Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000876897
Ethics application status
Approved
Date submitted
1/07/2021
Date registered
7/07/2021
Date last updated
7/07/2021
Date data sharing statement initially provided
7/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of enhanced messaging on COVID-19 testing intentions and behaviour.
Scientific title
Does a narrative-based animation or a fact-based animation increase COVID-19 testing intentions and behaviour in Australian citizens, compared to the current government information?
Secondary ID [1] 304671 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 322629 0
Condition category
Condition code
Public Health 320248 320248 0 0
Health promotion/education
Infection 320249 320249 0 0
Other infectious diseases
Respiratory 320250 320250 0 0
Other respiratory disorders / diseases
Mental Health 320305 320305 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a survey which will be conducted online through the Qualtrics platform. Participants will be recruited on social media (Facebook on Instagram) with an advertisement with the message ‘Over 18? We want to hear from you! Complete a short survey about COVID-19 and be in with the chance to win a $20 gift card’. If they click on the advert, participants will be directed to the landing page where they can read the PIS and Consent Form before accessing the survey.
The survey itself will be hosted on the survey platform Qualtrics, where it is possible to track adherence to the intervention, such that we can see at what point participants left the survey, if they did not complete it.
Participants will answer demographic questions and then will be randomised to receive one of two interventions or a control. This will take about 5 minutes to complete. Immediately following this, they will be asked our outcome questions, which will also take about 5 minutes to complete. Therefore the complete survey will take about 10 minutes in total.

Participants are told in the PIS that the results of the study will be posted on our website (https://sydneyhealthliteracylab.org.au).

INTERVENTIONS:
In a nationally representative survey our team ran in November 2020, we identified the most frequently identified reasons people had not to get a COVID-19 test, even if they had symptoms. Participants will be shown one of two animations which address the top barriers that were identified (I know what symptoms I have and don't believe they are COVID-19 ones e.g. hayfever/normal cold; I'm not sure my symptoms are bad enough; It is unlikely I have COVID-19 because there aren't many cases in my area; I’m not sure this symptom needs testing). In order to look at the best way to get across the message of getting tested for COVID-19, we will be comparing two animations, as well as comparing both of these against the control (so there are two intervention groups). One will be more direct focusing on the facts, and one based around a narrative. The fact-based animation directly addresses the barriers and describes to the listener why it is still important to get tested despite these barriers. The narrative animation is based around a story of two friends texting each other: one has mild symptoms of COVID-19 and thinks they should get tested, the other tries to convince them that they don’t need to. We have commissioned these animations through the website Fiverr, but haven’t got the final product yet.
Intervention code [1] 321033 0
Prevention
Intervention code [2] 321034 0
Behaviour
Comparator / control treatment
COVID-19 testing information on Australian Government website (NSW Health COVID-19 FAQ: https://www.health.nsw.gov.au/Infectious/covid-19/Pages/frequently-asked-questions.aspx#4 ).
Questions include ‘Is it safe to get tested for COVID-19?’ ‘Is COVID-19 testing painful?’ ‘Is COVID-19 testing free?’
The information is written for the control group (not a video). This control group will be compared in Hypothesis 1 against both intervention groups, and the two intervention groups will be compared against each other in Hypothesis 2.
Control group
Active

