Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000404628
Ethics application status
Approved
Date submitted
1/04/2014
Date registered
14/04/2014
Date last updated
8/01/2020
Date data sharing statement initially provided
8/01/2020
Date results provided
8/01/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised Controlled Evaluation of a Complex Intervention (Education and Logistical Strategies) to Promote Uptake of School-based Human Papillomavirus Vaccination among adolescents in a School-Based Program
Scientific title
Randomised Controlled Evaluation of a Complex Intervention to Promote Uptake of Adolescent School-based Human papillomavirus (HPV) Vaccination. The primary aim of the trial is to increase the uptake of vaccination in intervention schools compared to control schools.
Secondary ID [1] 284323 0
Nil
Universal Trial Number (UTN)
Trial acronym
HPV.edu
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human papillomavirus 291470 0
HPV related cancer 291471 0
Condition category
Condition code
Public Health 291837 291837 0 0
Health promotion/education
Cancer 291838 291838 0 0
Cervical (cervix)
Infection 291839 291839 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Arm: Students in schools in the intervention arm will receive standard treatment (see control) in addition to an intervention.

The intervention to be evaluated will take place over a 2 year time period, and is made up of three main components: an adolescent intervention, a parent/adolescent decision aid, and logistical strategies. Prior to the first dose of the HPV vaccination, education is delivered by school personnel through the school in an interactive session of approximately 45-50 minutes. The education intervention will take place before the first dose of the HPV vaccine is administered and ideally, before the vaccination consent forms have gone home to parents/guardians. As each school chooses when to undertake the education intervention as it fits in with their time-tabling, the time between the education intervention and the first dose of the vaccine will vary, but is most likely to take place within a few weeks of the administration of the first dose. An educational magazine is given to students as take-home information designed by and for adolescents; a website and app providing information for students to access in and outside of school; and distraction/relaxation app for students to be used on vaccination day.

A parent/adolescent HPV Decision Aid or a brief HPV information resource for parents and adolescents to use together is delivered to parents and adolescents at the time of the vaccination consent form.

Logistical strategies include 1) guidelines for nurses and teachers regarding set-up of the vaccination room; 2) strategies to promote improved consent form return (reminders, direct mail-out to parents, incentives e.g. classroom consent form return); 3) additional vaccination days to mop-up absent students.
Intervention code [1] 289040 0
Prevention
Intervention code [2] 289041 0
Lifestyle
Intervention code [3] 289042 0
Behaviour
Comparator / control treatment
The control treatment is the standard national school-based HPV vaccination program that takes place across all jurisdictions. This includes government funded HPV vaccination (three doses) for adolescents after parental/guardian consent has been granted. As part of this process parents/guardians receive a standard government brochure that provides information about HPV and HPV vaccination.
Control group
Active

Outcomes
Primary outcome [1] 291755 0
The primary outcome is the difference in three dose HPV immunisation completion rates between intervention and control groups at the end of the two years of the study. Student vaccination status in each of the participating schools will be provided by the councils and/or State Health Department at the end of the school year. In addition, this data will be also be collected from the HPV Vaccine Register which will be provided as coverage at the level of the schools.
Timepoint [1] 291755 0
Two years
Secondary outcome [1] 307430 0
1) the difference in scores of the HAVIQ (HPV Adolescent Vaccine Intervention Questionnaire) between students in intervention and control schools pre dose 1, pre dose 2, pre dose 3. This scale evaluates HPV and HPV vaccination knowledge and attitudes, HPV vaccination decision-making involvement, and HPV vaccine self-efficacy;
Timepoint [1] 307430 0
Two years
Secondary outcome [2] 307701 0
2) the difference between the time to vaccinate students in intervention and control groups, and the difference in proportion of consent form returns regardless of decision between intervention and control schools. This will be assessed using implementation logs kept by immunisation nurses that record how vaccination takes. In addition, consent form returns will be compared across intervention and control schools.
Timepoint [2] 307701 0
Two years

Eligibility
Key inclusion criteria
Australian adolescents attending high school who are eligible for the HPV vaccine as part of the school based vaccination program.
Minimum age
12 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No individuals within the exclusion criteria will be excluded.

