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Background: High-density microarray patch (HD-MAP) vaccines may increase vaccine acceptance and use. We aimed to ascertain whether professional immunizers (PIs) and other healthcare workers (HCWs) in Australia, a High-Income Country (HIC), found the HD-MAP applicator usable and acceptable for vaccine delivery., Methods: This feasibility study recruited PIs and HCWs to administer/receive simulated HD-MAP administration, including via self-administration. We assessed usability against essential and desirable criteria. Participants completed a survey, rating their agreement to statements about HD-MAP administration. A subset also participated in an interview or focus group. Survey data were analyzed using descriptive statistics, and interviews were transcribed and subject to thematic analysis., Results: We recruited 61 participants: 23 PIs and 38 HCWs. Findings indicated high usability and acceptability of HD-MAP use across both groups by a healthcare professional or trained user and for self-administration with safety measures in place. Most administrations met essential criteria, but PIs, on average, applied the HD-MAP for slightly less time than the required 10-seconds, which the HCWs achieved. PIs perceived safety concerns about home administration but found layperson self-administration acceptable in an emergency, pandemic, and rural or remote settings., Conclusions: Participants found HD-MAP administration usable and acceptable. Usability and acceptability are likely to be improved through end-user education and training.

Importance: Delivery of vaccination to adolescents via a school-based program provides an opportunity to promote their involvement in health decision-making, service provision, and self-efficacy (belief in one's ability to perform a certain behavior)., Objective: To examine the effect of a human papillomavirus (HPV) vaccination education and logistical intervention on adolescent psychosocial outcomes., Design, Setting, and Participants: In this cluster randomized trial and process and qualitative evaluation, adolescents aged 12 to 13 years (first year of high school) were recruited at high schools in Western Australia (WA) and South Australia (SA) in 2013 and 2014. Statistical analysis was performed from January 2016 to December 2020., Interventions: The complex intervention consisted of an adolescent intervention to promote knowledge and psychosocial outcomes, shared decisional support tool, and logistical strategies., Main Outcomes and Measures: Prespecified secondary outcomes were assessed. The HPV Adolescent Vaccination Intervention Questionnaire (HAVIQ) was used to measure changes in adolescent knowledge (6-item subscale), fear and anxiety (6-item subscale), self-efficacy (5-item subscale), and decision-making (8-item subscale). The hypothesis was that the intervention would improve adolescent involvement in vaccine decision-making (measured before dose 1 only), improve vaccine-related self-efficacy, and reduce vaccine-related fear and anxiety (measured before doses 1, 2, and 3). Mean (SD) scores for each subscale were compared between intervention and control students. In the process evaluation, focus groups were conducted. Analyses of the HAVIQ data were conducted from 2016 to 2020. Qualitative analyses of the focus groups were undertaken from 2017 to 2020., Results: The trial included 40 schools (21 intervention and 19 control) across sectors with 6967 adolescents (mean [SD] age, 13.70 [0.45] years). There were 3805 students (1689 girls and 2116 boys) in the intervention group and 3162 students (1471 girls and 1691 boys) in the control group. The overall response rate for the HAVIQ was 55%. In WA, where parental consent was required, the response rate was 35% (1676 of 4751 students); in SA, where parental consent was not required, it was 97% (2166 of 2216 students). The mean (SD) score for decision-making in the intervention group before dose 1 was 3.50 (0.42) of 5 points and 3.40 (0.40) in the control group, a small but significant difference of 0.11 point (95% CI, 0.06 to 0.16 point; P < .001). There was a small difference in favor of the intervention group in reduced vaccination-related anxiety (pre-dose 1 difference, -0.11 point [95% CI, -0.19 to -0.02 point]; pre-dose 2 difference, -0.18 point [95% CI, -0.26 to -0.10 point]; pre-dose 3 difference, -0.18 [95% CI, -0.24 to -0.11]) and increased vaccination self-efficacy (pre-dose 1 difference, 4.0 points; [95% CI, 1.0 to 7.0 points]; pre-dose 2 difference, 4.0 points [95% CI, 2.0 to 6.0 points]; pre-dose 3 difference, 3.0 points [95% CI, 1.0 to 5.0 points]). Focus group data from 111 adolescents in 6 intervention and 5 control schools revealed more confidence and less anxiety with each vaccine dose., Conclusions and Relevance: In this cluster randomized trial, there was a small difference in adolescent decisional involvement and vaccine-related confidence and reduced vaccination-related fear and anxiety that was maintained throughout the vaccine course in the intervention vs control groups. Guidelines for vaccination at school should incorporate advice regarding how this outcome can be achieved., Trial Registration: Australian and New Zealand Clinical Trials Registry: ACTRN12614000404628.

