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Not yet recruiting NCT07632963

Addressing HPV Vaccine Hesitancy by Co-Designing a Digital Health Intervention

No phase Interventional HPV Vaccine Acceptance Vaccine Decision Making HPV Vaccination

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HPV-Kompassen.
Who it may be relevant to
Registry conditions: HPV, Vaccine Acceptance, Vaccine Decision Making, HPV Vaccination. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

HPV-Kompassen: a Mixed-Methods Single-Arm Cluster Feasibility Study of a Co-Designed Web-Based Intervention To Strengthen HPV Vaccine Confidence and Uptake in Stockholm, Sweden

Overview

This study looks at a digital platform that supports HPV vaccination in schools. The goal is to see if it is useful, easy to use, and practical in real school settings, especially in areas where fewer people get vaccinated. Researchers will give Year 5 pupils (aged 11-12) and their parents or caregivers access to the platform. It provides clear, trusted information about the HPV vaccine for young people, parents, and school nurses. The aim is to make the vaccine easier to understand and to help answer any questions or concerns. After using the platform, participants will be asked to share their thoughts.

Interventions

  • Behavioral HPV-Kompassen
    HPV-Kompassen is a co-designed, web-based platform that provides tailored and synthesised information with the aim of strengthening confidence in and uptake of the HPV vaccine.

Primary outcome measures

  • Feasibility of implementation: Acceptability, appropriateness and feasibility of implementation [Time frame: Shortly after the intervention period (i.e., 'end of treatment') at 7 months.]
  • Feasibility of implementation: Acceptability, appropriateness and feasibility of implementation [Time frame: Shortly after the intervention period (i.e., 'end of treatment') at 7 months.]
  • Acceptability of intervention: Intervention delivery strategy [Time frame: Throughout the intervention period (i.e., months 0-7).]
  • Acceptability of intervention: Usability of intervention [Time frame: Immediately after the intervention period (i.e., 'end of treatment') at 7 months.]
  • Acceptability of intervention: Perceptions of intervention [Time frame: Shortly after the intervention period (i.e., 'end of treatment') at 7 months.]
  • Acceptability of intervention: Intervention engagement [Time frame: Throughout the intervention period (i.e., months 0-7).]
  • Acceptability of intervention: Intervention engagement [Time frame: End of intervention period (i.e., 'end of treatment') at 7 months.]
  • Feasibility of trial protocol: Feasibility of recruitment [Time frame: From start of school enrollment (i.e., pre-intervention) and throughout the intervention period (i.e., months 0-7).]
  • Feasibility of trial protocol: Participant retention [Time frame: From school enrollment (i.e., 'baseline') and throughout the intervention period (i.e., months 0-7).]
  • Feasibility of trial protocol: Feasibility of data collection methods [Time frame: Shortly after the intervention period (i.e., 'end of treatment') at 7 months.]

Eligibility criteria

We will aim to recruit 6-8 compulsory schools in Stockholm County to serve as clusters.

All Year 5 pupils and their caregivers in the study schools are invited.

Inclusion criteria

  • The school provides education to pupils in school year 5 and is scheduled to be open throughout the pilot trial period
  • The school is located in an area with HPV vaccine uptake <85.2% (the Stockholm regional average)
  • The head principal and school nurse both consent to participate
  • The school has the capacity to implement the intervention

Exclusion criteria

  • Failure to meet the inclusion criteria

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07632963 · 2023-00331

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