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Trial registered on ANZCTR


Registration number
ACTRN12618000789268
Ethics application status
Approved
Date submitted
19/04/2018
Date registered
10/05/2018
Date last updated
7/11/2022
Date data sharing statement initially provided
5/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
AUTOMATIC: Adaptive Trial of Messaging to Improve Immunisation Coverage
Scientific title
Randomised multi-arm Bayesian adaptive trial of SMS reminders to improve the timeliness of routine vaccination in children
Secondary ID [1] 290481 0
None
Universal Trial Number (UTN)
U1111-1189-6054
Trial acronym
AUTOMATIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vaccination 300855 0
Vaccine coverage 300858 0
Immunisation 300859 0
Condition category
Condition code
Infection 300679 300679 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One of 12 active arms covering two domains: (i) SMS content (neutral, positive, negative or social norms) and (ii) timing (-14, 0 or +7 days relative to the vaccination due date);

Neutral messages consist of :“[CLINIC NAME]: [Child’s name] is due for a X-month vaccination on XX/XX/XX. To book or opt-out of SMS, call XXXX XXXX. Replies are not monitored, pls ignore SMS if you have an appt”

Positive messages consist of :“[CLINIC NAME]: [Child’s name] is due for a vaccination on XX/XX/XX. Vaccinating on time gives [Child’s name] the best defence against infectious diseases. To book or opt-out of SMS, call XXXX XXXX. Replies are not monitored, pls ignore SMS if you have an appt”

Negative messages consist of :“[CLINIC NAME]: [Child’s name] is due for a vaccination on XX/XX/XX. Delaying a child’s vaccination can put them and other children at risk. To book or opt-out of SMS, call XXXX XXXX. Replies are not monitored, pls ignore SMS if you have an appt”

Social norm messages consist of :“[CLINIC NAME]: [Child’s name] is due for a vaccination on XX/XX/XX. Vaccinating on time protects [Child’s name] and other children who are too young to be vaccinated. To book or opt-out of SMS, call XXXX XXXX. Replies are not monitored, pls ignore SMS if you have an appt”

Neutral SMS sent 14 days before the due-date
OR
Positive SMS sent 14 days before the due-date
OR
Negative SMS sent 14 days before the due-date
OR
Social Norms SMS sent 14 days before the due-date
OR
Neutral SMS sent on the due-date
OR
Positive SMS sent on the due-date
OR
Negative SMS sent on the due-date
OR
Social Norms SMS sent on the due-date
OR
Neutral SMS sent 7 days after the due-date
OR
Positive SMS sent 7 days after the due-date
OR
Negative SMS sent 7 days after the due-date
OR
Social Norms SMS sent 7 days after the due-date
Intervention code [1] 296339 0
Behaviour
Comparator / control treatment
No SMS reminder (Control Group)
Control group
Active

Outcomes
Primary outcome [1] 300101 0
Vaccination status (vaccinated or unvaccinated) at 28 days after scheduled vaccine due date for the index child for the index vaccine. On occasion, vaccination might occur prior to the due date. Such occasions will be counted as vaccinated by 28 days after the due date if it occurs no more than 14 days before the scheduled due date.
Parents may have multiple children eligible for study inclusion and each child may receive multiple vaccine doses during the trial period. The index child is the first child scheduled to be vaccinated after the parent’s randomisation date and the index vaccine is the first scheduled vaccine date for each child after the parent’s randomisation date.
Timepoint [1] 300101 0
Vaccination status at 28 days after the vaccine due date as measured by the difference between date of index vaccine administration and due date as recorded in the SmartVax system.
Secondary outcome [1] 329046 0
Time to vaccination (in days): difference in days relative to the scheduled due date from 14 days before to the date of administration of the index vaccine for the index child, censored at 42 days post vaccine due-date. Time to vaccination (in days): difference in days relative to the scheduled due date from 14 days before to the date of administration of the index vaccine for the index child, censored at 42 days post vaccine due-date.
Timepoint [1] 329046 0
Any time between baseline (14 days prior to the scheduled vaccine date) and follow-up (28 days after the scheduled vaccine date). Events that occur prior to scheduled vaccine date will be coded as occurring on the scheduled vaccine date.
Secondary outcome [2] 329047 0
Time to vaccination from 14 days prior to vaccine due-date to the next vaccine administration date for every eligible scheduled vaccine for each child, censored at 42 days post vaccine due-date, grouped by child ID and nested in parent ID in the statistical analysis. Eligible scheduled child vaccines are those that occur after the parent’s randomisation date.
Timepoint [2] 329047 0
Each child for any vaccine will contribute data from 14 days prior until 42 days after their individual scheduled vaccine date to this analysis.
Secondary outcome [3] 329612 0
Vaccination status (vaccinated or unvaccinated) at 28 days after the scheduled vaccine due date for all vaccines and all children.
Timepoint [3] 329612 0
Each child for all vaccines will contribute data from 14 days prior until 28 days after their individual scheduled vaccine date to this analysis.