Background: This systematic review and meta-analysis aimed to assess the effectiveness of vaccination decision aids compared with usual care on vaccine uptake, vaccine attitudes, decisional conflict, intent to vaccinate and timeliness., Methods: Searches were conducted in OVID Medline, OVID Embase, CINAHL, PsycINFO, the Cochrane Library and SCOPUS. Randomised controlled trials were included if they evaluated the impact of decision aids as defined by the International Patient Decision Aids Standards Collaboration. Where possible, meta-analysis was undertaken. Where meta-analysis was not possible, we conducted a narrative synthesis. Risk of bias in included trials was assessed using the Cochrane Collaboration's risk of bias tool. Data were analysed using STATA., Results: Five RCTs were identified that evaluated the effectiveness of decision aids in the context of vaccination decision making. Meta-analysis of four studies showed that decision aids may have slightly increased vaccination uptake, but this was reduced to no effect once studies with higher risk of bias were excluded. Meta-analysis of three studies showed that decision aids moderately increased intention to vaccinate. Narrative synthesis of two studies suggested that decision aids reduced decisional conflict. One study reported that decision aids decreased perceived risk of vaccination. Content, format and delivery method of the decision aids varied across the studies. It was not clear from the information reported whether these variations affected the effectiveness of the decision aids., Conclusion: Decision aids can assist in vaccine decision making. Future studies of decision aids could provide greater detail of the decision aids themselves, which would enable comparison of the effectiveness of different elements and formats. Standardising decision aids would also allow for easier comparison between decision aids., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Introduction: An adverse reaction associated with vaccination is considered to be a key barrier to vaccinate, yet little attention has been given to interventions to reduce their occurrence. Exercise is a behavioural adjuvant which may also influence adverse reactions. Here, two randomized controlled trials are reported, examining the effects of exercise on self-reported adverse reactions following vaccination in adolescents and young adults., Methods: Study one; 116 adolescents receiving the HPV vaccine were randomly allocated to either Control (n = 56) or Pre-vaccine Exercise (n = 60) group (2015-2016). Exercise consisted of 15-minutes upper body exercise. Study two; 78 young adults receiving the influenza vaccine were randomly allocated to either Control (n = 19), or one of 3 exercise groups: Pre-vaccine Arm (n = 19), Pre-vaccine Leg (n = 20) or Post-vaccine Arm (n = 20) (2017). Exercise included 15-minutes of arm or leg exercises prior to or after vaccination. All participants in both studies completed an adverse events diary for seven-days post-vaccination., Results: Study one; Reported days of tenderness in female adolescents that exercised were significantly lower than control (p = 0.032), with a similar trend in reported days of pain (p = 0.050). Furthermore, days of feeling ill (p = 0.070) and reduced appetite (p = 0.067) were found to be lower with exercise, although not significant. Overall, female adolescents reported significantly more days of pain (p = 0.003), tenderness (p < 0.001), swelling (p = 0.011), and feeling ill (p = 0.0040). Study two; Exercise groups reported reduced days of swelling (p = 0.018), fever (p = 0.013), and lowered appetite (p = 0.011) across both genders. Furthermore, females reported reduced days of medication use with exercise (p = 0.034), and a trend toward reduced days of swelling (p = 0.052)., Discussion: In two separate trials, a short bout of exercise reduced reported adverse reactions after vaccinations for local and systemic adverse reactions. Gender differences in reported local and systemic adverse reactions were more evident among adolescents than young adults. These findings support the need for further work to examine the potential benefit of exercise in improving vaccination procedures., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Objectives: We describe the development and validation of measures of human papillomavirus (HPV)/HPV vaccination knowledge, fear/anxiety about vaccination, involvement in HPV vaccine decision-making, and self-efficacy with regard to getting the vaccine, designed to evaluate the efficacy of an intervention to affect these domains (collectively termed the HAVIQ: HPV Adolescent Vaccine Intervention Questionnaire)., Study Design: Literature search, cognitive interviews and cross-sectional survey., Methods: A literature search identified existing items that were modified for the present measures. Experts reviewed draft measures for face and content validity. Cognitive interviews with adolescents were also used to assess content validity. Adolescents completed the measures and an internal reliability analysis of each measure was performed., Results: The four experts concurred that the measures had face validity. Cognitive interviews identified items requiring refinement. Content validity was examined with ten experts and was deemed acceptable. There were 1800 adolescents who completed the measures; Cronbach's alpha was >0.6 for three of the four measures. The four final measures are brief, comprising 25 items in total., Conclusions: The measures are robustly developed and validity-tested. The HAVIQ may be used in research settings to evaluate adolescents' knowledge and experiences of the process of HPV vaccination in a school-based vaccination programme., (Copyright © 2017 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.)

