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Completed

NCT Number: NCT04459221

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

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.

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Key information

Conditions

Papilloma Viral Infection Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

9 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre Hospitalier Universitaire de la Réunion

Saint-Pierre, 97448, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Gardasil 9, 9-Valent Intramuscular Suspension

Drug

access to HPV vaccination near the college in a health bus

Primary outcomes

  1. Change the vaccination rate in girls

    Time frame: 9 month

    Number of girls having completed a complete vaccination schedule. Hypothesis: the intervention under study should increase the rate of vaccinated

Secondary outcomes

  1. increase the vaccination rate in all student

    Time frame: 9 month

    number of student having completed a complete vaccination schedule

  2. increase the vaccination rate in all student

    Time frame: 9 month

    number of student having completed a incomplete vaccination schedule

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Réunion

Other

Registry information

Acronym: PROM SSCOL

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 7, 2020
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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