Addressing HPV Vaccine Hesitancy by Co-Designing a Digital Health Intervention (HPV-END-IT)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HPV; HPV Vaccination; Vaccine Acceptance; Vaccine Decision Making
• Intervention / Treatment: Behavioral: HPV-Kompassen

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Helena Avermark; Phone Number: +4670-890 25 04; Email: helena.avermark@ki.se
• Study Contact Backup: Name: Asha Mohamed Ibrahim; Email: asha.mohamed.ibrahim@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; Participants in the intervention arm receive access to the co-designed, digital platform HPV-Kompassen (eng: The HPV Compass).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Shortly after the intervention period (i.e., 'end of treatment') at 7 months.
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?'.	Shortly after the intervention period (i.e., 'end of treatment') at 7 months.
Acceptability of intervention: Intervention delivery strategy	Defined as proportion of adolescents and caregivers that access platform at least once, measured through platform usage metrics.	Throughout the intervention period (i.e., months 0-7).
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.	Immediately after the intervention period (i.e., 'end of treatment') at 7 months.
Acceptability of intervention: Perceptions of intervention	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?".	Shortly after the intervention period (i.e., 'end of treatment') at 7 months.
Acceptability of intervention: Intervention engagement	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.	Throughout the intervention period (i.e., months 0-7).
Acceptability of intervention: Intervention engagement	Qualitative data collection using semi-structured interviews. These interviews aim to understand how, why, and to what extent participants engaged with the platform in practice. Participants (school nurses, adolescents and caregivers) are asked open-ended questions such as "Why did you choose to use the platform?" and "Why did you not use the platform, or use it less than expected?" Additional questions explore when and how the platform was accessed, which features were used, and what factors influenced engagement (e.g., time constraints, relevance of content, or integration with existing workflows).	End of intervention period (i.e., 'end of treatment') at 7 months.
Feasibility of trial protocol: Feasibility of recruitment	Measured through study notes, assessing two indicators: proportion of schools that consent to participate and proportion of participants that consent to participate in interviews.	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	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.	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	Measured using study records and survey data, assessing the completeness of data.	Shortly after the intervention period (i.e., 'end of treatment') at 7 months.

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Sibylle Herzig van Wees, Associate Professor, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: HPV vaccine; Human papilloma virus; Vaccine confidence; Vaccine uptake
• Other Study ID Numbers: 2023-00331

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No