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, ACTRN12614000404628 , 14.04.2014.

Background: After the introduction of a quadrivalent human papillomavirus (HPV) vaccination programme in Australia in April, 2007, we measured the prevalence of vaccine-targeted and closely related HPV types with the aim of assessing direct protection, cross-protection, and herd immunity., Methods: In this repeat cross-sectional study, we recruited women aged 18-24 years who attended Pap screening between October, 2005, and July, 2007, in three major metropolitan areas of Australia to form our prevaccine-implementation sample. For our postvaccine-implementation sample, we recruited women aged 18-24 years who attended Pap screening in the same three metropolitan areas from August, 2010, to November, 2012. We compared the crude prevalence of HPV genotypes in cervical specimens between the prevaccine and the postvaccine implementation groups, with vaccination status validated against the National HPV Vaccination Program Register. We estimated adjusted prevalence ratios using log linear regression. We estimated vaccine effectiveness both for vaccine-targeted HPV types (16, 18, 6, and 11) and non-vaccine but related HPV types (31, 33, and 45)., Findings: 202 women were recruited into the prevaccine-implementation group, and 1058 were recruited into the postvaccine-implementation group. Crude prevalence of vaccine-targeted HPV genotypes was significantly lower in the postvaccine-implementation sample than in the prevaccine-implementation sample (58 [29%] of 202 vs 69 [7%] of 1058; p<0·0001). Compared with the prevaccine-implementation sample, adjusted prevalence ratios for vaccine-targeted HPV genotypes were 0·07 (95% CI 0·04-0·14; p<0·0001) in fully vaccinated women and 0·65 (0·43-0·96; p=0·03) in unvaccinated women, which suggests herd immunity. No significant declines were noted for non-vaccine-targeted HPV genotypes. However, within the postvaccine-implementation sample, adjusted vaccine effectiveness against vaccine-targeted HPV types for fully vaccinated women compared with unvaccinated women was 86% (95% CI 71-93), and was 58% (26-76) against non-vaccine-targeted but related genotypes (HPV 31, 33, and 45)., Interpretation: 6 years after the initiation of the Australian HPV vaccination programme, we have detected a substantial fall in vaccine-targeted HPV genotypes in vaccinated women; a lower prevalence of vaccine-targeted types in unvaccinated women, suggesting herd immunity; and a possible indication of cross-protection against HPV types related to the vaccine-targeted types in vaccinated women., Funding: Australian National Health and Medical Research Council and Cancer Council Victoria., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Background: Public Health England has reported a decrease of up to 20.8% in new diagnoses of external genital warts (GWs) among women aged <19 years since the national vaccination program with the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine began in 2008. A post hoc analysis of the phase III PATRICIA (PApilloma TRIal against Cancer In young Adults) trial (NCT00122681) was performed to ascertain whether protection against low-risk HPV types was apparent., Methods: Vaccine efficacy (VE) at 48 months was assessed against 6-month persistent infection (6MPI) with low-risk HPV types in the total vaccinated cohort (TVC) and in the TVC naive (for 25 HPV types tested) populations., Results: In the TVC naive cohort, VE against 6MPI (95% confidence interval) was 34.5% (11.3 to 51.8) for HPV-6/11, 34.9% (9.1 to 53.7) for HPV-6, 30.3% (-45.0 to 67.5) for HPV-11, and 49.5% (21.0 to 68.3) for HPV-74., Conclusions: The HPV-16/18 AS04-adjuvanted vaccine appears to have moderate efficacy against persistent infections with a number of low-risk HPV types (HPV-6/11/74), which are responsible for the majority of external GWs, and recently, antibody and cell-mediated immune response to HPV-6/11 have been observed. These findings may help to explain the decrease in external GW diagnoses seen in England.

