Prospective, Randomized, Cluster-controlled, Multicenter Study to Evaluate the Impact of an HPV Primary Prevention Intervention on HPV Vaccination Rates Among Adolescents in the AuRA Region.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,422
- 试验地点
- 1
- 主要终点
- Vaccination
研究概览
简要总结
Human papillomaviruses (HPV) are very common contagious viruses: approximately 70% of men and women will be infected during their lifetime. Vaccination, recommended since 2007 for girls and since 2021 for all young people aged 11 to 14 (with catch-up vaccination possible up to age 26), remains insufficiently followed. Today, only 40.7% of adolescents are vaccinated in France, and the Auvergne Rhône Alpes region remains below the targets (47.5% for girls and 12.3% for boys). This is still far from the national target of 80% vaccination coverage by 2030, while 6,400 new cases of HPV-related cancers are reported each year. The PIMCOP regional study aims to assess the impact of a primary prevention intervention, co-developed with stakeholders and implemented in middle and high schools, on the HPV vaccination rate at 6 months among 11-17 year olds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for children :
- •Girl or boy, student at a public school participating in the study
- •Aged 11 to 17
- •Having received an information sheet about the study and having signed a declaration of non-objection
- •Whose parents have also received an information sheet and have not expressed their non-objection
- •Able to read, write, and understand French
- •Affiliated with the SS or equivalent
排除标准
- •for children:
- •children protected by the law
- •Inclusion Criteria for teachers :
- •Male or female, teacher at a public school participating in the study and supervising a participating class
- •Aged 18 or over
- •Having received an information sheet about the study and not having expressed their opposition
- •Able to read, write, and understand French
- •Affiliated with the SS or equivalent
- •Exclusion Criteria for teachers :
- •- Person specially protected by law
研究组 & 干预措施
Control
Provision of the interactive exhibition "Taking care of yourself and preventing cancer risks" for one week (5 working days)
Intervention : HPV animation
- Provision of the interactive exhibition "Taking care of yourself and preventing cancer risks" for one week (5 working days),
- Classroom presentation on HPV by a CLB-CPTS team
- Distribution of prevention materials.
干预措施: HPV animation (Behavioral)
结局指标
主要结局
Vaccination
时间窗: Month 6
Proportion of young people who received at least one dose of HPV vaccine in each of the two groups, assessed at 6 months
次要结局
- health literacy level(inclusion (Day 0), month 6)
- levels of knowledge about HPV-related risks and other cancer risk factors(inclusion (Day 0), month 6)
- acceptability(At the end of the intervention, maximum Day 5)