A Stepped-wedge, Cluster, and Randomized Trial to Evaluate Active Health Education Methods to Increase Human Papillomavirus Vaccine Coverage in Youth
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 151
- 主要终点
- Proportion of children and adolescents with at least one dose of HPV vaccination following the intervention
研究概览
简要总结
This study aims to evaluate the impact of active health education methodologies on increasing adherence to the HPV vaccine among schoolchildren. The project will involve 196 schools across Brazil, encompassing a total of 5,000 students.
A stepped-wedge implementation design will be applied, with clusters being randomized every two months to one of four interventions.
Each intervention will be implemented in 48 schools.
详细描述
The adherence to the HPV vaccine among young people has declined recently, particularly in Brazil. While previous studies have shown that interventions such as text messaging can increase vaccination coverage, there is still a lack of robust data on the effectiveness of direct interventions in school populations using active health education methods. This study aims to evaluate the impact of active health education methodologies on increasing adherence to the HPV vaccine among schoolchildren.
The project will involve 80 schools across Brazil, including a total of 5,000 students. These schools will be randomized into clusters of five.
The study will apply a stepped-wedge implementation design, with clusters being randomized every two months to one of four interventions:
Education for students and teachers training + Basic Health Unit action in schools Education for students without teachers training + Basic Health Unit action in schools Only Basic Health Unit activities Usual control
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Students of both sexes aged 9 to 14 years old.
排除标准
- •Students with a complete HPV vaccination (two doses) received.
- •Criteria for Clusters
- •Inclusion Criteria:
- •The school has enrolled students aged 9 to 14 years old.
- •Exclusion Criteria:
- •Schools that do not have students aged between 9 and 14;
- •Schools that provided only distance education
结局指标
主要结局
Proportion of children and adolescents with at least one dose of HPV vaccination following the intervention
时间窗: 12 months
Rate of HPV vaccination among childrens and adolescents
次要结局
- Proportion of teachers with complete HPV vaccination (two doses)(12 months)
- Proportion of children and adolescents with complete HPV vaccination(12 months)
- Proportion of vaccination refusal among teachers(12 months)
- Proportion of vaccination refusal among children and adolescents(12 months)