Minority stressors, traumatic events, and associations with mental health and school climate among gender and sexuality diverse young people in Australia: Findings from a nationally representative cohort study.

INTRODUCTION: Population-level, nationally representative data on the prevalence of minority stressors and traumatic events, mental ill-health effects, and the preventative utility of school climate, among gender and sexuality diverse young people in Australia, is significantly lacking. In this study, we estimated the prevalence and distribution of minority stressors and traumatic events among young people by sexuality identity (gay/lesbian, bisexual, other sexuality, heterosexual), sexuality diversity (sexuality diverse, not sexuality diverse), and gender identity (transgender, cisgender) and assessed associations with mental ill-health and the moderating role of school climate factors. METHODS: Using Wave 8 (2018) follow-up data from a population-level, nationally representative longitudinal cohort study, the sample comprised 3037 young people aged 17-19 years in Australia. Prevalence ratios for minority stressors and traumatic events were calculated for gender and sexuality diverse categories using logistic regression models. Linear regression models were used to test associations between traumatic events and minority stressors, and mental ill-health. Multivariate linear regression tested school climate factors as effect modifier between minority stressors and mental ill-health among sexuality diverse young people. RESULTS: Rates of traumatic events and minority stressors were highest among bisexual and gay/lesbian young people and were significantly associated with mental ill-health among all gender and sexuality diverse young people. Highest mental ill-health effects were observed among trans young people. Among sexuality diverse young people, positive and negative feelings toward school climate were associated with decreased and increased mental ill-health, respectively. After accounting for sexuality diversity, positive overall school climate appeared protective of mental ill-health effects of sexuality-based discrimination. DISCUSSION: Minority stressors, traumatic events, and associated mental ill-health are prevalent among gender and sexuality diverse young people in Australia, especially trans, bisexual, and gay/lesbian young people. Promotion of affirmative, safe, and inclusive school climate demonstrates significant promise for the prevention and early intervention of mental ill-health among gender and sexuality diverse young people.

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

Using a cluster-randomized trial design, we aimed to evaluate a complex intervention to increase uptake of human papillomavirus (HPV) vaccination in schools. The study was undertaken in high schools in Western Australia and South Australia between 2013 and 2015 with adolescents aged 12-13 years. Interventions included education, shared decision-making, and logistical strategies. The main outcome was school vaccine uptake. Secondary outcomes included consent forms returned and mean time to vaccinate 50 students. We hypothesised that a complex intervention would increase 3-dose HPV vaccine uptake. We recruited 40 schools (21 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.

Reinforcing or Disrupting Gender Affirmation: The Impact of Cancer on Transgender Embodiment and Identity.

There is a pressing need for greater understanding and focus on cancer survivorship and informal cancer caring of trans people (binary and non-binary), across tumor types, to inform culturally safe trans inclusive cancer information and care. This qualitative study, part of the mixed methods Out with Cancer project, examined experiences of trans embodiment and identity after cancer diagnosis and treatment. We drew on open-ended survey responses from 63 trans cancer survivors and 23 trans cancer carers, as well as interviews and a photo-elicitation activity with a subset of 22 participants (15 cancer survivors, 7 cancer carers). Reflexive thematic analysis identified three themes: Cancer enhances trans embodiment, through experiences of gender euphoria following cancer treatment, and acceleration of decisions about gender affirmation; cancer erases or inhibits gender affirmation; trans embodiment is invisible or pathologized in cancer care. These findings demonstrate that trans embodiment and identity, as well as the process of gender affirmation, may be disrupted by cancer or informal cancer caring. Conversely, cancer and cancer treatment can positively impact the embodied identity and lives of trans people, despite the anxiety and strain of negotiating medical procedures. However, if healthcare professionals operate within a cis-heteronormative framework and do not understand the meaning of embodied change following cancer treatment for trans individuals, these positive benefits may not be realized.

Guiding, sustaining and growing the public involvement of young people in an adolescent health research community of practice.

