Addressing HPV Vaccine Hesitancy by Co-Designing a Digital Health Intervention
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorKarolinska Institutet
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Failure to meet the inclusion criteria
Trial design
Design model
Single group
Treatments tested in this trial
HPV-Kompassen
BehavioralHPV-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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Intervention armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of implementation: Acceptability, appropriateness and feasibility of implementation
Measured using Weiner et al.'s implementation outcomes questionnaire (administered to school nurses in participating schools). The questionnaire consists of 12 statements, with four items each assessing the Acceptability of Intervention Measure (AIM), the Intervention Appropriateness Measure (IAM), and the Feasibility of Intervention Measure (FIM). Respondents rate their level of agreement with each statement using a five-point Likert scale, ranging from "completely disagree" to "completely agree." Responses are coded numerically from 1 to 5, with higher scores indicating stronger agreement. The 12 scores are summed to produce a total scale score ranging from 12 to 60, with higher scores reflecting more positive perceptions of the platform across the three implementation domains.
Time frame
Shortly after the intervention period (i.e., 'end of treatment') at 7 months.2
Feasibility of implementation: Acceptability, appropriateness and feasibility of implementation
Qualitative data will be collected through semi-structured interviews with school nurses in participating schools. An interview guide developed guided by the Consolidated Framework for Implementation Research (CFIR) will be used to ensure consistency while allowing flexibility to explore individual experiences in depth. The guide includes open-ended questions designed to capture perceptions (see outcome measure 5) and questions related to implementation, e.g., 'How did you experience implementing HPV-Kompassen alongside the regular school health services program?' and 'How well did HPV-Kompassen fit with how schools provide information about HPV vaccination?'.
Time frame
Shortly after the intervention period (i.e., 'end of treatment') at 7 months.3
Acceptability of intervention: Intervention delivery strategy
Defined as proportion of adolescents and caregivers that access platform at least once, measured through platform usage metrics.
Time frame
Throughout the intervention period (i.e., months 0-7).4
Acceptability of intervention: Usability of intervention
Usability is measured quantitatively using the Swedish version of the System Usability Scale (SUS). The SUS consists of 10 items assessing perceived usability across key dimensions such as complexity, ease of use, and confidence in using the system. Participants (school nurses, adolescents and caregivers) indicate their agreement with each item on a five-point Likert scale ranging from "strongly disagree" to "strongly agree." Responses are scored according to standard SUS procedures, resulting in a total score ranging from 0 to 100, with higher scores indicating better perceived usability.
Time frame
Immediately after the intervention period (i.e., 'end of treatment') at 7 months.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: