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Objective: To assess the effectiveness of an HPV vaccination programme in reducing the risk of cervical abnormalities identified at subsequent screening. Design: Retrospective cohort study using administrative health data. Setting: General population of Ferrara Province, Italy. Population: Female residents born in 1986–1993 and participating in the organized cervical screening programme in 2011–2018, who were eligible for HPV vaccination in catch‐up cohorts. Methods: Logistic regression to evaluate the potential association between abnormal cervical cytology and one, two, three or at least one dose of HPV vaccine. Main outcome measures: Cervical abnormalities, as predicted by low‐grade or high‐grade cytology, by number of vaccine doses, stratified by age. Results: The sample consisted of 7785 women (mean age 27.5 years, SD 2.3). Overall, 391 (5.0%) were vaccinated with ≥1 dose and 893 (11.5%) had abnormal cytology. Women receiving at least one vaccine dose were significantly less likely to have an abnormal cytology (adjusted odds ratio 0.52; 95% confidence interval 0.34–0.79). Similar results were observed for women receiving a single dose, for both bivalent and quadrivalent vaccines, and applying buffer periods (excluding cytological outcomes within 1 month, 6 months and 1 year of the first dose). Conclusions: In the context of an organised cervical screening programme in Italy, catch‐up HPV vaccination almost halved the risk of cytological abnormalities. Among Ferrara women, vaccination against human papillomavirus halved the risk of screening cervical abnormalities. Among Ferrara women, vaccination against human papillomavirus halved the risk of screening cervical abnormalities. [ABSTRACT FROM AUTHOR]

OBJECTIVE: Vaccination does not cause sudden infant death syndrome (SIDS). However, SIDS peaks at 2 months of age, when vaccination encounters are frequent. There are no published estimates using population data on age of death and immunization coverage to indicate to practitioners how often coincident vaccination may occur by chance. This study aimed to determine the probability that an Australian infant who has died of SIDS was vaccinated in the days before death. METHODS: An analytical study of population death data and immunization coverage was conducted for Australian children who were born between April 1, 2002, and March 31, 2003. Also evaluated were Australian children who were registered as dying of SIDS between 1997 and 2001. The main outcomes measured were distribution of SIDS deaths by age and distribution of immunization coverage by age. RESULTS: The probability of recent vaccination and SIDS coinciding varied by age and day of the week of death. The overall estimated probability of vaccination within the last 24 hours for a child who has died of SIDS in Australia is estimated as 1.3%. In the last 48 hours, it is 2.6%. With the average number of SIDS deaths for the period 1997-2001 equal to 130 cases per year, we estimated that a case of SIDS will occur when vaccination was given in the last 24 hours in 1.7 cases per year and within 48 hours in 3.5 cases. CONCLUSIONS: Although coincident vaccination and SIDS should not be a frequent problem, it can be expected to occur at least annually in Australia by chance alone. The probabilities of vaccination by age estimated in this study can also be applied to estimate the probability of a vaccination encounter for children who have experienced any unusual medical condition or death, when these occurrences are known to be unrelated to vaccination. [ABSTRACT FROM AUTHOR]

Objective: The coronavirus pandemic impacted health-seeking behaviour and access to primary care in Australia. We investigated factors associated with intention-to-attend and attendance of cervical screening during the pandemic, mainly in Victoria, Australia., Methods: We used questionnaire and attendance data (Aug 2020-Nov 2022) from Compass-PLUS, a sub-study of the Compass randomized-controlled trial of Human Papillomavirus-based vs cytology-based screening. Data was restricted to the HPV-screening arm for comparability to the national program. We investigated associations overall and for younger (25-39 years) and older (≥40 years) cohorts, between intention-to-attend/attendance, and socio-demographics, anxiety-related scores, and agreement with beliefs about screening during the pandemic (e.g. importance of screening, increased workload, working from home, risk of infection)., Results: Among 2,226 participants, positive intention to attend screening was more likely among those with a family history of cancer (p = 0.030) or living outside major cities (p = 0.024). Increased attendance was associated with increasing age (p < 0.001), prior regular cervical screening history [adjusted relative risk (aRR) for 2 screens in 6 years vs none: 1.23 (95 %CI 1.09,1.40); p < 0.001], and part-time employment or retirement compared to full-time employment [aRR:1.08 (1.02,1.14); aRR:1.12 (1.03, 1.22); respectively]. Lower attendance was related to increased agreement with statements indicating screening de-prioritisation (p-trend < 0.05) and higher recent anxiety, specifically in the older cohort (p-trend = 0.002)., Conclusions: Reduced priority of screening and heightened recent anxiety may partly explain indications of lower-than-expected cervical screening rates during the pandemic. It is important that catch-up of missed HPV screens is performed to prevent a possible increase in cancer diagnoses in the long term., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: KC and MS are co-PIs of an investigator-initiated trial of cervical screening, (Compass; ACTRN12613001207707 and NCT02328872) run by the Australian Centre for the Prevention of Cervical Cancer (ACPCC), which is a government-funded not-for-profit charity; ACPCC has received equipment and a funding contribution from Roche Molecular Diagnostics. KC, MS and DB are also co-PIs on a major investigator-initiated implementation program Elimination of Cervical Cancer in the Western Pacific (ECCWP) which receives support from the Minderoo Foundation, and equipment donations from Cepheid Inc. Neither KC, MS, nor their institutions have received direct funding from industry for any project. MS holds NHMRC grants for 5 projects, is the Director for Cancer Council Australia and Co-chair of HPV test characteristics expert panel and consultant for Cancer Care Ontario. MS’s institution, ACPCC, received donated HPV testing equipment for research purposes from the following companies: Roche, Seegene, Abbott, Becton Dickinson, Cepheid, AusDiganostics, Copan, Qiagen and Atila Biosystems. MAS reports salary support via fellowship grants from the NHMRC of Australia and Cancer Institute NSW and contracts paid to her institution (the Daffodil Centre) with the Commonwealth Department of Health (Australia) and National Screening Unit (New Zealand). The remaining authors have no conflicts of interests to declare., (© 2024 The Authors. Published by Elsevier Inc.)

Background In mid-2022 Australia's National Cervical Screening Program made self-collection of a vaginal sample an option for screening for young women or people with a cervix aged 25 to 29 years for the first time. This study explored what young women thought about, and wanted to know about, self-collection, and what their future screening preferences are. Methods Young women (n =21), aged 24-29years, were recruited through social media. Semi-structured interviews explored screening history, screening preferences and thoughts about self-collection. Data were analysed using an a priori coding framework informed by the Theoretical Framework of Acceptability. Results Young women valued the addition of self-collection to the national cervical screening program, believing it to be less invasive and more convenient. However, they also valued the choice to opt for a clinician-collected specimen if preferred. Conclusions Self-collection is a valuable addition to the National Cervical Screening Program. This study suggests that continued efforts are needed to raise awareness of its availability, and improve understanding about its accuracy, the ease of collection, that you still need to engage with a primary healthcare service to access it and that you can still opt for a clinician-collected test.

Background: The Japanese 2020 cervical screening guidelines recommend conventional cervical cytology screening every 2-years for women aged 20-69 years. The nonavalent human papillomavirus (HPV) vaccine has also recently been approved in Japan. We therefore evaluated the cost-effectiveness of cervical cancer screening strategies alongside universal nonavalent HPV vaccination of girls (12-16 years)., Methods: A cost-effectiveness analysis was performed using an age-specific Markov microsimulation model for Japan to evaluate total costs, quality adjusted life-years (QALYs) gained, incremental cost-effectiveness ratios (ICER), colposcopies, biopsies, precancer and cervical cancer treatments for 29 combined vaccination and screening strategies (conventional cytology, liquid-based cytology (LBC), HPV testing, and HPV self-collection). A cohort of 100,000 girls (12-16 years old) over a lifetime offered the nonavalent HPV vaccine was used (current vaccination coverage = 0.08%, current screening coverage = 43.7%). A discount rate of 3% was applied to costs and QALYs. Univariate and probabilistic sensitivity analysis was performed to assess robustness of the findings. Costs were reported in US dollars (2023)., Findings: Compared with conventional cytology, evaluated strategies would incur an additional cost of US$839,280-738,182,669 and gain 62,755-247,347 quality-adjusted-life-years. HPV testing distinguishing HPV16/18 with reflex LBC (3-yearly) would be most cost-effective (ICER = US$7511 per QALY gained). At a willingness-to-pay (WTP) of 1-times gross domestic product (GDP) per capita, the probability of it being cost-effective was 70%. At historically high vaccination coverage (70%) ICERs decreased overall but did not affect the ranking of the most cost-effective strategy. While a 5-yearly interval became more cost-effective than a 3-yearly interval. Including HPV self-collection for under-screened women made all strategies more cost-effective., Interpretation: At current cervical screening participation (43.7%) and low vaccination coverage (<1.0%), HPV testing distinguishing HPV16/18 with reflex LBC (3-yearly) would be the most cost-effective screening strategy compared to conventional cytology (2-yearly)., Funding: Grants-in-Aid for Scientific Research from the Japan Society for the Promotion of Science (17H03589) and Grants of the National Cancer Center Japan (Gan Kenkyu Kaihatsuhi 31-A-20 and 2023-A-23)., Competing Interests: KK received payment from the Japan Society for the Promotion of Science and National Cancer Center Japan. JSH received payment from the Australian National Health and Medical Research Council. JJO received payment from the Australian National Health and Medical Research Council., (© 2024 The Author(s).)

Background: In July 2022, self-collection became universally available as part of Australia's National Cervical Screening Program. This change aims to address screening inequities experienced among underscreened populations, including women of Indian descent. This study explored experiences of cervical screening, alongside the acceptability of self-collection, among women of Indian descent living in Victoria, Australia. We also aimed to articulate the informational needs to promote self-collection among this population., Methods: Five focus group discussions with 39 women living in Victoria were conducted in English (n = 3) and Punjabi (n = 2). Transcripts were thematically analysed, as informed by the Theoretical Framework of Acceptability., Results: Women were motivated by the choice to self-collect, perceiving the ability to maintain modesty and greater autonomy as key enablers. Healthcare practitioners were seen as central in supporting patient-centred models of care. Perceived barriers to self-collection included concerns around its accuracy and women's confidence in collecting their own sample. Widespread dissemination of culturally tailored promotion strategies communicating concepts such as 'privacy' and 'accuracy' were suggested by women to promote self-collection., Conclusion: Self-collection was highly acceptable among women of Indian descent, particularly when assured of its accuracy, and sociocultural norms and previous screening experiences are considered. This study highlights the huge potential that self-collection can play in increasing equity in Australia's cervical screening programme., Patient or Public Contribution: Members of the public were involved in focus group discussions. Findings were summarised and disseminated via a poster. A bicultural worker was involved in all stages of the research., (© 2024 The Authors. Health Expectations published by John Wiley & Sons Ltd.)

COVID-19 disrupted school attendance in many countries, delaying routine adolescent vaccination against human papillomavirus (HPV) in some settings. We used Policy1-Cervix , a dynamic model simulating HPV transmission, natural history, vaccination, cervical screening, and diagnosis of HPV-related cancers, to estimate the impact on HPV-related cancers from disruptions to HPV vaccination in a high-income setting. A baseline scenario of no disruption to HPV vaccination was modelled, which assumed uptake of the nonavalent vaccine at the age of 12 by 82.4% of females and 75.5% of males, as is the coverage in Australia. Additional lifetime HPV-related cancer cases were calculated for three disruption scenarios affecting one birth cohort (2008; aged 12 in 2020) compared to the baseline scenario: (1) 1-year delay (no doses missed); (2) 1- to 7-year delay (slow catch-up); (3) no catch-up (herd effects only). A fourth scenario assumed no catch-up HPV vaccination for two birth cohorts, that is all individuals born in 2008 and in 2009 missed vaccination (worst-case scenario). Compared to 1532 HPV-related cancer cases estimated for the baseline no disruption scenario, we found a 1-year delay could result in ≤0.3% more HPV-related cancers ( n = 4) but the increase would be greater if catch-up was slower (5%; n = 70), and especially if there was no catch-up (49%; n = 750). Additional cancers for a single missed cohort were most commonly cervical (23% of the additional cases) and anal cancers (16%) in females and oropharyngeal cancers in males (20%). In the worst-case scenario of two birth cohorts missing vaccination, ≤62% more HPV-related cancers would be diagnosed ( n = 1892). In conclusion, providing catch-up of missed HPV vaccines is conducted, short-term delays in vaccinating adolescents are unlikely to have substantial long-term effects on cancer., Competing Interests: LV, JK, RG No competing interests declared, MS receives salary support via fellowship grants from the National Health and Medical Research Council (NHMRC) of Australia and Cancer Institute NSW and contracts paid to her institution (the Daffodil Centre) with the Commonwealth Department of Health (Australia) and National Screening Unit (New Zealand), JB former employer ACPCC has received donated HPV tests and related items for validation and research purposes from Roche, Seegene, Abbott, Becton Dickinson, Cepheid and Copan, KC Co-PI of an investigator-initiated trial of cervical screening, “Compass”, run by the Australian Centre for Prevention of Cervical Cancer (ACPCC), which is a government-funded not-for-profit charity. Compass receives infrastructure support from the Australian government and the ACPCC has received equipment and a funding contribution from Roche Molecular Diagnostics, USA. Co-PI on a major implementation program Elimination of Cervical Cancer in the Western Pacific which has received support from the Minderoo Foundation and the Frazer Family Foundation and equipment donations from Cepheid Inc. Receives contract funding from Commonwealth Department of Health, Australia to her institution for work to monitor the safety of the National Cervical Screening Program. Also receives support for a range of other Australian and international government projects including support from philanthropic organizations, WHO, and government agencies related to cervical cancer control, (© 2023, Velentzis, Smith et al.)

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 intervention, 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 implementation 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, Evidence 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., Competing Interests: Declaration of Competing Interest Davies reported receiving personal fees from Pfizer to conduct education for primary care physicians outside the submitted work. Dr. Marshall reported receiving grants from GlaxoSmithKline outside the submitted work. Dr. Zimet reported receiving personal fees and grants from Merck and personal fees from Moderna and Pfizer outside the submitted work. Dr. Garland reported receiving grants and personal fees from Merck and serving on the Merck Global Advisory Board HPV outside the submitted work. Dr. Skinner reported that her institution received honoraria from GlaxoSmithKline and Seqirus. No other disclosures were reported., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: In view of the WHO's call for the elimination of cervical cancer as a public health problem, and current low screening coverage, Indian policy makers need evidence on how to effectively implement cervical screening programmes, ensuring equity in access. Our study will follow the INSPIRE implementation framework to co-design and test HPV-based screening approaches in two states of India with different health system organisation, based on understanding the status of screening as currently implemented, readiness and challenges to transition to HPV-based screening, and preferences of key stakeholders. Here, we describe our protocol for the formative phase of the study (SHE-CAN)., Methods: The study population includes women from vulnerable populations, defined as residents of tribal areas, rural villages, and urban slums, in the states of Mizoram and Tamil Nadu. The baseline assessment will use mixed methods research, with desktop reviews, qualitative studies, and surveys. A capacity assessment survey of screening and treatment facilities will be done, followed by interviews with healthcare providers, programme managers, and community health workers. Interviews will be conducted with previously screened women and focus group discussions with under and never-screened women and community members. Stakeholder workshops will be held in each state to co-design the approaches to delivering HPV-based screening among 30-49-year-old women., Discussion: The quality and outcomes of existing screening services, readiness to transition to HPV-based screening, challenges in providing and participating in the cervical cancer care continuum, and acceptability of screening and treatment approaches will be examined. The knowledge gained about the current system, as well as recognition of actions to be taken, will inform a stakeholder workshop to co-design and evaluate implementation approaches for HPV-based screening through a cluster randomised implementation trial., (© 2023. The Author(s).)

In this study, we aimed to document stakeholders' experiences of implementing Australia's renewed National Cervical Screening Program. In December 2017, the program changed from 2nd yearly cytology for 20-69 year olds to 5 yearly human papillomavirus (HPV) screening for women 25-74 years. We undertook semi-structured interviews with key stakeholders including government, program administrators, register staff, clinicians and health care workers, non-government organisations, professional bodies, and pathology laboratories from across Australia between Nov 2018 - Aug 2019. Response rate to emailed invitations was 49/85 (58%). We used Proctor et al's (2011) implementation outcomes framework to guide our questions and thematic analysis. We found that stakeholders were evenly divided over whether implementation was successful. There was strong support for change, but concern over aspects of the implementation. There was some frustration related to the delayed start, timeliness of communication and education, shortcomings in change management, lack of inclusion of Aboriginal and Torres Strait Islander people in planning and implementation, failure to make self-collection widely available, and delays in the National Cancer Screening Register. Barriers centred around a perceived failure to appreciate the enormity of the change and register build, and consequent failure to resource, project manage and communicate effectively. Facilitators included the good will and dedication of stakeholders, strong evidence base for change and the support of jurisdictions during the delay. We documented substantial implementation challenges, offering learnings for other countries transitioning to HPV screening. Sufficient planning, significant and transparent engagement and communication with stakeholders, and change management are critical., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: The CRE is a collaboration led by the Daffodil Centre (Cancer Council NSW and University of Sydney), the Australian Centre for the Prevention of Cervical Cancer (ACPCC), the University of Melbourne and the Kirby Institute, University of NSW. Both Cancer Council NSW and ACPCC participated in the implementation of the rNCSP and employees/representatives of these organisations were represented on the research team and invited to participate as stakeholders in the interviews. Where such potential conflict of interests could have arisen between interviewer/interviewee, interviews were conducted by people who were not conflicted and all interviews were analysed deidentified and consistently through thematic, coded analysis. The study was overseen by a scientific advisory committee.Box 1Facilitators and barriers to the implementation of Renewal identified by 49 stakeholders, 2018-2019 Facilitators to date1)Strong evidence base for change2)Goodwill and dedication of stakeholders, including ongoing advice and support from committees and advisory groups3)Ability of State and Territory programs to continue/ resume pre-Renewal operations (eg ongoing registry functions, program management and communications) during delay in transition and national registry operations Perceived future facilitators1)Clear communications to participants and providers, including data to show the program is working2)Getting the National Register up to full functionality, including:a.invitations, reminders, follow-up, and ready access to screening historiesb.improving data completeness and qualityc.using it to monitor and drive improvementd.moving away from paper-based communications and faxese.improving integration with laboratory and practice management systemsf.ensuring its algorithms provide clinical safety3)Good governance and planning, with sufficient capacity and dedicated resources.4)Specific improvements suggested included:a.simplifying some processes (such as colposcopy data collection and the layout of the guidelines)b.providing more support and information for practitionersc.timely guideline updatesd.continuous education and raising awareness in the population, including targeted campaigns for Aboriginal and Torres Strait Islander peoplee.expanding who can provide cervical screening, especially in rural and remote areas Barriers1.Failure to appreciate the enormity of the change and register build2.Importance of change management not acknowledged early enough3.Expertise of States and Territories not utilised adequately4.Absence of consistent central oversight, leadership and project management5.Workload of those responsible for implementing change was very high, with staff turnover and loss of knowledge6.Human cost of stress across all stakeholder groups7.Delays and issues with Register meant other important aspects of the rNCSP were insufficiently addressed8.Suboptimal communication, consultation, and transparency9.Late communication, particularly the announcement to delay the program. a.Program delay created operational issues, due to staff redundancies for State registers and cytologists in pathology labs, which happened too earlyb.Delay commonly conflated by the public with the belief that the program itself was flawed, creating mistrustc.Some practitioners had already told patients that their next screen would be the new test, or had patients hold off screening for the new test, only to have to explain to them on their return that it was not yet available10.Insufficient education for providers and the public.a.Not consistent or well-timed communication or education to support practitioners implementing the programb.Lack of clear and timely communication with the public11.Other practitioner level barriers included:a.Insufficient time to discuss cervical screening in consultationsb.Loss of the nurse led cervical screening MBS numberc.Difficulties implementing new clinical guidelines when providers and laboratories were not yet familiar with the detail and complexity (especially for people with previous abnormalities)d.Errors and frustrations with incorrect Register correspondence chasing colposcopy results12.Lack of a registered on-label indication for HPV testing on self-collected samples, creating lack of test availability which limited access13.Length of colposcopy waiting lists and associated delays in women being seen at colposcopy, (© 2023 The Authors.)

