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International audience; Introduction: 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.

IntroductionVaccination is an effective and safe strategy to prevent Human papillomavirus (HPV) infection and related harms. Despite various efforts by French authorities to improve HPV vaccine coverage (VC) these past few years, VC has remained far lower than in most other high-income countries. To improve it, we have coconstructed with stakeholders a school-based and primary care-based multicomponent intervention, and plan to evaluate its effectiveness, efficiency and implementation through a cluster randomised controlled trial (cRCT).Methods and analysisThis pragmatic cRCT uses an incomplete factorial design to evaluate three components applied alone or in combination: (1) adolescents and parents’ education and motivation at school, using eHealth tools and participatory learning; (2) general practitioners’ training on HPV using motivational interviewing techniques and provision of a decision aid tool; (3) free-of-charge access to vaccination at school. Eligible municipalities (clusters) are located in one of 14 preselected French school districts and must have only one secondary school which enrols at least 2/3 of inhabitants aged 11–14 years. A randomisation stratified by school district and deprivation index allocated 90 municipalities into 6 groups of 15. The expected overall sample size estimate is 41 940 adolescents aged 11–14 years. The primary endpoint is the HPV VC (≥1 dose) among adolescents aged 11–14 years, at 2 months, at the municipality level (data from routine databases). Secondary endpoints include: HPV VC (≥1 dose at 6 and 12 months; and 2 doses at 2, 6 and 12 months); differences in knowledge, attitudes, behaviours, and intention among adolescents, parents and general practitioners between baseline and 2 months after intervention (self-administered questionnaires); incremental cost-effectiveness ratio. Implementation measures include dose, fidelity, adaptations, reached population and satisfaction (activity reports and self-administered questionnaires).Ethics and disseminationThis protocol was approved by the French Ethics Committee ‘CPP Sud-Est VI’ on 22 December 2020 (ID-RCB: 2020-A02031-38). No individual consent was required for this type of research; all participants were informed of their rights, in particular not to participate or to oppose the collection of data concerning them. Findings will be widely disseminated (conference presentations, reports, factsheets and academic publications).Trial registration numberNCT04945655.

International audience; Background: 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.

Summary Objectives In France, cervical cancer screening is based on human papillomavirus (HPV) testing on cervical samples (women aged 30-65) and cytological examination of Pap smears (25-29), but screening coverage is unsatisfactory. The CapU3 study aimed to propose urinary HPV testing on 13,535 women aged 35 to 65 who had not had a Pap smear since 2010. Methods High-risk HPV (HR-HPV) detection was performed using a real-time PCR (Anyplex II HPV 28 Detection, Seegene®). Women with HR-HPV positive results were encouraged to have a cervical smear as soon as possible to detect the presence of cervical lesions. Results The participation rate was 15.4%. Out of the 1,915 analyzed specimens, 1,711 and 190 were negative and positive, respectively, for at least 1 HR-HPV genotype. HR-HPV genotypes other than HPV-16 or HPV-18 were mostly detected as HPV-53 (23.7%) and HPV-68 (14.2%). A satisfactory gynecological follow-up was observed for HPV-positive women (92.1%). 23 abnormal smears were observed and eight high-grade cytological lesions after colposcopy and biopsy were diagnosed. Conclusions As home HPV urinary testing is non-invasive and does not require medical attention, this method may be an alternative for women who are reluctant to have a Pap smear and thus extend screening coverage.

Introduction : Lors de l’etude, l’HAS recommandait 3 options de premier controle (C1) en cas de decouverte d’un ASC-US sur un frottis de depistage : un frottis a 6 mois, un test HPV ou une colposcopie.Notre objectif principal etait de connaitre l’option choisie du C1. Les objectifs secondaires etaient d’evaluer le nombre de C1 realises par les medecins generalistes, le taux de suivi et celui des comptes-rendus des frottis C1 adaptes.Methode : Etude retrospective descriptive, realisee sur les donnees de CAP Sante 49 (organisme departemental du depistage organise des cancers), concernant les femmes de 25 a 65 ans ayant un frottis de depistage avec un resultat ASC-US realise par un medecin generaliste.Resultats : 397 patientes incluses, 373 avec suivi soit 94 % dont 367 C1 et 6 traitements.Parmi les C1 : 212 frottis (57,76 %), 89 tests HPV (24,25 %), 40 colposcopies (10,9 %), 26 techniques couplees (7,08 %). 235 soit 64,03 % sont realises par les medecins generalistes, 130 soit 35,42 % par les gynecologues et 2 par les sages-femmes soit 0,54 %.Sur les 126 comptes-rendus de frottis normaux recus par les medecins generalistes, 70,63 % renseignaient l’antecedent d’ASC-US. Parmi eux 14 soit 15,7 % precisaient un delai de controle conforme aux recommandations.Conclusion : Cette etude realisee en 2014 montre le doublement des tests HPV par rapport a l’etude similaire de 2011. En decembre 2016, l’INCa a positionne ce test comme reference du controle des ASC-US. En 2018 debutera le depistage organise du cancer du col de l’uterus qui impliquera les medecins generalistes. Cette etude pourra servir de base pour evaluer les modifications de leur pratique.

Resume Detecte suffisamment tot, le cancer colorectal se guerit dans neuf cas sur dix. Ces donnees justifient un depistage precoce et organise, facilite par la mise a disposition d’un test immunologique rapide et efficace realise a domicile. Ce programme s’adresse aux femmes et aux hommes de 50 a 74 ans qui sont invites tous les deux ans a consulter leur medecin traitant. En incitant les populations a se faire depister, le pharmacien est implique dans cette demarche preventive.

