Study protocol : randomised controlled trial assessing the efficacy of strategies involving self-sampling in cervical cancer screening

Objectives: The cervical cancer screening coverage remains moderate (60%) in France. The aim of the study is to evaluate the efficacy of two experimental invitation strategies (offer of urine or vaginal self-sampling kits) to reach under-screened populations and compare them with the current invitation strategy in rural departments (low medical density and low participation rate) in France.Methods: The study is a randomised controlled trial with three arms: a control arm (conventional invitation letter) and two experimental arms (mailing of a urine or vaginal self-sampling kit). The target population includes women aged 30-65 years, who had no screening test recorded since more than 4 years and who did not respond to an invitation letter within 12 months before. The primary outcome measure is the participation rate in each arm. A team of psychologists will also investigate attitudes and experiences by semi-structured/focus-group interviews with voluntary CapU4 participants and with health professionals.Result and conclusion: CapU4 will identify effective strategies to reach women not responding to current screening invitations and will generate information about acceptance of self-sampling among women and health professionals

Optimizing Communication on HPV Vaccination to Parents of 11- to 14-Year-Old Adolescents in France: A Discrete Choice Experiment

International audienceBackground: With the aim to optimize communication during HPV vaccination campaigns in France, we elicited parental preferences around HPV vaccination.Methods: We conducted a single-profile discrete choice experiment (DCE) among parents of 11- to 14-year-old middle-school pupils, who completed an anonymous, self-administered, internet-based questionnaire during 2020-2021. The DCE comprised five attributes (vaccine-preventable disease, justification of optimal age, information on safety, indirect protection and coverage) of vaccination against an unnamed disease that were presented to respondents in ten choice tasks, or scenarios. We use fixed effect logit models to estimate attribute weights on theoretical vaccine acceptance, and random effect linear regression to estimate attribute coefficients on vaccine eagerness (decision and decision certainty). We estimated marginal effects of attributes on expected vaccine acceptance.Results: Vaccination scenarios were accepted by 55.6-89.2% of the 1291 participants. The largest marginal effects on expected vaccine acceptance in the full sample arose from prevention of cancer versus genital warts (+ 11.3 percentage points); from a "severe side effect suspicion that was not scientifically confirmed" versus a statement about "more benefits than risks" (+ 8.9 percentage points), and information on 80% vaccine coverage in neighbouring countries versus on "insufficient coverage" (+ 4.2 percentage points). Explaining the early age of vaccination by sexual debut had a strong negative impact among French monolingual parents with lower education level (vs age-independent, OR 0.48, 95% CI 0.27-0.86), but not other socio-economic groups. After removing low-quality responses (unvaried certainty and short questionnaire completion), among serial non-demanders with children not vaccinated against HPV, only disease elimination impacted vaccine eagerness positively (coefficient 0.54, 0.06-1.02).Discussion: Using DCEs to elicit parents' preferences around communication messages, notably on cancer prevention, vaccine coverage and information about vaccine safety, could help to optimize HPV vaccination promotion efforts

Optimising HPV vaccination communication to adolescents: a discrete choice experiment

International audienceBackground: Human Papillomavirus (HPV) vaccine coverage in France is below 30%, despite proven effectiveness against HPV infections and (pre-)cancerous cervical lesions. To optimise vaccine promotion among adolescents, we used a discrete choice experiment (DCE) to identify optimal statements regarding a vaccination programme, including vaccine characteristics.Methods: Girls and boys enrolled in the last two years of five middle schools in three French regions (aged 13-15 years) participated in an in-class cross-sectional self-administered internet-based study. In ten hypothetical scenarios, participants decided for or against signing up for a school-based vaccination campaign against an unnamed disease. Scenarios included different levels of four attributes: the type of vaccine-preventable disease, communication on vaccine safety, potential for indirect protection, and information on vaccine uptake among peers. One scenario was repeated with an added mention of sexual transmission.Results: The 1,458 participating adolescents (estimated response rate: 89.4%) theoretically accepted vaccination in 80.1% of scenarios. All attributes significantly impacted theoretical vaccine acceptance. Compared to a febrile respiratory disease, protection against cancer was motivating (odds ratio (OR) 1.29 [95%-CI 1.09-1.52]), but not against genital warts (OR 0.91 [0.78-1.06]). Compared to risk negation ("vaccine does not provoke serious side effects"), a reference to a positive benefit-risk balance despite a confirmed side effect was strongly dissuasive (OR 0.30 [0.24-0.36]), while reference to ongoing international pharmacovigilance without any scientifically confirmed effect was not significantly dissuasive (OR 0.86 [0.71-1.04]). The potential for indirect protection motivated acceptance among girls but not boys (potential for eliminating the disease compared to no indirect protection, OR 1.57 [1.25-1.96]). Compared to mentioning "insufficient coverage", reporting that ">80% of young people in other countries got vaccinated" motivated vaccine acceptance (OR 1.94 [1.61-2.35]). The notion of sexual transmission did not influence acceptance.Conclusion: HPV vaccine communication to adolescents can be tailored to optimise the impact of promotion efforts