Many countries with the highest burdens of cervical cancer have not yet offered human papillomavirus (HPV) vaccines to most of their age-eligible girls, who as adults also have limited or no access to effective cervical cancer screening or treatment. There are now 2 complementary developments that could make HPV vaccines more accessible and affordable: 1) the current and projected increases in HPV vaccine supply; and 2) the permissive recommendation for single-dose HPV vaccination schedules. This change in policy paired with the healthier HPV vaccine supply is an incredible opportunity to facilitate rapid access and expansion of HPV vaccination. Female adolescent vaccination including multiage cohorts must be prioritized. In the coming decades, this is the most cost-effective approach to avert millions of projected cervical cancer cases, which account for most HPV-related cancers globally., (Published by Oxford University Press 2022.)

There is a growing need to better understand the risk of malignancy in the multiple sclerosis (MS) population, particularly given the relatively recent and widespread introduction of immunomodulating disease modifying therapies (DMTs). Multiple sclerosis disproportionately affects women, and the risk of gynecological malignancies, specifically cervical pre-cancer and cancer, are of particular concern. The causal relationship between persistent human papillomavirus (HPV) infection and cervical cancer has been definitively established. To date, there is limited data on the effect of MS DMTs on the risk of persistent HPV infection and subsequent progression to cervical pre-cancer and cancer. This review evaluates the risk of cervical pre-cancer and cancer in women with MS, including the risk conferred by DMTs. We examine additional factors, specific to the MS population, that alter the risk of developing cervical cancer including participation in HPV vaccination and cervical screening programs., Competing Interests: FB has received travel support from Biogen and a travel grant from the European Committee for Treatment and Research in Multiple Sclerosis. YF has received travel support from Biogen and receives grant support from MS Research Australia, National Health and Medical Research Council of Australia, Australia and New Zealand Association of Neurologists, and Avant Foundation. HB served on scientific advisory boards for Biogen, Novartis and Sanofi-Aventis and received conference travel support from Novartis, Biogen and Sanofi Aventis, and serves on steering committees for trials conducted by Biogen and Novartis received research support from Merck, Novartis, and Biogen. VJ receives research grant support from MS Research Australia and the National Health and Medical Research Council of Australia (NHMRC 1156519). AV has received travel support and served on advisory boards for Novartis, Biogen, Merck Serono, Roche and Teva, and receives grant support from the National Health and Medical Research Council of Australia. The remaining author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Bridge, Brotherton, Foong, Butzkueven, Jokubaitis and Van der Walt.)

Background: Discrimination against racial and ethnic minority groups, especially the Muslim community, is more prevalent in Western countries and anti-Muslim belief, or Islamophobia, is also increasing around the world. Intersectionality of religion, race, and gender makes Muslim women vulnerable to racism. This study investigates different types of racism experienced by Muslim and non-Muslim women living in Victoria, Australia, and the adverse mental health outcome to them after experiencing racism., Method: Survey data were collected from 580 culturally and linguistically diverse (CALD) Victorian women from four local areas including both rural and urban communities. The survey asked about the participant's racism experience, types of racism, frequency of occurrence, and used the Kessler 6 Psychological Distress Scale to assess psychological distress after experiencing racism. The applied logistic regression analysis to assess the association between types of racism experiences and socio-demographic factors and to examine the impact of racism on individuals' psychological distress., Result: Muslim women, in general, had higher odds of experiencing racism (OR 1.70, 95% CI 1.02-2.83) than non-Muslim women, including types of racism such as being sworn at or verbally abused or exposed to offensive gestures (OR 1.78, 95% CI 1.11-2.85) and being told that they do not belong in Australia and should go back to their country (OR 1.61, 95% CI 1.00-2.58). Muslim women were more likely to be above the threshold for high or very high psychological distress than non-Muslim women, consistent across most types of racism., Conclusion: This study has found a higher prevalence of racism experienced by Muslim women compared to other ethnic minority groups and some types of racism are more likely to occur or be more toxic for Muslim women. Necessary intervention strategies should be implemented at every level of the society to raise awareness of and reduce exposure to racism among Muslim women.

The disrupted introduction of the HPV-based cervical screening program in several jurisdictions has demonstrated that the attitudes and beliefs of screening-eligible persons are critically implicated in the success of program implementation (including the use of self-sampling). As no up-to-date and validated measures exist measuring attitudes and beliefs towards HPV testing and self-sampling, this study aimed to develop and validate two scales measuring these factors. In October-November 2021, cervical screening-eligible Canadians participated in a web-based survey. In total, 44 items related to HPV testing and 13 items related to HPV self-sampling attitudes and beliefs were included in the survey. For both scales, the optimal number of factors was identified using Exploratory Factor Analysis (EFA) and parallel analysis. Item Response Theory (IRT) was applied within each factor to select items. Confirmatory Factor Analysis (CFA) was used to assess model fit. After data cleaning, 1027 responses were analyzed. The HPV Testing Attitudes and Beliefs Scale (HTABS) had four factors, and twenty-two items were retained after item reduction. The HPV Self-sampling Attitudes and Beliefs Scale (HSABS) had two factors and seven items were retained. CFA showed a good model fit for both final scales. The developed scales will be a valuable resource to examine attitudes and beliefs in anticipation of, and to evaluate, HPV test-based cervical screening.

Purpose: Although cervical cancer is a disease of inequity, it can be eliminated as a public health problem through vaccination, screening, and treatment. Human papillomavirus vaginal self-collection cervical screening is a high-performance test that can increase reach of screening. This review describes the different contexts and models of care used to pilot or implement self-collection within the Asia-Pacific, measures the extent that implementation outcome measures are reported and, where available, summarizes key implementation findings., Methods: A scoping review was conducted by searching five databases of the peer-reviewed literature on June 20, 2022. Two researchers assessed eligibility and extracted data independently to the model of care used and the Conceptual Framework for Implementation Outcomes. A mixed-method consolidation of findings (quantitative: count and frequencies; qualitative: content analysis) was undertaken to narratively report findings., Results: Fifty-seven articles, comprising 50 unique studies from 11 countries and two special autonomous regions, were included; 82% were conducted in trials. The implementation of self-collection was conducted in low- (2%), lower-middle- (32%), upper-middle- (32%), and high-income (35%) settings, with 10 different delivery models used; 80% delivered through practitioner-supported models with diversity in how samples were processed, and treatment was offered. Acceptability (73%) and appropriateness (64%) measures were most reported, followed by adoption (57%), feasibility (48%), and fidelity (38%). Only 7% of articles reported implementation cost or penetration measures. No articles reported sustainability measures., Conclusion: The literature confirms that self-collection cervical screening has been implemented within the Asia-Pacific region, with evidence demonstrating that it is acceptable and appropriate from the user's perspective. Well-designed, high-quality implementation trials and real-world evaluations of self-collection that report the breadth of implementation outcomes can support the progression toward the elimination of cervical cancer.

Background: In December 2017, the Australian National Cervical Screening Program transitioned from 2-yearly cytology-based to 5-yearly human papillomavirus (HPV)-based cervical screening, including a vaginal self-collection option. Until July 2022, this option was restricted to under- or never-screened people aged 30 years and older who refused a speculum exam. We investigated the perspectives and experiences of stakeholders involved in, or affected by, the initial implementation of the restricted self-collection pathway., Methods: Semi-structured interviews were conducted with 49 stakeholders as part of the STakeholder Opinions of Renewal Implementation and Experiences Study. All interviews were audio recorded and transcribed. Data were thematically analysed and coded to the Conceptual Framework for Implementation Outcomes., Results: Stakeholders viewed the introduction of self-collection as an exciting opportunity to provide under-screened people with an alternative to a speculum examination. Adoption in clinical practice, however, was impacted by a lack of clear communication and promotion to providers, and the limited number of laboratories accredited to process self-collected samples. Primary care providers tasked with communicating and offering self-collection described confusion about the availability, participant eligibility, pathology processes, and clinical management processes for self-collection. Regulatory delay in developing an agreed protocol to approve laboratory processing of self-collected swabs, and consequently initially having one laboratory nationally accredited to process samples, led to missed opportunities and misinformation regarding the pathway's availability., Conclusions: Whilst the introduction of self-collection was welcomed, clear communication from Government regarding setbacks in implementation and how to overcome these in practice were needed. As Australia moves to a policy of providing everyone eligible for screening the choice of self-collection, wider promotion to providers and eligible people, clarity around pathology processes and the scaling up of test availability, as well as timely education and communication of clinical management practice guidelines, are needed to ensure smoother program delivery in the future. Other countries implementing self-collection policies can learn from the implementation challenges faced by Australia.