Eligibility
Key inclusion criteria
Parents (18 years and older) of children aged 6 weeks – 4 years who are registered with a SmartVax registered GP clinic or community vaccination clinic

Parents must have a mobile phone number registered with the vaccine provider

The child must be due for an upcoming vaccine during the trial period

The child at the clinic previously, excluding 6 week old children their first vaccine dose

Eligible children must have their most recent details entered into their electronic medicalhealth record, including the parent mobile phone number and the child’s date of birth and name.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The parent(s) of the child have previously requested not to be contacted by the clinic via SMS

Parents who in the opinion of clinic staff would be unsuitable for inclusion in the study, for example because they are known to attend for routine vaccinations elsewhere, they have relocated outside of the clinic catchment area, the registered mobile phone number is known to be obsolete or wrong, or because they are registered as conscientious objectors to vaccination

The critical information required to produce a unique identification number has not been entered properly into the practice’s electronic medical record (i.e. parent mobile phone number, child’s date of birth, child’s first and surname)

Children known or suspected to be Ttwins and triplets will be excluded; producing a unique identification number will not be possible for siblings with the same birthdate

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)
The people administering and receiving the intervention are blinded prior to the SMS being sent as the allocation and delivery systems are centalised and automated.
The people recording the data and maintaining the trial database are blinded to intervention allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Response adaptive computer based central randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Bayesian adaptive, randomised, multi-arm pragmatic trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a Bayesian response-adaptive, randomised, multi-arm, pragmatic trial. The primary outcome is vaccination status (administered or not administered) by 28 days after the scheduled due date. Inferences in the trial will be based on a Bayesian logistic regression model for the primary outcome as a function of the interventions (type of message: neural, positive, negative, or social norms; and timing: -14, 0 or 7 days relative to scheduled due date), which will be used to calculate the posterior probability of superiority of each intervention arm conditional on the data observed. These posterior probabilities will be used to inform pre-specified decisions at scheduled interim analyses as the trial progresses. The first interim analysis occurs when the primary outcome has been observed on 1,500 participants, and subsequent interim analyses occur every additional 500 participants. For model parameters, weakly-informative prior distributions are specified. Model adjustment is made for the participants site, time of enrolment into the study, and the age at which the scheduled vaccination is to occur (2 months, 4 months, 6 months, 12 months, or 48 months).

The use of response-adaptive randomisation means that if an intervention allocation weighting is proportional to its probability of being the most effective intervention. Pre-specified decision rules are in place such that if at any interim analysis an intervention is declared inferior to control (no SMS message) that arm will be permanently dropped and if any single arm is declared more effective than control, then the control arm will be permanently dropped.

A secondary outcome is the time to vaccination in days for each participant relative to the scheduled due date. This outcome will be analysed using a discrete-time cumulative logistic model with similar adjustments and priors as the primary outcome model. The baseline log-hazard will be modelled flexibly using penalised O'Sullivan splines. Intervention effects are assumed to satisfy an assumption of proportional continuation ratios and are time-varying in that the intervention effect only applies from the time the SMS message was sent.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/08/2020
Actual
14/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10000
Accrual to date
6583
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 294898 0
Government body
Name [1] 294898 0
WA Department of Health
Country [1] 294898 0
Australia
Funding source category [2] 302968 0
Other Collaborative groups
Name [2] 302968 0
RACP Foundation
Country [2] 302968 0
Australia
Funding source category [3] 309964 0
Charities/Societies/Foundations
Name [3] 309964 0
Ramaciotti Foundation
Country [3] 309964 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Telethon Kids Institute
Address
100 Roberts Road Subiaco WA 6008
Country
Australia
Secondary sponsor category [1] 293736 0
None
Name [1] 293736 0
Address [1] 293736 0
Country [1] 293736 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296275 0
University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 296275 0
Ethics committee country [1] 296275 0
Australia
Date submitted for ethics approval [1] 296275 0
23/11/2016
Approval date [1] 296275 0
30/05/2017
Ethics approval number [1] 296275 0
RA/4/1/8810

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

Contacts
Principal investigator
Name 70242 0
Dr Tom Snelling
Address 70242 0
Telethon Kids Institute
100 Roberts Rd
Subiaco WA 6008
Country 70242 0
Australia
Phone 70242 0
+61 401355389
Fax 70242 0
Email 70242 0
tom.snelling@sydney.edu.au
Contact person for public queries
Name 70243 0
Tom Snelling
Address 70243 0
Telethon Kids Institute
100 Roberts Rd
Subiaco WA 6008
Country 70243 0
Australia
Phone 70243 0
+61 401355389
Fax 70243 0
Email 70243 0
tom.snelling@sydney.edu.au
Contact person for scientific queries
Name 70244 0
Tom Snelling
Address 70244 0
Telethon Kids Institute
100 Roberts Rd
Subiaco WA 6008
Country 70244 0
Australia
Phone 70244 0
+61 401355389
Fax 70244 0
Email 70244 0
tom.snelling@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Summary-level trial results will be shared and individual participant data can be requested subject to necessary HREC approvals. As a minimum, data sharing will include de-identified participant data including group allocation and time difference between scheduled vaccine date and vaccine administration date (in days).
When will data be available (start and end dates)?
Summary-level results will be available 12 months after study completion, where study completion is 3 months after the last participant has been recruited or when the trial has stopped early for success or failure.
Individual data availability:
Start Date: 1 year after study completion
End Date: 5 years after study completion.
Available to whom?
Researchers who provide a formal proposal and statistical analysis plan to the study team, including research hypotheses, how they will use data and how the results will be disseminated, will be considered, pending necessary ethics and governance approvals.
Available for what types of analyses?
The data is suitable for efficacy analyses based on time to event data. No safety data is available.
How or where can data be obtained?
A mechanism will be determined between the Chief Investigator, trial sponsor and the researchers requesting the data. This will include controlled access documented in a data use agreement between the researchers and the trial sponsor.


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
SourceTitleYear of PublicationDOI
EmbaseThe AuTOMATIC trial: a study protocol for a multi-arm Bayesian adaptive randomised controlled trial of text messaging to improve childhood immunisation coverage.2023https://dx.doi.org/10.1186/s13063-023-07097-3
N.B. These documents automatically identified may not have been verified by the study sponsor.