participating in this 
study, and who meet the study criteria will be identified and offered 
participation in the study. Participants will undergo verbal or written 
informed consent followed by HCV point-of-care testing. As this is an 
observational cohort study, further study procedures will comprise 
data collection only.  
 
For participants who have previously been told they have HCV 
infection, or for people who have previously received HCV treatment, 
testing will be performed using point-of-care HCV RNA testing via 
Xpert HCV Viral Load Fingerstick assay using the GeneXpert 
machine (results in one hour).  
 
For all other participants who have not previously been told they 
have HCV infection nor have previously received HCV treatment, 
testing will be performed using point-of-care HCV antibody testing. If 
the result is HCV antibody positive, individuals will undergo reflex 
HCV RNA testing.  
 
Participants will not receive treatment as a part of this study. 
Participants who are HCV RNA positive will be linked to standard of 
care for any other clinical assessments and treatment initiation. 
 

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Statistics 
Primary outcome 
The proportion of HCV RNA detectable participants who initiate HCV 
treatment within 12 weeks of HCV RNA testing. 
 
Sample size 
Overall, 40,000 point-of-care HCV tests will be performed in different 
settings as part of the Australian National HCV Point-of-care Testing 
Program. It is estimated that the HCV prevalence will be 15% 
(n=6,000 people who are HCV RNA detectable) and the treatment 
uptake following testing will be 65% (n=3,900). Under these 
assumptions, the 95% confidence intervals around the estimate for 
HCV treatment uptake will be 64.0%-66.0% and for HCV RNA 
prevalence will be 14.7%-15.4%. For analyses evaluating factors 
associated with HCV treatment uptake, we will have 90% power to 
detect an odds ratio of 1.20 or greater (alpha=0.05) for a variable 
that is 50% prevalent (i.e. recent injecting drug use).   
 
Analysis will follow the STROBE guidelines for observational studies. 
The analysis of the primary outcome will occur when all patients have 
completed 12 weeks of follow-up (from enrolment) or have been 
permanently lost to follow-up. Participant flow will be summarised, 
showing the numbers of participants included. 
 
 
 

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1. Background and rationale 
In Australia, hepatitis C virus (HCV)-related morbidity and mortality have doubled in the past 
decade, with health care costs of $220 million per annum.1 In 2019, 128,000 Australians were living 
with HCV infection.2 The majority of new (90%) and existing (80%) cases of HCV infection in 
Australia occur among people who inject drugs (PWID).1,2  
 
The advent of simple direct-acting antiviral (DAA) HCV therapies with cure rates >95% is one of 
the greatest medical advances in decades, having led to a reversal in liver-related mortality.11 In 
Australia, treatment uptake has declined between 2016 (32,000 treated) and 2019/20 (2019: 
11,500; 2020: 8,500).1 Progress towards HCV elimination has been impeded by COVID-19, 
affecting the delivery of national and state-based HCV strategies. Improving HCV treatment uptake 
to reduce disease burden is a key aim of global, national and state-based HCV strategies.2-4  
 
Globally, HCV testing and diagnosis remains low.4 Testing pathways involve an HCV antibody test 
to confirm exposure and an HCV RNA test to detect active infection. This two-step pathway requires 
up to 5 visits to practitioners and off-site phlebotomists, leading to a drop-off in the diagnosis of 
active infection.2 In Australia, 81% of people have had HCV antibody testing (indicates exposure), 
but only 47% have been HCV RNA tested (indicates active infection and the need for HCV 
treatment).5 Mathematical modelling suggests that HCV RNA testing needs to increase by at least 
50% annually to achieve elimination in Australia by 2030.6 
 
Point-of-care HCV testing increases linkage to care.7 Our group led the first evaluation of a point-
of-care HCV RNA assay8,9, the Xpert HCV Viral Load Fingerstick point-of-care test, enabling same-
day diagnosis of active infection in one hour (sensitivity and specificity, 100%) at the point-of-care, 
enabling diagnosis and treatment in a single visit, improving treatment uptake.9 This research 
facilitated the recent approval of the assay by the Therapeutics Good Administration (TGA), 
providing an unprecedented opportunity to scale-up HCV testing and treatment. Scale-up of HCV 
testing will be most impactful in settings with high HCV prevalence (e.g. those providing care for 
people who inject drugs), including prisons, drug treatment clinics, and needle and syringe 
programs. Point-of-care HCV RNA testing can also be combined with outreach models and mobile 
clinics to provide access to testing and treatment to those who may not have been tested or treated 
to date. The next step is to translate this novel discovery into routine clinical practice to scale-up 
testing and treatment to facilitate HCV elimination. 
 
The Kirby Institute is an international leader in research evaluating the Xpert HCV assay, having 
built a large network of Xpert platforms for HCV testing in needle and syringe programs, prisons, 
drug treatment clinics, tertiary hospitals, and Aboriginal Community Controlled Health Services. In 
Kirby-led research, point-of-care HCV testing interventions in needle and syringe programs and 
prisons have resulted in high HCV treatment uptake (75-90%). The Kirby Institute and Flinders 

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University also have a strong track record of implementing point-of-care testing for STIs and 
COVID-19, providing an ideal foundation to scale-up point-of-care HCV testing in Australia. 
 
The Kirby Institute and Flinders University will establish the Australian National HCV Point-of-care 
Testing Program for the scale-up of point-of-care HCV testing in services caring for people with risk 
factors for the acquisition of HCV infection (e.g. drug treatment clinics, needle and syringe 
programs, prisons, mobile outreach services, community health services, mental health services, 
and homelessness services).  
 
In settings with lower HCV antibody prevalence, immediate point-of-care HCV RNA testing may 
not be cost-effective ($60/test), and a screening strategy using a point-of-care HCV antibody test 
(approximately $10/test) followed by a HCV RNA test in people who are HCV antibody positive 
may be more acceptable to clients and service providers given a quicker turnaround time for an 
HCV antibody detectable result. However, although there are HCV antibody tests available for use 
in Australia, there are none currently approved by the Therapeutics Goods Administration. 
Therefore, testing can only be evaluated within a research study with appropriate informed consent. 
It is critical to evaluate the cost and time effectiveness of different testing strategies to optimise 
testing and government funding and to inform clinical utility.  
 
This protocol describes an observational cohort study that will be established to evaluate HCV 
treatment uptake following scale-up of point-of-care HCV antibody testing followed by HCV RNA 
testing. This information will provide critical information on the effectiveness of this testing strategy 
to enhance HCV treatment.  
 
2. Hypotheses 
 
Primary Hypothesis 
An intervention integrating HCV RNA testing (predominantly through point-of-care testing) will lead 
to a high uptake of HCV treatment (>65%) among people at increased risk for HCV infection. 
 
3. Study objectives 
Primary Objective 
To evaluate the proportion of HCV infected (HCV RNA quantifiable) participants who initiate HCV 
treatment at 12 weeks following HCV RNA testing.  
  
Secondary Objectives 
1. To evaluate the proportion of people who accept point-of-care testing among those offered 
testing. 
2. To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people 
tested. 

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3. To evaluate the HCV antibody prevalence among people tested. 
4. 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; 
5. To evaluate the proportion of HCV RNA positive participants who initiate HCV treatment at 
12 months (52 weeks) following HCV RNA testing. 
6. 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;   
7. 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) following point-of-care HCV 
antibody testing with reflex HCV RNA testing in those who are HCV antibody detectable 
who received HCV treatment. 
8. To evaluate the proportion of participants who are HCV RNA negative at 12 months (52 
weeks) following HCV RNA testing. 
9. To evaluate the cost-effectiveness of this testing strategy. 
 
4. Participant population 
Participants will be included from settings that provide services to people with a risk factor for the 
acquisition of HCV infection, including drug treatment clinics, needle and syringe programs, 
prisons, mobile outreach services, community health services, mental health services, 
homelessness services, and other appropriate settings nationally. It is anticipated approximately 
40,000 participants will be screened for HCV infection using point-of-care HCV testing.   
 