Background: WHO recommends human papillomavirus (HPV) testing and same-day treatment for cervical screening in low-income and middle-income countries (LMICs); however, few published data exist on the validity of the strategy. We aimed to evaluate the clinical performance, treatment completion rates, adverse events profile, and acceptability of a fully integrated strategy, comprising point-of-care HPV DNA testing of self-collected specimens and same-day thermal ablation, for screening of cervical cancer in women in Papua New Guinea., Methods: HPV-STAT was a large-scale, prospective, single-arm intervention trial conducted at two clinical sites in Papua New Guinea. Cervical screening clinics with an on-site consultant gynaecologist were selected in consultation with national and provincial health authorities, church health services, and local stakeholders. Eligible participants were women aged 30-59 years attending cervical screening services at the two clinics, who were willing to comply with study procedures and able to provide written informed consent. Women self-collected vaginal specimens for point-of-care GeneXpert testing (Cepheid, Sunnyvale, CA, USA) for oncogenic HPV types. Women testing positive for HPV underwent pelvic examination followed by same-day thermal ablation or referral for gynaecology review. All HPV-positive women and a 15% random sample of HPV-negative women provided a clinician-collected cervical specimen for liquid-based cytology. The primary outcome was clinical performance (ie, sensitivity, specificity, positive predictive value [PPV], and negative predictive value [NPV]) of the strategy for the detection of high-grade squamous intraepithelial lesion (HSIL) or worse. This trial is registered with ISRCTN, ISRCTN13476702., Findings: Between June 5, 2018, and Jan 6, 2020, we recruited 4285 women, 3638 (84·9%) of whom tested negative for HPV and 647 (15·1%) tested positive for one or more oncogenic HPV type. Sensitivity of the algorithm to detect HSIL or worse was 85·4% (95% CI 81·0-89·6), with specificity 89·6% (88·6-90·6), PPV 35·2% (31·6-39·0), and NPV 98·9% (98·6-99·2). Among HPV-positive women, 602 (93·0%) received same-day thermal ablation and 42 (6·5%) were referred for gynaecology review, 37 (88·1%) of whom attended. Acceptability was high among both HPV-positive and HPV-negative women. Among the 329 HPV-positive women who attended a 3-month follow-up visit, 51 (15·5%) reported mild adverse symptoms that resolved in all cases by the follow-up visit. There were no serious adverse events., Interpretation: We conducted the first real-world evaluation of a fully integrated point-of-care HPV self-collect, test, and treat strategy for same-day cervical screening in a LMIC and found it to be effective, acceptable, and safe when implemented at scale in primary health-care facilities in Papua New Guinea. Our findings support the introduction and scale-up of HPV screening and treatment for the control and elimination of cervical cancer in LMICs, as recommended by WHO., Funding: Australian National Health and Medical Research Council., Competing Interests: Declaration of interests The Papua New Guinea Institute of Medical Research (AJBV, AK-H, JG, JB, GM, and PJT) and the Kirby Institute, UNSW Sydney (AJBV, SGB, AK-H, HW, RG, and JMK) have received subsidised test kits for research from Cepheid. VCS Foundation (MS, JMLB, and GT) has received donated test kits for research from Roche, Abbott, Seegene, Cepheid, AusDiagnostics, and Becton Dickinson. AJBV, MS, and KC jointly lead the Elimination of Cervical Cancer in the Western Pacific programme with philanthropic funding support from the Minderoo Foundation and the Frazer Family Foundation; and equipment, tests, and consumables donated by Cepheid for HPV-based cervical screening in Papua New Guinea and Vanuatu. SMG is a member of the Merck HPV Global Advisory Board and has led investigator-initiated grants from Merck on HPV in young women. All other authors declare no competing interests. All authors declare that neither they or their institutions have received direct funding from industry for this or any other research project., (Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Aboriginal and Torres Strait Islander women have lower participation in Australia's National Cervical Screening Program than other Australian women. Under-screened (including never screened) women's voices are rarely heard in research evidence, despite being a priority group for interventions to increase cervical screening participation. This study aimed to describe under-screened Aboriginal and Torres Strait Islander women's perspectives on cervical screening. Participants were 29 under-screened (women who had either never screened, had not screened in the previous five years or had recently screened in the past three months after more than five years) Aboriginal and Torres Strait Islander women from five communities across three states/territories. Female Aboriginal and Torres Strait Islander researchers Yarned with women about why they did not participate in screening and how to improve screening. Yarning is an Indigenous qualitative research method in which relationships and trust facilitate culturally safe conversation. Transcripts were analysed thematically. The proportion of eligible women who screened within 30 days after the Yarn was calculated. We identified four themes describing how the harms outweighed the benefits of cervical screening for under-screened women. These were: 1) distress, discomfort, and trauma; 2) lack of privacy and control; 3) complicated relationships with health care providers (HCPs); and 4) pressured, insensitive, and/or culturally unsafe communication from HCPs. Under-screened women who had recently screened had maintained privacy and control through self-collection and had experienced trauma-informed and empathetic care from their HCPs. While we cannot unequivocally attribute women's subsequent participation in screening to their involvement in this study, it is notable that one third of eligible under-screened women were screened within 30 days after the Yarn. Enhancing privacy, implementing trauma-informed approaches to care and sensitivity to the clinician-client relationship dynamics could enhance women's sense of comfort in, and control over, the screening procedure. The opportunity to Yarn about cervical screening and self-collection may address these issues and support progress toward cervical cancer elimination in Australia., Competing Interests: The authors have read the journal’s policy and have the following conflicts: The study is affiliated with Southern Queensland Centre of Excellence in Aboriginal and Torres Strait Islander Primary Health Care, Wuchopperen Health Service Pty Ltd and Yerin Eleanor Duncan Aboriginal Health Centre. These commercial affiliations provided support in the form of salaries for authors CM, JM, and EW, respectively. This does not alter our adherence to all the PLOS ONE policies on sharing data and materials.

Objective: To examine the impact of self-reported human papillomavirus (HPV) test result (HPV negative, HPV positive, HPV result unknown) on a range of psychosocial outcomes., Methods: Women and other people with a cervix in Australia aged 25-74 years who reported having participated in cervical screening since December 2017 were recruited through Facebook and Instagram to complete an online survey. The primary outcome measures were anxiety, emotional distress, and general distress., Results: Nine hundred fifteen participants completed the online survey; 73.2% reported testing HPV negative ('HPV-'), 15% reported testing HPV positive ('HPV+') and 11.8% reported that they did not know/remember their test result ('HPV unknown'). Compared to participants testing HPV-, participants testing HPV+ had higher mean anxiety (41.67 vs. 37.08, p < 0.001) and emotional distress scores (11.88 vs. 7.71, p < 0.001). Concern about test result (34.3% vs. 1.3%, p < 0.001), perceived risk compared to average women (55.4% vs. 14.1%, p < 0.001), and cancer worry (27.8% vs. 5.9%, p < 0.001) were also greater among HPV+ participants than participants testing HPV-. Participants testing HPV+ felt less reassured about their screening result than participants testing HPV- (16% vs. 75.1%, p < 0.001). Participants testing HPV+ had greater knowledge of HPV (11.96 vs. 10.36 out of 16, p < 0.001) and HPV testing (3.94 vs 3.28 out of 5, p < 0.001) than participants who reported testing HPV-., Conclusions: Elevated levels of anxiety and emotional distress were found in those testing HPV+ compared with those testing HPV-. Future research should examine what strategies should be used to deliver test results and what additional information is provided, in order to alleviate anxiety among individuals testing HPV+., (© 2022 The Authors. Psycho-Oncology published by John Wiley & Sons Ltd.)

