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)

Centre Hospitalier Universitaire de la Réunion

Status and phase

Completed

Phase 4

Conditions

Papilloma Viral Infection

Treatments

Drug: Gardasil 9, 9-Valent Intramuscular Suspension

Study type

Interventional

Funder types

Other

Identifiers

NCT04459221

2020/CHU/05

2020-002332-73 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

355 patients

Sex

All

Ages

9 to 17 years old

Volunteers

Accepts Healthy Volunteers

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)