Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001517763
Ethics application status
Approved
Date submitted
30/11/2022
Date registered
6/12/2022
Date last updated
6/12/2022
Date data sharing statement initially provided
6/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised comparison of the impact of different Communication Strategies For COVID-19 Rapid Antigen Self-Tests.
Scientific title
Randomised comparison of the impact of different Communication Strategies provided in COVID-19 Rapid Antigen Self-Tests on decisions to self-isolate and take other preventative measures.
Secondary ID [1] 308525 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 328351 0
Condition category
Condition code
Infection 325390 325390 0 0
Other infectious diseases
Respiratory 325435 325435 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to one of three options: intervention; usual care or control.

The intervention combines (1) health literacy sensitive design version of the Flowflex rapid antigen test (RAT) for the detection of COVID-19 infection instructions and (2) diagnostic accuracy information from a population based study of the Flowflex RAT.
(1) Health-literacy sensitive instructions
RAT instructions have been refined to make the intervention more readable and understandable for everyone, including people with lower health literacy status. This was achieved through the use of simple language, colourful icon arrays and evaluation using the Sydney Health Literacy Lab Health Literacy Editor (Ayre et al., 2021).
(2) Diagnostic accuracy information.
The instructions include the diagnostic accuracy information reported in the population-based study of the Flowflex RAT (Schuit et al 2022) where participants performed self-testing themselves (rather than a health professional performing the test).

Usual care: comparator instructions are the routinely included Flowflex RAT instructions and diagnostic accuracy information provided in the Flowflex RAT kit by the manufacturer.

Control: no instructions provided

We estimate that it will take approximately 5 minutes for participants in the intervention and usual care groups to read the instructions (no instructions for control group). The instructions are static but have been optimised for viewing on a mobile phone screen.

The intervention will be delivered once online, as part of an online survey. Participants in each of the 3 randomised groups will be asked to read through the materials for the condition they have been allocated to, and to imagine they are in 5 different hypothetical scenarios. For example: "Imagine you have been unwell with symptoms including headache, sore throat, fever, runny nose, and loss of taste and smell. Would you do a RAT?"
Participants are then asked to answer the survey questions about whether they think they are infected with COVID-19, whether they are still infectious, and what (if any) preventative actions they would take.

Adherence will be measured using survey analytics and participants who complete the survey too quickly (defined as faster than the top 10% of completion time in the pilot testing) will be excluded. This is because very fast responders may not have read the intervention materials or survey questions and may provide unreliable data
Intervention code [1] 324966 0
Behaviour
Comparator / control treatment
Control group: no information will be provided on interpreting the RAT results or the diagnostic accuracy of the test.

Participants in both this group will respond to questions based on the same hypothetical scenarios outlined for the intervention and usual care groups.
Control group
Active

Outcomes
Primary outcome [1] 333248 0
The proportion of participants who intend to self-isolate in each of the five scenarios will be assessed using a study specific question about intention to isolate. Results for intention to self-isolate will be dichotomised into complete and partial self-isolation.
Timepoint [1] 333248 0
After randomisation
Secondary outcome [1] 416326 0
The proportion of participants who would report the test result for each of the 5 scenarios will be assessed using a study-specific survey.
Timepoint [1] 416326 0
After randomisation
Secondary outcome [2] 416327 0
Participants’ estimates of the probability of being infected by COVID-19 in each scenario, measured with a 5-point categorical scale (very unlikely, unlikely, neither likely nor unlikely, likely, and very likely) and a numeric scale (from 0 [no chance] to 100 [definitely infected]) collected using a study specific survey.
Timepoint [2] 416327 0
After randomisation
Secondary outcome [3] 416328 0
Participant evaluation of readability of materials assessed using 5 categories (very difficult, difficult, neutral, easy and very easy) collected using a study specific survey.
Timepoint [3] 416328 0
After randomisation
Secondary outcome [4] 416329 0
Content analysis of additional free text responses provided by participants and addressing reasoning behind their choices will be collected in a study specific survey.
Timepoint [4] 416329 0
After randomisation
Secondary outcome [5] 416541 0
The proportion of participants who would undergo repeat testing for each of the 5 scenarios will be assessed using a study-specific survey.
Timepoint [5] 416541 0
After randomisation
Secondary outcome [6] 416542 0
The proportion of participants who would avoid visiting people at higher risk of developing complications from COVID-19 (such as older people) for each of the 5 scenarios will be assessed using a study-specific survey.
Timepoint [6] 416542 0
After randomisation
Secondary outcome [7] 416543 0
The proportion of participants who would avoid crowds for each of the 5 scenarios will be assessed using a study-specific survey.
Timepoint [7] 416543 0
After randomisation
Secondary outcome [8] 416544 0
The proportion of participants who would avoid keep 1.5m away from others for each of the 5 scenarios will be assessed using a study-specific survey.
Timepoint [8] 416544 0
After randomisation
Secondary outcome [9] 416545 0
The proportion of participants who would wash hands more frequently for each of the 5 scenarios will be assessed using a study-specific survey.
Timepoint [9] 416545 0
After randomisation
Secondary outcome [10] 416546 0
The proportion of participants who would wear a mask for each of the 5 scenarios will be assessed using a study-specific survey.
Timepoint [10] 416546 0
After randomisation

