Evaluation of the Impact of a HPV Vaccination Talk with Third Grade Students (HPV-ADO)

October 7, 2024 updated by: Hopital Foch

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

1170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1rst Secondary outcoume
Time Frame: 8 weeks
Evaluate the implementation of sexuality education sessions as part of middle school educational programs.
8 weeks
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

8 weeks
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

8 weeks
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

8 weeks
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.

6 months after talk

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 23, 2024

Primary Completion (Estimated)

April 23, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

September 9, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 7, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2023_0258 (Other Identifier: HopitalFoch)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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