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Trial registered on ANZCTR


Registration number
ACTRN12620000804987
Ethics application status
Approved
Date submitted
1/06/2020
Date registered
10/08/2020
Date last updated
10/08/2020
Date data sharing statement initially provided
10/08/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Vaxcards: A statewide trial on the effectiveness of a collectible card game on the education and uptake of vaccination
Scientific title
A Statewide trial on the effectiveness of a collectible card game on the education and uptake of vaccination with a pragmatic cluster randomised control trial.
Secondary ID [1] 301419 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record
This record is a follow-up study of ACTRN12618001753246

Health condition
Health condition(s) or problem(s) studied:
vaccination education 317701 0
vaccine uptake 317965 0
Condition category
Condition code
Infection 315779 315779 0 0
Other infectious diseases
Public Health 316000 316000 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The school children will already be undertaking the vaccination program as part of their year 7 program at their school and consent for vaccination is done separately by the Department of Health and Human Services. For this study, we will offer parents the chance to return the vaxcards game intervention if they do not wish for their children to participate. De-identified, routinely collected information about returned consent forms will be provided to the investigators by Casey Council for the schools involved in the trial.

All students in the normal vaccination program are provided the consent form for community vaccination by the council for content to vaccinate. The experimental group will also be provided a 1 page handout about receiving a game of vaxcards when their consent form is returned. In term 1 the students who return their consent form will be provided a pack of the vaccination card game Vaxcards. The return rate of consent forms will form the primary outcome measure.

There will be slight variations in the timing of the intervention among sub groups in the experimental group.
1. receiving the starter pack of vaxcards at the time of the council consent form, school posters, teachers provided lesson plans, HPV card at time of vaccination.
-starter pack contains: instructions on how to play the game, names and characters of 11 diseases (hepatitis B, measles, meningococcal, pneumococcal, rotavirus, rubella, mumps, varicella, dipthteria, pertussis, tetanus and HPV). Cards contain information on the disease symptoms, vector, method of infection eg droplet/blood, incidence. worldwide mortality.
2. receiving the starter pack of vaxcards at the time of the council consent form, school posters, teachers provided lesson plans, HPV card at time of vaccination, class sets of full packs.
-full pack contains all disease character cards (influenza, measles, meningococcal, mumps, pertussis, rubella, tetanus, hpv, dengue, HIV, hookworm, leishmaniasis, malaria, schistosomiasis, dipthteria, hepatitis B, chagas, smallpox, polio, cooler, typhoid, hepatitis A, Japanese encephalitis, tuberculosis, rabies, yellow fever, rotavirus, varicella.)
3. receiving the random pack of vaxcards at the time of the council consent form, school posters, teachers provided lesson plans, class sets of full packs.
-random packs will contain 7 random characters above + always contain year 7 vaccine specific cards HPV, dipthteria, tetanus, pertussis.
4. receiving the full pack of vaxcards at the time of the council consent handout, school posters, teachers provided lesson plans.

For the teacher-provided lesson plans:
- modules/topics covered during the intervention lessons include: herd immunity, why are people vaccine hesitant, risk and benefit of vaccines, story of smallpox eradication, how vaccines work, differences between pathogens, how disease spreads, how vaccines are made.
- the frequency and duration of intervention lessons will be decided by the teacher but modules are provided include 3-4 x 50minute lessons
- teachers providing these lessons will be provided videos and material links for reading/upskilling prior to class delivery.

After Vaccination programs are complete, both experimental and control group students and parents will be asked to complete the attached knowledge, attitudes and behaviours survey delivered through an email link or by mail by the school to the Qualtrics platform where they will be provided information and consent to the survey. This will form the secondary outcome measurement.


The intervention will be delivered once and are intended to be kept by participants and are provided with instructions on how to play the game but not provided indications of use, they may play with the cards as they wish. There are no strategies implemented to assess/monitor adherence to the intervention.

Schools participating in the vaccination program will email parents and students with instructions for completing survey with explanatory statement and consent box hosted by Qualtrix
Intervention code [1] 317731 0
Other interventions
Comparator / control treatment
The control group will participate in the routine vaccination program and will not be consented for the primary outcome measurement of vaccination, as this will be routinely collected by the council and consent for this is separately done by the Department of health and human services. We will, however, measure their consent return rate. The reason to not consent them is so they do not have a change to their consent rates with an observer effect. This has been presented to the ethics committee and accepted as they would usually go through the consent form return process as part of normal council vaccinations and the consent process to the vaccination is separate to converting for the trial. Their vaccinaiton card return rates will simply be recorded for comparison to the intervention groups as a baseline measure.

Control Schools participating in the trial will email parents and students with instructions for completing survey with an explanatory statement and consent box hosted by Qualtrix 2 weeks after vaccination.

Control schools will be offered a printable copy of the intervention for group 1, the starter set box 1 month after surveys have been collected and informed of the study.
Control group
Active

Outcomes
Primary outcome [1] 323983 0
Return rate of 'yes' consent form for vaccination of the groups, routinely collected by the councils for both the intervention and control groups.
This data will be collected from the councils by data sharing summary totals at the school level, as they are routinely recorded and provided to the health department.
Timepoint [1] 323983 0
timepoint 0 will be the vaccination program data from 2019 for each school.
(2020 vaccination data will not be used as timepoint 0 baseline due to the interruption of schools programs from COVID19)
end of council vaccination program for 2021 to the participating schools will form timepoint 1.
Secondary outcome [1] 383490 0
quantitative survey composite data of parental knowledge, attitudes and behaviors towards vaccination. Survey used will be the validated Vaccine Confidence Index(tm)
Timepoint [1] 383490 0
2 weeks after vaccination in the council school vaccination program for 2021

