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Trial registered on ANZCTR


Registration number
ACTRN12624000219583
Ethics application status
Approved
Date submitted
18/01/2024
Date registered
5/03/2024
Date last updated
5/03/2024
Date data sharing statement initially provided
5/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness, acceptability and feasibility of offering Hepatitis C testing to adults attending community laboratories
Scientific title
A pilot to assess the effectiveness, acceptability and feasibility of two models of verbal consent for Hepatitis C testing at community laboratory collection sites in the Northern Region
Secondary ID [1] 311324 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 332575 0
Condition category
Condition code
Infection 329272 329272 0 0
Other infectious diseases
Public Health 329330 329330 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is testing obtaining verbal consent by the phlebotomist for screening for Hepatitis C virus (HCV) infection in community laboratory settings.

Staff at the study sites will undergo training prior to the start of the study and be asked to attend a 1 hour workshop conducted by the study project and clinical leads which 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 participant information sheets made available for the two weeks preceding the study and during the study period at each collection site. A free phone number will be provided for participants wanting more information about the study to be able to discuss this 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 sites (community laboratories) during the 2 week study period. The consent process is documented on a study form for each potential participant.

A small number of potential participants will be approached via phone call and verbal consent obtained by a research assistant to participate in a phone interview (a single 10-15 minute discussion) about their experience of being offered hep C testing in a community laboratory setting.

Laboratory staff (phlebotomists and laboratory leadership) will be offered the opportunity to participate 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 in staff workplaces and will be a single 30-60 minute discussion.

Fidelity to the intervention will be assessed using the study form which records who obtained consent at each study site and records of attendance at the study site during the study period provided by the laboratory.

Study Procedure for those tested:
A separate blood tube will be collected for participants that verbally consent, this allows the sample to be processed separately and the results managed separately by the study clinical results management team. All results will be returned to participants by study staff. Any participant that has a positive test will be counselled, assessed, and offered treatment for HCV as indicated by their test results. Participants with chronic HCV infection detected will be offered the option of being treated by their own primary care provider, another community provider, or the study team clinicians. All treatment for HCV in New Zealand is fully funded and free of charge to the patient.
Intervention code [1] 327766 0
Early detection / Screening
Comparator / control treatment
The comparator group is consent for screening for Hep C obtained by a research assistant in a community laboratory setting. Research assistants will undergo training prior to the start of the study and be asked to attend a 1 hour workshop conducted by the study project and clinical leads which 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 research assistant in the waiting area. Potential participants attending a study site (community laboratories) during the 2 week study period will be offered the opportunity to participate. The consent process is documented on a study form for each potential participant.

Research assistants and other study staff will be offered the opportunity to participate focus groups to share their experience of the acceptability and feasibility of the intervention. Consent for focus group participation will be obtained by the project lead and documented. Focus groups will be offered in study staff workplaces and will be a single 30-60 minute discussion.

Fidelity to the comparator group will be assessed using the study form which records who obtained consent at each study site and records of attendance at the study site during the study period provided by the laboratory.

Control group
Active

Outcomes
Primary outcome [1] 337091 0
To determine effectiveness of two models of verbal consent for Hepatitis C screening
Timepoint [1] 337091 0
Time taken to achieve 400 consents to Hep C blood tests (expected 2 week period)
Primary outcome [2] 337288 0
To determine acceptability of two models of verbal consent for Hepatitis C screening
Timepoint [2] 337288 0
Time taken to achieve 400 consents to Hep C blood tests (expected 2 week period)
Primary outcome [3] 337290 0
To determine feasibility of two models of verbal consent for Hepatitis C screening
Timepoint [3] 337290 0
During the two week study period (or the time it takes for 400 consents to be obtained)
Secondary outcome [1] 430648 0
Hepatitis C infection detection rate
Timepoint [1] 430648 0
4 weeks after receiving verbal consent
Secondary outcome [2] 431346 0
Laboratory site staff perspectives (phlebotomists and laboratory leadership)
Timepoint [2] 431346 0
2 weeks after all focus group discussions.
Secondary outcome [3] 431347 0
Acceptability of consent for hep C testing in community laboratory among those who decline testing
Timepoint [3] 431347 0
2 weeks after declining hep C testing
Secondary outcome [4] 431348 0
Acceptability of consent for hep C testing in community laboratory among those who consent to testing
Timepoint [4] 431348 0
4 weeks after receiving verbal consent to testing
Secondary outcome [5] 431349 0
Study staff perspectives including research assistants, clinicians,
Timepoint [5] 431349 0
2 weeks after all focus group discussions.

