{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T06:58:14Z","timestamp":1790837894700,"version":"4.1.0"},"reference-count":40,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2022,3,23]],"date-time":"2022-03-23T00:00:00Z","timestamp":1647993600000},"content-version":"unspecified","delay-in-days":22,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"ITMO Cancer AVIESAN","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2022,2,8]]},"published-print":{"date-parts":[[2022,3]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Vaccination 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).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This pragmatic cRCT uses an incomplete factorial design to evaluate three components applied alone or in combination: (1) adolescents and parents\u2019 education and motivation at school, using eHealth tools and participatory learning; (2) general practitioners\u2019 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\u201314 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\u2009940 adolescents aged 11\u201314 years. The primary endpoint is the HPV VC (\u22651\u2009dose) among adolescents aged 11\u201314 years, at 2 months, at the municipality level (data from routine databases). Secondary endpoints include: HPV VC (\u22651\u2009dose 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\u2009months 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).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This protocol was approved by the French Ethics Committee \u2018CPP Sud-Est VI\u2019 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).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04945655\">NCT04945655<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2021-057943","type":"journal-article","created":{"date-parts":[[2022,3,28]],"date-time":"2022-03-28T12:05:47Z","timestamp":1648469147000},"page":"e057943","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":27,"title":["Impact of a school-based and primary care-based multicomponent intervention on HPV vaccination coverage among French adolescents: a cluster randomised controlled trial protocol (the PrevHPV study)"],"prefix":"10.1136","volume":"12","clinical-trial-number":[{"clinical-trial-number":"nct04945655","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0192-8447","authenticated-orcid":false,"given":"Aur\u00e9lie","family":"Bocquier","sequence":"first","affiliation":[{"name":"Universit\u00e9 de Lorraine, APEMAC, Nancy, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Morgane","family":"Michel","sequence":"additional","affiliation":[{"name":"Universit\u00e9 de Paris, ECEVE UMR 1123, Paris, France"},{"name":"Assistance Publique-H\u00f4pitaux de Paris, H\u00f4tel Dieu, URC Eco Ile-de-France \/ H\u00f4pital Robert Debr\u00e9, Unit\u00e9 d\u2019\u00e9pid\u00e9miologie clinique, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruno","family":"Giraudeau","sequence":"additional","affiliation":[{"name":"Universit\u00e9 de Tours, Universit\u00e9 de Nantes, INSERM, SPHERE U1246, INSERM CIC 1415, CHRU de Tours, Tours, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2190-9961","authenticated-orcid":false,"given":"St\u00e9phanie","family":"Bonnay","sequence":"additional","affiliation":[{"name":"Universit\u00e9 de Lorraine, APEMAC, Nancy, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amandine","family":"Gagneux-Brunon","sequence":"additional","affiliation":[{"name":"Centre International de Recherche en Infectiologie, Team GIMAP, Univ Lyon, Universit\u00e9 Jean Monnet, Universit\u00e9 Claude Bernard Lyon 1, Inserm, U1111, CNRS, UMR530, CIC INSERM 1408 Vaccinologie, CHU de Saint-Etienne, Saint-Etienne, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aur\u00e9lie","family":"Gauchet","sequence":"additional","affiliation":[{"name":"Universit\u00e9 Grenoble Alpes, LIP\/PC2S, EA 4145, Grenoble, France"},{"name":"Univ. Savoie Mont Blanc, LIP\/PC2S, Chamb\u00e9ry, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Serge","family":"Gilberg","sequence":"additional","affiliation":[{"name":"D\u00e9partement de M\u00e9decine G\u00e9n\u00e9rale, Universit\u00e9 Paris - 24 rue du Faubourg, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne-Sophie","family":"Le Duc-Banaszuk","sequence":"additional","affiliation":[{"name":"Centre R\u00e9gional de Coordination des D\u00e9pistages des cancers-Pays de la Loire, Angers, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0797-9971","authenticated-orcid":false,"given":"Judith E","family":"Mueller","sequence":"additional","affiliation":[{"name":"Unit\u00e9 Epid\u00e9miologie des maladies \u00e9mergentes, Institut Pasteur, 25 rue du Dr Roux, Paris, France"},{"name":"EHESP French School of Public Health, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karine","family":"Chevreul","sequence":"additional","affiliation":[{"name":"Universit\u00e9 de Paris, ECEVE UMR 1123, Paris, France"},{"name":"Assistance Publique-H\u00f4pitaux de Paris, H\u00f4tel Dieu, URC Eco Ile-de-France \/ H\u00f4pital Robert Debr\u00e9, Unit\u00e9 d\u2019\u00e9pid\u00e9miologie clinique, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathalie","family":"Thilly","sequence":"additional","affiliation":[{"name":"Universit\u00e9 de Lorraine, APEMAC, Nancy, France"},{"name":"Universit\u00e9 de Lorraine, CHRU-Nancy, D\u00e9partement M\u00e9thodologie, Promotion, Investigation, Nancy, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2022,3,24]]},"reference":[{"key":"2025121400364406000_12.3.e057943.1","unstructured":"World Health Organisation . 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