Objective: School-based vaccination is becoming a more widely used method of vaccine delivery. However, evaluations of school-based vaccination program implementation have not been systematically reviewed. This paper describes the results of a systematic review of the literature on process (or implementation) evaluations of school-based vaccination delivery., Methods: Search terms: "school based vaccination" OR (("schools" OR "school") AND ("immunisation" OR "immunization" OR "vaccination"))., Limits: Humans; English language; Age: 6-18 (school-age children and adolescents); No editorials; No letters. Databases: PUBMED; Embase.com; Cochrane Database of Systematic Reviews; Cinahl; Web of Science; PsycINFO. Inclusions: Articles must have originated from an advanced economic 'developed' country, be peer-reviewed, available in English, randomised or non-randomised controlled design, published from 1970 to August 2010 and focused on vaccinations provided in the school setting and during school time which reported one or more outcomes., Exclusions: qualitative or descriptive papers without any evaluation component; papers that only reported on impact evaluation (i.e. number of students vaccinated); and those published before 1970., Results: A total of 14 articles were identified as including some element of a process evaluation of a school-based vaccination program. Nurses, parents, teachers, and adolescents were involved in measures of procedural factors related to school-based vaccination implementation. Outcomes included return rates of consent forms; knowledge about the specific vaccine offered; attitudes toward vaccination and school-based vaccination; reasons for non-vaccination; resources, support, and procedures related to implementation; and environmental factors within the school that may impact vaccination success. Vaccination coverage was also reported in the majority of papers., Conclusions: Many studies reported on the importance of ensuring all stakeholders (school nurses, parents, teachers, and adolescents) receive appropriate information and are involved in the vaccination program and implementation processes. Specific consent form dissemination procedures have demonstrated higher return rates. Further controlled studies are needed to determine the best practice approach to implementing these programs is a variety of contexts., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

Objectives: To examine the experience of fear, the fear response, and factors affecting fear in adolescents undergoing school-based human papillomavirus (HPV) vaccination., Design, Participants and Setting: A purposive sampling strategy and qualitative methods, including observation and face-to-face interviews. Focus groups comprised adolescent girls who were involved in HPV vaccination in 2007 at schools in Sydney, New South Wales. Individual interviews were conducted with parents, teachers and vaccination nurses., Results: Data from observing vaccination days at three schools and from interviewing 130 adolescents in 20 focus groups, 38 parents, 10 teachers and seven nurses were included in the analysis. All participants discussed the issue of fear and distress experienced by adolescent girls in relation to HPV vaccination. Observations corroborated the focus group and interview data. Our results indicated that fear was promoted by witnessing the fear reactions of peers; perceived judgement by peers; lack of information or misinformation; and being vaccinated later in the day. Fear was moderated by procedural factors, the support of peers, appropriate knowledge, and nurses' distraction techniques or approach. Fear also affected acceptance of HPV vaccination., Conclusions: Fear of HPV vaccination was a near universal experience among adolescents in the school setting and was often associated with significant distress that had an adverse impact on the vaccination process. School vaccination could be improved by proactively managing fear and distress.

Objectives: Australia was one of the first countries to implement a nationwide program providing HPV vaccination to girls at school. To date, there are no published studies describing decision-making processes and behavior postimplementation of HPV vaccination of adolescents participating in a school-based program., Design: A purposive sample of nine schools was selected to reflect a range of vaccination coverage and school types. Semistructured focus groups with girls and interviews with parents, teachers, and immunization nurses (n = 185) were conducted until saturation was reached. Transcripts were analyzed inductively and emergent themes were subject to constant comparison., Main Outcome Measures: Explanatory model of decision-making in HPV vaccination., Results: An explanatory model of decision-making and behavior was constructed from the data. Five decision-making states emerged across a continuum of vaccination behavior: active decision-vaccinated, passive decision- vaccinated, passive decision- not vaccinated, active decision- not vaccinated, and antivaccination. A range of factors influenced participants in each decision-behavior state. Adolescents were often part of the decision-making process. Where adolescents were not involved, nonagreement sometimes occurred., Conclusion: We have presented a variety of paths girls and their parents experience regarding decision-making and behavior in HPV vaccination. Attitudes, past experiences, and worldviews contributed to this process., (© 2010 APA, all rights reserved.)