Outcomes
Primary outcome [1] 328115 0
Intention to get tested for COVID-19:
Over the next 4 weeks, I plan to get tested if I have COVID-19 symptoms
[7 point scale from Strongly disagree to Strongly agree]
Timepoint [1] 328115 0
Immediately post-intervention
Primary outcome [2] 328116 0
Intention to get tested for COVID-19 as a hypothetical:
Imagine you woke up with a sore throat tomorrow. Would you get tested straight away?
[7 point scale from Strongly disagree to Strongly agree]
Timepoint [2] 328116 0
Immediately post-intervention
Primary outcome [3] 328117 0
Perceived intention for someone else to get tested for COVID-19:
Most people my age would get tested after seeing this information/video.
[7 point scale from Strongly disagree to Strongly agree]
Timepoint [3] 328117 0
Immediately post-intervention
Secondary outcome [1] 397676 0
Intentions about other COVID-19 prevention behaviours – measured using a 7 point Likert scale strongly agree-strongly disagree with answers averaged across the following questions – ‘Over the next 4 weeks, I plan to stay home if I have COVID-19 symptoms’; ‘Over the next 4 weeks, I plan to stay 1.5m away from others that I don’t live with where I can’; ‘Over the next 4 weeks, I plan to wash my hands or use sanitiser to protect me and others from COVID-19’; ‘Over the next 4 weeks, I plan to wear a mask in crowded indoor areas’; 'If I get tested for COVID-19, I plan to isolate until I get my test results'
This is a composite outcome, so the outcome will be an average of the participants' responses to the above measures
Timepoint [1] 397676 0
Immediately post-intervention
Secondary outcome [2] 397677 0
Understanding of messaging - measured using the sum of participants’ correct answers to the following 4 questions:-
1. When do you need to get tested? (1 point per correct answer, max 3)
a. Any mild/slight symptoms, moderate/uncomfortable symptoms, symptoms are severe/disrupt your plans
b. any length of time with symptoms / symptoms lasting 2 days / symptoms lasting 3 days
c. 1 symptom in a single day / 2 symptoms in a single day /3 or more symptoms in a single day
2. What are the 6 main COVID-19 symptoms you should get tested for? select from the list: Sore throat
Headache
Loss of taste or smell
Fever
Digestive issues
Conjunctivitis
Cough
Runny nose
Muscle aches
Shortness of breath or difficulty breathing
Vomiting
Diarrhea
3. If you have symptoms of COVID-19, you should get tested when… Select all that apply (1 point if all selected or c only)
a. there are hotel quarantine cases in your state
b. there are local cases in your community
c. there are no local cases in your community
4. Should you get tested if you have unusual or new cold-like symptoms that you think are due to: (5 point scale from Yes definitely to No definitely not)
a. A cold
b. Cold weather
c. Flu
d. Hayfever
e. Allergies
Timepoint [2] 397677 0
Immediately post-intervention
Secondary outcome [3] 397678 0
Self-efficacy – measured using Hamilton et al’s measure of self-efficacy for social distancing due to COVID-19, and altering it to reflect self-efficacy of getting tested. The measure uses a 7 point Likert scale strongly agree-strongly disagree, and we will be averaging answers across the following items:-
It is mostly up to me whether I get tested for COVID-19
I have complete control over whether I get tested for COVID-19
It would be easy for me to get tested for COVID-19
I am confident that I could get tested for COVID-19
Timepoint [3] 397678 0
Immediately post-intervention
Secondary outcome [4] 397679 0
Perceptions of the information/video (from Davis et al, 2016):
Please show below how you felt about the information/video you just saw. The information/video was…
[5 point scale from Strongly disagree to Strongly agree]
a. worth remembering
b. attention-grabbing
c. powerful
d. informative
e. meaningful
f. convincing
Timepoint [4] 397679 0
Immediately post-intervention
Secondary outcome [5] 397680 0
Message credibility from Appleman and Sunder (2015):
How well do the following adjectives describe the content you just read/watched?
[7 point scale from Describes very poorly to Describes very well]
a. accurate
b. authentic
c. believable
Timepoint [5] 397680 0
Immediately post-intervention
Secondary outcome [6] 397681 0
Personal relevance. This question was slightly adapted from the scale from Scherer et al (2013):
Show how much you agree with the following:
[7 point scale from Strongly disagree to Strongly agree]
a. I found the information was created personally for me
b. I felt that the information was relevant to me
c. I felt that the information was designed specifically for me
Timepoint [6] 397681 0
Immediately post-intervention
Secondary outcome [7] 397682 0
Qualitative measure, a question asking: Do you have any feedback on COVID-19 testing or this survey?
Timepoint [7] 397682 0
Immediately post-intervention (this is the last question asked in the survey)

