NCT06631794

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,170

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2024

Completed
29 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
15 days until next milestone

Study Start

First participant enrolled

October 23, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

6 months

First QC Date

September 9, 2024

Last Update Submit

October 7, 2024

Conditions

Outcome Measures

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.

    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.

    12 months preceding the talk and the 6 months following the talk

Secondary Outcomes (5)

  • 1rst Secondary outcoume

    8 weeks

  • 2nd Secondary outcoume

    8 weeks

  • 3rd secondary outcoume

    8 weeks

  • 4 th secondary outcoume

    8 weeks

  • 5 th secondary outcoume

    6 months after talk

Interventions

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

Eligibility Criteria

Age14 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

David Zuckman, Doctor

CONTACT

Kewin KP Panel, Master

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2024

First Posted

October 8, 2024

Study Start

October 23, 2024

Primary Completion

April 23, 2025

Study Completion

October 1, 2025

Last Updated

October 8, 2024

Record last verified: 2024-10