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Trial registered on ANZCTR


Registration number
ACTRN12617001310358
Ethics application status
Approved
Date submitted
7/09/2017
Date registered
12/09/2017
Date last updated
12/09/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Trialling a modified consent card and school package for improving outcomes in the secondary school vaccine program
Scientific title
Trialling a modified consent card and school package to increase consent card return rates, vaccination rates, and improve data quality within the secondary school vaccine program
Secondary ID [1] 292824 0
None
Universal Trial Number (UTN)
U1111-1201-7581
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Genital warts 304659 0
Cervical cancer 304660 0
Human papillomavirus 304694 0
Condition category
Condition code
Infection 303979 303979 0 0
Sexually transmitted infections
Public Health 304004 304004 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Background: In order for a student to be immunised within the secondary school vaccine program, their parent or guardian must complete and return a vaccine consent card. Unfortunately, approximately 9% of students do not return a consent card, and without further contact from council are prevented from receiving vaccines within the school program. This also occurs when parents/guardians return the consent card with missing or incorrect information leaving follow-up actions necessary for a valid consent. With this backdrop, efforts to improve consent card return rates and data quality have the potential to increase vaccination rates.

Within the school vaccine program, state government (i.e., Department of Health and Human Services (DHHS)) distribute the consent card to local government (i.e., councils). Each council then distributes the consent cards to the schools in their area. The school immunisation coordinator (i.e., person at the school responsible for managing the vaccine program at the school) distributes and collects the consent cards from parents/students and then council come back to the school to collect the returned cards.

Intervention (arm A): A new consent card was trialled (card incorporated plain language and social norming principles) alongside a new mode of card delivery. Specifically, DHHS distributed the consent cards directly to schools along with a letter to the school Principal and the school immunisation coordinator (the letters also incorporated social norming principles). They did this during December 2016. They also distributed a smaller batch of cards early in the school year (February 2017) so schools could re-distribute the consent card to any students who had not returned a consent card. The letters were personalized (i.e., the name of the school Principal / school immunization coordinator).

Please find the new consent card and letters attached to the original ANZCTR registration record.
Intervention code [1] 299077 0
Prevention
Comparator / control treatment
Control (arm B). The control group did not receive the intervention. They continued to receive the older card from council as per normal.
Control group
Active

Outcomes
Primary outcome [1] 303317 0
Proportion of year 7 students who returned a consent card.

Councils keep track of this information as part of their usual delivery/management of the school vaccine program (i.e., number of students enrolled in year 7 and number of cards returned).
Timepoint [1] 303317 0
Within one week of the first school visit of the 2017 secondary school vaccine program
Secondary outcome [1] 338618 0
Proportion of returned cards that had missing or incorrect information.

Council do not routinely collect this information, however, they do routinely check each card for this information. Hence, the researchers simply asked them to keep a tally of how many of the returned cards at each school had missing or incorrect information.
Timepoint [1] 338618 0
Councils were asked to provide this information within one week of each school having their first school visit.
Secondary outcome [2] 338619 0
Proportion of all year 7 students who had a dose of the HPV vaccine at the first school visit.

Councils routinely collect this information (number of students enrolled in year 7 and number of students who received a dose of the vaccine at the first school session).
Timepoint [2] 338619 0
Councils were asked to provide this information within one week of each school having their first school visit.

Eligibility
Key inclusion criteria
From the 79 councils across Victoria, only councils that have at least two schools who:
1) had not received their 2017 consent cards
2) were expected to have more than 20 students enrolled in year 7 in 2017.

Schools that fit within this description (within participating councils) were included in the study.
Minimum age
10 Years
Maximum age
14 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
There were no unique exclusion criteria for any participant group (i.e., school Principals, school immunization coordinators, students) beyond that outline above in the key inclusion criteria section.

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 not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Excel's RANDBETWEEN function (with condition that each council has similar number of schools allocated to the intervention condition and the control condition).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Councils provide the data in aggregate format (i.e., for each school in their area they list 1) number of year 7 students enrolled, number of cards returned, number of cards with missing or incorrect information, number of HPV encounters at first school visit). The research team then turned this into individual level data to use for analysis.

Analysis: Multilevel Modeling where the outcome is regressed onto study condition whilst accounting for the nested structure of the data (i.e, students nested within schools which are nested within councils).