Inclusion criteria 
Participants are eligible for inclusion if the following criteria are met: 
a. Provide informed consent 
b. ≥ 18 years of age. 
 
Exclusion criteria 
b. Is unable or unwilling to provide informed consent  
 
5. Study design 
This is an observational cohort study. Participants will attend a single visit where they will provide 
informed consent and receive point-of-care HCV testing. All other study procedures will comprise 
data collection only. 
 
Participants will be offered treatment as standard of care. Participants who are HCV RNA 
detectable will also be linked to standard of care for any other clinical assessments and treatment 

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initiation, and local health staff may provide counselling and medical advice for these tests, and 
link participants with support services available in their state or territory.  
Participants who return to the same site at a later date and require further HCV testing (as standard 
practice or due to a risk factor) can do so through the study without having to consent and enrol 
again. There is no time restrictions for when participants can receive another test, this is dependent 
on the individual case.  
 
6. Treatment of participants 
No treatment will be prescribed as a part of this study.  
 
7. Study procedures 
7.1 Visits and Procedures  
All participants receiving HCV testing at the participating sites will be identified. Site staff will 
discuss the research study will participants, and written or verbal consent will be obtained. If written 
consent, the participant will date and sign the participant information sheet and consent form 
together with the data and signature of the person conducting the consent discussion. If verbal 
consent is utilised the person conducting the consent will sign the verbal consent form to confirm 
that the study has been explained to the participant and consent has been given. A copy of the 
signed participant information and consent form will then be offered to the participant. Participants 
will then undergo HCV point-of-care testing. Further study procedures will comprise data collection 
at Week 12 and Week 52 only.  
 
For participants who have previously been told they have HCV infection, or for people who have 
previously received HCV treatment, testing will be performed using point-of-care HCV RNA testing 
via Xpert HCV Viral Load Fingerstick assay using the GeneXpert machine (results in one hour). 
For all other participants who have not previously been told they have HCV infection nor have 
previously received HCV treatment, testing will be performed using point-of-care HCV antibody 
testing (results within 20 minutes). If the result is HCV antibody positive, individuals will undergo 
reflex HCV RNA testing. Where possible, the HCV RNA test will be performed via Xpert HCV Viral 
Load Fingerstick assay using the GeneXpert machine. If not available, HCV RNA testing will be 
performed via other standard of care methods. 
 
The following participant information will be collected as part of this study, from the participating 
sites existing medical records available at the site, by site staff: 
• 
Name code 
• 
Aboriginal and Torres Strait Islander status 
• 
Gender 
• 
Age 
• 
Medical Record Number 
• 
HCV testing and status  

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Additional data collection for HCV RNA positive patients only: 
• 
Previous HCV treatment 
• 
HIV testing and status 
• 
HBV testing and status 
• 
HCV treatment regimen prescribed 
• 
HCV treatment proposed duration 
• 
HCV treatment start and end date 
• 
Treatment completion (including reasons for not completing treatment) 
• 
Treatment outcome (including reasons for not responding to treatment) 
 
Additionally, a record of the overall number of patients who declined an HCV RNA test will be 
obtained from sites that record this data. 
 
Assessment 
/ 
Procedure 
HCV Testing 
Data 
Review* 
(Week 12) 
Data Review* 
(Week 52) 
Provide 
informed 
consent 
X 
 
 
Basic 
demographics 
X 
 
 
Finger-stick 
point-
of-care HCV testing  
X 
 
 
Treatment uptake 
 
X 
X 
Treatment outcome 
 
X 
X 
HCV RNA status 
 
 
X 
HIV/HBV 
testing 
and status 
 
 
X 
*Data review of medical records for patients who are HCV RNA detectable only 
 
7.2 Study case report forms (CRFs) 
Electronic case report forms will be completed for each participant to capture study specific 
information. Data will be collected through electronic case report forms designed for this study and 
through secure IT/connectivity solutions designed for the transmission of testing results.  
 