Objective: To measure the uptake of preadolescent measles-mumps-rubella (MMR) and adolescent hepatitis B vaccinations and assess the influence of certain demographic factors on the uptake of these vaccines., Design: Prevalence surveys of uptake rates of preadolescent (school Year 6; age 10-11 years) MMR and adolescent (school Year 9; age 13-14 years) hepatitis B vaccination., Setting: City of Darebin, an inner northern metropolitan region of Melbourne, 1996., Subjects: 1160 Year 6 school students (580 boys) and 1102 Year 9 school students (548 boys)., Intervention: School-based vaccination program administered by Darebin Council., Results: 83% of Year 6 students were vaccinated with the MMR vaccine (84.1% of girls and 81.9% of boys). 71.6% of Year 9 students completed the full course of hepatitis B vaccination (68.9% of boys and 74.2% of girls). There was a higher uptake of MMR in non-government primary schools, but no other demographic factors (sex, economic status, non-English-speaking background, parental education, school class size) were associated., Conclusions: These uptake rates do not meet National Health and Medical Research Council (NHMRC) recommendations. Further study is required to determine and quantify the factors that affect vaccination uptake in adolescence. Programs may then be developed to improve vaccination uptake.

The article offers information on the General Practitioners (GP) having an important role in supporting adolescent vaccination, including ensuring vaccinations are up to date and in promoting health literacy among parents and adolescents. It highlights that they can opportunistically prioritise vaccination during routine consultations and ensure the adolescent is up to date with the vaccination schedule recommended in the National Immunisation Program.

Background: Current HPV vaccines do not protect against all oncogenic HPV types. Following vaccination, type replacement may occur, especially if different HPV types competitively interact during natural infection. Because of their common route of transmission, it is difficult to assess type interactions in observational studies. Our aim was to evaluate type replacement in the setting of HPV vaccine randomized controlled trials (RCTs).Methods: Data were pooled from the Costa Rica Vaccine Trial (CVT; NCT00128661) and PATRICIA trial (NCT001226810)-two large-scale, double-blind RCTs of the HPV-16/18 AS04-adjuvanted vaccine-to compare cumulative incidence of nonprotected HPV infections across trial arms after four years. Negative rate difference estimates (rate in control minus vaccine arm) were interpreted as evidence of replacement if the associated 95% confidence interval excluded zero. All statistical tests were two-sided.Results: After applying relevant exclusion criteria, 21 596 women were included in our analysis (HPV arm = 10 750; control arm = 10 846). Incidence rates (per 1000 infection-years) were lower in the HPV arm than in the control arm for grouped nonprotected oncogenic types (rate difference = 1.6, 95% confidence interval [CI] = 0.9 to 2.3) and oncogenic/nononcogenic types (rate difference = 0.2, 95% CI = -0.3 to 0.7). Focusing on individual HPV types separately, no deleterious effect was observed. In contrast, a statistically significant protective effect (positive rate difference and 95% CI excluded zero) was observed against oncogenic HPV types 35, 52, 58, and 68/73, as well as nononcogenic types 6 and 70.Conclusion: HPV type replacement does not occur among vaccinated individuals within four years and is unlikely to occur in vaccinated populations. [ABSTRACT FROM AUTHOR]