Eligibility
Key inclusion criteria
Live in Australia, aged 18-39, not University educated
Minimum age
18 Years
Maximum age
39 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
We will be recruiting participants via social media (Facebook and Instagram). If they choose to click through via the advert to the survey, participants will be directed to the landing page where they can read the PIS and Consent Form before accessing the survey questions.
The survey itself will be hosted on the Qualtrics platform, which allows randomisation of participants such that participants are evenly randomised to each given condition.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The Qualtrics platform includes a “Randomizer” tool to evenly allocate participants to each condition. Participants will be randomised once, to the government FAQs, the fact-based animation or the narrative-based animation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Statistical analysis will be conducted using planned contrasts between the intervention arm and control arm, implemented in regression models. Analyses will control for baseline testing intentions. The influence of age, gender, language, health literacy, risk perception, and trust will be examined by including appropriate interaction terms within the regression models. The total sample size required is 1500. This is based on 50% of participants having strong positive intention, increasing to 60% in intervention group (which corresponds to an OR of 1.50), which would require 466 per group (so 1398 in total) to have 80% power to detect pairwise differences at a multiple-comparison adjusted alpha level of 0.025. The 1500 is to allow for some wriggle room from the 1398.

Hypotheses

1. Compared to control (gov FAQs: group 1) the enhanced intention interventions (animation: groups 2 and 3) will result in:
a) Higher intentions to get tested if symptomatic (Likert scale)
b) Higher understanding of COVID-19 (new knowledge scale for symptom barriers)
c) Higher self efficacy (average across Likert scales)
d) Higher perceived effectiveness of the message
e) Higher credibility in the message
f) Higher feeling of personal relevance of the message
g) No effect on other COVID-19 behaviours (self-isolation if symptomatic, social distancing, washing hands, wearing masks indoors)

2. Compared to the fact-based animation (group 2), the narrative-based animation (group 3) will result in:
a) Higher intentions to get tested if symptomatic (Likert scale)
b) Higher understanding of COVID-19 (new knowledge scale for symptom barriers)
c) Higher self efficacy (average across Likert scales)
d) Higher perceived effectiveness of the message
e) Higher credibility in the message
f) Higher feeling of personal relevance of the message
g) No effect on other COVID-19 behaviours (self-isolation if symptomatic, social distancing, washing hands, wearing masks indoors)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/08/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309037 0
University
Name [1] 309037 0
Marie Bashir Institute at the University of Sydney
Country [1] 309037 0
Australia
Primary sponsor type
University
Name
Marie Bashir Institute at the University of Sydney
Address
Westmead Institute for Medical Research, 176 Hawkesbury Road, Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 309974 0
None
Name [1] 309974 0
Address [1] 309974 0
Country [1] 309974 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308915 0
Human Research Ethics Committee, The University of Sydney
Ethics committee address [1] 308915 0
Ethics committee country [1] 308915 0
Australia
Date submitted for ethics approval [1] 308915 0
Approval date [1] 308915 0
25/06/2021
Ethics approval number [1] 308915 0

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

Contacts
Principal investigator
Name 112330 0
Prof Kirsten McCaffery
Address 112330 0
Edward Ford Building A27, The University of Sydney, NSW, 2006, Australia
Country 112330 0
Australia
Phone 112330 0
+61 2 9351 7220
Fax 112330 0
Email 112330 0
[email protected]
Contact person for public queries
Name 112331 0
Carissa Bonner
Address 112331 0
Edward Ford Building A27, The University of Sydney, NSW, 2006, Australia
Country 112331 0
Australia
Phone 112331 0
+61 2 9351 7125
Fax 112331 0
Email 112331 0
[email protected]
Contact person for scientific queries
Name 112332 0
Carissa Bonner
Address 112332 0
Edward Ford Building A27, The University of Sydney, NSW, 2006, Australia
Country 112332 0
Australia
Phone 112332 0
+61 2 9351 7125
Fax 112332 0
Email 112332 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?
Anonymous quantitative data on outcomes for each group
When will data be available (start and end dates)?
For 2 years after all data has been collected
Available to whom?
Other researchers
Available for what types of analyses?
Quantitative analysis
How or where can data be obtained?
University of Sydney repository - please email [email protected] to discuss access to this


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12370Study protocol    382318-(Uploaded-01-07-2021-12-21-15)-Study-related document.docx



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.