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

2. června 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

100

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Jiný
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Intervention arm
Participants in the intervention arm receive access to the co-designed, digital platform HPV-Kompassen (eng: The HPV Compass).
Behaviorální: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Feasibility of implementation: Acceptability, appropriateness and feasibility of implementation
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Karolinska Institutet

Vyšetřovatelé

  • Vrchní vyšetřovatel: Sibylle Herzig van Wees, Associate Professor, Karolinska Institutet

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. srpna 2026

Primární dokončení (Odhadovaný)

1. června 2027

Dokončení studie (Odhadovaný)

1. června 2027

Termíny zápisu do studia

První předloženo

27. května 2026

První předloženo, které splnilo kritéria kontroly kvality

2. června 2026

První zveřejněno (Aktuální)

8. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

8. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

2. června 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • 2023-00331

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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