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 involved contacting the holder of the allocation schedule who was “off-site” or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation: Schools will stratified by state (WA or SA) and sector (Government, Independent single sex, Independent co-educational, Catholic single sex, Catholic co-educational) and within strata randomised using permuted blocks. Randomisation lists will be created using the software program Rand.exe (Clinical trials : a methodologic perspective. Piantadosi, Steven. Hoboken, N.J. : Wiley-Interscience, c2005. 2nd ed.)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Open (masking not used): The researchers recruiting schools and the contact people at the schools will be blind to which arm of the trial the school would be allocated at the time the school agrees to take part in the study. The trial statistician, who has no involvement in recruitment, will allocate schools using the randomization list after the school has agreed to take part. Schools will be allocated according to the list in the order in which they are recruited. After the school has been allocated recruiters and schools will no longer be blind to intervention/control status. Where possible the schools will not be allocated until the target number in the strata has been reached.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total of 36 schools will allow the detection of a change in the percentage of students vaccinated from 70% to 80% at a significance level of 0.05 and with a power of 80% and assuming an intraclass correlation coefficient of 0.05 (Donner, 2000). We estimated the ICC from a pilot study in NSW to be 0.04, and other cluster trials in adolescents health behaviours have reported ICC’s of less than 0.05 (Murray, 2003) To allow for the possibility of schools dropping out we will increase the number of schools by 10% and recruit a total of 40 schools. On average each school of the 36 schools will have 150 students giving a total sample size of 5400 students.
With a total of 36 schools we would be able to detect the following differences between the intervention and control groups for the four secondary outcomes 1) Knowledge: minimum detectable difference "equals" = 0.7; 2) Self-efficacy: minimum detectable difference "equals" = 18; 3) Fear/anxiety: minimum detectable difference "equals"= 0.7; 4). Decision making: minimum detectable difference "equals"= 0.5, all assuming an ICC of 0.05, power of 80%, significance of 0.05 and standard deviations derived from a pilot study evaluating each of these measures and allowing for a 40% non-completion of these outcomes.
Outcome measures and analysis:
Primary outcome measurement: Vaccination uptake for all participating schools will be sought from WA Health and SA Health for the previous year of school vaccination and in the two years of the study implementation. The three-dose HPV immunisation completion rates will be compared between the intervention and control schools.
Primary outcome analysis: The primary analysis will compare vaccination rates using the Mantel-Haenszel method taking into account the stratification by year, state and school sector and adjusted for clustering. (Donner, 2000) In addition, logistic regression models will be used to adjust for baseline vaccination rates (average of the previous 2 years), school type (single sex, or mixed), school size and SEIFA index using generalized estimating equations (GEE) with robust standard errors. The level of implementation of the intervention will also be included in the regression model to determine its impact on vaccination rates.
Secondary outcome measurement: The questionnaire will be administered in schools in control and intervention groups pre dose 1 (all domains of the questionnaire: 'Skills Inventory', 'Feelings toward vaccination', 'Knowledge'), pre dose 2 ('Skills inventory', and 'feelings towards vaccination'), and post dose 3 ('Knowledge' and self-reported vaccination status). Pre-dose 1 control school data will provide a ‘baseline mean knowledge score’- this approach allows for evaluation of the intervention without the possibility of questionnaire impact confounding the outcome. In both groups, consent form return, proportion of students vaccinated and time to vaccinate 50 students will be measured at dose 1, 2 and 3.

Secondary outcome analysis: Mean change in scores of knowledge, self-efficacy, fear/anxiety, and decision making will be compared between groups using two-sample t-tests with appropriate adjustment for clustering. Baseline scores for knowledge will be taken from the control group. Also, the mean scores of fear/anxiety and self-efficacy before the first vaccination and before the second vaccination for the intervention group will be compared. Proportion of consent form returns will be compared between groups pre dose 1 using Chi square test with appropriate adjustment for clustering. Time taken to vaccinate will be measured by nurses during each immunisation day in both intervention and control schools. It will be calculated as the mean time to vaccinate 50 girls in intervention schools compared with control schools. Mean time to vaccinate will be compared between groups in both years of the study to determine effect of the intervention on time.

