Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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 registered on ANZCTR


Registration number
ACTRN12624000852550
Ethics application status
Approved
Date submitted
4/06/2024
Date registered
9/07/2024
Date last updated
9/07/2024
Date data sharing statement initially provided
9/07/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acceptability and feasibility of community (home-based) self-sampling of Australian adults with influenza-like illness: A pilot study
Scientific title
Acceptability and feasibility of community (home-based) self-sampling of Australian adults with influenza-like illness: A pilot study
Secondary ID [1] 312190 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
influenza 333859 0
Condition category
Condition code
Infection 330534 330534 0 0
Other infectious diseases
Public Health 330791 330791 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The iSwab study tests the feasibility and acceptability of community (home)-based self-swabbing for patients experiencing influenza-like-illness (ILI) (self-reported fever, cough, and fatigue).
Participating GPs will invite eligible patients to take an iSwab (self-swab) kit home, swab themselves, and return the swab, consent materials, and surveys about their experience by post. Participants will receive a $50 Prezzee gift card for completing the surveys and returning the swab.

The iSwab kit is a complete self-swab kit for patients to review and complete research material, conduct a deep nasal swab on themselves, place the swab in viral transport media, and return the swab to the pathology lab by Express post.

The iSwab kit contains:
- Participant informed consent information containing information about the study
- Consent form to complete to participate
- Written instructions for how to self-swab and return the swab via post
- Personal protective equipment (PPE) (gloves), a nasal swab, viral transport media tube to place the swab inside, and safe postal packaging
- Two surveys to complete to assess the feasibility and acceptability of the process
- Reply paid envelopes for the surveys and consent, and pre-paid express post envelopes the swab.

Reading the information, conducting the swab, and completing the surveys is expected to take 30 minutes, Participants are asked to complete the swab and study materials as soon as possible after receiving them. The swab can be returned up to two weeks after being taken (if the envelope is stored in the fridge). Travel time to the nearest Australia Post Express post box will depend on the participant's location.

Pathology results will be collected by the study team but will not be used to monitor adherence. Identifiable participant details will be collected only to send remuneration ($50 gift card).
Intervention code [1] 328744 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338437 0
Number of swabs returned
Timepoint [1] 338437 0
Within 14 days of patient receiving swab
Secondary outcome [1] 435935 0
Acceptability of home-swabbing
Timepoint [1] 435935 0
prior to and after swab

Eligibility
Key inclusion criteria
Patients over 16 years who:
1. are able to give informed consent, read and understand written instructions and deemed able to take a respiratory swab on themselves by their general practitioner.
AND
2. are identified as fitting the Australian Sentinel Practices Research Network (ASPREN) ILI case definition (cough, fever (self-reported) and fatigue with onset in the last 7 days) or World Health Organisation (WHO) ILI case definition (acute respiratory infection with a fever of greater than or equal to 38 C°, cough and onset within the last 10 days)
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children and patients who the general practitioner considers should not take part in the research study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
16/02/2022
Date of last participant enrolment
Anticipated
Actual
11/10/2023
Date of last data collection
Anticipated
Actual
13/10/2023
Sample size
Target
1000
Accrual to date
Final
468
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316564 0
Commercial sector/Industry
Name [1] 316564 0
Sanofi International
Country [1] 316564 0
France
Primary sponsor type
Individual
Name
Nigel Stocks
Address
Country
Australia
Secondary sponsor category [1] 318860 0
None
Name [1] 318860 0
Address [1] 318860 0
Country [1] 318860 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315352 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 315352 0
https://www.adelaide.edu.au/research-services/ethics-compliance-integrity/human-research-ethics/human-research-ethics-committee
Ethics committee country [1] 315352 0
Australia
Date submitted for ethics approval [1] 315352 0
20/02/2021
Approval date [1] 315352 0
25/05/2021
Ethics approval number [1] 315352 0
H-2021-077

Summary
Brief summary
This research study tests whether people, who are feeling unwell with an influenza-like illness, find swabbing themselves at home to be an acceptable method of detecting influenza and other viruses. Patients experiencing cough, fever, and fatigue will be provided with a home-swab kit by their GPs. After they swab themselves at home, patients will return the swab by post to the pathology provider, and answer survey questions about their experience.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134430 0
Prof Nigel Stocks
Address 134430 0
Discipline of General Practice, University of Adelaide, Level 8, 115 Grenfell Street, Adelaide SA 5000
Country 134430 0
Australia
Phone 134430 0
+61 8 8313 3462
Fax 134430 0
Email 134430 0
[email protected]
Contact person for public queries
Name 134431 0
Monique Chilver
Address 134431 0
ASPREN, University of Adelaide, Level 8, 115 Grenfell Street, Adelaide SA 5000
Country 134431 0
Australia
Phone 134431 0
+61 8 8313 3463
Fax 134431 0
Email 134431 0
[email protected]
Contact person for scientific queries
Name 134432 0
Monique Chilver
Address 134432 0
ASPREN, University of Adelaide, Level 8, 115 Grenfell Street, Adelaide SA 5000
Country 134432 0
Australia
Phone 134432 0
+61 8 8313 3463
Fax 134432 0
Email 134432 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.