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
NCT ID: NCT04459221
Last Updated: 2022-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
355 participants
INTERVENTIONAL
2020-11-01
2021-12-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Facilitating access to HPV vaccination
Gardasil 9, 9-Valent Intramuscular Suspension
access to HPV vaccination near the college in a health bus
promotion of HPV vaccination
No interventions assigned to this group
Interventions
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Gardasil 9, 9-Valent Intramuscular Suspension
access to HPV vaccination near the college in a health bus
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
9 Years
17 Years
ALL
Yes
Sponsors
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Centre Hospitalier Universitaire de la Réunion
OTHER
Responsible Party
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Locations
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Centre Hospitalier Universitaire de la Réunion
Saint-Pierre, , France
Countries
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References
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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.
Other Identifiers
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2020-002332-73
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2020/CHU/05
Identifier Type: -
Identifier Source: org_study_id
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