Study of the Impact of a School Program Combining - Promotion of HPV Vaccination and HPV Vaccine Offer in Middle School - on Adherence to HPV Vaccination in Middle School Students

Papilloma Viral Infection Clinical Trial

— PROM SSCOL  

Official title:

Study of the Impact of a School Program Combining - Promotion of HPV Vaccination and HPV Vaccine Offer in Middle School - on Adherence to HPV Vaccination in Middle School Students

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04459221
• Other study ID #: 2020/CHU/05
• Secondary ID: 2020-002332-73
• Status: Completed
• Phase: Phase 4
• Start date: November 1, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: March 2022
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cervical cancer (CCU) is the fourth most common cancer in women worldwide. In Reunion island, CCU is the third leading cause of cancer in women (standardized incidence rate on the world population (TIS) in 2013 of 10.3 / 100,000) and is the eighth deadliest cancer with a rate standardized mortality of 4.8 / 100,000, almost three times higher than in mainland France where it was 1.7 / 100,000 in 2018. CCU results from infection with the human papillomavirus (HPV), which is the most common sexually transmitted viral infection. CCU prevention is mainly based on cervical smear screening and anti HPV vaccination (VHPV) which has demonstrated its effectiveness on the prevalence of HPV carriage, but also on incidence of condyloma or intermediate grade dysplasia. Since HPV is mainly transmitted sexually, it is important to vaccinate before the start of sex. In Reunion island, the HPV vaccination coverage rate is the lowest in France, estimated by Public Health France at 8.1% among girls aged 16 years in 2018, while the already low national average was established 23.7%. Thus, in view of the epidemiological situation in Reunion island (high incidence and mortality for the CCU, very low VHPV coverage rate), we thought it would be interesting to study the impact of a health promotion program sex and prevention of sexually transmitted infections (STIs) including papillomavirus-related pathologies, with a program to promote HPV vaccination among young students in middle school.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: December 30, 2021
• Est. primary completion date: June 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 17 Years

Eligibility

Inclusion Criteria:

• schooled in one of the classes drawn at random in the 2 colleges selected for the study,
• members or beneficiaries of a social security scheme,
• having agreed to participate in the study and whose parents or holder (s) of parental authority have signed a free, informed and written consent.

Exclusion Criteria:

• under the age of 9, or over the age of 17 at inclusion,
• with hypersensitivity to the active substances or to any of the excipients of the vaccine (Gardasil 9®),
• with a permanent contraindication to vaccination.
• having already initiated the HPV vaccination (complete or incomplete scheme). Students with an incomplete vaccination schedule will be referred to their attending physician to complete the missing dose (s).
• pregnancy or breastfeeding (based on the declaration)

Related Conditions & MeSH terms

• Papilloma
• Papilloma Viral Infection
• Papillomavirus Infections
• Virus Diseases

Intervention

Drug:
• Gardasil 9, 9-Valent Intramuscular Suspension
access to HPV vaccination near the college in a health bus

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de la Réunion	Saint-Pierre

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change the vaccination rate in girls	Number of girls having completed a complete vaccination schedule. Hypothesis: the intervention under study should increase the rate of vaccinated	9 month
Secondary	increase the vaccination rate in all student	number of student having completed a complete vaccination schedule	9 month
Secondary	increase the vaccination rate in all student	number of student having completed a incomplete vaccination schedule	9 month