TeenagersHPV-ADONCT06631794
Evaluation of the Impact of a HPV Vaccination Talk with Third Grade Students
An observational study of Teenagers, run by Hopital Foch.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Teenagers
- What is being tested?
- A short talk about the importance of HPV vaccination
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- How many people
- 1,170 participants
- Where
- No sites listed yet
- Study dates
- 23 Oct 2024to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 3rd grade students enrolled in public secondary schools in Suresnes and Rueil-Malmaison.
Who may be able to join
- 3rd grade students enrolled in public secondary schools in Suresnes and Rueil-Malmaison.
Who cannot join
- Students absent on the day of the talk.
- Students unwilling/unable to complete questionnaire.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Teenagers
- Being tested
- A short talk about the importance of HPV vaccination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A short talk about the importance of HPV vaccinationBehavioural
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months preceding the talk and the 6 months following the talk
Secondary outcomes (5)
1rst Secondary outcoume
Evaluate the implementation of sexuality education sessions as part of middle school educational programs.
Measured: 8 weeks
2nd Secondary outcoume
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
Measured: 8 weeks
3rd secondary outcoume
Evaluate middle-school students; satisfaction with the HPV vaccination information talk.
This outcome will be evaluated through questionnaire
Measured: 8 weeks
4 th secondary outcoume
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
Measured: 8 weeks
5 th secondary outcoume
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.
Measured: 6 months after talk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start23 Oct 2024 (estimated)
- Primary completion23 Apr 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TeenagersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Collaborators
- Agence Regionale de Sante d'Ile de France, Ospharm coopérative, French Interregional Group of Clinical Research and Innovation, Communauté professionnelle territoriale de santé
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631794
- Sponsor's protocol ID
- 2023_0258
- Other IDs
- 2023_0258
- Acronym
- HPV-ADO
- Status last verified
- Oct 2024
- First submitted
- 9 Sep 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of a HPV Vaccination Talk with Third Grade Students on Their Papillomavirus Vaccination Coverage.
- ClinicalTrials.gov ID
- NCT06631794
- Acronym / sponsor ID
- HPV-ADO / 2023_0258
- Conditions
- Teenagers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,170 participants (estimated)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Collaborators
- Agence Regionale de Sante d'Ile de France, Ospharm coopérative, French Interregional Group of Clinical Research and Innovation, Communauté professionnelle territoriale de santé
- Study start
- 23 Oct 2024 (estimated)
- Primary completion
- 23 Apr 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 3rd grade students enrolled in public secondary schools in Suresnes and Rueil-Malmaison.
Key inclusion criteria (1 listed)
- 3rd grade students enrolled in public secondary schools in Suresnes and Rueil-Malmaison.
Key exclusion criteria (2 listed)
- Students absent on the day of the talk.
- Students unwilling/unable to complete questionnaire.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A short talk about the importance of HPV vaccinationInvestigator 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 | Behavioural | – |
Primary outcome
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.
5 secondary outcomes
1rst Secondary outcoume
Time frame: 8 weeks
2nd Secondary outcoume
Time frame: 8 weeks
3rd secondary outcoume
Time frame: 8 weeks
4 th secondary outcoume
Time frame: 8 weeks
5 th secondary outcoume
Time frame: 6 months after talk
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Teenagers, run by Hopital Foch.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Zuckman, Doctor (0146252093, d.zucman@hopital-foch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 12 months preceding the talk and the 6 months following the talk). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.