HPVHPV-END-ITNCT07632963
Addressing HPV Vaccine Hesitancy by Co-Designing a Digital Health Intervention
A study testing HPV-Kompassen in people with HPV and Vaccine Acceptance, run by Karolinska Institutet.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- HPV, Vaccine Acceptance, Vaccine Decision Making
- What is being tested?
- HPV-Kompassen
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Failure to meet the inclusion criteria
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Asha Mohamed Ibrahim contact
About this study
Official title: 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.
- Conditions
- HPV, Vaccine Acceptance, Vaccine Decision Making, HPV Vaccination
- Being tested
- HPV-Kompassen
- Keywords
- Human papilloma virus, HPV vaccine, Vaccine uptake, Vaccine confidence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV-KompassenBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Participants in the intervention arm receive access to the co-designed, digital platform HPV-Kompassen (eng: The HPV Compass). Receives: Behavioral: HPV-Kompassen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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?'.
Measured: 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.
Measured: 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.
Measured: 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?".
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Shortly after the intervention period (i.e., 'end of treatment') at 7 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study startAug 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPVStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, non-randomized cluster feasibility study using a mixed methods approach
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibylle Herzig van Wees, Karolinska Institutet
- Investigators
- Sibylle Herzig van Wees, Associate Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632963
- Sponsor's protocol ID
- 2023-00331
- Other IDs
- 2023
- Acronym
- HPV-END-IT
- Status last verified
- May 2026
- First submitted
- 27 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07632963
- Acronym / sponsor ID
- HPV-END-IT / 2023-00331
- Conditions
- HPV, Vaccine Acceptance, Vaccine Decision Making, HPV Vaccination
- Keywords
- Human papilloma virus, HPV vaccine, Vaccine uptake, Vaccine confidence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, non-randomized cluster feasibility study using a mixed methods approach
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: HPV-KompassenParticipants in the intervention arm receive access to the co-designed, digital platform HPV-Kompassen (eng: The HPV Compass). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Failure to meet the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV-KompassenHPV-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. | Behavioural | Intervention arm |
Primary outcome
Feasibility of implementation: Acceptability, appropriateness and feasibility of implementation
Time frame: 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.
Feasibility of implementation: Acceptability, appropriateness and feasibility of implementation
Time frame: 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?'.
Acceptability of intervention: Intervention delivery strategy
Time frame: 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.
Acceptability of intervention: Usability of intervention
Time frame: 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.
Acceptability of intervention: Perceptions of intervention
Time frame: 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?".
Acceptability of intervention: Intervention engagement
Time frame: 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.
Acceptability of intervention: Intervention engagement
Time frame: 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).
Feasibility of trial protocol: Feasibility of recruitment
Time frame: 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.
Feasibility of trial protocol: Participant retention
Time frame: 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.
Feasibility of trial protocol: Feasibility of data collection methods
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Asha Mohamed Ibrahim contact
Sibylle Herzig van Wees, Associate Professor principal investigator
Karolinska Institutet
Questions about this trial
What is this clinical trial studying?
A study testing HPV-Kompassen in people with HPV and Vaccine Acceptance, run by Karolinska Institutet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helena Avermark (+4670-890 25 04, helena.avermark@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of implementation: Acceptability, appropriateness and feasibility of implementation (time frame: Shortly after the intervention period (i.e., 'end of treatment') at 7 months.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.