NCT06513494

Active Health Education to Increase HPV Vaccine Coverage in Youth: A Stepped-wedge, Cluster, and Randomized Trial

A Stepped-wedge, Cluster, and Randomized Trial to Evaluate Active Health Education Methods to Increase Human Papillomavirus Vaccine Coverage in Youth

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 5,000 (estimated)
• Sponsor: Hospital Israelita Albert Einstein · Academic / Other
• Sex: All
• Age: 9 Years – 14 Years
• Healthy volunteers: Accepted

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

Conditions

• Vaccine Refusal
• Vaccine Hesitancy

Interventions

Type	Name	Description
BEHAVIORAL	Active Students Education plus Teacher Training	The teacher undergoes 30 hours of self-instructional training on vaccination through an online platform tailored for the relevant age group. Additionally, students receive active vaccinations and health education over two months
BEHAVIORAL	Active Students Education	Students receive active vaccinations and health education over two months.
BEHAVIORAL	Basic Health Unit Active Orientation	Nurses from basic health units will conduct an active orientation session at schools about vaccination for students.
OTHER	Usual care	No project interventions will be carried out.

Timeline

• Start date: 2025-03-24
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2024-07-22
• Last updated: 2025-11-18

Locations

79 sites across 1 country: Brazil