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)
Primary Purpose
Papilloma Viral Infection
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Gardasil 9, 9-Valent Intramuscular Suspension
Sponsored by
About this trial
This is an interventional prevention trial for Papilloma Viral Infection
Eligibility Criteria
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)
Sites / Locations
- Centre Hospitalier Universitaire de la Réunion
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Facilitating access to HPV vaccination
promotion of HPV vaccination
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
increase the vaccination rate in all student
number of student having completed a complete vaccination schedule
increase the vaccination rate in all student
number of student having completed a incomplete vaccination schedule
Full Information
NCT ID
NCT04459221
First Posted
July 1, 2020
Last Updated
March 1, 2022
Sponsor
Centre Hospitalier Universitaire de la Réunion
1. Study Identification
Unique Protocol Identification Number
NCT04459221
Brief 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
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
June 25, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de la Réunion
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papilloma Viral Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
355 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Facilitating access to HPV vaccination
Arm Type
Experimental
Arm Title
promotion of HPV vaccination
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Gardasil 9, 9-Valent Intramuscular Suspension
Intervention Description
access to HPV vaccination near the college in a health bus
Primary Outcome Measure Information:
Title
Change the vaccination rate in girls
Description
Number of girls having completed a complete vaccination schedule. Hypothesis: the intervention under study should increase the rate of vaccinated
Time Frame
9 month
Secondary Outcome Measure Information:
Title
increase the vaccination rate in all student
Description
number of student having completed a complete vaccination schedule
Time Frame
9 month
Title
increase the vaccination rate in all student
Description
number of student having completed a incomplete vaccination schedule
Time Frame
9 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Centre Hospitalier Universitaire de la Réunion
City
Saint-Pierre
ZIP/Postal Code
97448
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35700023
Citation
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.
Results Reference
derived
Learn more about this trial
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
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