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

2 juin 2026 mis à jour par: Sibylle Herzig van Wees, Karolinska Institutet

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

100

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Intervention arm
Participants in the intervention arm receive access to the co-designed, digital platform HPV-Kompassen (eng: The HPV Compass).
Comportemental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Feasibility of implementation: Acceptability, appropriateness and feasibility of implementation
Délai: Shortly 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.
Shortly after the intervention period (i.e., 'end of treatment') at 7 months.
Feasibility of implementation: Acceptability, appropriateness and feasibility of implementation
Délai: Shortly after the intervention period (i.e., 'end of treatment') at 7 months.
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
Délai: Throughout 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.
Throughout the intervention period (i.e., months 0-7).
Acceptability of intervention: Usability of intervention
Délai: Immediately 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.
Immediately after the intervention period (i.e., 'end of treatment') at 7 months.
Acceptability of intervention: Perceptions of intervention
Délai: Shortly 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?".
Shortly after the intervention period (i.e., 'end of treatment') at 7 months.
Acceptability of intervention: Intervention engagement
Délai: Throughout 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.
Throughout the intervention period (i.e., months 0-7).
Acceptability of intervention: Intervention engagement
Délai: End of intervention period (i.e., 'end of treatment') at 7 months.
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
Délai: From 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.
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
Délai: From 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.
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
Délai: Shortly after the intervention period (i.e., 'end of treatment') at 7 months.
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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Karolinska Institutet

Les enquêteurs

  • Chercheur principal: Sibylle Herzig van Wees, Associate Professor, Karolinska Institutet

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 août 2026

Achèvement primaire (Estimé)

1 juin 2027

Achèvement de l'étude (Estimé)

1 juin 2027

Dates d'inscription aux études

Première soumission

27 mai 2026

Première soumission répondant aux critères de contrôle qualité

2 juin 2026

Première publication (Réel)

8 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

8 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 juin 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • 2023-00331

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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