NCT04459221

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
355

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

March 2, 2022

Status Verified

March 1, 2022

Enrollment Period

8 months

First QC Date

July 1, 2020

Last Update Submit

March 1, 2022

Conditions

Papilloma Viral Infection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • increase the vaccination rate in all student

    9 month

  • increase the vaccination rate in all student

    9 month

Study Arms (2)

Facilitating access to HPV vaccination

EXPERIMENTAL
Drug: Gardasil 9, 9-Valent Intramuscular Suspension

promotion of HPV vaccination

NO INTERVENTION

Interventions

Gardasil 9, 9-Valent Intramuscular SuspensionDRUG

access to HPV vaccination near the college in a health bus

Facilitating access to HPV vaccination

Eligibility Criteria

Age9 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de la Réunion

Saint-Pierre, 97448, France

Location

Related Publications (1)

  • 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.

    PMID: 35700023DERIVED

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Human Papillomavirus Recombinant Vaccine nonavalent

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2020

First Posted

July 7, 2020

Study Start

November 1, 2020

Primary Completion

June 25, 2021

Study Completion

December 30, 2021

Last Updated

March 2, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)