Effectiveness of a School- and Primary Care–Based HPV Vaccination Intervention

International audienceImportance - The human papillomavirus (HPV) vaccine is safe and effective, yet vaccination coverage remains below public health objectives in many countries. Objective - To examine the effectiveness of a 3-component intervention on HPV vaccination coverage among adolescents aged 11 to 14 years 2 months after the intervention ended, each component being applied alone or in combination. Design, Setting, and Participants - A cluster randomized trial with incomplete factorial design (PrevHPV) was conducted between July 1, 2021, and April 30, 2022, in French municipalities receiving 0, 1, 2, or 3 components of the intervention. Randomization was stratified by school district and municipalities’ socioeconomic level. Analyses were carried out on 11- to 14-year-old adolescents living in all participating municipalities, regardless of what had been implemented. Intervention - The PrevHPV intervention had 3 components: (1) educating and motivating 11- to 14-year-old adolescents in middle schools, along with their parents; (2) training general practitioners (GPs) on up-to-date HPV information and motivational interviewing techniques; and (3) free HPV vaccination at school. Main Outcomes and Measures - The primary outcome was HPV vaccination coverage (≥1 dose) 2 months after the intervention ended among 11- to 14-year-old adolescents living in participating municipalities, based on the French national reimbursement database and data collected during the trial in groups randomized to implement at-school vaccination. Results - A total of 91 municipalities comprising 30 739 adolescents aged 11 to 14 years (15 876 boys and 14 863 girls) were included and analyzed. Half the municipalities were in the 2 lowest socioeconomic quintiles and access to GPs was poor in more than two-thirds of the municipalities. Thirty-eight of 61 schools (62.3%) implemented actions and 26 of 45 municipalities (57.8%) had at least 1 trained GP. The median vaccination coverage increased by 4.0 percentage points (IQR, 2.0-7.3 percentage points) to 14.2 percentage points (IQR, 9.1-17.3 percentage points) at 2 months. At-school vaccination significantly increased vaccination coverage (5.50 percentage points [95% CI, 3.13-7.88 percentage points]) while no effect was observed for adolescents’ education and motivation (−0.08 percentage points [95% CI, −2.54 to 2.39 percentage points]) and GPs’ training (−1.46 percentage points [95% CI, −3.44 to 0.53 percentage points]). Subgroup analyses found a significant interaction between at-school vaccination and access to GPs, with a higher effect when access was poor (8.62 percentage points [95% CI, 5.37-11.86 percentage points] vs 2.13 percentage points [95% CI, −1.25 to 5.50 percentage points]; P = .007 for interaction). Conclusions and Relevance - In this cluster randomized trial, within the context of the late COVID-19 pandemic period and limited school and GP participation, at-school HPV vaccination significantly increased vaccination coverage. The trial did not show a significant effect for training GPs and education and motivation, although it may be observed after more time has elapsed after the intervention

Do boys have the same intentions to get the HPV vaccine as girls? Knowledge, attitudes, and intentions in France

International audienceBackground: The vaccine coverage against human papillomavirus (HPV) vaccination remains low in France. The objective of this study was to study adolescent perceptions by comparing boys and girls, in order to build effective school-based interventions.Methods: This paper presents a cross-sectional study in French middle school pupils. They completed online questionnaires on their knowledge and attitudes toward the HPV vaccine, HPV vaccination status, their intention, reasons to vaccinate or not to vaccinate, and psychological antecedents of vaccination. A structural equation modeling (SEM) analysis was used to test the hypothesized model.Results: The participants are 818 pupils aged from 12 to 16 years (Mage = 13.78). Most pupils were in the pre-contemplative stage (62.7 % of boys and 40.8 % of girls). SEM analysis indicated that the relationship between the level of HPV knowledge, the representations of vaccines in general, and vaccine intention was mediated by attitudes towards the HPV vaccine among both boys and girls.Conclusions: These findings reveal a high percentage of boys who do not feel concerned by the HPV vaccine and highlight the need to consider the psychological antecedents of vaccination in general in addition to the specific attitudes to the HPV vaccine

Co‐development of a school‐based and primary care‐based multicomponent intervention to improve HPV vaccine coverage amongst French adolescents (the PrevHPV Study)

International audienceIntroduction: Despite various efforts to improve human papillomavirus (HPV) vaccine coverage in France, it has always been lower than in most other high-income countries. The health authorities launched in 2018 the national PrevHPV research programme to (1) co-develop with stakeholders and (2) evaluate the impact of a multicomponent complex intervention aimed at improving HPV vaccine coverage amongst French adolescents.Objective: To describe the development process of the PrevHPV intervention using the GUIDance for rEporting of intervention Development framework as a guide.Methods: To develop the intervention, we used findings from (1) published evidence on effective strategies to improve vaccination uptake and on theoretical frameworks of health behaviour change; (2) primary data on target populations' knowledge, beliefs, attitudes, preferences, behaviours and practices as well as the facilitators and barriers to HPV vaccination collected as part of the PrevHPV Programme and (3) the advice of working groups involving stakeholders in a participatory approach. We paid attention to developing an intervention that would maximise reach, adoption, implementation and maintenance in real-world contexts.Results: We co-developed three components: (1) adolescents' and parents' education and motivation using eHealth tools (web conferences, videos, and a serious video game) and participatory learning at school; (2) general practitioners' e-learning training on HPV using motivational interviewing techniques and provision of a decision aid tool and (3) easier access to vaccination through vaccination days organised on participating middle schools' premises to propose free of charge initiation of the HPV vaccination.Conclusion: We co-developed a multicomponent intervention that addresses a range of barriers and enablers of HPV vaccination. The next step is to build on the results of its evaluation to refine it before scaling it up if proven efficient. If so, it will add to the small number of multicomponent interventions aimed at improving HPV vaccination worldwide.Patient or Public Contribution: The public (adolescents, their parents, school staff and health professionals) participated in the needs assessment using a mixed methods approach. The public was also involved in the components' development process to generate ideas about potential activities/tools, critically revise the successive versions of the tools and provide advice about the intervention practicalities, feasibility and maintenance