title: 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.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Australian and New Zealand Clinical Trials Registry, ACTRN12614000404628 , 14.04.2014.
authors.affiliation: Paediatrics and Child Health, Faculty of Medicine, University of Sydney, Locked Bag 4001, Westmead, Sydney, NSW, 2054, Australia. Rachel.Skinner@health.nsw.gov.au.
authors.forename: S Rachel
authors.initials: SR
authors.lastname: Skinner
authors.affiliation: Paediatrics and Child Health, Faculty of Medicine, University of Sydney, Locked Bag 4001, Westmead, Sydney, NSW, 2054, Australia. Cristyn.Davies@sydney.edu.au.
authors.forename: Cristyn
authors.initials: C
authors.lastname: Davies
authors.affiliation: CUNY School of Public Health, City University New York, New York City, NY, USA. spring.cooper@sph.cuny.edu.
authors.forename: Spring
authors.initials: S
authors.lastname: Cooper
authors.affiliation: Vaccine Trials Group, Telethon Kids Institute, Perth, WA, Australia. Tanya.Stoney@telethonkids.org.au.
authors.forename: Tanya
authors.initials: T
authors.lastname: Stoney
authors.affiliation: Vaccinology & Immunology Research Trials Unit, Women's & Children's Hospital, Adelaide, South Australia, Australia. Helen.Marshall@adelaide.edu.au.
authors.forename: Helen
authors.initials: H
authors.lastname: Marshall
authors.affiliation: Vaccine Trials Group, Telethon Kids Institute, Perth, WA, Australia. Jane.Jones@telethonkids.org.au.
authors.forename: Jane
authors.initials: J
authors.lastname: Jones
authors.affiliation: Vaccinology & Immunology Research Trials Unit, Women's & Children's Hospital, Adelaide, South Australia, Australia. joanne.collins@adelaide.edu.au.
authors.forename: Joanne
authors.initials: J
authors.lastname: Collins
authors.affiliation: Vaccine Trials Group, Telethon Kids Institute, Perth, WA, Australia. Heidi.Hutton@telethonkids.org.au.
authors.forename: Heidi
authors.initials: H
authors.lastname: Hutton
authors.affiliation: Vaccinology & Immunology Research Trials Unit, Women's & Children's Hospital, Adelaide, South Australia, Australia. adriana.parrella@adelaide.edu.au.
authors.forename: Adriana
authors.initials: A
authors.lastname: Parrella
authors.affiliation: Pediatrics & Clinical Psychology, Indiana University, Indianapolis, IN, USA. gzimet@iu.edu.
authors.forename: Gregory
authors.initials: G
authors.lastname: Zimet
authors.affiliation: The Kirby Institute, Faculty of Medicine, UNSW Australia, Sydney, NSW, Australia. dregan@kirby.unsw.edu.au.
authors.forename: David G
authors.initials: DG
authors.lastname: Regan
authors.affiliation: Deakin University, SRC Population Health, Deakin Health Economics, Melbourne, VIC, Australia. patti.whyte@deakin.edu.au.
authors.forename: Patti
authors.initials: P
authors.lastname: Whyte
authors.affiliation: National HPV Vaccination Program Register, VCS, and School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia. jbrother@vcs.org.au.
authors.forename: Julia M L
authors.initials: JM
authors.lastname: Brotherton
authors.affiliation: Vaccine Trials Group, Telethon Kids Institute, Perth, WA, Australia. peter.richmond@uwa.edu.au.|School of Paediatrics and Child Health, University of Western Australia, Perth, WA, Australia. peter.richmond@uwa.edu.au.
authors.forename: Peter
authors.initials: P
authors.lastname: Richmond
authors.affiliation: School of Public Health, University of Sydney, Sydney, NSW, Australia. kirsten.mccaffery@sydney.edu.au.
authors.forename: Kirsten
authors.initials: K
authors.lastname: McCaffrey
authors.affiliation: Women's Centre for Infectious Diseases, The Royal Women's Hospital, Melbourne, VIC, Australia. Suzanne.Garland@thewomens.org.au.
authors.forename: Suzanne M
authors.initials: SM
authors.lastname: Garland
authors.affiliation: School of Public Health, University of Sydney, Sydney, NSW, Australia. julie.leask@sydney.edu.au.
authors.forename: Julie
authors.initials: J
authors.lastname: Leask
authors.affiliation: Westmead Clinical School, University of Sydney, Sydney, NSW, Australia. melissa.kang@sydney.edu.au.
authors.forename: Melissa
authors.initials: M
authors.lastname: Kang
authors.affiliation: School of Population Health, University of Adelaide, Adelaide, SA, Australia. annette.braunackmayer@adelaide.edu.au.
authors.forename: Annette
authors.initials: A
authors.lastname: Braunack-Mayer
authors.affiliation: The Kirby Institute, Faculty of Medicine, UNSW Australia, Sydney, NSW, Australia. jkaldor@kirby.unsw.edu.au.
authors.forename: John
authors.initials: J
authors.lastname: Kaldor
authors.affiliation: School of Public Health, University of Sydney, Sydney, NSW, Australia. kevin.mcgeechan@sydney.edu.au.
authors.forename: Kevin
authors.initials: K
authors.lastname: McGeechan
mesh_terms: D000293:Adolescent; D000328:Adult; D001315:Australia; D003657:Decision Making; D004644:Emotions; D005260:Female; D006266:Health Education; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D017589:Immunization Programs; D008297:Male; D027383:Papillomaviridae; D030361:Papillomavirus Infections / Q000517:prevention & control* / Q000821:virology; D053918:Papillomavirus Vaccines; D010290:Parents; D010342:Patient Acceptance of Health Care; D015397:Program Evaluation; D012107:Research Design; D012574:Schools; D020377:Self Efficacy; D013334:Students / Q000523:psychology; D014611:Vaccination; D055815:Young Adult
chemical_list: D053918:Papillomavirus Vaccines