Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000475448
Ethics application status
Approved
Date submitted
2/05/2025
Date registered
16/05/2025
Date last updated
16/05/2025
Date data sharing statement initially provided
16/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness, acceptability and feasibility of offering Hepatitis C testing to adults attending community laboratories in New Zealand
Scientific title
The effectiveness, acceptability, and feasibility of two models of verbal consent for Hepatitis C testing at community laboratory collection sites across New Zealand.
Secondary ID [1] 314347 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is a national study following on from a pilot study in 2024 with the following ANZCTR Registration number: ACTRN12624000219583.

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 337326 0
Condition category
Condition code
Infection 333710 333710 0 0
Other infectious diseases
Public Health 333711 333711 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group is offering Hepatitis C virus (HCV) testing by a community laboratory phlebotomist working in a community laboratory collection centre (study site) with documented verbal consent.

Staff at the study site will undergo training prior to the start of the study which will be a 1-hour workshop conducted by the study project and clinical leads. This training will cover the purpose of the study, study procedures, informed consent, and study documentation.

Potential study participants will be informed about the study through posters and patient information sheets made available for the two weeks preceding the study and during the study before at each study site. A free phone number will be provided for potential participants wanting more information about the study to be able to discuss with the study team,

Verbal consent will be obtained during a brief face-to-face interaction with a phlebotomist to potential participants attending a study site during the 2-week study period. The consent process is documented on a study form for each potential participant.

Attendees who decline HCV testing will be offered the opportunity to provide feedback on their experience of the study through an online survey, a one-time offer of participation will be made via text message with a link to the online survey.

Laboratory staff [phlebotomists and leadership) will be offered the opportunity to participate in focus groups to share their experience of the acceptability and feasibility of the intervention. Consent for focus group participation will be obtained by a research assistant and documented. Focus groups will be offered via videoconference and be a single 30–60-minute discussion,

Fidelity to the intervention will be assessed using the study form which records who obtained the consent and attendance records for the study period provided by the community laboratory provider.

Study procedure for those tested:
Separate blood tubes will be collected for participants who consent to HCV testing, allowing the study samples to be processed separately and results managed by the study clinicians. All results will be returned to participants by study staff. Any participant that has a positive HCV test will be counselled, assessed and offered treatment for HCV as indicated by their test results. Participants with chronic HCV infection detected will be linked through to treatment with their own primary care provider, another community provider, or a Health New Zealand clinician. All treatment for HCV in New Zealand is fully funded and free of charge.

For participants tested as part of the study, the community laboratories will provide records of HCV testing since 1/1/2020 for analysis. Participants who were tested will be offered the opportunity to participate in an online survey about their experiences of the study.
Intervention code [1] 330960 0
Early detection / Screening
Comparator / control treatment
The comparator group is offering Hepatitis C virus (HCV) testing by a research assistant embedded in a community laboratory collection centre (study site) with documented verbal consent. Research assistants will undergo training prior to the start of the study which will be a 1-hour workshop conducted by the study project and clinical leads. This training will cover the purpose of the study, study procedures, informed consent, and study documentation.

Verbal consent will be obtained during a brief face-to-face interaction with a phlebotomist to potential participants attending a study site during the 2-week study period. The consent process is documented on a study form for each potential participant. All other study processes/procedures for attendees to a study site are as per the intervention group.

Research assistants and other study staff will be offered the opportunity to participate in focus groups to share their experience of the acceptability and feasibility of the intervention. Consent for focus group participation will be obtained by a research assistant and documented. Focus groups will be offered via videoconference and be a single 30–60-minute discussion,
Control group
Active