BACKGROUND: Public involvement in health research and its translation is well recognized to improve health interventions. However, this approach is insufficiently practised and evidenced in relation to young people. This paper presents an analysis of the process of co-producing a framework, partnership model and a growing network of young people informing and guiding an adolescent health research community of practice. METHODS: A Living Lab is a participatory research approach that brings together a broad range of stakeholders in iterative cycles of research, design, development, pilot-testing, evaluation and delivery to implement effective responses to complex phenomena. The geographical setting for this study was Sydney, NSW, Australia, and involved both youth and adult stakeholders from this region. The study spanned three phases between July 2018 and January 2021, and data collection included a range of workshops, a roundtable discussion and an online survey. RESULTS: The co-production process resulted in three key outputs: first, an engagement framework to guide youth participation in health research; second, a partnership model to sustain youth and adult stakeholder collaboration; third, the growth of the public involvement of young people with a range of projects and partners. CONCLUSIONS: This study investigated the process of co-producing knowledge with young people in an adolescent health community of practice. A reflexive process supported youth and adult stakeholders to collaboratively investigate, design and pilot-test approaches that embed young people's engagement in adolescent health research. Shared values and iterative methods for co-production can assist in advancing mutual learning, commitment and trust in specific adolescent health research contexts. PUBLIC CONTRIBUTION: Young people guiding and informing an adolescent health research community of practice were involved in this study, and one of the participants is a paper co-author.

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

BACKGROUND: The National Human Papillomavirus (HPV) Vaccination Program in Australia commenced in 2007 for females and in 2013 for males, using the quadrivalent HPV vaccine (HPV 6,11,16,18). Thus far, we have demonstrated very substantial reductions in genital warts and in the prevalence of HPV among young Australian women, providing early evidence for the success of this public health initiative. Australia has a long history of school-based vaccination programs for adolescents, with comparatively high coverage. However, it is not clear what factors promote success in a school vaccination program. The HPV.edu study aims to examine: 1) student knowledge about HPV vaccination; 2) psycho-social outcomes and 3) vaccination uptake. METHODS/DESIGN: HPV.edu is a cluster randomised trial of a complex intervention in schools aiming to recruit 40 schools with year-8 enrolments above 100 students (approximately 4400 students). The schools will be stratified by Government, Catholic, and Independent sectors and geographical location, with up to 20 schools recruited in each of two states, Western Australia (WA) and South Australia (SA), and randomly allocated to intervention or control (usual practice). Intervention schools will receive the complex intervention which includes an adolescent intervention (education and distraction); a decisional support tool for parents and adolescents and logistical strategies (consent form returns strategies, in-school mop-up vaccination and vaccination-day guidelines). Careful process evaluation including an embedded qualitative evaluation will be undertaken to explore in depth possible mechanisms for any observed effect of the intervention on primary and secondary outcomes. DISCUSSION: This study is the first to evaluate the relative effectiveness of various strategies to promote best practice in school-based vaccination against HPV. The study aims to improve vaccination-related psychosocial outcomes, including adolescent knowledge and attitudes, decision-making involvement, self-efficacy, and to reduce fear and anxiety. The study also aims to improve school vaccination program logistics including reduction in time spent vaccinating adolescents and increased number of consent forms returned (regardless of decision). Less anxiety in adolescents will likely promote more efficient vaccination, which will be more acceptable to teachers, nurses and parents. Through these interventions, it is hoped that vaccination uptake will be increased. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry, ACTRN12614000404628 , 14.04.2014.

Perceived facilitators and barriers to the uptake of the human papillomavirus (HPV) vaccine among adolescents of Arabic-speaking mothers in NSW, Australia: A qualitative study.

Background: Australia has a large immigrant population but there is little data regarding whether human papillomavirus (HPV) vaccination coverage in adolescents varies according to parents' cultural or ethnic background. This work aims to identify facilitators and barriers to HPV vaccination of adolescents as perceived by Arabic-speaking mothers in Western Sydney, South Western Sydney and Wollongong, NSW, Australia. Methods: A purposive sampling approach was applied to recruit mothers of adolescents from Arabic speaking backgrounds who had at least one child eligible for the HPV school-based vaccination program. Face-to-face semi-structured well as online interviews were conducted in Arabic between April 2021 and July 2021. The interviews were audio-recorded, transcribed, and translated into English and examined using thematic analysis. Results: Sixteen mothers of adolescents from Arabic backgrounds described facilitators and barriers to HPV vaccination. A) Facilitators of HPV vaccination included: knowledge of HPV disease, trust in the school vaccination program, opportunistic recommendations from healthcare workers, information from friends. B) Barriers to accessing HPV vaccination included communication gaps: breakdown in school-parent information flow, lack of access to the Arabic language version of the information sheet, mother - GP communication barriers, mother-child communication gap; and health system gaps: missed opportunities for vaccination. C) Mothers' suggestions to improve HPV vaccination acceptance: to involve religious and cultural leadership, encourage engagement with GPs, and provide school-based education for parents and students. Conclusion: Parents could benefit from assistance with HPV vaccination decision making. Interventions via schools, health professionals and religious and cultural organisations could play important roles in HPV vaccination acceptance for Arabic speaking immigrant families and in introducing their adolescent children to this vaccine.

Childhood and Adolescence Gender Role Nonconformity and Gender and Sexuality Diversity in Young Adulthood.

Importance: Sexuality- and gender-diverse youth experience disproportionate health and social adversity. Accurate early-life indicators are important for development of supportive approaches. Objective: To examine whether commonly used items measuring childhood conformity to gender roles are associated with sexual orientation in young adulthood. Design, Setting, and Participants: This single-center, prospective cohort study (the Raine Study) assessed 2868 children of 2900 women who were recruited during pregnancy from August 1, 1989, to April 30, 1992, with follow-up ongoing. The Achenbach System of Empirically Based Assessment (ASEBA) Child Behavior Checklist, Teacher Report Form, and Youth Self-Report tools were used to survey parents, teachers, and youths to examine gender diversity among the participating youths. Parents were followed up at years 5, 8, 10, 14, and 17, adolescents at years 14, 17, and 27, and teachers at years 10 and 14. Data were analyzed from August 1, 2020, to July 31, 2023. Exposures: Parent and teacher report that a child "behaves like the opposite sex" (gender role behavior), and parent and self-report that a child "wishes to be the opposite sex" (gender role wish), in response to assessment items. Main Outcome Measures: Year 27 self-reported sexual identity, attraction, and behavior. Results: Of the 2868 children in the original birth cohort, 1154 (40.2%) participated in the year 27 follow-up, of whom 608 (52.7%) were recorded female at birth and 546 (47.3%) were recorded male at birth. Of these, 582 who were recorded female at birth continued to identify as female (cisgender) (95.7%), and 515 recorded male at birth continued to identify as male (cisgender) (94.3%); 47 (4.1%) did not complete the questionnaire. Of cisgender participants, 76 of 605 women (12.6%) and 52 of 540 men (9.6%) had a diverse sexual identity, 204 of 605 women (33.8%) and 77 of 540 men (14.3%) were same-gender attracted, and 100 of 605 women (18.6%) and 39 of 540 men (7.2%) had ever engaged in same-gender sexual behavior. Across all follow-ups, after adjusting for gender, nonconforming gender role behavior was consistently associated with diverse sexual identity and behavior (adjusted odds ratio [aOR] for identity, 2.8; 95% CI, 1.9-4.2; behavior aOR, 2.4; 95% CI, 1.6-3.5). Self-reported gender role wish was consistently associated with diverse sexual orientation (identity aOR, 2.3; 95% CI, 1.4-3.8; attraction aOR, 1.7; 95% CI, 1.1-2.5; behavior aOR, 1.9; 95% CI, 1.2-2.9). Conclusions and Relevance: In this cohort study, ASEBA gender role nonconformity was associated with diverse sexual orientation, beginning in early childhood. Findings suggest that the ASEBA measures should not be used to infer sexual orientation or gender diversity in clinical or research settings; asking direct questions may provide more accurate data.

A digital innovation typology: Navigating the complexity of emerging technologies to negotiate health systems research with young people.

Objective: This study aims to explore young people's perspectives of emerging technologies and health systems research in an adolescent health community of practice. Methods: The context of this integrated knowledge translation study is the Wellbeing Health & Youth Centre of Research Excellence in Adolescent Health. A theory-building, non-systematic review was conducted to examine the concepts and interrelationships of emerging technologies associated with digital innovation and health systems. This typology informed the design of an online workshop with young people to explore their views, concerns, and ideas about health systems research. Results: A digital innovation typology was identified to differentiate and explain emerging technology concepts and interrelationships that can be applied to the health systems context. Aligned with this typology, youth perspectives about digital health challenges and opportunities were identified to support future research, policy, and practice. Conclusion: The integrated findings from this study can assist the navigation of complex emerging technologies, and the negotiation of equitable health systems research, between youth and adult stakeholders. Further, with these typology-related resources, mutual learning and the public involvement of young people in health systems research and priority setting agendas can be supported.

