Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000606785
Ethics application status
Approved
Date submitted
14/04/2022
Date registered
22/04/2022
Date last updated
22/04/2022
Date data sharing statement initially provided
22/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Uptake and impact of Government recommendations about COVID-19 (coronavirus)-Stage 3, Trial 1, vulnerable subgroup populations
Scientific title
Uptake and impact of Government recommendations about COVID-19 (coronavirus)-Stage 3, Trial 1, vulnerable subgroup populations
Secondary ID [1] 306867 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 infection 325959 0
Condition category
Condition code
Public Health 323275 323275 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study has two intervention factors, each with two levels delivered in a 2x2 factorial arrangement.
Factor 1: Who is providing the message (General Practitioner versus Community Representative).
Factor 2: How the message is delivered (Animation versus Talking Head).

Each participant will be exposed to each of the four combinations of these factor levels across four different messaging contexts. These contexts are:
1. Getting your booster vaccine
2. Wearing a mask outdoors when you can’t physically distance
3. Staying at home when you have a new cough symptom
4. Using QR check in codes when required

Provision of these intervention combinations across these different contexts is enabled through our "helix", counterbalanced randomised trial design. A Latin square approach has been used to order the exposure of participants to each intervention level combination to eliminate study level order effects.

Each intervention will be delivered as a pre-recorded video and all informational material related to each context area will be provided in this format. Each video will be of approximately 1-2minutes duration. Each participant will be exposed to all levels of the intervention, with each intervention level being presented in a different context area as per a counterbalanced, 'helix' trial approach (DOI https://doi.org/10.1186/s13012-019-0896-0).
It is anticipated that these videos will be observed over an approximate 20minute period. Participants will observe the videos either in their own home, or at a partner organisation service provider location relative to their vulnerable population subgroup (e.g. meeting place for our ATSI subgroup).
Progression of the participant through each of the intervention/context combinations will be monitored via the online data collection platform (Qualtrics). Qualtrics enables extraction of all responses including partial completions, and allows tracking and recording of in-complete survey entries.
Intervention code [1] 323367 0
Behaviour
Comparator / control treatment
The comparators in this study are the different levels of the interventions.
Specifically we will be comparing:
1. General Practitioner 'talking head' visual stimulus delivered health message versus Community Representative 'talking head' visual stimulus delivered health message
2. General Practitioner animation visual stimulus delivered health message versus Community Representative animation visual stimulus delivered health message
3. General Practitioner 'talking head' visual stimulus delivered health message versus Community Representative animation visual stimulus delivered health message
4. General Practitioner animation visual stimulus delivered health message versus Community Representative 'talking head' visual stimulus delivered health message

Comparisons are not being made between context areas as a part of the primary analysis, however, we will investigate interaction effects of the different intervention comparisons across the different context areas so that we can understand whether certain interventions work better in certain contexts.
Control group
Active

Outcomes
Primary outcome [1] 331073 0
Stated intention to undertake a context specific behaviour with responses scaled using a 5 point Likert scale ('much less inclined', 'less inclined', 'about the same', 'more inclined' and 'much more inclined').
The specific questions for each context are:
1.Now that you have watched the video, please indicate if it has made you feel more or less inclined to have a further dose of the COVID-19 vaccine (when you become eligible to receive it). This includes a 4th dose if you have already had 3 doses.
2. Has viewing this material made you feel more or less inclined to wear a mask outside when you are unable to socially distance?
3. Has viewing this material made you feel more or less inclined to spend time with people you do not live with if you were to develop a cough (but that was the only issue)?
4. Has watching this material made you feel more or less inclined to use QR code check-ins every time you visit a venue if there were to be a future pandemic like the COVID-19 pandemic?
Timepoint [1] 331073 0
Immediately following viewing the intervention.
Primary outcome [2] 331074 0
Stated intention to encourage family or friends to undertake a context specific behaviour scaled using a 5 point Likert scale ('extremely unlikely', 'unlikely', 'neutral', 'likely', 'extremely likely').
The specific questions for each context are:
1. If you had a family member or friend who was unsure about having a COVID-19 vaccine booster (3rd dose), how likely would you be to encourage them to get the vaccine?
2. If you had a family member or friend who was unsure about whether they should wear a mask outside if they are unable to socially distance, how likely would you be to encourage them to wear one?
3. If you had a family member or friend who was unsure about spending time with people they do not live with if they developed a cough (but that was the only issue), how likely would you be to encourage them to stay away from other people while they had a cough?
4.If you had a family member or friend who was unsure about using QR code check-ins every time they visited a venue in a future pandemic, how likely would you be to encourage them to use QR code check-ins?
Timepoint [2] 331074 0
Immediately following viewing the intervention.
Secondary outcome [1] 408645 0
Stated feelings of inclusion and representation in the developed video for each context area and how this correlates with level of agreement of the message in the video. Responses scaled using a 5 point Likert scale ('strongly disagree', 'disagree', neither agree nor disagree', 'agree', 'strongly agree'). The specific questions measuring this include:
1. We would like to further understand how well represented you felt in this video. Please indicate how much you agree to the following statement: I felt strongly represented in this video.
2. We are interested in understanding in how much feeling like you are strongly represented in a health message video makes you more likely to agree with the message in the video.
Please indicate how much you agree with the following statement: I am more inclined to agree with the message in a health video if I feel strongly represented in it.
Timepoint [1] 408645 0
Question 1: Immediately following viewing the intervention.
Question 2: At the end of all interventions delivered (end of survey).

