Schoolbased HPV-counselling and -Vaccination, a User-centred Intervention Targeting Children and Parents With Ethnic Minority Background
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 640
- 试验地点
- 1
- 主要终点
- HPV-vaccination coverage in intervention group
研究概览
简要总结
This study is designed as a non-randomized implementation study consisting of a user-centered school-based HPV-counselling and HPV-vaccination (HPVV) program. The aim is to improve HPVV coverage among children with ethnic minority background with minimum 10%-point in the intervention group.
详细描述
Background:
Human Papillomavirus (HPV)-related cancers are considered the most preventive cancer form due to vaccination. HPVV in Denmark is a part of a national children vaccination programme. Despite free access to vaccination, children and adolescents with ethnic minority background attend substantially less to the vaccination programme than native Danes (79 vs 93%). Among some ethnic minority groups, the HPVV coverage is as low as 65%. Barriers among ethnic minorities towards vaccination for HPV are complex, thus insufficient understanding of HPV, emotional barriers to sexuality and cultural taboos are of significance. Schoolbased vaccination can improve HPVV uptake, and counselling supporting vaccination could be significant when targeting ethnic minority families.
Aim:
To test schoolbased HPV-counselling of parents and pupils together with schoolbased HPVV, in schools with more than 25% ethnic minority pupils, to improve HPVV coverage among children with ethnic minority background.
Hypotheses and aims:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pupils in 4th, 5th and 6th grade at 5 schools with > 25% ethnic minority pupils, located in Aarhus, Denmark.
- •Age 9 - 15
- •For vaccination there will be mandatory parental consent
排除标准
- •Pupils from other schools or grades.
- •Exclusion criteria from vaccination will be medical history of severe anaphylactic reaction
- •Exclusion criteria from vaccination will be already initiated vaccination at general practitioner.
研究组 & 干预措施
School-based HPV-counselling and HPV-vaccination
640 pupils
干预措施: School-based HPV-counselling and HPV-vaccination. (Other)
Control group
The control population will be approximately 2560 children comparable in age and regions in Denmark with similar high concentration of ethnic minority populations.
结局指标
主要结局
HPV-vaccination coverage in intervention group
时间窗: 1 year
HPV coverage between intervention and control group as a total and stratified by ethnicity
次要结局
- Estimated effect of HPV-counselling(1 year)