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

NCT07632963 | Not Yet Recruiting

• 1 other identifier: 2023-00331
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vaccine Decision Making; HPV Vaccination; HPV; Vaccine Acceptance

Keywords

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

Outcome Measures

Primary Outcomes (10)

• 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.

Study Arms (1)

Intervention arm

EXPERIMENTAL

Participants in the intervention arm receive access to the co-designed, digital platform HPV-Kompassen (eng: The HPV Compass).

Behavioral: HPV-Kompassen

Interventions

HPV-Kompassen BEHAVIORAL

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.

Intervention arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Officials

• Sibylle Herzig van Wees, Associate Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helena Avermark

CONTACT

+4670-890 25 04; helena.avermark@ki.se

Asha Mohamed Ibrahim

CONTACT

asha.mohamed.ibrahim@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

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

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 8, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share