Immunogenicity, safety, usability and acceptability of microarray patches for vaccination: a systematic review and meta-analysis.

BACKGROUND: Microarray patches (MAPs) deliver vaccines to the epidermis and the upper dermis, where abundant immune cells reside. There are several potential benefits to using MAPs, including reduced sharps risk, thermostability, no need for reconstitution, tolerability and self-administration. We aimed to explore and evaluate the immunogenicity, safety, usability and acceptability of MAPs for vaccination. METHODS: We searched CINAHL, Cochrane Library, Ovid Embase, Ovid MEDLINE and Web of Science from inception to January 2023. Eligibility criteria included all research studies in any language, which examined microarrays or microneedles intended or used for vaccination and explored immunogenicity, safety, usability or acceptability in their findings. Two reviewers conducted title and abstract screening, full-text reviewing and data extraction. RESULTS: Twenty-two studies were included (quantitative=15, qualitative=2 and mixed methods=5). The risk of bias was mostly low, with two studies at high risk of bias. Four clinical trials were included, three using influenza antigens and one with Japanese encephalitis delivered by MAP. A meta-analysis indicated similar or higher immunogenicity in influenza MAPs compared with needle and syringe (N&S) (standardised mean difference=10.80, 95% CI: 3.51 to 18.08, p<0.00001). There were no significant differences in immune cell function between MAPs and N&S. No serious adverse events were reported in MAPs. Erythema was more common after MAP application than N&S but was brief and well tolerated. Lower pain scores were usually reported after MAP application than N&S. Most studies found MAPs easy to use and highly acceptable among healthcare professionals, laypeople and parents. CONCLUSION: MAPs for vaccination were safe and well tolerated and evoked similar or enhanced immunogenicity than N&S, but further research is needed. Vaccine uptake may be increased using MAPs due to less pain, enhanced thermostability, layperson and self-administration. MAPs could benefit at-risk groups and low and middle-income countries. PROSPERO REGISTRATION NUMBER: CRD42022323026.

Usability, acceptability, and feasibility of a High-Density Microarray Patch (HD-MAP) applicator as a delivery method for vaccination in clinical settings.

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

Professional immunizers and healthcare workers found high-density microarray patch devices highly usable and acceptable to administer vaccines.HD-MAPs may have advantages over intramuscular injections in clinical settings and in pandemics.Vaccination with HD-MAP may improve acceptance for those with needle-related anxiety.

Knowledge, Attitudes, and Perceptions of the Arabic-Speaking Community in Sydney, Australia, toward the Human Papillomavirus (HPV) Vaccination Program: A Qualitative Study.

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

Effective fertility counselling for transgender adolescents: a qualitative study of clinician attitudes and practices.

OBJECTIVE: Fertility counselling for trans and gender diverse (TGD) adolescents has many complexities, but there is currently little guidance for clinicians working in this area. This study aimed to identify effective strategies for-and qualities of-fertility counselling for TGD adolescents based on clinicians' experiences. DESIGN: We conducted qualitative semi-structured individual interviews in 2019 which explored clinician experiences and fertility counselling practices, perspectives of the young person's experience and barriers and facilitators to fertility preservation access. Data were analysed using thematic analysis. SETTING: This qualitative study examined experiences of clinicians at the Royal Children's Hospital-a tertiary, hospital-based, referral centre and the main provider of paediatric TGD healthcare in Victoria, Australia. PARTICIPANTS: We interviewed 12 clinicians from a range of disciplines (paediatrics, psychology, psychiatry and gynaecology), all of whom were involved with fertility counselling for TGD adolescents. RESULTS: Based on clinician experiences, we identified five elements that can contribute to an effective approach for fertility counselling for TGD adolescents: a multidisciplinary team approach; shared decision-making between adolescents, their parents and clinicians; specific efforts to facilitate patient engagement; flexible personalised care; and reflective practice. CONCLUSIONS: Identification of these different elements can inform and hopefully improve future fertility counselling practices for TGD adolescents, but further studies examining TGD adolescents' experiences of fertility counselling are also required.