7.3 Process evaluation  
Process outcomes will be tracked via our central point-of-care test database that captures 
deidentified individual patient and quality management electronic test results from the GeneXpert 

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platform (includes valid/invalid results). Using connectivity software, data are captured in real-time, 
cleaned and analysed to generate process outcomes, displayed on our internal dashboard, and 
available for real-time reporting. We will evaluate the proportion of tests with an invalid/error/no 
result (usually <5% but an important indicator of problems with point-of-care testing procedures 
and prompt review of training). We record the numbers of staff trained (initial and refresher 
courses), and frequency/outcomes of quality assurance/competency testing.  
 
8. Statistics 
8.1 Primary outcome 
The proportion of HCV RNA detectable participants who initiate HCV treatment within 12 weeks of 
HCV RNA testing. 
 
8.2 Sample size 
Overall, 40,000 point-of-care HCV tests will be performed in different settings as part of the 
Australian National HCV Point-of-care Testing Program. It is estimated that the HCV prevalence 
will be 15% (n=6,000 people who are HCV RNA detectable) and the treatment uptake following 
testing will be 65% (n=3,900). Under these assumptions, the 95% confidence intervals around the 
estimate for HCV treatment uptake will be 64.0%-66.0% and for HCV RNA prevalence will be 
14.7%-15.4%. For analyses evaluating factors associated with HCV treatment uptake, we will have 
90% power to detect an odds ratio of 1.20 or greater (alpha=0.05) for a variable that is 50% 
prevalent (i.e. recent injecting drug use).   
 
Analysis will follow the STROBE guidelines for observational studies. The analysis of the primary 
outcome will occur when all patients have completed 12 weeks of follow-up (from enrolment) or 
have been permanently lost to follow-up. Participant flow will be summarised, showing the numbers 
of participants included. The primary endpoint will be the proportion of participants who initiate HCV 
treatment within 12 weeks of HCV RNA testing. The secondary endpoints will be: 
• 
Proportion of people who accept point-of-care testing among those offered testing. 
• 
Proportion of people who are HCV RNA detectable among people tested.  
• 
Time to HCV treatment uptake following finger-stick point-of-care HCV antibody testing 
with reflex HCV RNA testing among people who receive treatment. 
• 
Proportion of HCV RNA detectable participants who initiate HCV DAA treatment at 12 
months (52 weeks) following enrolment. 
• 
Proportion of participants who complete HCV direct-acting antiviral (DAA) treatment. 
• 
Proportion of participants who achieve an SVR (defined as HCV RNA below the lower limit 
of quantitation at post treatment week 12). 
• 
To evaluate the proportion of HCV RNA detectable participants who are HCV RNA negative 
at 12 months (52 weeks) following finger-stick point-of-care HCV antibody testing with 
reflex HCV RNA testing. 
• 
Cost-effectiveness of different testing strategies. 

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Participant characteristics at baseline will be summarised. Factors hypothesised to be associated 
with treatment initiation within 12 weeks of testing will be determined a priori and will include age, 
gender, Aboriginal and Torres Strait Islander status, and geography. Logistic regression will be 
used to assess factors associated with treatment initiation. Secondary analyses will be performed 
on these outcomes with stratified analyses performed where possible. 
 
A detailed statistical analysis plan will be developed towards completion of the study, and prior to 
analyses being performed. 
 
9. Data collection, source documents and record retention 
The Principal Investigator and the institution where the study will be conducted will permit study-
related monitoring, audits and ethics committee review providing direct access to source 
documents. Flinders University, NSW Pathology (NSW study sites) and Cepheid may also request 
to conduct an audit or inspection at sites. Prior to this they would seek permission from the site to 
access study related records physically at site.  
 
Data will be collected on study specific electronic or paper copy case record forms. The Principal 
Investigator is responsible for ensuring the data collected are complete, accurate and recorded in 
a timely manner. 
 
Data will be collected in a de-identified format and submitted to the Kirby. All data will be stored in 
the secure study database, RedCap, and will be kept on a secure password protected server 
hosted by UNSW Sydney, until its destruction. Only approved site staff and study staff, will have 
access to this data. Site staff will be responsible for collecting and entering the data for their site, 
and will only have access to the study data collected at their own site. 
 