Eligibility
Key inclusion criteria
We have 6 specific subgroup populations of interest for this study, below outlines the group and it's associated inclusion criteria.
1. People living with a disability and their carers: Participants must be 18 years of age or older, reside in Australia, be currently living with a disability or is a carer for someone who has a disability.
2. Aged care workers: Participants must be aged 18 years or older, reside in Australia, and be an aged care worker.
3. Refugee and asylum seekers: Participants must be aged 18 years or older, reside in Australia as a refugee or asylum seeker and be able to read/speak English, Dari or Sinhalese.
4. Deaf, hard of hearing people: Participants must be aged 18 years or older, reside in Australia and are deaf or those that are hard of hearing.
5. Aboriginal and Torres Strait Islander people: Participants must be aged 18 year or older, reside in Australia and have a heritage of Aboriginal or Torres Strait Islander.
6. Street-based sex workers: Participants must be aged 18 years or older, reside in Australia and be working as a street-based sex worker.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Across all groups key exclusion criteria include:
1. Anyone who is not currently living in Australia.
2. Anyone who is under the age of 18 years.

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)
Qualtrics data collection platform has an inbuilt randomisation function. Therefore, random allocation will be fully concealed from participants and investigators involved in recruitment and data collection.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
In built random allocation sequence within Qualtrics data collection platform.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This design will use a "helix" counterbalanced design, involving factorial allocation of two interventions each with two levels (2x2 factorial) across four context areas. The ordering of presentation of intervention combinations to participants will follow a Latin square pattern to eliminate study level order effects.

For more information on helix counterbalanced designs please refer to:
Sarkies MN, Skinner EH, Bowles KA, Morris ME, Williams C, O’Brien L, Bardoel A, Martin J, Holland AE, Carey L, White J. A novel counterbalanced implementation study design: methodological description and application to implementation research. Implementation Science. 2019 Dec;14:45.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mixed model analyses will be used treating the intervention levels as fixed factors, participants as random factors. Context will be ignored when investigating intervention main effects as it will be balanced across the different intervention levels. Interaction effects will be investigated to explore impacts of intervention combinations (simple effects), while also exploring interactions of main effects and simple effects across vulnerable participants subgroups, and context areas.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/04/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311185 0
Government body
Name [1] 311185 0
Australian Government Department of Health (Medical Research Future Fund-Communication Strategies and Approaches During Outbreaks)
Country [1] 311185 0
Australia
Primary sponsor type
Individual
Name
Terry Haines
Address
Monash University
School of Primary and Allied Health Care
Level 3, Building G Peninsula Campus
47-49 Moorooduc Hwy
Frankston VIC 3199
Country
Australia
Secondary sponsor category [1] 312603 0
None
Name [1] 312603 0
Address [1] 312603 0
Country [1] 312603 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310718 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 310718 0
Ethics committee country [1] 310718 0
Australia
Date submitted for ethics approval [1] 310718 0
31/03/2022
Approval date [1] 310718 0
08/04/2022
Ethics approval number [1] 310718 0
30698

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

Contacts
Principal investigator
Name 118622 0
Prof Terry Haines
Address 118622 0
Monash University
School of Primary and Allied Health Care
Level 3, Building G, Peninsula Campus
47-49 Moorooduc Hwy
Frankston VIC 3199
Country 118622 0
Australia
Phone 118622 0
+61 433596526
Fax 118622 0
Email 118622 0
[email protected]
Contact person for public queries
Name 118623 0
Terry Haines
Address 118623 0
Monash University
School of Primary and Allied Health Care
Level 3, Building G, Peninsula Campus
47-49 Moorooduc Hwy
Frankston VIC 3199
Country 118623 0
Australia
Phone 118623 0
+61 433596526
Fax 118623 0
Email 118623 0
[email protected]
Contact person for scientific queries
Name 118624 0
Terry Haines
Address 118624 0
Monash University
School of Primary and Allied Health Care
Level 3, Building G, Peninsula Campus
47-49 Moorooduc Hwy
Frankston VIC 3199
Country 118624 0
Australia
Phone 118624 0
+61 433596526
Fax 118624 0
Email 118624 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
Potentially identifiable and sensitive data being collected


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.