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NCT Number: NCT06631794

Evaluation of the Impact of a HPV Vaccination Talk with Third Grade Students

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.

This 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.

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Key information

Conditions

Teenagers

Age range

14 year–14 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 3rd grade students enrolled in public secondary schools in Suresnes and Rueil-Malmaison.

Exclusion criteria

  • Students absent on the day of the talk.
  • Students unwilling/unable to complete questionnaire.

Treatment and study plan

A short talk about the importance of HPV vaccination

Behavioral

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.

The 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....

A 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

Primary outcomes

  1. 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.

    Time frame: 12 months preceding the talk and the 6 months following the talk

    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.

    The 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.

Secondary outcomes

  1. 1rst Secondary outcoume

    Time frame: 8 weeks

    Evaluate the implementation of sexuality education sessions as part of middle school educational programs.

  2. 2nd Secondary outcoume

    Time frame: 8 weeks

    Evaluate the knowledge of Suresnes and Rueil-Malmaison 3rd grade students about HPV infection and HPV vaccination before and after the talk.

    This outcome will be evaluated through questionnaire

  3. 3rd secondary outcoume

    Time frame: 8 weeks

    Evaluate middle-school students; satisfaction with the HPV vaccination information talk.

    This outcome will be evaluated through questionnaire

  4. 4 th secondary outcoume

    Time frame: 8 weeks

    Evaluate adherence to the sexual health talk by Suresnes and Rueil-Malmaison middle schools.

    This outcome will be assessed through the mesearement of the rate of completed questionnaires

  5. 5 th secondary outcoume

    Time frame: 6 months after talk

    Estimating the rate of young people born in 2010 vaccinated against HPV by gender.

    The estimation rate will be calculated with data collected from the ospharm cooperative application.

Study contacts

Contact information is provided by the study sponsor or research team.

David Zuckman, Doctor

CONTACT

[email protected]

0146252093

Kewin KP Panel, Master

CONTACT

[email protected]

0146253576

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Collaborators

  • Agence Regionale de Sante d'Ile de France
  • Communauté professionnelle territoriale de santé
  • French Interregional Group of Clinical Research and Innovation
  • Ospharm coopérative

Registry information

Official study title

Evaluation of the Impact of a HPV Vaccination Talk with Third Grade Students on Their Papillomavirus Vaccination Coverage.

Acronym: HPV-ADO

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 8, 2024
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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