We will investigate whether the intervention improves vaccination rates through its effect on fear reduction, and self-efficacy increase, by comparing estimates of the effect of the intervention both with, and without, adjustment for the possible intermediary variables of fear/anxiety, and self-efficacy. These logistic regression models will use GEE and robust standard errors to account for the clustering.
Donner A, Klar N: Design and analysis of cluster randomization trials in health research. London: Arnold; 2000.
Murray DM, Blistein JL (2003). Methods to reduce the impact of intraclass correlation in group-randomized trials. Eval Rev. Feb;27(1):79-103.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2013
Actual
1/02/2013
Date of last participant enrolment
Anticipated
17/02/2014
Actual
7/02/2015
Date of last data collection
Anticipated
Actual
7/02/2015
Sample size
Target
4400
Accrual to date
Final
7010
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment postcode(s) [1] 7909 0
6008 - Subiaco
Recruitment postcode(s) [2] 7910 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 288960 0
Government body
Name [1] 288960 0
National Health and Medical Research Council
Country [1] 288960 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Discipline of Paediatrics and Child Health,
University of Sydney,
Children’s Hospital at Westmead,
Locked Bag 4001, Westmead, NSW 2054
Country
Australia
Secondary sponsor category [1] 287638 0
None
Name [1] 287638 0
Address [1] 287638 0
Country [1] 287638 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290770 0
Women's and Children's Hospital (WCHN) Human Research Ethics Committee
Ethics committee address [1] 290770 0
Ethics committee country [1] 290770 0
Australia
Date submitted for ethics approval [1] 290770 0
10/10/2012
Approval date [1] 290770 0
03/12/2012
Ethics approval number [1] 290770 0
REC2507/10/15 (HREC/12/WCHN/76 )
Ethics committee name [2] 290826 0
Department of Health WA
Ethics committee address [2] 290826 0
Ethics committee country [2] 290826 0
Australia
Date submitted for ethics approval [2] 290826 0
26/09/2012
Approval date [2] 290826 0
17/01/2013
Ethics approval number [2] 290826 0
AHEC ECOO422

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

Contacts
Principal investigator
Name 47206 0
A/Prof Rachel Skinner
Address 47206 0
Discipline of Paediatrics and Child Health,
University of Sydney,
Children’s Hospital at Westmead,
Locked Bag 4001, Westmead, NSW 2054
Country 47206 0
Australia
Phone 47206 0
+61 2 98453377
Fax 47206 0
Email 47206 0
[email protected]
Contact person for public queries
Name 47207 0
Rachel Skinner
Address 47207 0
Discipline of Paediatrics and Child Health,
University of Sydney,
Children’s Hospital at Westmead,
Locked Bag 4001, Westmead, NSW 2054
Country 47207 0
Australia
Phone 47207 0
+61 2 98453377
Fax 47207 0
Email 47207 0
[email protected]
Contact person for scientific queries
Name 47208 0
Rachel Skinner
Address 47208 0
Discipline of Paediatrics and Child Health,
University of Sydney,
Children’s Hospital at Westmead,
Locked Bag 4001, Westmead, NSW 2054
Country 47208 0
Australia
Phone 47208 0
+61 2 98453377
Fax 47208 0
Email 47208 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


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
EmbaseHPV.edu study protocol: a cluster randomised controlled evaluation of education, decisional support and logistical strategies in school-based human papillomavirus (HPV) vaccination of adolescents.2015https://dx.doi.org/10.1186/s12889-015-2168-5
EmbaseEffect of a School-Based Educational Intervention About the Human Papillomavirus Vaccine on Psychosocial Outcomes Among Adolescents: Analysis of Secondary Outcomes of a Cluster Randomized Trial.2021https://dx.doi.org/10.1001/jamanetworkopen.2021.29057
EmbaseComplex intervention to promote human papillomavirus (HPV) vaccine uptake in school settings: A cluster-randomized trial.2023https://dx.doi.org/10.1016/j.ypmed.2023.107542
N.B. These documents automatically identified may not have been verified by the study sponsor.