Eligibility
Key inclusion criteria
Adults 35 years and older attending one of the study sites for blood collection
Minimum age
35 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
people under 35 years of age, inability to consent

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)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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
Anticipated sample size of 1600 participants assuming a 25% consent rate. Study will end once 300-400 participants are tested for HCV (estimated study period is 2 weeks). This includes 10-15 participants who declined testing for phone interview regarding decline. Study and collection centre staff will be interviewed for their perspectives.

Data analysis will be undertaken by co-investigators to examine key outcome measures as described in the study’s research objectives:
• proportion of people who consent / decline by verbal consent method
• demographic characteristics of people who decline

Qualitative analysis of feedback from laboratory and research staff and those who decline/withdraw will also be performed:
• Key themes from focus groups with staff
• Participant feedback survey
• Reasons given for decline
Costs, time and other feasibility issues will be identified from the focus groups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/04/2024
Actual
Date of last participant enrolment
Anticipated
3/06/2024
Actual
Date of last data collection
Anticipated
3/06/2024
Actual
Sample size
Target
1600
Accrual to date
Final
Recruitment outside Australia
Country [1] 26080 0
New Zealand
State/province [1] 26080 0
Auckland and Northland

Funding & Sponsors
Funding source category [1] 315575 0
Government body
Name [1] 315575 0
Te Whatu Ora Northern Region Laboratory Innovation Programme
Country [1] 315575 0
New Zealand
Funding source category [2] 315577 0
Government body
Name [2] 315577 0
Te Whatu Ora Service Innovation and Improvement
Country [2] 315577 0
New Zealand
Primary sponsor type
Government body
Name
Te Whatu Ora Service Innovation and Improvement
Address
74 Taharoto Road, Takapuna, Auckland, 0622
Country
New Zealand
Secondary sponsor category [1] 317670 0
Commercial sector/Industry
Name [1] 317670 0
Awanui Group
Address [1] 317670 0
37-41 Carbine Rd, Mt Wellington, Auckland 1060
Country [1] 317670 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314473 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 314473 0
133 Molesworth St, Wellington 5013
Ethics committee country [1] 314473 0
New Zealand
Date submitted for ethics approval [1] 314473 0
06/11/2023
Approval date [1] 314473 0
11/01/2024
Ethics approval number [1] 314473 0
EXP 17876

Summary
Brief summary
This project is designed as a pilot study that will provide insights into the feasibility, acceptability and best approach for using verbal
consent in a laboratory setting to inform a larger scale hepatitis C screening programme.
Policy Objectives
The project is conducted within a framework of assessing the feasibility, acceptability and effectiveness of two models of verbal consent for hepatitis C screening in the general population of the Northern region. This project sits within the wider regional and
national hepatitis C elimination strategy.

Primary Research Objective:
To determine effectiveness of two models of verbal consent for hepatitis C screening (measured by proportion of people who consent, decline, or withdraw).

Secondary Research Objectives:
To determine the feasibility and acceptability of utilising verbal consent for hepatitis C screening
Trial website
Trial related presentations / publications
Public notes
Waiver of consent has been sought and approved by the ethics committee to access demographic data for all adults attending a study site for laboratory testing during the study period and used to calculate consent, decline, and withdrawal rates.

Contacts
Principal investigator
Name 131706 0
Dr Karen Bartholomew
Address 131706 0
Te Whatu Ora Waitemata, 74 Taharoto Road, Takapuna, Auckland 0622
Country 131706 0
New Zealand
Phone 131706 0
+64 0212115629
Fax 131706 0
Email 131706 0
[email protected]
Contact person for public queries
Name 131707 0
Karen Bartholomew
Address 131707 0
Te Whatu Ora Waitemata, 74 Taharoto Road, Takapuna, Auckland 0622
Country 131707 0
New Zealand
Phone 131707 0
+64 0212115629
Fax 131707 0
Email 131707 0
[email protected]
Contact person for scientific queries
Name 131708 0
Karen Bartholomew
Address 131708 0
Te Whatu Ora Waitemata, 74 Taharoto Road, Takapuna, Auckland 0622
Country 131708 0
New Zealand
Phone 131708 0
+64 0212115629
Fax 131708 0
Email 131708 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.