Eligibility
Key inclusion criteria
Resides in Australia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals will be excluded if they have participated in pilot testing of the intervention or completed the survey too quickly (defined as faster than the top 10% of completion time in the pilot testing) This is because very fast responders may not have read the intervention materials or survey questions and may provide unreliable data.


Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed as randomisation will be conducted centrally by a third party. (Qualtrics)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using Qualtrics survey software (Qualtrics, Provo, UT)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was calculated assuming a similar proportion of people will choose to self-isolate in the control and usual care conditions as was observed in a similar study (Woloshin 2022). We estimated a sample size of 225 participants with 75 participants per group which would provide 80% power to detect a pairwise difference in the proportion choosing to self-isolate as small as 10%. The assumptions are a 10% dropout rate, a = 0.05, the normal approximation to the binomial distribution, and the standard formula for comparing proportions in independent equal-sized groups.
We will use an intention to treat approach (ITT) to estimate the effects of the two interventions, by comparing outcomes across randomised groups. We will estimate unadjusted and adjusted effects using multivariable regression models to increase precision of estimates. Covariates will be measured through the baseline questionnaire and include prior COVID-19 infection and recent testing experience of the participants. The effects of participants’ health literacy on intervention effects will also be explored. We will use logistic regression for binary outcomes, linear regression for continuous outcomes and Poisson regression for count outcomes. Qualitative (thematic) analysis will be used to analyse free-text answers in the surveys.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/12/2022
Actual
Date of last participant enrolment
Anticipated
19/12/2022
Actual
Date of last data collection
Anticipated
19/12/2022
Actual
Sample size
Target
225
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 312764 0
Government body
Name [1] 312764 0
NHMRC Investigator Grant #1174523
Country [1] 312764 0
Australia
Primary sponsor type
University
Name
Sydney School of Public Health, The University of Sydney
Address
Edward Ford Building A27
The University of Sydney
Camperdown NSW 2006 Australia
Country
Australia
Secondary sponsor category [1] 314397 0
None
Name [1] 314397 0
Address [1] 314397 0
Country [1] 314397 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312064 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 312064 0
Ethics committee country [1] 312064 0
Australia
Date submitted for ethics approval [1] 312064 0
15/08/2022
Approval date [1] 312064 0
08/09/2022
Ethics approval number [1] 312064 0
2022/419

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

Contacts
Principal investigator
Name 123334 0
A/Prof Katy Bell
Address 123334 0
Rm 101 Edward Ford Building A27
The University of Sydney
Camperdown NSW 2006 Australia
Country 123334 0
Australia
Phone 123334 0
+61293514823
Fax 123334 0
Email 123334 0
[email protected]
Contact person for public queries
Name 123335 0
Katy Bell
Address 123335 0
Rm 101 Edward Ford Building A27
The University of Sydney
Camperdown NSW 2006 Australia
Country 123335 0
Australia
Phone 123335 0
+61293514823
Fax 123335 0
Email 123335 0
[email protected]
Contact person for scientific queries
Name 123336 0
Katy Bell
Address 123336 0
Rm 101 Edward Ford Building A27
The University of Sydney
Camperdown NSW 2006 Australia
Country 123336 0
Australia
Phone 123336 0
+61293514823
Fax 123336 0
Email 123336 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All non-identifiable participant data will be made available to other researchers to maximise the benefits that can be derived from the data. A data dictionary and code book will be available. It will be made available in Excel format either .csv or .xlsx format.
When will data be available (start and end dates)?
Data will be available from within 12 Months of final publication of all study results until 15 years after trial completion.
Available to whom?
Data will be made available on a case by case basis at the discretion of the Coordinating Principal Investigator, Associate Professor Katy Bell.
Available for what types of analyses?
Data will be made available on a case by case basis at the discretion of the Coordinating Principal Investigator, Associate Professor Katy Bell.
How or where can data be obtained?
Access to the data will be arranged by contacting the Coordinating Principal Investigator, Associate Professor Katy Bell by email at [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17740Study protocol    The protocol will be published on the Open Science... [More Details]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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