Background: The human papillomavirus (HPV) test has emerged as a significant improvement over cytology for primary cervical cancer screening. In Canada, provinces and territories are moving toward implementing HPV testing in cervical cancer screening programs. Although an abundance of research exists on the benefits of HPV-based screening, there is a dearth of research examining women's understanding of HPV testing. In other countries, failure to adequately address women's concerns about changes has disrupted the implementation of HPV-based screening., Objective: The aims of the multipart study described in this paper are to develop psychometrically valid measures of cervical cancer screening-related knowledge, attitudes, and beliefs; to examine the feasibility of a questionnaire examining psychosocial factors related to HPV-based screening; and to investigate psychosocial correlates of women's intentions to participate in HPV-based screening., Methods: We conducted a web-based survey (study 1) of Canadian women to assess the acceptability and feasibility of a questionnaire, including the validation of scales examining cervical cancer knowledge, HPV testing knowledge, HPV testing attitudes and beliefs, and HPV test self-sampling attitudes and beliefs. Preferences for cervical cancer screening were assessed using the best-worst scaling methodology. A second web-based survey (study 2) will be administered to a national sample of Canadian women between June 2022 and July 2022 using the validated scales. Differences in the knowledge, attitudes, beliefs, and preferences of women who are currently either underscreened or adequately screened for cervical cancer will be examined through bivariate analyses. Multinomial logistic regression will be used to estimate the associations between psychosocial and sociodemographic factors and intentions to undergo HPV-based screening., Results: Between October 2021 and November 2021, a total of 1230 participants completed the questionnaire in study 1, and 1027 (83.49%) responses were retained after data cleaning methods were applied. Feasibility was comparable with similar population-based surveys in terms of survey length, participant attrition, and the number of participants excluded after data cleaning. As of May 2022, analysis of study 1 is ongoing, and results are expected to be published in the summer of 2022. Data collection is expected to begin for study 2 in the summer of 2022. Results are expected to be published between late 2022 and early 2023., Conclusions: Findings will provide direction for Canadian public health authorities to align guidelines to address women's concerns and optimize the acceptability and uptake of HPV-based primary screening. Validated scales can be used by other researchers to improve and standardize the measurement of psychosocial factors affecting HPV test acceptability. Study results will be disseminated through peer-reviewed journal articles; conference presentations; and direct communication with researchers, clinicians, policy makers, media, and specialty organizations., International Registered Report Identifier (irrid): DERR1-10.2196/38917., (©Gabrielle Griffin-Mathieu, Ben Haward, Ovidiu Tatar, Patricia Zhu, Samara Perez, Gilla K Shapiro, Emily McBride, Erika L Thompson, Laurie W Smith, Aisha K Lofters, Ellen M Daley, Juliet R Guichon, Jo Waller, Marc Steben, Kathleen M Decker, Marie-Helene Mayrand, Julia M L Brotherton, Gina S Ogilvie, Gregory D Zimet, Teresa Norris, Zeev Rosberger. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 16.06.2022.)

Background: In Australia in 2017, 89% of 15-year-old females and 86% of 15-year-old males had received at least one dose of the HPV vaccine. However, considerable variation in HPV vaccination initiation (dose one) across schools remains. It is important to understand the school-level characteristics most strongly associated with low initiation and their contribution to the overall between-school variation., Methods: A population-based ecological analysis was conducted using school-level data for 2016 on all adolescent students eligible for HPV vaccination in three Australian jurisdictions. We conducted logistic regression to determine school-level factors associated with lower HPV vaccination initiation (< 75% dose 1 uptake) and estimated the population attributable risk (PAR) and the proportion of schools with the factor (school-level prevalence)., Results: The factors most strongly associated with lower initiation, and their prevalence were; small schools (OR = 9.3, 95%CI = 6.1-14.1; 33% of schools), special education schools (OR = 5.6,95%CI = 3.7-8.5; 8% of schools), higher Indigenous enrolments (OR = 2.7,95% CI:1.9-3.7; 31% of schools), lower attendance rates (OR = 2.6,95%CI = 1.7-3.7; 35% of schools), remote location (OR = 2.6,95%CI = 1.6-4.3; 6% of schools,) and lower socioeconomic area (OR = 1.8,95% CI = 1.3-2.5; 33% of schools). The highest PARs were small schools (PAR = 79%, 95%CI:76-82), higher Indigenous enrolments (PAR = 38%, 95%CI: 31-44) and lower attendance rate (PAR = 37%, 95%CI: 29-46)., Conclusion: This analysis suggests that initiatives to support schools that are smaller, with a higher proportion of Indigenous adolescents and lower attendance rates may contribute most to reducing the variation of HPV vaccination uptake observed at a school-level in these jurisdictions. Estimating population-level coverage at the school-level is useful to guide policy and prioritise resourcing to support school-based vaccination programs., (© 2022. The Author(s).)

Objective: This study aimed to describe Aboriginal and Torres Strait Islander women's views of self-collection introduced in the renewed National Cervical Screening Program., Methods: A total of 79 Aboriginal and/or Torres Strait Islander women (50 screened in previous five years, 29 under-screened) from five clinics across three Australian states/territories participated. Topics discussed were perceptions of self-collection, the instruction card and suggestions for implementing self-collection. We employed yarning (a qualitative method), which established relationships and trust between participants and researchers to facilitate culturally safe conversations. Transcripts were analysed thematically., Results: Most women were unaware of self-collection before the yarn but found it to be an acceptable way to participate in cervical screening. Women perceived self-collection would be convenient, provide a sense of control over the screening experience, and maintain privacy and comfort. The instructions were perceived to be simple and easy to follow. Women had concerns about collecting the sample correctly and the accuracy of the sample (compared to clinician-collected samples)., Conclusions: Self-collection is acceptable to Aboriginal and Torres Strait Islander women., Implications for Public Health: Given the inequitable burden of cervical cancer experienced by Aboriginal and Torres Strait Islander women, self-collection is likely to significantly improve participation and ultimately improve cervical cancer outcomes., (© 2022 The Authors.)

Background: We assessed the effectiveness of an HPV (human papillomavirus) vaccination program in lowering cervical abnormality risk, and conferring herd protection., Methods: Retrospective cohort study using linked screening and vaccination administrative health data of the general population of Ancona Province, Italy. We included all female residents born in 1990-1993, eligible for catch-up HPV vaccination up to age 25 years, and adhering to organized screening in 2015-2020 (n = 4,665). Cervical abnormalities rates were compared between: Vaccinated and unvaccinated women, and cohorts with high and low vaccination uptake. Analyses were adjusted for age, country of birth, screening tests number, laboratory, and municipality average income. Main outcomes were ASC-US+ or LSIL+ Pap smears, and CIN1+ or CIN2+ histology., Results: Mean screening age was 26.6±1.5 years, and 1,118 screened women (24.0%) were vaccinated (mean vaccination age 19.2±1.5 years). The diagnosed cervical abnormalities were: 107 LSIL+ (2.3%), 70 CIN1+ (1.5%), and 35 CIN2+ (0.8%). The adjusted odds ratios of LSIL+, CIN1+, and CIN2+ among vaccinated versus unvaccinated women were, respectively: 0.55 [(95% confidence interval (CI), 0.33-0.91)], 0.43 (95% CI, 0.22-0.86), and 0.31 (95% CI, 0.11-0.91). Among the unvaccinated, those in the highest-uptake (45.3%) 1993 cohort, versus the last pre-vaccination 1990 cohort, showed AORs of LSIL+ and CIN1+ of 0.23 (95% CI, 0.10-0.50), and 0.22 (95% CI, 0.07-0.69), respectively., Conclusions: In the first evaluation from Central Italy, catch-up HPV vaccination considerably reduced the risk of all cervical abnormalities diagnosed within organized screening, and conferred an elevated degree of herd protection among unvaccinated women., Impact: The high protection conferred by HPV vaccination suggests the need to update cervical screening., (©2022 American Association for Cancer Research.)

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.

Abstract: For 27 years, national prospective data on selected rare childhood diseases have been collected monthly by the Australian Paediatric Surveillance Unit (APSU) from paediatricians and other clinical specialists who report cases in children aged up to 16 years. We report here the annual results of APSU surveillance in 2020 for ten rare communicable diseases and complications of communicable diseases, namely: acute flaccid paralysis (AFP); congenital cytomegalovirus (CMV) infection; neonatal herpes simplex virus (HSV) infection; perinatal exposure to human immunodeficiency virus (HIV); paediatric HIV infection; severe complications of seasonal influenza; juvenile onset recurrent respiratory papillomatosis (JoRRP); congenital rubella syndrome; congenital varicella syndrome; and neonatal varicella infection. We describe the results for each disease in the context of the total period of study, including demographics, clinical characteristics, treatment and short-term outcomes. Despite challenges presented by the coronavirus disease 2019 (COVID-19) pandemic in 2020, more than 1,400 paediatricians reported regularly to the APSU and an overall monthly reporting rate of > 90% was achieved. The minimum AFP target of 1 case per 100,000 children aged less than 15 years was achieved and there were few cases of vaccine-preventable diseases (JoRRP, rubella, varicella). However, high cases of congenital CMV, neonatal HSV and perinatal exposure to HIV persist. There were no severe complications of seasonal influenza reported for the first time in 13 years. This is consistent with other surveillance data reporting a decline of influenza and other communicable diseases in 2020, and likely reflects the wider effects of public health measures to reduce transmission of SARS-CoV-2 in the Australian community., (© Commonwealth of Australia CC BY-NC-ND.)

Background: 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., Methods: 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., Results: 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., Conclusion: 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., 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. Published by Elsevier Ltd.)