Prior to this a series of randomization checks will be performed (to ensure randomization lead to equivalent groups). The factors assessed include: School type (e.g., secondary vs. P-12 vs. special/language), school sector (e.g., state vs. independent vs. catholic), region (e.g., metro vs. regional).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 297454 0
Government body
Name [1] 297454 0
Public Sector Innovation, Department of Premier and Cabinet, Victorian State Government
Address [1] 297454 0
Public Sector Innovation
Department of Premier and Cabinet
Level 29, 35 Collins Street
Melbourne VIC 3000
Australia
Country [1] 297454 0
Australia
Primary sponsor type
University
Name
Monash University
Address
BehaviourWorks Australia
Monash Sustainable Development Institute
Monash University
8 Scenic Boulevard, Clayton Campus
Clayton, VIC, 3800
Australia
Country
Australia
Secondary sponsor category [1] 296450 0
Government body
Name [1] 296450 0
Department of Health and Human Services
Address [1] 296450 0
Immunisation Section
Health Protection Branch
Regulation, Health Protection & Emergency Management Division
50 Lonsdale Street
Melbourne, VIC, 3000
Australia
Country [1] 296450 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298560 0
Monash University Human Research Ethics Commettee
Ethics committee address [1] 298560 0
Monash University
Room 111, Chancellery Building E
24 Sports Walk
Clayton Campus
Wellington Rd
Clayton VIC 3800
Australia
Ethics committee country [1] 298560 0
Australia
Date submitted for ethics approval [1] 298560 0
19/10/2016
Approval date [1] 298560 0
07/11/2016
Ethics approval number [1] 298560 0
2016-1081-1027

Summary
Brief summary
The Gardasil quadrivalent 3-dose human papillomavirus (HPV) vaccine, which protects against genital warts and most cervical cancers, is provided in Victoria through a secondary school program, administered by local government (i.e., councils). In order for a student to be immunised within this program, their parent or guardian must complete and return a vaccine consent card. Unfortunately, approximately 9% of students do not return a consent card, and without further contact from council are prevented from receiving vaccines within the school program. This also occurs when parents/guardians return the consent card with missing or incorrect information leaving follow-up actions necessary for a valid consent. With this backdrop, efforts to improve consent card return rates and data quality have the potential to increase vaccination rates.

The aim of this trial was to assess whether these outcomes could be improved by modifying using a new consent card (card incorporated plain language and social norming principles) alongside a new mode of card delivery. Specifically, DHHS distributed the consent cards directly to schools along with a letter to the school Principal and the school immunisation coordinator (the letters also incorporated social norming principles). They did this during December 2016. They also distributed a smaller batch of cards early in the school year (February 2017) so schools could re-distribute the consent card to any students who had not returned a consent card.

It was hypothesized that this intervention (i.e., new and card and mode of delivery) would 1) increase the likelihood that a parent would complete and return the consent card, 2) the parent would be more likely to complete the card with no missing or incorrect information, and 3) more students would receive the HPV vaccine at the first school visit.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2021 2021 0 0
Attachments [2] 2022 2022 0 0
Attachments [3] 2023 2023 0 0
Attachments [4] 2024 2024 0 0

Contacts
Principal investigator
Name 77470 0
A/Prof Peter Bragge
Address 77470 0
BehaviourWorks Australia
Monash Sustainable Development Institute
Monash University
8 Scenic Boulevard, Clayton Campus
Clayton, VIC, 3800
Australia
Country 77470 0
Australia
Phone 77470 0
+61 3 9905 9664
Fax 77470 0
Email 77470 0
peter.bragge@monash.edu
Contact person for public queries
Name 77471 0
Mr Fraser Tull
Address 77471 0
BehaviourWorks Australia
Monash Sustainable Development Institute
Monash University
8 Scenic Boulevard, Clayton Campus
Clayton, VIC, 3800
Australia
Country 77471 0
Australia
Phone 77471 0
+61 (0)407 965 196
Fax 77471 0
Email 77471 0
fraser.tull@monash.edu
Contact person for scientific queries
Name 77472 0
Mr Fraser Tull
Address 77472 0
BehaviourWorks Australia
Monash Sustainable Development Institute
Monash University
8 Scenic Boulevard, Clayton Campus
Clayton, VIC, 3800
Australia
Country 77472 0
Australia
Phone 77472 0
+61 (0)407 965 196
Fax 77472 0
Email 77472 0
fraser.tull@monash.edu

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary