Skip to main content
main-content

01.12.2015 | Study protocol | Ausgabe 1/2015 Open Access

BMC Public Health 1/2015

HPV.edu study protocol: a cluster randomised controlled evaluation of education, decisional support and logistical strategies in school-based human papillomavirus (HPV) vaccination of adolescents

Zeitschrift:
BMC Public Health > Ausgabe 1/2015
Autoren:
S. Rachel Skinner, Cristyn Davies, Spring Cooper, Tanya Stoney, Helen Marshall, Jane Jones, Joanne Collins, Heidi Hutton, Adriana Parrella, Gregory Zimet, David G. Regan, Patti Whyte, Julia M. L. Brotherton, Peter Richmond, Kirsten McCaffrey, Suzanne M. Garland, Julie Leask, Melissa Kang, Annette Braunack-Mayer, John Kaldor, Kevin McGeechan
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​s12889-015-2168-5) contains supplementary material, which is available to authorized users.

Competing interests

SR Skinner’s institution has received funds from GSK to reimburse 1. Costs associated with collection of data on HPV vaccine clinical efficacy trials, 2. Costs associated with travel to conferences to present data from HPV vaccine clinical efficacy trials. SR Skinner’s institution has received honoraria from GSK and Pfizer for participation in advisory boards and for educational presentations. SR Skinner’s institution has received funds from GSK and bioCSL to conduct investigator driven research.
T Stoney is a PI on GSK sponsored clinical trials for Cervarix, for which her institution received funding, one of which is ongoing.  She is a member of Asia Pacific Study Follow-up Committee for Studies Zoster (GSK), for which she has received honoraria. She has received travel support from bioCSL, Merck and GSK to attend and/or present at scientific meetings and conferences.
H Marshall’s institution has received funds from GSK to reimburse 1. Investigator led research on pertussis epidemiology 2. Costs associated with travel to conferences to present data on meningococcal epidemiology and vaccines and from CSL to fund an investigator led study. H Marshall has not received any personal funding from Industry.
J Jones received travel support from GSK to attend scientific meetings.
H Hutton received sponsorship from GSK for conference expenses.
GD Zimet's institution has received funds from Merck to conduct investigator driven research.  In the past year, GD Zimet received honoraria of less than $5,000 US from Merck for serving on a one-time advisory panel.
JML Brotherton's institution has received funds from bioCSL to conduct investigator driven research.
P Richmond is a member of a scientific advisory board for bioCSL, received honoraria from Baxter for speaking at scientific meetings, travel support to speak at scientific meetings for Pfizer and Sanofi Pasteur, and travel support from Pfizer, GSK and bioCSL to present scientific data at international meetings.
SM Garland has received grant support to her institution from CSL Bio, Merck and GlaxoSmithKline and has received funding through her institution to conduct HPV vaccine studies for MSD GSK (VIVIANNE) trial. She is a member of the Merck Global Advisory Board as well as the Merck Scientific Advisory Committee for HPV (unpaid position).

Authors’ contributions

SRS led the conception and design of the study, contributed to the collection of data, contributed to analysis and interpretation of analysis, led the drafting of the manuscript, and gave final approval for publication and is accountable for all aspects of the work and its presentation within the manuscript. CD contributed to study design, collection of data, analysis and interpretation, and drafting of the manuscript. SC contributed to study design, and collection of data, and critically reviewed the manuscript. TS contributed to study design, collection of data, interpretation of analysis, and critically reviewed the manuscript. HM contributed to study design, collection of data, interpretation of analysis, and drafting of the manuscript. JJ contributed to collection of data, interpretation of analysis, and critically reviewed the manuscript. JC contributed to collection of data, interpretation of analysis, and critically reviewed the manuscript. HH contributed to collection of data, interpretation of analysis, and critically reviewed the manuscript. AP contributed to collection of data, interpretation of analysis, and critically reviewed the manuscript. GZ contributed to study design, interpretation of analyses, and critically reviewed the manuscript. DGR contributed to study design, interpretation of analyses, and critically reviewed the manuscript. PW contributed to study design, interpretation of analyses, and critically reviewed the manuscript. JMLB contributed to study design, interpretation of analyses, and critically reviewed the manuscript. PR contributed to study design, interpretation of analyses, and critically reviewed the manuscript. KMcC contributed to study design, interpretation of analyses, and critically reviewed the manuscript. SMG contributed to study design, interpretation of analyses, and critically reviewed the manuscript. AB-M contributed to study design, interpretation of analyses, and critically reviewed the manuscript. JK contributed to study design, interpretation of analyses, and critically reviewed the manuscript. KMcG contributed to study design, interpretation of analyses, and drafting of the manuscript. All authors read and approved the final manuscript.

Abstract

Background

The National Human Papillomavirus (HPV) Vaccination Program in Australia commenced in 2007 for females and in 2013 for males, using the quadrivalent HPV vaccine (HPV 6,11,16,18). Thus far, we have demonstrated very substantial reductions in genital warts and in the prevalence of HPV among young Australian women, providing early evidence for the success of this public health initiative. Australia has a long history of school-based vaccination programs for adolescents, with comparatively high coverage. However, it is not clear what factors promote success in a school vaccination program. The HPV.edu study aims to examine: 1) student knowledge about HPV vaccination; 2) psycho-social outcomes and 3) vaccination uptake.

Methods/Design

HPV.edu is a cluster randomised trial of a complex intervention in schools aiming to recruit 40 schools with year-8 enrolments above 100 students (approximately 4400 students). The schools will be stratified by Government, Catholic, and Independent sectors and geographical location, with up to 20 schools recruited in each of two states, Western Australia (WA) and South Australia (SA), and randomly allocated to intervention or control (usual practice). Intervention schools will receive the complex intervention which includes an adolescent intervention (education and distraction); a decisional support tool for parents and adolescents and logistical strategies (consent form returns strategies, in-school mop-up vaccination and vaccination-day guidelines). Careful process evaluation including an embedded qualitative evaluation will be undertaken to explore in depth possible mechanisms for any observed effect of the intervention on primary and secondary outcomes.

Discussion

This study is the first to evaluate the relative effectiveness of various strategies to promote best practice in school-based vaccination against HPV. The study aims to improve vaccination-related psychosocial outcomes, including adolescent knowledge and attitudes, decision-making involvement, self-efficacy, and to reduce fear and anxiety. The study also aims to improve school vaccination program logistics including reduction in time spent vaccinating adolescents and increased number of consent forms returned (regardless of decision). Less anxiety in adolescents will likely promote more efficient vaccination, which will be more acceptable to teachers, nurses and parents. Through these interventions, it is hoped that vaccination uptake will be increased.

Trial registration

Australian and New Zealand Clinical Trials Registry, ACTRN12614000404​628, 14.04.2014.
Zusatzmaterial
Additional file 1: HPV.edu: An educational intervention about HPV and the HPV vaccine. (DOC 50 kb)
12889_2015_2168_MOESM1_ESM.doc
Additional file 2: Vaccination logistical interventions. (DOC 145 kb)
12889_2015_2168_MOESM2_ESM.doc
Literatur
Über diesen Artikel

Weitere Artikel der Ausgabe 1/2015

BMC Public Health 1/2015 Zur Ausgabe