Introduction: Aboriginal and Torres Strait Islander women experience a higher burden of cervical cancer than non-Indigenous women in Australia. Cervical cancer is preventable partly through human papillomavirus (HPV) vaccination; in Australia, this is delivered through the national school-based immunisation programme. While HPV vaccination uptake is high among Australian adolescents, there remain gaps in uptake and completion among Aboriginal and Torres Strait Islander adolescents. This study aims to gain a comprehensive understanding of the barriers and facilitators to HPV vaccination uptake and completion among Aboriginal and Torres Strait Islander adolescents in Queensland, Australia., Methods and Analysis: The study will be guided by an Indigenist research approach and an ecological model for health promotion. Yarning, a qualitative Indigenous research method, will be conducted in up to 10 schools. Participants will include Year 7 (12/13 years old) Aboriginal and Torres Strait Islander adolescents; parents/caregivers; and local key informants and immunisation programme partners involved in the delivery of school-based HPV immunisation programme. Participants will be recruited through school representatives and investigator networks using purposive and snowball sampling and samples of convenience. Field notes, HPV vaccination clinic observations and sequential diagramming of the HPV vaccination process will be conducted. Thematic analysis of data will be led by Aboriginal and Torres Strait Islander researchers. Synthesised sequential diagrams of the process of HPV vaccination and qualitative themes summarising key findings will be produced., Ethics and Dissemination: The Aboriginal Health and Medical Research Council of New South Wales Ethics Committee (1646/20), the Australian National University Human Research Ethics Committee (HREC, 2020/478), the HREC of the Northern Territory Department of Health and Menzies School of Health Research (19-3484) and the Townsville Hospital and Health Service HREC (HREC/QTHS/73789) have approved the study. Dissemination will occur via conferences and peer-reviewed publications. Further dissemination will be determined in partnership with the Aboriginal and Torres Strait Islander Steering Committee, including Youth Representatives and Consultation Network., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: 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)., Methods: 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., Results: 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., Conclusions: 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., Competing Interests: Declaration of Competing Interest SRS’s institution received funding from Seqirus and Merck for her contribution to educational activities for the general public and professionals. HM is an investigator on clinical vaccine trials sponsored by Industry. Her institution receives funding from GSK, Pfizer and Sanofi-Pasteur for Investigator led studies. She does not receive any personal payments from Industry. TS has received a consultancy services fee from GSK Biologicals for review of a new simplified informed consent form. She has received travel support to attend investigator meetings conducted by GSK Biologicals, Novavax Inc., Janssen Cilag Pty Ltd and Merck Sharp & Dohme. She has been an investigator on clinical vaccine trials sponsored by Industry (GSK Biologicals, Novavax, Merck Sharpe & Dohme, Janssen Cilag Pty Ltd, MedImmune, Pfizer) for which her institution received funding. GZ has received honoraria from Sanofi Pasteur for work on the Adolescent Immunization Initiative and honoraria and travel support from Merck for consultations on HPV vaccination. GZ has received research funding from Merck, administered by his institution, related to HPV vaccination., (Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: In 2017, the Australian National Cervical Screening Program (NCSP) implemented five-yearly primary human papillomavirus (HPV) screening for women aged 25-74. It is important that clinicians are able to explain the NCSP changes to women and confidently address concerns., Aims: This study examined Australian clinicians' attitudes toward and experiences of the NCSP renewal since its implementation., Materials and Methods: Cross-sectional survey of clinicians (general practitioners, obstetricians and gynaecologists) involved in cervical screening, distributed two years after implementation of the renewed NCSP. Responses were analysed using descriptive statistics and thematic analysis., Results: Six hundred and seven participants completed the survey. More than 80% of clinicians were comfortable with the main NCSP changes: extended screening intervals, increased age of first screening, and screening test used. However, only 47% of clinicians reported having utilised the National Cancer Screening Register, and a third of clinicians did not believe that self-collection was a reasonable alternative to practitioner-collected screening for under-screened women. Increased demands for colposcopy were reported. All clinicians identified at least one area of educational need, including the management of women with a history of screen-detected abnormalities in the previous program (34.9%), post-colposcopy management for women with no abnormalities detected (25.5%), and screening in complex scenarios (eg immunocompromise) (26.5%)., Conclusions: Overall, Australian clinicians are comfortable with the main changes to the cervical screening program. Certain areas may require further policy review, such as screening in complex clinical scenarios, colposcopy availability, accessibility of the Register and self-collection. These issues could be meaningful for other countries switching to HPV-based screening., (© 2021 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.)

Background: Despite prophylactic human papillomavirus (HPV) vaccination being a safe, effective and cost-effective public health intervention for the prevention of cervical cancer, the HPV vaccine is not actively recommended or promoted by the Ministry of Health Labour and Welfare in Japan. With already very low levels of cervical screening below 30%, and vaccination levels that are below levels that award any population effect at 0.3% of the eligible population, cervical cancer mortality is higher than other similar high-income countries at 4.4/100,000 (2900) deaths per year in 2015. There is limited population-based or nationally representative data for HPV genotype distribution in Japan, thus making an assessment of the burden of vaccine-preventable cervical cancer difficult. Therefore, this systematic review and meta-analysis aims to determine the HPV genotype prevalence and age distribution of HPV infection in women with a cytological or histological diagnosis of normal through cervical cancer in Japan. We anticipate this information will guide and enhance programme interventions to reduce vaccine-preventable cervical cancer mortality in Japan., Methods: PubMed, Embase and the Japan Medical Abstract Society Database will be searched from the date of establishment to March 2021 to identify original research articles that report the prevalence of HPV genotypes in Japanese women with normal cervical cytology, low grade, high grade and cancerous cervical lesions. No exclusion criteria relating to language or publication date will be applied. The quality of the studies will be assessed using the Joanna Briggs checklist for prevalence studies. Randomised control trials, cohort studies, cross-sectional and prevalence studies will be considered eligible. Study findings will be combined using a traditional random-effects or fixed-effects meta-analysis to summarise pooled prevalence and 95% confidence intervals depending on heterogeneity. Subgroup analyses and meta-regression will be used to investigate heterogeneity, and sensitivity analyses will be conducted to assess the robustness of the findings., Discussion: To our knowledge, this is the first systematic review protocol that includes both Japanese and English peer-reviewed articles for the determination of genotype-specific HPV prevalence in cytological or histological confirmed normal cervical specimens, low- and high-grade intraepithelial lesions and cervical cancers by age in Japan. We anticipate this information will guide and enhance programme interventions to reduce vaccine-preventable cervical cancer mortality in Japan., Systematic Review Registration: PROSPERO CRD42018117596.

Objective: To investigate perspectives of primary health care providers (HCPs) on providing cervical screening for Aboriginal and Torres Strait Islander women, who experience a higher burden of cervical cancer than other Australian women., Methods: Semi-structured interviews with 13 HCPs from four Australian Indigenous primary health care centres (PHCCs). Transcripts were thematically analysed., Results: HCPs discussed the need to approach cervical screening with sensitivity to women's emotional and cultural needs and sustaining relationships built on trust and respect. HCPs reported challenges in promoting screening to Aboriginal and Torres Strait Islander women due to cumbersome systems, competing clinical priorities, workforce capacity limitations and specific challenges associated with implementing the renewed National Cervical Screening Program., Conclusions: In practice, HCPs experience several challenges to delivering cervical screening. Understanding HCPs' perspectives on their approach to cervical screening delivery, and the systems in which this occurs, can help to ensure that they receive adequate support and resources to deliver cervical screening to Aboriginal and Torres Strait Islander women. Implications for public health: It is important that HCPs adopt a multi-faceted, person-centred approach to cervical screening that is responsive to women's needs and that works synchronously with supportive PHCC services and systems and the National Cancer Screening Register., (© 2021 The Authors.)

In order to achieve the global elimination of cervical cancer as a public health problem, close surveillance of progress in public health and clinical activities and outcomes across the three pillars of vaccination, screening and treatment will be required. Surveillance should ideally occur within an integrated system that is planned, funded, and regularly evaluated to ensure it is providing timely, accurate and relevant feedback for action. In this paper, we conceptualise the main public health surveillance objectives as process and outcome measures in each of the three pillars. Process measures include coverage/participation measures for vaccination, screening and treatment alongside the ongoing assessment of the quality and reach of these programs and activities. Outcome measures related to the natural history of human papillomavirus (HPV) infection include HPV infection prevalence, precursor cervical lesions and cervical cancers (including stage at diagnosis, cancer incidence and mortality). These outcome measures can be used for monitoring the effectiveness of the three core activities in the short, medium and long term to assess whether these interventions are effectively reducing their occurrence. We discuss possible methods for the surveillance of these measures in the context of country capacity, drawing from examples in Australia, the USA and in low and middle income countries., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objective: To assess the effectiveness of an HPV vaccination programme in reducing the risk of cervical abnormalities identified at subsequent screening., Design: Retrospective cohort study using administrative health data., Setting: General population of Ferrara Province, Italy., Population: Female residents born in 1986-1993 and participating in the organized cervical screening programme in 2011-2018, who were eligible for HPV vaccination in catch-up cohorts., Methods: Logistic regression to evaluate the potential association between abnormal cervical cytology and one, two, three or at least one dose of HPV vaccine., Main Outcome Measures: Cervical abnormalities, as predicted by low-grade or high-grade cytology, by number of vaccine doses, stratified by age., Results: The sample consisted of 7785 women (mean age 27.5 years, SD 2.3). Overall, 391 (5.0%) were vaccinated with ≥1 dose and 893 (11.5%) had abnormal cytology. Women receiving at least one vaccine dose were significantly less likely to have an abnormal cytology (adjusted odds ratio 0.52; 95% confidence interval 0.34-0.79). Similar results were observed for women receiving a single dose, for both bivalent and quadrivalent vaccines, and applying buffer periods (excluding cytological outcomes within 1 month, 6 months and 1 year of the first dose)., Conclusions: In the context of an organised cervical screening programme in Italy, catch-up HPV vaccination almost halved the risk of cytological abnormalities., Tweetable Abstract: Among Ferrara women, vaccination against human papillomavirus halved the risk of screening cervical abnormalities., (© 2020 Royal College of Obstetricians and Gynaecologists.)

