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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

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000404628
Acronym
HPV.edu
Enrollment
7010
Registered
2014-04-14
Start date
2013-02-01
Completion date
2015-02-07
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The study is evaluating the effect of a complex intervention including education and logistical strategies, to promote uptake of school-based Human Papillomavirus (HPV) vaccination among adolescents in the Australian national School-Based Vaccination Program. Who is it for? We will recruit a random sample of Australian secondary schools to be part of this study; adolescents in these schools who are offered HPV vaccine as part of the national school vaccination program have the option to participate in our study. Trial details Schools participating in this trial will be randomly (by chance) divided into one of two groups. Schools who are in one group will deliver a complex intervention for promoting the uptake of the HPV vaccination among adolescents in a school-based program which consists of 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. 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) up to one additional vaccination visit to deliver mop-up vaccination to students incompletely vaccinated. Participants in the second group will receive 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, and nurses follow standard state health department policy for delivery of vaccine in schools.

Interventions

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

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.

Sponsors

University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
12 Years to 15 Years
Healthy volunteers
Yes

Inclusion criteria

Australian adolescents attending high school who are eligible for the HPV vaccine as part of the school based vaccination program.

Exclusion criteria

No individuals within the exclusion criteria will be excluded.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 15, 2026