Background: Although the risk of human papillomavirus (HPV) infection is greatest in young women, women older than 25 years remain at risk. We present data from the VIVIANE study of the HPV 16/18 AS04-adjuvanted vaccine in adult women after 7 years of follow-up.Methods: In this phase 3, double-blind, randomised controlled trial, healthy women older than 25 years were enrolled (age stratified: 26-35 years, 36-45 years, and ≥46 years). Up to 15% in each age stratum had a history of HPV infection or disease. Women were randomly assigned (1:1) to receive HPV 16/18 vaccine or aluminium hydroxide control, with an internet-based system. The primary endpoint was vaccine efficacy against 6-month persistent infection or cervical intraepithelial neoplasia grade 1 or greater (CIN1+) associated with HPV 16/18. We did analyses in the according-to-protocol cohort for efficacy and total vaccinated cohort. Data for the combined primary endpoint in the according-to-protocol cohort for efficacy were considered significant when the lower limit of the 96·2% CI around the point estimate was greater than 30%. For all other endpoints and cohorts, data were considered significant when the lower limit of the 96·2% CI was greater than 0%. This study is registered with ClinicalTrials.gov, number NCT00294047.Findings: The first participant was enrolled on Feb 16, 2006, and the last study visit took place on Jan 29, 2014. 4407 women were in the according-to-protocol cohort for efficacy (n=2209 vaccine, n=2198 control) and 5747 women in the total vaccinated cohort (n=2877 vaccine, n=2870 control). At month 84, in women seronegative for the corresponding HPV type in the according-to-protocol cohort for efficacy, vaccine efficacy against 6-month persistent infection or CIN1+ associated with HPV 16/18 was significant in all age groups combined (90·5%, 96·2% CI 78·6-96·5). Vaccine efficacy against HPV 16/18-related cytological abnormalities (atypical squamous cells of undetermined significance and low-grade squamous intraepithelial lesion) and CIN1+ was also significant. We also noted significant cross-protective efficacy against 6-month persistent infection with HPV 31 (65·8%, 96·2% CI 24·9-85·8) and HPV 45 (70·7%, 96·2% CI 34·2-88·4). In the total vaccinated cohort, vaccine efficacy against CIN1+ irrespective of HPV was significant (22·9%, 96·2% CI 4·8-37·7). Serious adverse events related to vaccination occurred in five (0·2%) of 2877 women in the vaccine group and eight (0·3%) of 2870 women in the control group.Interpretation: In women older than 25 years, the HPV 16/18 vaccine continues to protect against infections, cytological abnormalities, and lesions associated with HPV 16/18 and CIN1+ irrespective of HPV type, and infection with non-vaccine types HPV 31 and HPV 45 over 7 years of follow-up.Funding: GlaxoSmithKline Biologicals SA. [ABSTRACT FROM AUTHOR]

Objective: Australia has implemented a nation-wide programme providing a human papillomavirus (HPV) vaccine to girls and boys through school-based programmes. Previous research has identified three distinct areas for attention: (1) lack of understanding about HPV and HPV vaccination, (2) young people’s desire for involvement in decision-making about HPV vaccination and (3) fear of HPV vaccination. We aimed to develop an intervention to address young people’s low levels of understanding, to promote their involvement in consent and reduce vaccination-related fear and anxiety. Design, Setting, Methods: Formative qualitative research was conducted in six public, private and Catholic schools in the Sydney metropolitan area. Girls who were offered the vaccine in a school programme and aged 12–13 years were interviewed in focus groups. Piloting of materials was conducted in three private schools across Sydney with both girls and boys, and changes and additions were made to the materials in accordance with feedback. Results: We developed an educational intervention aimed at addressing gaps in young people’s knowledge and understanding, and offering strategies to improve confidence with vaccination and reduce needle-related anxiety. Components of the final intervention include film chapters, a magazine, a website, an app and teacher support materials. The intervention is designed for teachers and/or nurses to deliver and is linked to the school-based HPV vaccination programme. Conclusions: This is the first educational intervention designed for young people in HPV school-based vaccination, to be developed from empirical data with the involvement of young people themselves. [ABSTRACT FROM AUTHOR]

Vaccines are available against human papillomavirus (HPV), the causal agent of cervical and other cancers. Efficacy data from the HPV-16/18 AS04-adjuvanted vaccine clinical trial program were reviewed. Six randomized, controlled phase II/III trials evaluating cervical endpoints enrolled women from diverse populations and geographical locations. The program analyzed extensively the cohorts most relevant from a public health perspective: the total vaccinated cohort (TVC), approximating a general population including those with existing or previous HPV infection, and TVC-naïve, approximating a population of young women before sexual debut. Results show that the vaccine reduces HPV-16/18 infection and associated cervical endpoints in women regardless of age, location, or sexual experience. It provides cross-protection against some non-vaccine oncogenic HPV types and types causing genital warts, and may be effective against vulvar, oral, and anal HPV infection. Early epidemiology data following its introduction suggest a decline in the prevalence of vaccine and some non-vaccine HPV types. [ABSTRACT FROM PUBLISHER]

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, ACTRN12614000404628 , 14.04.2014. [ABSTRACT FROM AUTHOR]

The article provides information on a study which examined the factors that were perceived to affect school-based human papillomavirus (HPV) vaccination program in Sydney, New South Wales. Background information on the delivery of vaccination strategies for young adolescent girls in New South Wales is offered. Data collection was done through structured focus groups with girls offered the vaccine, one-on-one interviews with parents, teachers and nurses and observations in schools during vaccination delivery. The categorization of the themes that emerged from the participants' experience is explained.