Background: Cervical screening on self-collected samples has mainly been considered for targeted use in underscreened women. Updated evidence supports equivalent sensitivity of PCR-based human papillomavirus (HPV) testing on self-collected and clinician-collected samples., Methods: Using a well-established model, we compared the lifetime impact on cancer diagnoses and deaths resulting from cervical screening using self-collected samples only, with and without the existing restriction in Australia to women aged 30+ years and ≥2 years overdue, compared with the mainstream program of 5-yearly HPV screening on clinician-collected samples starting at 25 years of age. We conservatively assumed sensitivity of HPV testing on self-collected relative to clinician-collected samples was 0.98. Outcomes were estimated either in the context of HPV vaccination ("routinely vaccinated cohorts;" uptake as in Australia) or in the absence of HPV vaccination ("unvaccinated cohorts")., Results: In unvaccinated cohorts, the health benefits of increased participation from self-collection outweighed the worst case (2%) loss of relative test sensitivity even if only 15% of women, who would not otherwise attend, used it ("additional uptake"). In routinely vaccinated cohorts, population-wide self-collection could be marginally (0.2%-1.0%) less effective at 15% additional uptake but 6.2% to 12.4% more effective at 50% additional uptake. Most (56.6%-65.0%) of the loss in effectiveness in the restricted self-collection pathway in Australia results from the requirement to be 2 or more years overdue., Conclusions: Even under pessimistic assumptions, any potential loss in test sensitivity from self-collection is likely outweighed by improved program effectiveness resulting from feasible levels of increased uptake., Impact: Consideration could be given to offering self-collection more widely, potentially as an equal choice for women. See related commentary by Lim, p. 245 ., (©2020 American Association for Cancer Research.)

Background: Colposcopy has been recommended for all women with recurrent post-coital bleeding (PCB) even if their cervical cytology or co-test (involving oncogenic human papillomavirus (HPV) DNA testing and cytology) are negative., Aims: To determine the risk of cervical cancer and its precursors among women with recurrent PCB with negative cytology or co-test., Materials and Methods: A retrospective analysis of two cohorts of women with PCB referred to a tertiary colposcopy clinic. Cohort (1) (n = 1846) between 1 January 2000 and 31 December 2016 (cytology-based screening) and Cohort (2) (n = 215) from 1 January 2018 to 31 December 2019 after introduction of primary HPV screening., Results: In 1217 (65.9%) women in Cohort (1) referred with negative cytology, there was one cancer (0.08%) and 22 high-grade squamous intraepithelial lesions (HSIL (cervical intraepithelial neoplasia 2/3)) on histopathology. In Cohort (2), there was no cancer or HSIL in 83 women with negative co-tests (negative for oncogenic HPV and cytology). False-negative cytology after a negative referral cytology or co-test was low with 2% of repeat cytology at initial colposcopy showing possible HSIL or worse., Conclusions: Women presenting with PCB and negative cytology alone have a low risk of cancer and could have HPV testing before being triaged to colposcopy. We showed that with the assurance of a negative co-test and the low likelihood of false-negative cytology, these women could avoid colposcopy unless cervical cancer is clinically suspected. There is a need for a larger cohort study to substantiate our findings with more precision., (© 2020 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.)

Background The prevalence of genital tract vaccine-type human papillomavirus (HPV) is on the decline due to high vaccine uptake through the national HPV immunisation program in Australia. The aim of this study was to investigate HPV vaccine coverage and factors associated with HPV in a vaccine-eligible sample of young Australian females., Methods: Females aged 16-25 years were recruited into the Young Female Health Initiative study, a young women's health study, via Facebook advertising from 2012 to 2017. Sexually active participants were asked to provide a self-collected vaginal swab for the detection of HPV DNA; positive samples were genotyped. Self-reported HPV vaccination status was confirmed by the National HPV Vaccination Program Register. Outcomes of the study were HPV acquisition and genotype, HPV vaccination status and factors associated with HPV., Results: Overall, 22.8% of samples (95% confidence interval (CI) 17.8-27.8%; n = 62/272) were positive for any HPV DNA, of which 19.1% (95% CI 14.4-23.8%; n = 52/272) were oncogenic types. HPV 16 was detected in three samples (1.1%; 95% CI -0.1%, 2.3%; two not HPV vaccinated and one vaccinated after sexual debut). Early sexual debut (<16 years) and multiple sexual partners were independently associated with an increased risk of any HPV., Conclusions: In a community sample of vaccine-eligible-age females with a high vaccine uptake, the prevalence of vaccine-related HPV genotypes is extremely low. Early sexual debut and multiple sexual partners are positively associated with HPV, underscoring the importance of vaccination at the routinely recommended age of 12-13 years for best vaccine impact.

In December 2017, the Australian National Cervical Screening Program (NCSP) changed from 2-yearly cervical cytology to 5-yearly primary human papillomavirus (HPV) testing, starting at age 25 and with an exit test when aged 70-74. Women showed limited awareness of these changes prior to their implementation. We explored women's preferences for how similar cancer screening changes could be communicated to the public in the future, including when, how, and using what methods. Six focus groups including 49 women aged 18-74 were conducted in November 2017. Focus groups were guided by information available on the NCSP website and information developed by the researchers. Generally, women suggested that communication of changes to cancer screening programs would ideally occur between 6 and 12 months ahead of their implementation and that they would like the opportunity to be involved in consultation about the changes. The NCSP website was described as answering basic questions, but also raising further questions for which there were no answers provided. Most groups preferred information which included evidence behind the changes and wanted an option of more information. Similar suggestions were made across all focus groups about how communications could be delivered, with recognition that the mode of delivery should differ by age. Women were still seeking information about the test itself and a symptom list, in order to be aware of these over the five-year period. These findings make an important and timely contribution which could help inform other countries considering making changes to their cancer screening programs in the future., Competing Interests: 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., (© 2020 The Authors. Published by Elsevier Inc.)

Objectives: Using laser capture microdissection (LCM) and sensitive human papillomavirus (HPV) genotyping, we aimed to determine the distribution of vaccine-preventable types in cervical intraepithelial neoplasia grade 3 (CIN3) lesions and adenocarcinoma in situ (AIS) in young women in Victoria, Australia, offered catch-up HPV vaccination, as a baseline for ongoing vaccine impact monitoring. We also compared findings with available pre-vaccination estimates from women with HPV detected on concurrently-collected cytology samples., Methods: Consecutive histologically-confirmed CIN3/AIS biopsies were collected between May 2011 and December 2014 from vaccine-eligible women (born after 30th June 1981). Genotypes present in whole tissue sections (WTS) were determined by a sensitive reverse hybridisation assay; RHA kit HPV SPF10-LiPA25, v1 (Labo Bio-medical Products). Where multiple genotypes were detected, lesions were isolated using LCM and genotyped. Cervical cytology samples from a pre-vaccine cohort had been previously collected and genotyped using HPV Linear Array HPV Genotyping Test (Roche Diagnostics). Mixed-genotype detections in this cohort were resolved to single-lesion-attributable genotypes using hierarchical attribution., Results: Overall, 213 and 530 cases were included from pre- and post-vaccine time-periods, respectively. In 18-25 year-olds, the proportion of HPV16/18-positive CIN3/AIS decreased significantly over time from 69% in 2001-2005 (pre-vaccine), to 62% in 2011-2012 (post-vaccine), to 47% in 2013-2014 (p-trend = 0.004). There was no significant change in HPV16/18 in 26-32 year-olds (p-trend = 0.15). In 2013/14, nonavalent vaccine types accounted for 80% of CIN3/AIS in 18-25 year old women and 90% in 26-32 year old women., Conclusion: Four to 8 years following implementation of HPV vaccination in Australia, approximately 70% of CIN3/AIS in young women was due to HPV16/18. Our data, despite some limitations due to change in methods between pre- and post-vaccine periods, suggests that for vaccine-eligible women aged 18-25 at the time of biopsy, the proportion of HPV16/18-attributable CIN3/AIS lesions is significantly declining post-vaccination., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Professor Suzanne Garland, has received Grants to her institution to measure vaccine impact and effectiveness in a young women’s study and as an Investigator Initiated grant from Merck. She has received speaking fees from MSD for work performed in her personal time and is a member of the Merck HPV Global Advisory Board. Alyssa Cornall is an investigator on a research study funded by Seqirus (cervical cancer typing study) and has received an educational grant from Seqirus. Julia Brotherton reports employment as the Medical Director of the National HPV Vaccination Program Register, which was owned and funded by the Australian Government Department of Health. Julia Brotherton and Sepehr Tabrizi have been investigators on investigator-initiated HPV epidemiology studies which have received unrestricted partial funding for laboratory components from Seqirus (cervical cancer typing study) and Merck (recurrent respiratory papillomatosis study) but have never received any personal financial benefits. Sepehr Tabrizi also reports grants from The Royal Women's Hospital during the conduct of the study. C. David Wrede is the Deputy Chair of VCS Foundation Pty Ltd and a Board member since 2010, he has received sponsorship and honoraria from Seqirus. All authors attest they meet the ICMJE criteria for authorship., (Crown Copyright © 2020. Published by Elsevier Ltd. All rights reserved.)