Eligibility
Key inclusion criteria
State of Victoria school vaccination program for year 7 students and parents of students.
Minimum age
11 Years
Maximum age
No limit
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)
Allocation is concealed to the statistician through a central computer randomization code
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sample
Clusters randomly selected.
Each school is a cluster.
- Aiming for 75% metro 25% rural/regional representation
we aim for:
18/24 treatment clusters in metro
54/72 control clusters in metro
6/24 treatment clusters in non-metro
18/72 control clusters in non-metro

Randomization stratification
Each ‘treatment cluster/school’ will be randomly matched with three ‘control cluster/school’.
Matching stratification variables are:
- LGA
- Size (less than 100pupils; 100+)
- Vaccine_baseline (low/high determined by above or below 80%)
If necessary, if an LGA doesn’t have 4 comparable schools, then we will match using these
stratification variables:
- Size (less than100pupils; 100+)
- Vaccine_baseline (low/high determined by above or below 80%)
- Metro/non-metro

- Indexed relative social disadvantage (IRSD) quintile or quartile
Randomization logic
Schools are drawn from the state of Victoria without replacement. This means that once a school
has been randomly selected, it cannot be selected again.
First at the Local Government Area (council) level
1. Randomly select a LGA area in Victoria:
o If LGA has 4 comparable schools, then go to Box 1.
2. Repeat step 1, ensuring new cluster names are created.
3. Stop when one of the two options come first:
4. Stop when we have 75% metro schools. Then target non-metro areas.
or
5. Stop when we have 25% metro schools. Then target metro areas.

Box 1:
Randomly start at a, b, c, or d:
randomly select one school (create new cluster name eg “clusterTa1”),
allocate as treatment “intervention a”.
randomly select three control schools (create new cluster names eg
clusterC1, clusterC2, clusterC3) with same Size (less than 100pupils; 100+) and
Vaccine_baseline (low/high)
repeat step (a) immediately but allocate as treatment “intervention b”
randomly select three control schools with same Size and Vaccine_baseline
repeat step (a) but allocate as treatment “intervention c”
randomly select three control schools with same Size and Vaccine_baseline
repeat step (a) but allocate as treatment “intervention d”
randomly select three control schools with same Size and Vaccine_baseline
complete a-d above before going to step 2 above.


To allocate schools to one of four treatment groups, randomisation by minimiation was done to ensure a balance of these variables in each of the 4 Tx groups:
- school Size (less than 100pupils; 100+)
- Vaccine_baseline (low/high determined by above or below 80%)
- Metro/non-metro
- single sex
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
the primary outcome measure is the return of the form (yes/no) from 120 students per school, significance level set at 0.05, intraclass correlation coefficient (ICC) within schools of 0.3, approximately half the schools receiving the intervention (ie steps equal to 1) , and data examined at two time points (baseline, year 1).

Quantitative surveys on likert scales will be analysed using chi-squared.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2021
Actual
Date of last participant enrolment
Anticipated
31/01/2021
Actual
Date of last data collection
Anticipated
1/12/2021
Actual
Sample size
Target
11700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 305858 0
Government body
Name [1] 305858 0
Department of Premier and Cabinet
Country [1] 305858 0
Australia
Funding source category [2] 306020 0
University
Name [2] 306020 0
Monash University
Country [2] 306020 0
Australia
Funding source category [3] 306021 0
Commercial sector/Industry
Name [3] 306021 0
Public Health Association Australia and GSK
Country [3] 306021 0
Australia
Primary sponsor type
University
Name
Monash University
Address

Department of General Practice,
Ferntree Gully Rd
Notting hill 3168
Victoria
Country
Australia
Secondary sponsor category [1] 306306 0
Government body
Name [1] 306306 0
Department of Premier and Cabinet
Address [1] 306306 0
Behavioural Insights Team
1 Treasury Place, Melbourne
Vic 3000
Aus
Country [1] 306306 0
Australia
Other collaborator category [1] 281340 0
Government body
Name [1] 281340 0
Department of Health and Human Services
Address [1] 281340 0
50 Lonsdale St, Melbourne VIC 3000
Country [1] 281340 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306118 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 306118 0
Ethics committee country [1] 306118 0
Australia
Date submitted for ethics approval [1] 306118 0
31/07/2019
Approval date [1] 306118 0
31/10/2019
Ethics approval number [1] 306118 0
22340

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

Contacts
Principal investigator
Name 102774 0
Dr Daniel S Epstein
Address 102774 0
Department of General Practice
1/270 Ferntree Gully Rd, Notting Hill VIC 3168
Country 102774 0
Australia
Phone 102774 0
+61 3 99024514
Fax 102774 0
Email 102774 0
[email protected]
Contact person for public queries
Name 102775 0
Daniel S Epstein
Address 102775 0
Department of General Practice
1/270 Ferntree Gully Rd, Notting Hill VIC 3168
Country 102775 0
Australia
Phone 102775 0
+61 3 99024514
Fax 102775 0
Email 102775 0
[email protected]
Contact person for scientific queries
Name 102776 0
Daniel S Epstein
Address 102776 0
Department of General Practice
1/270 Ferntree Gully Rd, Notting Hill VIC 3168
Country 102776 0
Australia
Phone 102776 0
+61 3 99024514
Fax 102776 0
Email 102776 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
Data will not be collected at an individual level, but at school level.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8129Ethical approval    379929-(Uploaded-01-06-2020-14-39-55)-Study-related document.pdf
8130Informed consent form    379929-(Uploaded-22-06-2020-10-15-33)-Study-related document.pdf



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.