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 (PROM SSCOL)

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.

Study Overview

• Status: Completed
• Conditions: Papilloma Viral Infection
• Intervention / Treatment: Drug: Gardasil 9, 9-Valent Intramuscular Suspension

• Study Type: Interventional
• Enrollment (Actual): 355
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Saint-Pierre, France, 97448
    • Centre hospitalier universitaire de la Réunion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Facilitating access to HPV vaccination	Drug: Gardasil 9, 9-Valent Intramuscular Suspension; access to HPV vaccination near the college in a health bus
No Intervention: promotion of HPV vaccination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
increase the vaccination rate in all student	number of student having completed a complete vaccination schedule	9 month
increase the vaccination rate in all student	number of student having completed a incomplete vaccination schedule	9 month

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Réunion

Publications and helpful links

General Publications

• Tran PL, Chirpaz E, Boukerrou M, Bertolotti A. Impact of a Papillomavirus Vaccination Promotion Program in Middle School: Study Protocol for a Cluster Controlled Trial. JMIR Res Protoc. 2022 Jun 13;11(6):e35695. doi: 10.2196/35695.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): June 25, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: July 1, 2020
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: March 1, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; DNA Virus Infections; Tumor Virus Infections; Neoplasms, Squamous Cell; Virus Diseases; Papillomavirus Infections; Papilloma
• Other Study ID Numbers: 2020/CHU/05; 2020-002332-73 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No