To make accurate determinations regarding potential and actual impact of HPV vaccine programs, precise estimates of genotype-specific contributions to disease are required for pre- and post-vaccine populations. Definitive determination of lesion-specific genotypes, particularly where multiple genotypes are detected in a sample, can be technically demanding and resource intensive; therefore, most prevalence studies use mathematical algorithms to adjust for multiple genotype detections. There are currently several algorithms, which can produce genotype estimates within a wide range of variability. The use of these for cervical cytology samples has recently been assessed for accuracy against a definitive reference standard, but none have yet been assessed for multiple-genotype-containing whole biopsy specimens. Using laser capture microdissection (LCM) on biopsy samples, lesion-specific genotype prevalence data were generated for a cohort of 516 young Australian women (aged 18-32 years) with cervical intraepithelial neoplasia grade 3 or adenocarcinoma in situ. Using whole tissue section genotype data from the same cohort, including 71 (13.7%) with multiple genotypes, lesion-associated genotype prevalence was estimated using four different attribution algorithms. The proportion of lesions attributable to HPV16 and HPV18 by LCM were 58.4% and 5%, respectively; hierarchical, proportional, single type/minimum and any type/maximum attribution estimates were comparable across genotypes. For analyses utilising whole tissue biopsy cervical specimens, attribution estimates are appropriate for estimating the proportional contribution of individual genotypes to lesions in a population., 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., (Crown Copyright © 2020. Published by Elsevier Ltd. All rights reserved.)

Background: Early detection of breast cancer can improve survival rates and decrease mortality rates. This study investigates whether there are significant differences in participation in breast screening among women born in Muslim countries compared to women born in Non-Muslim countries and Australia., Methods: Screening data from January 1st, 2000 to December 31st, 2013 from the Breast Screen Victoria Registry (BSV) was linked with hospital records from the Victorian Admitted Episodes Dataset (VAED). Countries having more than 50% of their population as Muslim were categorised as Muslim countries. Age adjusted rates were calculated for women born in Muslim and Non-Muslim countries and compared with the Australian age adjusted rates. Logistic regression assessed the association between screening status and other factors which include country of birth, marital status, age and socio-economic status., Results: Women born in Muslim countries (Odds Ratio (OR) = 0.70, 95%CI = 0.68-0.72) and in other Non-Muslim countries (OR = 0.87, 95%CI = 0.86-0.88) had lower odds of participation in breast screening than Australian born women. Women aged 60-64 years (OR = 1.42, 95%CI = 1.40-1.44) had higher odds of participation in the BreastScreen program than 50-54 age group., Conclusion: This study provides valuable insights to understanding breast screening participation among women born in Muslim countries residing in Victoria. This population level study contributes to the broader knowledge of screening participation of women born in Muslim countries, an understudied population group in Australia and across the world. This study has implications for breast screening programs as it highlights the need for culturally sensitive approaches to support breast screening participation among women born in Muslim countries., Competing Interests: Tahira Yeasmeen and Margaret Kelaher certify that they have NO affiliations with or involvement in any organization or entity with any financial interest, or non-financial interest in the subject matter or materials discussed in this manuscript. Julia Brotherton and Michael Malloy report the following affiliation or involvement in an organization or entity with a financial or non-financial interest in the subject matter or materials discussed in this manuscript. Julia Brotherton is affiliated with VCS Foundation. Michael Malloy is affiliated with VICNISS, Melbourne Health and formerly with VCS Foundation.

Background: Autoimmune conditions (AICs) and/or their treatment may alter risk of human papilloma virus (HPV) infection and females with AICs are therefore at an increased risk of cervical dysplasia. However, inclusion of these at-risk populations in cervical cancer screening and HPV-vaccination guidelines, are mostly lacking. This study aimed to determine the prevalence of cervical dysplasia in a wide range of AICs and compare that to HIV and immunocompetent controls to support the optimisation of cervical cancer preventive health measures., Methods: Data linkage was used to match cervical screening episodes to emergency department records of females with AICs or HIV to immunocompetent controls over a 14-year period. The primary outcome was histologically confirmed high-grade cervical disease. Results, measured as rates by cytology and histology classification per 1,000 females screened, were analysed per disease group, and intergroup comparisons were performed., Results: Females with inflammatory bowel disease (2,683), psoriatic and enteropathic arthropathies (1,848), multiple sclerosis (MS) (1,426), rheumatoid arthritis (1,246), systemic lupus erythematosus and/or mixed connective tissue disease (SLE/MCTD) (702), HIV (44), and 985,383 immunocompetent controls were included. SLE/MCTD and HIV groups had greater rates of high-grade histological and cytological abnormalities compared to controls. Increased rates of low-grade cytological abnormalities were detected in all females with AICs, with the exception of the MS group., Conclusions: Females with SLE/MCTD or HIV have increased rates of high-grade cervical abnormalities. The increased low-grade dysplasia rate seen in most females with AICs is consistent with increased HPV infection. These findings support expansion of cervical cancer preventative programs to include these at-risk females., Competing Interests: Dr Foster, Dr Malloy, A/Prof Van Doornum, Dr Unglik and A/Prof Brotherton have no conflict of interest to declare. Dr Jokubaitis has received speaker’s honoraria from Biogen, and conference travel support from Merck. She receives research funding from MS Research Australia, and the Australian National Health and Medical Research Council (NHMRC). Mr. Wrede has received Honoraria and Sponsorship from Biogen and Seqirus. He is Deputy Chairman of the Board of VCS Foundation Pty Ltd. He is a member of the Clinical Expert Panel reviewing the Australian Cervical Screening Program. Prof Butzkueven serves as the Director of the MSBase foundation. He serves on steering committees and advisory boards for Biogen, Roche, Merck, Sanofi, Novartis. He has received speaker’s honoraria, travel support and receives research grant support from Roche, Biogen, Merck, Sanofi, Novartis and Teva. Prof Sasadeusz has been on advisory boards for Merck. Prof Macrae is on advisory committee for Pfizer and receives funding for the conduct of multiple clinical trials in inflammatory bowel disease. He receives funding from Cancer Australia, Cancer Council NSW, and NHMRC for investigator-initiated studies. A/Prof van der Walt has received speaker’s honoraria, travel support and served on advisory boards for Biogen, Merck, Sanofi, Novartis and Teva. She receives funding from the NHMRC Australia. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Aboriginal and Torres Strait Islander (collectively, Indigenous Australian) women experience a higher burden of cervical cancer than other women. The National Cervical Screening Program (NCSP) is failing to meet the needs of Indigenous Australian women, resulting in many women not regularly participating in cervical screening. However, one third of Indigenous Australian women do participate in cervical screening. The reasons that some women in this population commence and continue to screen remain unheard but could provide insights to support women who currently do not participate. We aimed to describe Indigenous Australian women's experiences and views of participation in cervical screening by yarning (a culturally-appropriate interview technique) with 50 Indigenous Australian women aged 25-70 years who had completed cervical screening in the past five years, recruited via Primary Health Care Centres (PHCCs) from three jurisdictions. Aboriginal or Torres Strait Islander women researchers conducted the interviews. Thematic analysis identified six themes: screening as a means of staying strong and in control; overcoming fears, shame, and negative experiences of screening; needing to talk openly about screening; the value of trusting relationships with screening providers; logistical barriers; and overcoming privacy concerns for women employed at PHCCs. Despite describing screening as shameful, invasive, and uncomfortable, women perceived it as a way of staying healthy and exerting control over their health. This ultimately supported their participation and a sense of empowerment. Women valued open discussion about screening and strong relationships with health providers. We identified logistical barriers and specific barriers faced by women employed at PHCCs. This study is strengthened by a research approach that centred Indigenous Australian women's voices. Understanding the experiences of Indigenous Australian women who participate in screening will help screening providers support women to start and continue to screen regularly. Recommendations for practice are provided., Competing Interests: The authors have read the journal's policy and have the following conflicts: The study is affiliated with Southern Queensland Centre of Excellence in Aboriginal and Torres Strait Islander Primary Health Care, Wuchopperen Health Service Pty Ltd and Yerin Eleanor Duncan Aboriginal Health Centre. These commercial affiliations provided support in the form of salaries for authors CM, JM, and EW, respectively. This does not alter our adherence to all the PLOS ONE policies on sharing data and materials.

Objectives: To compare the performance of dual immunostaining of p16INK4a and Ki-67 proteins performed on self-collected vaginal specimens and clinician-collected cervical specimens, and to evaluate the performance of this technique in predicting high-grade disease., Methods: Women aged 30-59 years (n = 1005) were recruited at two well-women clinics in Papua New Guinea. Each woman provided both cervical and vaginal specimens that were tested for high-risk human papillomavirus (hrHPV) DNA using the Xpert HPV Test (Cepheid) at point of care. A subset of paired cervical and vaginal specimens (n = 243) were selected to undergo CINTec® PLUS (Roche) p16/Ki-67 dual-stain cytology and liquid-based cytology (LBC)., Results: Fifty-five pairs (22%) were excluded from further analysis because the smears were not assessable. Of the 189 remaining paired specimens, 74 pairs (39.1%) were positive for one or more hrHPV genotypes. When comparing results of the dual stain, the overall percent agreement, positive and negative percent agreements and κ value between the cervical and vaginal specimens were 87.8% (CI 82.3-92.1%), 64.6% (CI 49.5-77.8%), 95.7% (CI 91.0-98.0%) and 0.65 (CI 0.51-0.79%) respectively. The sensitivity of the dual stain performed on the cervical specimen to predict high-grade disease, determined by LBC, was superior to that of the dual stain performed on the vaginal specimen: 100% (CI 84.6-100%) versus 68.2% (CI 45.1-86.1%)., Conclusion: Although further evaluation may be warranted, these findings indicate that dual-stain testing of vaginal specimens cannot be advocated as part of cervical screening programmes in low- and middle-income countries. However, dual-stain cytology performed on cervical specimens may have a role in quality assurance in such settings., (Copyright © 2019 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.)