School-based HPV vaccination positively impacts parents' attitudes toward adolescent vaccination.

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.

Effect of a School-Based Educational Intervention About the Human Papillomavirus Vaccine on Psychosocial Outcomes Among Adolescents: Analysis of Secondary Outcomes of a Cluster Randomized Trial.

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.

School-Level Variation in Coverage of Co-Administered dTpa and HPV Dose 1 in Three Australian States.

BACKGROUND: Australian adolescents are routinely offered HPV and dTpa (diphtheria, tetanus, pertussis) vaccines simultaneously in the secondary school vaccination program. We identified schools where HPV initiation was lower than dTpa coverage and associated school-level factors across three states. METHODS: HPV vaccination initiation rates and dTpa vaccination coverage in 2016 were calculated using vaccine databases and school enrolment data. A multivariate analysis assessed sociodemographic and school-level factors associated with HPV initiation being >5% absolute lower than dTpa coverage. RESULTS: Of 1280 schools included, the median school-level HPV initiation rate was 85% (interquartile range (IQR):75-90%) and the median dTpa coverage was 86% (IQR:75-92%). Nearly a quarter (24%) of all schools had HPV vaccination initiation >5% lower than dTpa coverage and 11 % had >10% difference. School-level factors independently associated with >5% difference were remote schools (aOR:3.5, 95% CI = 1.7-7.2) and schools in major cities (aOR:1.8, 95% CI = 1.0-3.0), small schools (aOR:3.3, 95% CI = 2.3-5.7), higher socioeconomic advantage (aOR:1.7, 95% CI = 1.1-2.6), and lower proportions of Language-background-other-than-English (aOR:1.9, 95% CI = 1.2-3.0). CONCLUSION: The results identified a quarter of schools had lower HPV than dTpa initiation coverage, which may indicate HPV vaccine hesitancy, and the difference was more likely in socioeconomically advantaged schools. As hesitancy is context specific, it is important to understand the potential drivers of hesitancy and future research needs to understand the reasons driving differential uptake.

Producing cosmopolitan sexual citizens on The L Word.

Using Showtime's The L Word as a case study, we argue that lesbian sexuality and lesbian lifestyles are produced alongside broader discourses of cosmopolitan consumer citizenship. The lesbian characters in this program are first and foremost constructed through their investments in certain neo-liberal consumer and lifestyle practices that limit the possibility of what lesbian subjectivities and/or lesbian politics can or cannot become. We offer an alternative strategy of reading lesbians in image-based media and popular culture that attends to the ways in which lesbian subjectivities are produced in a climate of neo-liberal consumer and lifestyle practices that have shifted the ways in which sexual citizens are produced. Our aim is to provide a critical framework that can be applied to other lesbian-themed television texts and to a range of other image-based visual media including film, commercial advertising, and new media.

Fit4YAMs: Structuring a Lifestyle Intervention for Rural Overweight and Obese Young Adult Males Using Participatory Design.

PURPOSE: Young adult males (YAMs) are understudied with respect to lifestyle interventions to address overweight and obesity in this group. This study reports on the participatory design of the structure and delivery of the Fit4YAMs text message-based lifestyle intervention for 18- to 25-year-old rural YAMs in Australia. METHODS: Two semi-structured focus group discussions were held with six overweight or obese YAMs. Sessions explored their preferences for the structure and delivery of a weight loss intervention. Focus groups were recorded, and the contents transcribed verbatim for thematic analysis. RESULTS: The YAMs were unanimous in their preference for a highly personalized intervention program, complete with personalized goal setting, personalized motivation and engagement strategies, and personalized text message content. A text message frequency of three-four messages per week was deemed optimal for this group. Minimal direct contact by the intervention team was requested, but with clear guidelines and reminders of key contacts whom they could contact should they require help and guidance. The YAMs also agreed that a comprehensive goal setting session and personalization session prior to commencement of the intervention would be best. CONCLUSIONS: To engage rural YAMs in lifestyle interventions, a high degree of personalization of the program appears important. Although initially more time and resource intensive than a less personalized approach, it is essential to identify strategies to prevent and reverse weight gain in this hard to engage group. Maximizing their engagement using a more personalized approach could be the key to promoting long-term health outcomes in this group.