Background: Little is known about acceptability of the human papillomavirus (HPV) vaccine among parents of adolescents from culturally and linguistically diverse backgrounds in Australia. This study aimed to explore the knowledge and attitudes of parents from Arabic backgrounds towards HPV vaccination offered to their children in the national school-based vaccination program. Methods: Qualitative interviews were conducted in Western Sydney, with parents of adolescents from Arabic backgrounds. Recruitment was via informal personal contacts and passive snowballing. Face-to-face semi-structured interviews were conducted in Arabic. These were audio-recorded, transcribed, and translated into English. Thematic analysis was used to identify emerging themes. Results: Commonly identified themes across fifteen interviews included: (1) lack of awareness and knowledge of HPV and its vaccination, (2) awareness and understanding of the government vaccination information sheet, (3) parents' preferences for information provision, (4) the role of parents' religious beliefs in forming attitudes about HPV vaccination, and (5) lost opportunities to educate parents about HPV vaccination during general practitioner (GP) visits. Conclusion: The findings point to the need to address cultural, language, and communication barriers to improve awareness and acceptability of HPV vaccination in the Arabic community. Educational strategies should be tailored to this community based on their specific information needs and preferences. [ABSTRACT FROM AUTHOR]

Australia commenced an ongoing school based government funded human papillomaviruses (HPV) (cervical cancer prevention) vaccination program in April 2007 for adolescent females aged 12–13 years. In addition, up to December 31, 2009, a catch-up program for young females 13–26 years of age was offered: a school-based vaccination program was used to offer HPV vaccine to girls enrolled in school (14–17 years), and general practitioners or other community health provider offered vaccine to young women aged 18–26 years. To date, only the quadrivalent vaccine (HPV 6/11/16/18) has been utilized in the funded program. Acceptance of the vaccine is high with coverage of 3 doses of the HPV vaccine in the school age cohort around 70%, and just over 30% in the older age cohort. Since the vaccination program was initiated, a reduction in new cases of genital warts of 73% among vaccine eligible age females has been evidenced in STI clinics across Australia. A reduction of 44% of new cases in young males (not a part of the free program) was also documented during this same time period, suggesting significant herd immunity. Similarly, in the state of Victoria, a small but significant decrease in high grade abnormalities in Pap screening findings has been reported in young women<18 years for the period 2007–9, as compared to pre-vaccination. Challenges for the future include how we can sustain and improve HPV vaccination coverage in young Australian women, while maintaining cervical cancer screening participation and reviewing cervical cancer screening methods. [Copyright &y& Elsevier]

• A wide range of HPV types were commonly detected among 18–35 year old women. • Prevalence of HPV6/11/16/18 was very low and influenced by vaccination status only. • Prevalence of non-vaccine types was influenced by known risk factors for infection. • Vaccinated women are benefiting from cross-protection against HPV types 31/33/45. • HPV vaccination has changed the epidemiology of HPV infection in Australian women. In Australia, high and widespread uptake of the quadrivalent human papillomavirus (HPV) vaccine has led to substantial population-level reductions in the prevalence of quadrivalent vaccine targeted HPV genotypes 6/11/16/18 in women aged ≤ 35 years. We assessed risk factors for HPV detection among 18–35 year old women, 9–12 years after vaccine program introduction. Women attending health services between 2015 and 2018 provided a self-collected vaginal specimen for HPV genotyping (Roche Linear Array) and completed a questionnaire. HPV vaccination status was validated against the National Register. Adjusted odds ratios (aORs) and 95% confidence intervals (CI) were calculated for factors associated with HPV detection. Among 1564 women (median age 24 years; IQR 21–27 years), Register-confirmed ≥ 1-dose vaccine coverage was highest at 69.3% and 68.1% among women aged 18–21 and 22–24 years respectively, decreasing to 42.9% among those aged 30–35 years. Overall prevalence of quadrivalent vaccine-targeted HPV types was very low (2.0%; 95% CI: 1.4–2.8%) and influenced only by vaccination status (5.5% among unvaccinated compared with 0.7% among vaccinated women; aOR = 0.13 (95% CI: 0.05–0.30)). Prevalence of remaining HPV types, at 40.4% (95% CI: 38.0–42.9%), was influenced by established risk factors for HPV infection; younger age-group (p-trend < 0.001), more recent (p < 0.001) and lifetime sexual partners (p-trend < 0.001), but not vaccination status. Prevalence of HPV31/33/45, which shared risk factors with that of non-vaccine targeted HPV types, was also lower among vaccinated (4%) compared with unvaccinated (7%) women (aOR = 0.51; 95% CI: 0.29–0.89), indicative of cross-protection. Vaccination has changed the epidemiology of HPV infection in Australian women, having markedly reduced the prevalence of vaccine-targeted types, including amongst women with known risk factors for infection. Vaccinated women appear to be benefiting from modest cross-protection against types 31/33/45 afforded by the quadrivalent HPV vaccine. These results reinforce the importance of HPV vaccination. [ABSTRACT FROM AUTHOR]

