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Active health education to increase HPV vaccine coverage in schoolchildren

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

Not applicable Interventional Hospital Israelita Albert Einstein · NCT06513494

This project will try different active health-education approaches in schools to see if they increase HPV vaccination among 9–14-year-old students in Brazil.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment5000 (estimated)
Ages9 Years to 14 Years
SexAll
SponsorHospital Israelita Albert Einstein Academic / other
Locations79 sites (Crato, Ceará and 78 other locations)
Trial IDNCT06513494 on ClinicalTrials.gov

What this trial studies

The trial uses a stepped-wedge, cluster-randomized design in which school clusters cross over to interventions every two months. Four approaches are compared: student education plus teacher training with Basic Health Unit activities, student education with Basic Health Unit activities, Basic Health Unit activities alone, and usual care. About 5,000 students in roughly two hundred schools across Brazil are enrolled and schools are randomized in clusters. Outcomes focus on HPV vaccine uptake (completion of recommended doses) following the interventions.

Who should consider this trial

Good fit: Ideal participants are students aged 9 to 14 years who have not yet completed the HPV vaccination series and who attend a participating school in Brazil.

Not a fit: Students who have already received the full two-dose HPV vaccination series, or those not enrolled at participating schools, are unlikely to benefit from the interventions.

Why it matters

Potential benefit: If successful, the interventions could substantially increase HPV vaccine uptake among school-aged children and reduce future HPV-related disease.

How similar studies have performed: Previous work using reminders and messaging has increased vaccination coverage, but direct active health-education approaches in school populations have less robust, mixed evidence.

Eligibility criteria

Show full inclusion / exclusion criteria 
Criteria for students

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

Where this trial is running

Crato, Ceará and 78 other locations

+29 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Vaccine RefusalVaccine Hesitancyvaccination coverageHPV vaccinestepped-wedge designstudents
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.