Complex intervention to promote human papillomavirus (HPV) vaccine uptake in school settings: A cluster-randomized trial

Using a cluster-randomized trial design, we aimed to evaluate a complex intervention to increase uptake of human papillomavirus (HPV) vaccination in schools. The study was undertaken in high schools in Western Australia and South Australia between 2013 and 2015 with adolescents aged 12-13 years. Interventions included education, shared decision-making, and logistical strategies. The main outcome was school vaccine uptake. Secondary outcomes included consent forms returned and mean time to vaccinate 50 students. We hypothesised that a complex intervention would increase 3-dose HPV vaccine uptake. We recruited 40 schools (21 interven-tion, 19 control) with 6, 967 adolescents. There was no difference between intervention and control (3-dose mean 75.7% and 78.9%, respectively). Following adjustment for baseline covariates, absolute differences in coverage in favour of the intervention group were: dose 1, 0.8% (95% CI,-1.4,3.0); dose 2, 0.2% (95% CI,-2.7, 3.1); dose 3, 0.5% (95% CI,-2.6, 3.7). The percentage of returned consent forms in intervention schools (91.4%) was higher than in control schools (difference: 6%, 95% CI, 1.4, 10.7). There was a shorter mean time to vaccinate 50 students at dose 3. The difference for dose 3 was 110 min (95% CI, 42, 177); for dose 2, 90 min (95% CI,-15, 196); and dose 1, 28 min (95% CI,-71, 127). Logs revealed the inconsistent implementation of logistical strategies. The intervention had no impact on uptake. Inadequate resourcing for logistical strategies and advisory board reluctance toward strategies with potential financial implications impacted the imple-mentation of logistical components.Trial registration: Australian and New Zealand Clinical Trials Registry, ACTRN12614000404628, 14.04.2014. The study protocol was published in 2015 before data collection was finalised (Skinner et al., 2015). The HPV.edu study group: We would like to acknowledge the contributions to this study by members of the HPV. edu Study Group, including: Professor Annette Braunack-Mayer: Australian Centre for Health Engagement, Ev-idence and Values, School of Health and Society, Faculty of Arts, Social Sciences and Humanities, University of Wollongong, NSW, Australia; Dr. Joanne Collins: Women's and Children's Health Network and School of Medicine and Robinson Research Institute, University of Adelaide, SA, Australia; Associate Professor Spring Cooper: School of Public Health, City University of New York (CUNY), New York, NY, USA; Heidi Hutton: Telethon Kids Institute, University of Western Australia, WA, Australia; Jane Jones: Telethon Kids Institute, University of Western Australia, WA, Australia; Dr. Adriana Parrella: Women's and Children's Health Network and School of Medicine and Robinson Research Institute, University of Adelaide, SA, Australia; and South Australian Health and Medical Research Institute (SAHMRI), Adelaide, Australia; Associate Professor David G. Regan: The Kirby Institute for Infection and Immunity in Society, Faculty of Medicine, UNSW Sydney, NSW, Australia; Professor Peter Richmond: Perth Children's Hospital, Child and Adolescent Health Service, Western Australia, Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, WA, Australia, and School of Medicine, University of Western Australia, Perth, WA, Australia; Dr. Tanya Stoney: Telethon Kids Institute, University of Western Australia, WA, Australia. Contact for the HPV.edu study group: Cristyn. Davies@sydney.edu.au or Rachel.Skinner@sydney.edu.au.