A Stepped-wedge, Cluster, and Randomized Trial to Evaluate Active Health Education Methods to Increase Human Papillomavirus Vaccine Coverage in Youth
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Vaccine Refusal
- Sponsor
- Hospital Israelita Albert Einstein
- Enrollment
- 5000
- Locations
- 79
- Primary Endpoint
- Proportion of children and adolescents with at least one dose of HPV vaccination following the intervention
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
Brief Summary
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.
Detailed Description
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Students of both sexes aged 9 to 14 years old.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Proportion of children and adolescents with at least one dose of HPV vaccination following the intervention
Time Frame: 12 months
Rate of HPV vaccination among childrens and adolescents
Secondary Outcomes
- 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)