Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-01-07 @ 5:42 AM
Study NCT ID:
NCT06631794
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-08
First Post:
2024-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Impact of a HPV Vaccination Talk with Third Grade Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1170}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-23', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-07', 'studyFirstSubmitDate': '2024-09-09', 'studyFirstSubmitQcDate': '2024-10-07', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact Assessement of a sexual health talk with middle school students in 3rd grade on the dispensation of HPV vaccines among young people born in 2010.', 'timeFrame': '12 months preceding the talk and the 6 months following the talk', 'description': 'The aim of this study is to evaluate the impact of a sexual health talk with middle school students in 3rd grade on the dispensation of HPV vaccines among young people born in 2010.\n\nThe main evaluation criterion for this study is the number of monthly HPV vaccine dispensations among young people born between 01/01/2010 and 31/12/2010. These data will be communicated by the OSPHARM cooperative or by pharmacies, over the 12 months preceding the talk and the 6 months following, in order to be able to assess the impact of the latter on dispensations.'}], 'secondaryOutcomes': [{'measure': '1rst Secondary outcoume', 'timeFrame': '8 weeks', 'description': 'Evaluate the implementation of sexuality education sessions as part of middle school educational programs.'}, {'measure': '2nd Secondary outcoume', 'timeFrame': '8 weeks', 'description': 'Evaluate the knowledge of Suresnes and Rueil-Malmaison 3rd grade students about HPV infection and HPV vaccination before and after the talk.\n\nThis outcome will be evaluated through questionnaire'}, {'measure': '3rd secondary outcoume', 'timeFrame': '8 weeks', 'description': 'Evaluate middle-school students; satisfaction with the HPV vaccination information talk.\n\nThis outcome will be evaluated through questionnaire'}, {'measure': '4 th secondary outcoume', 'timeFrame': '8 weeks', 'description': 'Evaluate adherence to the sexual health talk by Suresnes and Rueil-Malmaison middle schools.\n\nThis outcome will be assessed through the mesearement of the rate of completed questionnaires'}, {'measure': '5 th secondary outcoume', 'timeFrame': '6 months after talk', 'description': 'Estimating the rate of young people born in 2010 vaccinated against HPV by gender.\n\nThe estimation rate will be calculated with data collected from the ospharm cooperative application.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Teenagers']}, 'descriptionModule': {'briefSummary': 'This is a prospective pragmatic study to assess the impact of a HPV vaccination talk in secondary school on actual vaccine dispensing in test communes compared with control communes. The talk consist on a briefing on the importance of vaccination.\n\nThis is a controlled study, since two communes will benefit from the HPV vaccination talk, while the other two will serve as controls without set up of the HPV vaccination talk. The set up of this presentation will be open-label.', 'detailedDescription': 'The main aim of the present study is to investigate the impact of HPV vaccination talk with 3rd grade school children on HPV vaccine dispensing by making them actors in their own health. A significant benefit on vaccination coverage is expected. In addition, a flyer providing information and raising awareness of infections and the benefits of HPV vaccination will be sent to parents at the end of the talk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '14 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '3rd grade students enrolled in public secondary schools in Suresnes and Rueil-Malmaison.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 3rd grade students enrolled in public secondary schools in Suresnes and Rueil-Malmaison.\n\nExclusion Criteria:\n\n* Students absent on the day of the talk.\n* Students unwilling/unable to complete questionnaire.'}, 'identificationModule': {'nctId': 'NCT06631794', 'acronym': 'HPV-ADO', 'briefTitle': 'Evaluation of the Impact of a HPV Vaccination Talk with Third Grade Students', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Foch'}, 'officialTitle': 'Evaluation of the Impact of a HPV Vaccination Talk with Third Grade Students on Their Papillomavirus Vaccination Coverage.', 'orgStudyIdInfo': {'id': '2023_0258'}, 'secondaryIdInfos': [{'id': '2023_0258', 'type': 'OTHER', 'domain': 'HopitalFoch'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'A short talk about the importance of HPV vaccination', 'type': 'BEHAVIORAL', 'description': 'Investigator plan to set up a short talk to 3rd grade classes in addition to the usual sexual health training. The issue of HPV vaccination will be systematically addressed for 10 minutes to encourage catch-up vaccination.\n\nThe usual training include different themes such us : definition of sexual health, anatomy, sexually transmitted infections contraception/condoms, menstrual cycles, voluntary interruption of pregnancy, consent, sexual abuse/violence/harassment, pornography, anti-discrimination....\n\nA 45-minute talk will include 2 or 3 topics from the above list. A ten minutes of talk will be added to the usual training to explain the HPV vaccination (a topic not usually addressed in sexual health training), covering the following elements: definition of HPV infection'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'David Zuckman, Doctor', 'role': 'CONTACT', 'email': 'd.zucman@hopital-foch.com', 'phone': '0146252093'}, {'name': 'Kewin KP Panel, Master', 'role': 'CONTACT', 'email': 'k.panel@hopital-foch.com', 'phone': '0146253576'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Foch', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agence Regionale de Sante d'Ile de France', 'class': 'UNKNOWN'}, {'name': 'Ospharm coopérative', 'class': 'UNKNOWN'}, {'name': 'French Interregional Group of Clinical Research and Innovation', 'class': 'OTHER'}, {'name': 'Communauté professionnelle territoriale de santé', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}