HPV InfectionNCT06162676
Game-Based Intervention to Promote HPV Vaccination
A study testing HPV game in people with HPV Infection and Vaccine-Preventable Diseases, run by Michigan State University at 1 site in United States.
Trial summary
This study will examine the feasibility and acceptability of an innovative game-based intervention designed for families of youth aged 11-14 to promote HPV vaccination; will explore changes in key outcomes and related measures; and will identify factors contributing to or impeding effective implementation in health… Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- HPV Infection, Vaccine-Preventable Diseases
- What is being tested?
- HPV game
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 11 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Youth: (1) 11-14 years old; (2) have not received the 1st dose of HPV vaccine; (3) speak and read English
- Parent: (1) are the parent/legal guardian of the participating child; (2) ≥ 18 years old; (3) speak English or Spanish; (4) own a smartphone; (5) agree to participate in the research activities at study sites; (6) agree to receive text messages.
- Healthcare providers: (1) ≥ 20 years old; (2) speak English or Spanish); (3) work at study sites
Who cannot join
- Individuals are unable to comprehend the consent or assent forms due to cognitive issues
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan State University
East Lansing, Michigan, 48824
About this study
Official title: Pilot Testing of a Game-Based Intervention to Promote HPV Vaccination in Families With Unvaccinated Children
This study will examine the feasibility and acceptability of an innovative game-based intervention designed for families of youth aged 11-14 to promote HPV vaccination; will explore changes in key outcomes and related measures; and will identify factors contributing to or impeding effective implementation in health clinic settings. The intervention and its approach have the potential to reduce health disparities in HPV-associated cancers in youth via low-cost technology and timely intervention.
Read the detailed description
Guided by Social Cognitive Theory, we propose to
- examine the feasibility and acceptability of a new HPV preventive intervention, the HPV Detective video game, designed for youth and their parents;
- explore pre-post, intervention-related change in vaccine intent and uptake as well as change in theoretically posited intervention mediators; and
- assess the potential for broader intervention implementation. Using a sequential mixed-methods, 2-group (intervention vs usual care), longitudinal design, 64 parent-youth dyads (32/per study condition) will be recruited.
Parent-youth dyads in the intervention will play HPV Detective (tablet format) at the clinic prior to the healthcare provider visits. The control dyads will receive standard clinic treatment.
- Conditions
- HPV Infection, Vaccine-Preventable Diseases
- Being tested
- HPV game
- Keywords
- adolescent, parent, game intervention, HPV prevention
- Medical subject headings
- Papillomavirus Infections, Vaccine-Preventable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV gameBehavioural
A brief health game for parent-child dyads to promote child's HPV vaccination
| Study group | Role | What they receive |
|---|---|---|
| HPV game group | Experimental | Parent-child dyads receive a HPV game intervention Receives: Behavioral: HPV game |
| Usual care | No intervention | Parent-child dyads receive child's usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of eligible individuals agreeing to participate
Assessed by the % of eligible individuals agreeing to participate
Measured: 2 years
Percentage of eligible individuals who complete the intervention (intervention arm only) and assessments (all participants)
Assessed by the % of eligible individuals who complete the intervention and assessments
Measured: 2 years
Ease of use (intervention arm only)
(1) device-recorded time to complete interactive modules and the full game; (2) self reported easy of use
Measured: 2 years
Parent and child acceptability of the intervention (intervention arm only)
Assessed by a 12-item Likert scale.
Measured: 2 years
Intention to vaccinate the child against HPV
Assessed by a Likert scale question: how likely will you (parent) vaccinate your child against HPV? Responses: (1) Very unlikely to (5) Very likely
Measured: 2 years
Child vaccination status (1st & 2nd doses).
Assessed by one binary (yes/no) question regarding whether or not the child has received the 1st \& 2nd dose of HPV vaccine.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start1 Apr 2024
- Primary completion30 Jul 2025
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- intervention vs. usual care (control)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University
- Responsible party
- Principal investigator, Angela Chia-Chen Chen, Michigan State University
- Investigators
- ANGELA CHEN, PhD, Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162676
- Sponsor's protocol ID
- STUDY00009385
- Status last verified
- May 2026
- First submitted
- 30 Nov 2023
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study will provide de-identified survey data stored in an encrypted electronic database. They will be available free of identifiers to avoid the possibility of disclosing identify of research participants. Quantitative data collected from this study will be made available to qualified scientists for research purposes following acceptance for publication of the main findings derived from the final data set.