De-identified data collected from this research project may be used in future research projects 
following separate review and approval from a Human Research Ethics Committee (HREC).  
 
The informed consent forms will be stored at site level according to the site’s local process, and in 
accordance with ICH-GCP guidelines. Archiving and subsequent secure destruction of the 
informed consent forms and other study specific documents at site level are the responsibility of 
the Principal Investigator. When the period for archiving has elapsed, sites will be notified by the 
Sponsor, UNSW Sydney, to securely destroy the documents in accordance with ICH-GCP 
guidelines. 
 
10.1 Submission of data 
Electronic CRFs: Following each participant HCV test or medical record review, the designated site 
staff will complete the visit specific CRF. Once all required information is received the CRF shall 

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be considered complete. Project Team staff will then monitor the data for completeness and 
accuracy. Any CRF discrepancies, either manual or automatic, will be addressed with the site staff 
for clarification. 
 
The site Principal Investigator is responsible for ensuring the completion of accurate source 
documentation to support data collected on case report forms.  
 
It is not acceptable for the CRF to be the only record of study participation and progress must also 
be recorded in each participant’s medical record. This is to ensure that anyone accessing the 
medical record has adequate knowledge that the participant is a clinical trial participant. 
 
Any document that acts as a source document (the point of the initial recording of a piece of data) 
should have evidence of who the person recording or reviewing the data is. Persons completing 
the source documents must be listed as a site staff member. 
 
The sponsor’s monitor might visit sites to conduct monitoring. Flinders and/or Cepheid may also 
visit the sites to access study related documents.  
 
The Principal Investigator is responsible for retaining all essential documents listed in ICH Good 
Clinical Practice guidelines. These must be organised in a comprehensive filing system that is 
accessible to study monitors and other relevant personnel. 
 
10.2 Archiving 
The Principal Investigator is responsible for ensuring all study documents are retained for a 
minimum of 7 years or as per local site guidelines, whichever is longer, following completion and 
publication of the study. 
 
11. Ethics committee/regulatory approval  
The sponsor is responsible for ensuring regulatory approval for the study is obtained where 
required. 
 
The site Principal Investigator is responsible for obtaining IRB/EC approval for the protocol in 
compliance with local regulatory requirements prior to entering any participant into the study. The 
approval letter/document must clearly identify the protocol and all documents approved by the 
IRB/IEC including version number & date of the protocol. A copy of the approval document must 
be sent to the study sponsor.  
 
The site Principal Investigator must also obtain approval for any amendments to the protocol. The 
Principal Investigator must comply with all IRB/IEC reporting requirements for all adverse events, 

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annual updates and end of study reports and must agree to abide by any IRB/IEC conditions of 
approval. 
 
The site Principal Investigator (or designee) is responsible for ensuring freely-given consent is 
obtained from each potential participant prior to the conduct of any protocol-specific procedures. 
The Principal Investigator may delegate the task of obtaining consent to appropriately qualified 
Sub-investigator(s). 
 
Consent for this study will occur either via hardcopy or verbal consent, depending on the 
site/participant preference. If hardcopy, the participant will date and sign the participant information 
and consent form together with the date and signature of the person conducting the consent 
discussion. If verbal consent is utilised the person conducting the consent will sign the verbal 
consent form to confirm that the study has been explained to the participant and consent has been 
given. 
 
For hardcopy consent, if the participant is illiterate, an impartial witness should be present during 
the entire consent discussion. Once the discussion is complete, the participant must sign and date 
the informed consent form, if capable. The impartial witness must also sign and date the consent 
form along with the person who conducted the consent discussion. 
 
A copy of the participant information and consent form will be offered to the participant, either 
hardcopy or electronic copy (via email or SMS) to keep. The participant must be informed in a 
timely manner of any new information that becomes available during the course of the study that 
may affect their willingness to continue study participation. 
 
This study shall be conducted in accordance with the ethical principles laid out in the Declaration 
of Helsinki (most current issued version) and the National Statement on Ethical Conduct in 
Research Involving Humans (most current issued version). 
 