• Parents' have positive attitudes towards school-based vaccination for adolescents. • HPV vaccine decision-making for parents is influenced by school-based vaccination. • Schools are well-positioned to integrate positive messages about HPV vaccination. • Well-implemented HPV vaccination programs may help assuage vaccine safety scares. This qualitative study aimed to explore parental attitudes, knowledge and decision-making about HPV vaccination for adolescents in the context of a gender-neutral school-based Australian National Immunisation Program (NIP). Semi-structured interviews with parents of adolescents eligible for HPV vaccination were undertaken as part of an evaluation of a cluster-randomised controlled trial of a complex intervention in 40 schools (2013–2015). In this qualitative study, we purposively recruited a nested sample of parents from 11 schools across two Australian jurisdictions. Interviews explored parent knowledge and understanding of the HPV vaccine program; HPV vaccination decision-making; their adolescent's knowledge about HPV vaccination; and their adolescent's understanding about HPV vaccination, sexual awareness and behaviour. Transcripts were analysed using inductive and deductive thematic analysis. Parents' of 22 adolescents had positive attitudes towards the program; the school-based delivery platform was the key driver shaping acceptance of and decision-making about HPV vaccination. They had difficulty recalling, or did not read, HPV vaccination information sent home. Some adolescents were involved in discussions about vaccination, with parents' responsible for ultimate vaccine decision-making. All parents supported in-school education for adolescents about HPV and HPV vaccination. Parents' knowledge about HPV vaccination was limited to cervical cancer and was largely absent regarding vaccination in males. Parents' positive attitudes towards the NIP and inclusion of the HPV vaccine is central to their vaccine decision-making and acceptance. More intensive communication strategies including school education opportunities are required to improve parents' knowledge of HPV-related disease and to promote vaccine decision-making with adolescents. [ABSTRACT FROM AUTHOR]

Abstract: The region encompassing Australasia and Oceania, including Australia, New Zealand, Fiji and Papua New Guinea, is a diverse one with respect to ethnicities, cultures and behaviours. It includes countries with comprehensive cervical cytology screening programmes which can be credited with significant reductions in cervical cancer incidence and mortality, and countries with no prevention programmes and significantly higher incidence and mortality. As elsewhere in the world, human papillomavirus (HPV)-16 and 18 are the commonest high-risk types, with the highest rates in women under 25 years of age. These two high-risk HPV types are found most frequently in cervical cancers and high-grade dysplasias, although there are minimal data for many countries in Oceania. In April 2007, Australia became the first country worldwide to commence a government funded universal HPV vaccine programme. The school-based programme targets 12-year old females in an ongoing schedule, with a catch-up programme up to 26 years of age, to be completed in mid-2009. Vaccine introduction has been comprehensively rolled out, with around 75% uptake of the complete vaccine schedule among school-girls in the first year of this initiative. This represents a successful model for other countries. We present data on cervical cancer, risk factors and prevention strategies, including epidemiology of HPV and HPV vaccine strategies. [Copyright &y& Elsevier]

The article focuses on the efficacy of the human papillomaviruses (HPV)-16/18 AS04-adjuvanted vaccine, the final analysis in PApilloma TRial against Cancer In young Adults (PATRICIA). Analyses were done on women 15-25 years old, who were vaccinated at months 0, 1, and 6, in the according-to-protocol cohort for efficacy, total vaccinated cohort (TVC) and TVC-naive. Findings revealed that the vaccine was highly effective against cervical intraepithelial neoplasia 2+ (CIN2+) associated with HPV-16/18 and non-vaccine oncogenic HPV types.