During the study, the HAS (French Board of Health) recommended 3 options for the first test (C1) in case of presence of ASC-US: a smear to be carried out after 6 months, an HPV test or a colposcopy.Our main objective was to find out which C1 option was chosen. The secondary objectives were to evaluate the number of C1's carried out by general practitioners, the follow-up rate and that of adapted C1 smear reports.Retrospective descriptive study based on the data obtained from CAP Santé 49 (departmental organization of cancer screening), concerning women between the ages of 25 and 65 years old having had a smear test with a positive ASC-US result carried out by a general practitioner.Based on 397 female patients, 373 with a 94% follow-up of which 367 C1's and 6 treatments. Among the C1's: 212 smears (57.76%), 89 tests HPV (24.25%), 40 colposcopies (10.9%), 26 double techniques (7.08%). 235 representing 64.03% were carried out by general practitioners, 130 representing 35.42% by gynecologists and 2 representing 0,54% by midwives. Of the 126 normal smear reports received by general practitioners, 70.63% gave information about an ASC-US antecedent. Among them 14 representing 15.7% complied with the recommended specified time intervals.This study which was carried out in 2014 demonstrates that HPV tests have doubled compared to a similar study carried out in 2011. In December 2016, the INCa (French National Cancer Institute) qualified this test as being the reference test for ASC-US checks. In January 2018, general cervical cancer screening involving general practitioners will be carried out. This study will serve as a basis on which to evaluate their practices.

International audience; In France, cervical cancer screening is currently based on cytological examination of a Pap smear for women aged 25 to 65, but screening coverage is unsatisfactory. Previous studies have shown that self-sampling for human papillomavirus (HPV) testing increases rates of compliance. With this purpose in mind, we performed the CapU study to evaluate the acceptance of a urinary HPV test. Letters proposing a new cervical cancer screening method using at-home urine self-sampling were sent to 5000 women aged 40-65 years who had not had a Pap smear over the past three years. The participating patients had to send their urine samples to the Angers Hospital Virology Laboratory for analysis using real-time PCR. Of the 771 samples received, 687 were analyzed. High-risk HPV were detected in 29 women. In follow-up, 28 women with positive urinary HPV results had a Pap smear or colposcopy done. The cytological results showed nine abnormal Pap smears, among which histology studies confirmed three cases of cervical intraepithelial neoplasia grade III lesions. Our study shows that urinary HPV testing may be pertinent to women who do not have cervical Pap smears done and lead to the diagnosis of high-grade cervical lesions.

Objectif L’infection a papillomavirus humains (HPV) oncogenes est un facteur obligatoire dans l’emergence du cancer du col uterin. Actuellement en France, le depistage du cancer du col de l’uterus repose sur l’examen cytologique d’un frottis cervico-uterin (FCU) chez les femmes âgees de 25 a 65 ans. Malheureusement, le taux de couverture du frottis reste insuffisant puisqu’il n’etait que de 58 % en France entre 2006 et 2008. Dans le but d’augmenter la couverture de ce depistage, nous avons mene une etude pilote dans le departement du Maine-et-Loire dont l’objectif etait de mesurer l’adhesion des femmes a un test HPV urinaire par rapport au frottis cervico-uterin. Ce projet a ete realise en collaboration avec la structure de gestion Cap Sante 49 et a recu un financement de la Ligue departementale contre le cancer. Methodes Entre novembre 2012 et janvier 2013, 5 000 courriers ont ete envoyes a des femmes âgees de 40 a 65 ans ne souhaitant pas beneficier d’un FCU apres deux lettres d’incitation au frottis espacees de neuf mois. Ce courrier proposait de faire un prelevement urinaire pour evaluer une nouvelle methode de depistage du cancer du col. Le prelevement etait ensuite envoye au laboratoire de virologie du CHU d’Angers. La recherche des HPV dans les urines a ete realisee a l’aide d’une technique de PCR en temps reel commercialisee par les laboratoires Abbott (Abbott Real Time High Risk HPV). Cette technique permet le genotypage simultane des HPV 16 et 18 et la detection d’un complexe de 12 autres HPV oncogenes (HPV HR). En cas de resultat positif, la patiente etait contactee par son medecin afin de realiser un FCU dans les plus brefs delais. Resultats 771 prelevements ont ete recus au laboratoire et 678 ont ete analyses. Parmi eux, 29 etaient positifs pour l’HPV. 2 infections HPV 16, 4 coinfections HPV 16 + un autre HPV HR, 1 coinfection HPV18 + un autre HPV HR, 22 infections avec un HPV HR autre que HPV 16 ou 18. Les FCU, realises chez toutes les femmes dont le test HPV etait positif, ont revele la presence de 9 FCU normaux : 3 ASC-US, 1 ASC-H, 2 LSIL et 3 HSIL. Les investigations complementaires ont permis de confirmer 3 lesions stade CIN3. Conclusion Notre etude montre l’adhesion plus facile au test HPV urinaire pour les femmes qui refusaient le FCU. Nous avons pu depister des lesions cervicales de haut grade chez ces femmes qui n’etaient pas suivies regulierement. Le test HPV urinaire pourrait etre une alternative au depistage classique par frottis permettant d’etendre la couverture du depistage du cancer du col en France, notamment chez les femmes en situation precaire.