12. Confidentiality of data 
By signing the Clinical Trial Agreement, the site Principal Investigator affirms to the sponsor that 
information provided to them by the sponsor will be maintained in confidence and divulged only as 
necessary to the ethics committee and institution employees directly involved in the study. Both 
ethics committee members and employees must also understand the confidentiality requirements 
for any information divulged to them. The data generated by this study will be considered 
confidential, except where it is included in a publication as agreed in the publication policy of this 
protocol. 
 

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All patient data will be stored in a de-identified form and individuals will only be identified 
by a study number and age. Data will be stored in a secure location for a minimum of 7 years, or 
as per local site guidelines, whichever is longer. 
 
Data confidentiality will be maintained at all times and no documents containing the participating 
institution’s name or other identifying information will be made publicly available. 
 
13. Governance 
The study is sponsored by UNSW and coordinated through the Kirby Institute. It is funded by the 
Commonwealth Government, the National Health and Medical Research Council, and NSW Health. 
The Kirby Institute has established governance and implementation structures which use resources 
efficiently to deliver program objectives on schedule. 
 
14. Quality Control (QC) and Quality Assurance (QA) 
The sponsor agrees to be responsible for implementing and maintaining quality control and quality 
assurance systems with written standard operating procedures to ensure the study is conducted 
and data are generated, documented and reported in compliance with the protocol, Good Clinical 
Practice standards and all applicable local laws and regulations relating to the conduct of a clinical 
trial. 
 
15. Publication Policy 
The results of this study may be published and presented at scientific meetings. Publication of data 
derived from this protocol will be governed by the Project Team. All published data will be non-
identifiable group data.  
 
 

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17. List of References 
1. 
Sievert W, Razavi H, Estes C, Thompson AJ, Zekry A, Roberts SK, Dore GJ. Enhanced 
antiviral treatment efficacy and uptake in preventing the rising burden of hepatitis C-related 
liver disease and costs in Australia. J Gastroenterol Hepatol 2014;29 Suppl 1:1-9. 
2. 
Commonwealth of Australia. Fourth National Hepatitas C Strategy 2014–2017. Canberra, 
Australia: Commonwealth of Australia 2014. 
3. 
NSW Ministry of Health. NSW Hepatitis Strategy 2014-2020. Sydney, Australia: NSW 
Ministry of Health; 2014. 
4. 
Grebely J, Hajarizadeh B, Dore GJ. Direct-acting antiviral hepatitis C therapy for people 
who inject drugs. Nat Rev Gastroenterol Hepatol 2017;In Press. 
5. 
The Kirby Institute. Annual Surveillance Report on HIV, viral hepatitis and STIs in 
Australia 2017: The Kirby Institute; 2017. 
6. 
Meyer JP, Moghimi Y, Marcus R, Lim JK, Litwin AH, Altice FL. Evidence-based interventions 
to enhance assessment, treatment, and adherence in the chronic Hepatitis C care 
continuum. Int J Drug Policy 2015;26:922-935. 
7. 
Grebely J, Applegate TL, Cunningham P, Feld JJ. Hepatitis C point-of-care diagnostics: in 
search of a single visit diagnosis. Expert Rev Mol Diagn 2017; 17(12): 1109-15. 
8.  
Grebely J, Lamoury FMJ, Hajarizadeh B, et al. Evaluation of the Xpert HCV Viral Load 
point-of-care assay from venepuncture-collected and finger-stick capillary whole-blood 
samples: a cohort study. Lancet Gastroenterol Hepatol 2017; 2(7): 514-20. 
9.  
Lamoury FMJ, Bajis S, Hajarizadeh B, et al. Evaluation of the Xpert HCV Viral Load 
Finger-Stick Point-of-Care Assay. J Infect Dis 2018; 217(12): 1889-96. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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18. Abbreviations List 
 
CRF 
Case Report Form 
DAA 
Direct Acting Antiviral 
HCV 
Hepatitis C Virus 
IRB 
Institutional Review Board (Human Research Ethics Committee) 
PWID 
People Who Inject Drugs 
POCT 
Point of Care Testing 
RNA 
Ribonucleic Acid