Addressing HPV Vaccine Hesitancy by Co-Designing a Digital Health Intervention (HPV-END-IT)
2 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
100
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Helena Avermark
- Número de teléfono: +4670-890 25 04
- Correo electrónico: helena.avermark@ki.se
Copia de seguridad de contactos de estudio
- Nombre: Asha Mohamed Ibrahim
- Correo electrónico: asha.mohamed.ibrahim@ki.se
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intervention arm
Participants in the intervention arm receive access to the co-designed, digital platform HPV-Kompassen (eng: The HPV Compass).
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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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Feasibility of implementation: Acceptability, appropriateness and feasibility of implementation
Periodo de tiempo: 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.
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Feasibility of implementation: Acceptability, appropriateness and feasibility of implementation
Periodo de tiempo: 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?'.
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Shortly after the intervention period (i.e., 'end of treatment') at 7 months.
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Acceptability of intervention: Intervention delivery strategy
Periodo de tiempo: 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).
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Acceptability of intervention: Usability of intervention
Periodo de tiempo: Immediately after the intervention period (i.e., 'end of treatment') at 7 months.
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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.
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Immediately after the intervention period (i.e., 'end of treatment') at 7 months.
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Acceptability of intervention: Perceptions of intervention
Periodo de tiempo: 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?".
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Shortly after the intervention period (i.e., 'end of treatment') at 7 months.
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Acceptability of intervention: Intervention engagement
Periodo de tiempo: Throughout the intervention period (i.e., months 0-7).
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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.
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Throughout the intervention period (i.e., months 0-7).
|
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Acceptability of intervention: Intervention engagement
Periodo de tiempo: 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).
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End of intervention period (i.e., 'end of treatment') at 7 months.
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Feasibility of trial protocol: Feasibility of recruitment
Periodo de tiempo: From start of school enrollment (i.e., pre-intervention) and throughout the intervention period (i.e., months 0-7).
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Measured through study notes, assessing two indicators: proportion of schools that consent to participate and proportion of participants that consent to participate in interviews.
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From start of school enrollment (i.e., pre-intervention) and throughout the intervention period (i.e., months 0-7).
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Feasibility of trial protocol: Participant retention
Periodo de tiempo: From school enrollment (i.e., 'baseline') and throughout the intervention period (i.e., months 0-7).
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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.
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From school enrollment (i.e., 'baseline') and throughout the intervention period (i.e., months 0-7).
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Feasibility of trial protocol: Feasibility of data collection methods
Periodo de tiempo: Shortly after the intervention period (i.e., 'end of treatment') at 7 months.
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Measured using study records and survey data, assessing the completeness of data.
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Shortly after the intervention period (i.e., 'end of treatment') at 7 months.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Sibylle Herzig van Wees, Associate Professor, Karolinska Institutet
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de agosto de 2026
Finalización primaria (Estimado)
1 de junio de 2027
Finalización del estudio (Estimado)
1 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
27 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
2 de junio de 2026
Publicado por primera vez (Actual)
8 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
2 de junio de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2023-00331
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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