NCT06513494 Active Health Education to Increase HPV Vaccine Coverage in Youth: A Stepped-wedge, Cluster, and Randomized Trial
| NCT ID | NCT06513494 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Israelita Albert Einstein |
| Condition | Vaccine Refusal |
| Study Type | INTERVENTIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2025-03-24 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 5,000 participants in total. It began in 2025-03-24 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Prof. Henrique A Fonseca, PhD
STUDY CHAIR
Academic Research Organization - Hospital Israelita Albert Einstein
Frequently Asked Questions
Who can join the NCT06513494 clinical trial?
This trial is open to participants of all sexes, aged 9 Years or older, up to 14 Years, studying Vaccine Refusal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06513494 currently recruiting?
Yes, NCT06513494 is actively recruiting participants. Contact the research team at soraya.cruz@einstein.br for enrollment information.
Where is the NCT06513494 trial being conducted?
This trial is being conducted at Crato, Brazil, Crato, Brazil, Crato, Brazil, Crato, Brazil and 11 additional locations.
Who is sponsoring the NCT06513494 clinical trial?
NCT06513494 is sponsored by Hospital Israelita Albert Einstein. The principal investigator is Prof. Henrique A Fonseca, PhD at Academic Research Organization - Hospital Israelita Albert Einstein. The trial plans to enroll 5,000 participants.