Outcomes
Primary outcome [1] 341304 0
Consent rate
Timepoint [1] 341304 0
Once at the end of the two-week recruitment period for each study site
Primary outcome [2] 341305 0
Decline rate
Timepoint [2] 341305 0
Once at the end of the two-week recruitment period for each study site
Primary outcome [3] 341306 0
Screened rate
Timepoint [3] 341306 0
Once at the end of the two-week recruitment period for each study site
Secondary outcome [1] 447076 0
Missed opportunity rate
Timepoint [1] 447076 0
Once at the end of the two-week recruitment period for each study site.
Secondary outcome [2] 447077 0
HCV prevalence
Timepoint [2] 447077 0
4 weeks after the participant was tested for HCV
Secondary outcome [3] 447078 0
Linkage to care rate
Timepoint [3] 447078 0
In the 6 months after the participant was tested for HCV
Secondary outcome [4] 447079 0
HCV treatment rate
Timepoint [4] 447079 0
In the 6 months after the participant was tested for HCV
Secondary outcome [5] 447080 0
Acceptability of being offered HCV testing at a community lab
Timepoint [5] 447080 0
In the 4 weeks after consenting to be tested for HCV
Secondary outcome [6] 447081 0
Reasons for declining testing
Timepoint [6] 447081 0
4 weeks after being invited to participate in an online decline survey
Secondary outcome [7] 447082 0
5-year testing history
Timepoint [7] 447082 0
HCV Testing between 1 Jan 2020 and the date of testing during the study
Secondary outcome [8] 447083 0
Laboratory staff perspectives
Timepoint [8] 447083 0
2 weeks after all focus groups are completed
Secondary outcome [9] 447084 0
Study staff perspectives (research assistants, study clinicians)
Timepoint [9] 447084 0
2 weeks after all focus groups are completed

Eligibility
Key inclusion criteria
Adults aged 16 years and older attending a study site during the recruitment period
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children aged <16 years
Inability to consent
Not eligible for publicly funded healthcare in New Zealand.
Already attending the laboratory for HCV testing

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was stratified by health districts. Sites were randomised in pairs across 9 districts. Sealed envelope randomisation was employed.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations estimate that at least 18 study sites (clusters), 9 in each group, are required to identify an 8% difference in consent rate between the intervention group and the comparator group, with the average cluster size being 1100, power of 80%, type I error rate at 0.05 and ICC (intra-cluster correlation coefficient) at 0.02. It means at least 9,582 participants per group or 19,164 eligible participants who may be offered a test in total for the two groups. This study aims to test 15,300 consented people (approx. 850 per site) so that HCV prevalence rate (a secondary outcome measure) can be estimated confidently as well. Assuming an 70% offer rate, and a 75% consent rate, approximately 20,400 people may be offered an HCV blood test of an estimated 29,100 attendees. To minimise unequal cluster sizes, the recruitment period will be adjusted based on usual attendance numbers and range from 5-10 working days. Recruitment will be monitored, and the recruitment period extended for sites where recruitment is slower.

Approximately 5,000 people who decline an HCV test will be offered an optional online decline survey, assuming a 5% participation rate, there will be an estimated 250 participants.

Approximately 80 laboratory staff and research assistants will be invited to participate in a 30-60 min focus group discussion.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/05/2025
Actual
Date of last participant enrolment
Anticipated
25/07/2025
Actual
Date of last data collection
Anticipated
31/10/2025
Actual
Sample size
Target
16000
Accrual to date
Final
Recruitment outside Australia
Country [1] 27028 0
New Zealand
State/province [1] 27028 0

Funding & Sponsors
Funding source category [1] 318865 0
Government body
Name [1] 318865 0
Te Whatu Ora Planning, Funding and Outcomes
Country [1] 318865 0
New Zealand
Primary sponsor type
Government body
Name
Te Whatu Ora Planning, Funding and Outcomes
Address
Country
New Zealand
Secondary sponsor category [1] 321325 0
None
Name [1] 321325 0
Address [1] 321325 0
Country [1] 321325 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317480 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 317480 0
Ethics committee country [1] 317480 0
New Zealand
Date submitted for ethics approval [1] 317480 0
11/03/2025
Approval date [1] 317480 0
02/04/2025
Ethics approval number [1] 317480 0
2025 EXP 22425

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141186 0
Dr Karen Bartholomew
Address 141186 0
Te Whatu Ora Waitemata, 74 Taharoto Road, takapuna, Auckland 0622
Country 141186 0
New Zealand
Phone 141186 0
+64 0212115629
Fax 141186 0
Email 141186 0
[email protected]
Contact person for public queries
Name 141187 0
Karen Bartholomew
Address 141187 0
Te Whatu Ora Waitemata, 74 Taharoto Road, takapuna, Auckland 0622
Country 141187 0
New Zealand
Phone 141187 0
+64 0212115629
Fax 141187 0
Email 141187 0
[email protected]
Contact person for scientific queries
Name 141188 0
Karen Bartholomew
Address 141188 0
Te Whatu Ora Waitemata, 74 Taharoto Road, takapuna, Auckland 0622
Country 141188 0
New Zealand
Phone 141188 0
+64 0212115629
Fax 141188 0
Email 141188 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.