Safety, tolerability, acceptability and immunogenicity of an influenza vaccine delivered to human skin by a novel high-density microprojection array patch (Nanopatch™).

BACKGROUND: Injection using needle and syringe (N&S) is the most widely used method for vaccination, but requires trained healthcare workers. Fear of needles, risk of needle-stick injury, and the need to reconstitute lyophilised vaccines, are also drawbacks. The Nanopatch (NP) is a microarray skin patch comprised of a high-density array of microprojections dry-coated with vaccine that is being developed to address these shortcomings. Here we report a randomised, partly-blinded, placebo-controlled trial that represents the first use in humans of the NP to deliver a vaccine. METHODS: Healthy volunteers were vaccinated once with one of the following: (1) NPs coated with split inactivated influenza virus (A/California/07/2009 [H1N1], 15 µg haemagglutinin (HA) per dose), applied to the volar forearm (NP-HA/FA), n = 15; (2) NPs coated with split inactivated influenza virus (A/California/07/2009 [H1N1], 15 µg HA per dose), applied to the upper arm (NP-HA/UA), n = 15; (3) Fluvax® 2016 containing 15 µg of the same H1N1 HA antigen injected intramuscularly (IM) into the deltoid (IM-HA/D), n = 15; (4) NPs coated with excipients only, applied to the volar forearm (NP-placebo/FA), n = 5; (5) NPs coated with excipients only applied to the upper arm (NP-placebo/UA), n = 5; or (6) Saline injected IM into the deltoid (IM-placebo/D), n = 5. Antibody responses at days 0, 7, and 21 were measured by haemagglutination inhibition (HAI) and microneutralisation (MN) assays. FINDINGS: NP vaccination was safe and acceptable; all adverse events were mild or moderate. Most subjects (55%) receiving patch vaccinations (HA or placebo) preferred the NP compared with their past experience of IM injection with N&S (preferred by 24%). The antigen-vaccinated groups had statistically higher HAI titres at day 7 and 21 compared with baseline (p < 0.0001), with no statistical differences between the treatment groups (p > 0.05), although the group sizes were small. The geometric mean HAI titres at day 21 for the NP-HA/FA, NP-HA/UA and IM-HA/D groups were: 335 (189-593 95% CI), 160 (74-345 95% CI), and 221 (129-380 95% CI) respectively. A similar pattern of responses was seen with the MN assays. Application site reactions were mild or moderate, and more marked with the influenza vaccine NPs than with the placebo or IM injection. INTERPRETATION: Influenza vaccination using the NP appeared to be safe, and acceptable in this first time in humans study, and induced similar immune responses to vaccination by IM injection.

Safety, acceptability and tolerability of uncoated and excipient-coated high density silicon micro-projection array patches in human subjects.

Most vaccinations are performed by intramuscular injection with a needle and syringe. However, this method is not ideal due to limitations, such as the risk of needle-stick injury, the requirement for trained personnel to give injections and the need to reconstitute lyophilized vaccines. Therefore, we tested an alternative delivery technology that overcomes the problems with needle and syringe. The Nanopatch™ is an array of 10,000 silicon micro-projections per cm2 that can be dry-coated with vaccine for skin delivery. The high number and density of micro-projections means that high velocity application is required to achieve consistent skin penetration. Before clinically testing a vaccine Nanopatch, this study tests the safety, tolerability and acceptability/utility of uncoated and excipient-coated Nanopatches in healthy adults. Nanopatches were applied to skin of the upper arm and volar forearm and left in contact with the skin for two minutes before removal. The application sites were assessed for local skin response over 28 days. Acceptability interviews were also performed. No unexpected adverse events directly related to the Nanopatch application were reported. All applications of the Nanopatch resulted in an expected erythema response which faded between days 3 and 7. In some subjects, some skin discolouration was visible for several days or up to 3 weeks after application. The majority (83%) of subjects reported a preference for the Nanopatch compared to the needle and syringe and found the application process to be simple and acceptable. On a pain scale from 0 to 10, 78% of applications were scored "0" (no pain) with the average scores for less than 1. The results from this study demonstrate the feasibility of the Nanopatch to improve vaccination by showing that application of the product without vaccine to human skin is safe, tolerable and preferred to needle and syringe administration. Clinical trial registry ID: ACTRN1261500083549.