Schoolbased HPV-counselling and -Vaccination

NCT05681169 | Completed DMC

• 1 other identifier: Schoolbased HPV-vaccination
• Study Type: interventional
• Target: 640
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed as a non-randomized implementation study consisting of a user-centered school-based HPV-counselling and HPV-vaccination (HPVV) program. The aim is to improve HPVV coverage among children with ethnic minority background with minimum 10%-point in the intervention group.

Conditions

HPV; Complex Intervention

Keywords

HPV; Vaccination program; Complex intervention; School-based; Patient involvement

Outcome Measures

Primary Outcomes (1)

• HPV-vaccination coverage in intervention group

  HPV coverage between intervention and control group as a total and stratified by ethnicity

  1 year

Secondary Outcomes (1)

• Estimated effect of HPV-counselling

  1 year

Other Outcomes (1)

• Qualitative perception of intervention

  three months

Study Arms (2)

School-based HPV-counselling and HPV-vaccination

EXPERIMENTAL

640 pupils

Other: School-based HPV-counselling and HPV-vaccination.

Control group

NO INTERVENTION

The control population will be approximately 2560 children comparable in age and regions in Denmark with similar high concentration of ethnic minority populations.

Interventions

School-based HPV-counselling and HPV-vaccination. OTHER

1. Scholl-based parental HPV-counselling 2. Scholl-based pupil HPV-counselling 3. Scholl-based HPVV

School-based HPV-counselling and HPV-vaccination

Eligibility Criteria

• Age: 9 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pupils in 4th, 5th and 6th grade at 5 schools with \> 25% ethnic minority pupils, located in Aarhus, Denmark.
• Age 9 - 15
• For vaccination there will be mandatory parental consent

You may not qualify if:

• Pupils from other schools or grades.

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus Municipality, Denmark: collaborator
• Neighbourhood mothers, Gellerup: collaborator

Study Sites (1)

Anne Katrine Leonhard

Aarhus, 8210, Denmark

Location

Related Publications (1)

• Leonhard AK, Badre-Esfahani SK, Larsen MB, Petersen LK, Seibaek L. "Two shots for life. HPV-vaccination at your school". Co-creation of a complex intervention to reduce ethnic inequity in childhood HPV-vaccination in Denmark. PLoS One. 2025 Aug 20;20(8):e0323870. doi: 10.1371/journal.pone.0323870. eCollection 2025.

  PMID: 40833975 DERIVED

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Lene K Seibæk, Prof

  University of Aarhus

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-randomized implementation study, ratio between intervention and control group will be 1:4.

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: January 12, 2023
• Study Start: August 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: May 1, 2024
• Last Updated: December 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available from spring 2023 to summer 2025.

Locations

DK (1)