search
Back to results

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
Centre Hospitalier Universitaire de la Réunion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Papilloma Viral Infection

Eligibility Criteria

9 Years - 17 Years (Child)All SexesAccepts 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)

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

First Posted
July 1, 2020
Last Updated
March 1, 2022
Sponsor
Centre Hospitalier Universitaire de la Réunion
search

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

We'll reach out to this number within 24 hrs