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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07632963
Acronym
HPV-END-IT
Enrollment
100
Registered
2026-06-08
Start date
2026-08-01
Completion date
2027-06-01
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HPV, HPV Vaccination, Vaccine Acceptance, Vaccine Decision Making

Keywords

Human papilloma virus, HPV vaccine, Vaccine uptake, Vaccine confidence

Brief summary

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

BEHAVIORALHPV-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.

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

Single-arm, non-randomized cluster feasibility study using a mixed methods approach

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of implementation: Acceptability, appropriateness and feasibility of implementationShortly after the intervention period (i.e., 'end of treatment') at 7 months.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.
Acceptability of intervention: Intervention delivery strategyThroughout the intervention period (i.e., months 0-7).Defined as proportion of adolescents and caregivers that access platform at least once, measured through platform usage metrics.
Acceptability of intervention: Usability of interventionImmediately after the intervention period (i.e., 'end of treatment') at 7 months.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.
Acceptability of intervention: Perceptions of interventionShortly after the intervention period (i.e., 'end of treatment') at 7 months.Qualitative data will be collected through semi-structured interviews with participants (school nurses, adolescents and caregivers), focusing on their perceptions of the intervention. An interview guide is used to ensure coverage of key domains while allowing flexibility to explore individual experiences in depth. The guide includes open-ended questions assessing implementation (see outcome measure 2) and perceptions of the intervention, such as "Can you briefly describe your experience of using HPV-Kompassen?" and "Did the information seem credible to you?".
Acceptability of intervention: Intervention engagementThroughout the intervention period (i.e., months 0-7).Defined as proportion of adolescents and caregivers that actively engage with the platform least once (e.g., visit different modules), measured through platform usage metrics.
Feasibility of trial protocol: Feasibility of recruitmentFrom start of school enrollment (i.e., pre-intervention) and throughout the intervention period (i.e., months 0-7).Measured through study notes, assessing two indicators: proportion of schools that consent to participate and proportion of participants that consent to participate in interviews.
Feasibility of trial protocol: Participant retentionFrom school enrollment (i.e., 'baseline') and throughout the intervention period (i.e., months 0-7).Measured using study records and platform metrics, assessing two indicators: Proportion of schools retained until study end and proportion of participants using platform who complete the end line survey.
Feasibility of trial protocol: Feasibility of data collection methodsShortly after the intervention period (i.e., 'end of treatment') at 7 months.Measured using study records and survey data, assessing the completeness of data.

Contacts

CONTACTHelena Avermark
helena.avermark@ki.se+4670-890 25 04
CONTACTAsha Mohamed Ibrahim
asha.mohamed.ibrahim@ki.se
PRINCIPAL_INVESTIGATORSibylle Herzig van Wees, Associate Professor

Karolinska Institutet

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 9, 2026