Publications
Reifsnider E, Subedi S, Ghonaim N, Whaley M, Chen AC. Acceptability, Usability, and Clinical Integration of a Clinic-Based Digital Game for HPV Education: Qualitative Perspectives from Adolescents, Parents, and Healthcare Providers. Vaccines (Basel). 2026 Jan 26;14(2):116. doi: 10.3390/vaccines14020116.
PubMed 41746039
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing of a Game-Based Intervention to Promote HPV Vaccination in Families With Unvaccinated Children
- ClinicalTrials.gov ID
- NCT06162676
- Acronym / sponsor ID
- STUDY00009385
- Conditions
- HPV Infection, Vaccine-Preventable Diseases
- Keywords
- adolescent, parent, game intervention, HPV prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- Arizona State University
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 8 Dec 2023 (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 will examine the feasibility and acceptability of an innovative game-based intervention designed for families of youth aged 11-14 to promote HPV vaccination; will explore changes in key outcomes and related measures; and will identify factors contributing to or impeding effective implementation in health clinic settings. The intervention and its approach have the potential to reduce health disparities in HPV-associated cancers in youth via low-cost technology and timely intervention.
Detailed description
Guided by Social Cognitive Theory, we propose to
- examine the feasibility and acceptability of a new HPV preventive intervention, the HPV Detective video game, designed for youth and their parents;
- explore pre-post, intervention-related change in vaccine intent and uptake as well as change in theoretically posited intervention mediators; and
- assess the potential for broader intervention implementation. Using a sequential mixed-methods, 2-group (intervention vs usual care), longitudinal design, 64 parent-youth dyads (32/per study condition) will be recruited.
Parent-youth dyads in the intervention will play HPV Detective (tablet format) at the clinic prior to the healthcare provider visits. The control dyads will receive standard clinic treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- intervention vs. usual care (control)
| Arm | Type | Receives |
|---|---|---|
| HPV game group | Experimental | Behavioral: HPV gameParent-child dyads receive a HPV game intervention |
| Usual care | No intervention | –Parent-child dyads receive child's usual care |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Youth: (1) 11-14 years old; (2) have not received the 1st dose of HPV vaccine; (3) speak and read English
- Parent: (1) are the parent/legal guardian of the participating child; (2) ≥ 18 years old; (3) speak English or Spanish; (4) own a smartphone; (5) agree to participate in the research activities at study sites; (6) agree to receive text messages.
- Healthcare providers: (1) ≥ 20 years old; (2) speak English or Spanish); (3) work at study sites
Key exclusion criteria (1 listed)
- Individuals are unable to comprehend the consent or assent forms due to cognitive issues
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 gameA brief health game for parent-child dyads to promote child's HPV vaccination | Behavioural | HPV game group |
Primary outcome
Percentage of eligible individuals agreeing to participate
Time frame: 2 years
Assessed by the % of eligible individuals agreeing to participate
Percentage of eligible individuals who complete the intervention (intervention arm only) and assessments (all participants)
Time frame: 2 years
Assessed by the % of eligible individuals who complete the intervention and assessments
Ease of use (intervention arm only)
Time frame: 2 years
(1) device-recorded time to complete interactive modules and the full game; (2) self reported easy of use
Parent and child acceptability of the intervention (intervention arm only)
Time frame: 2 years
Assessed by a 12-item Likert scale.
Intention to vaccinate the child against HPV
Time frame: 2 years
Assessed by a Likert scale question: how likely will you (parent) vaccinate your child against HPV? Responses: (1) Very unlikely to (5) Very likely
Child vaccination status (1st & 2nd doses).
Time frame: 2 years
Assessed by one binary (yes/no) question regarding whether or not the child has received the 1st \& 2nd dose of HPV vaccine.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Results publication: PubMed 41746039Reifsnider E, Subedi S, Ghonaim N, Whaley M, Chen AC. Acceptability, Usability, and Clinical Integration of a Clinic-Based Digital Game for HPV Education: Qualitative Perspectives from Adolescents, Parents, and Healthcare Providers. Vaccines (Basel). 2026 Jan 26;14(2):116. doi: 10.3390/vaccines14020116.
- Individual participant dataSharing planned: Yes. This study will provide de-identified survey data stored in an encrypted electronic database. They will be available free of identifiers to avoid the possibility of disclosing identify of research participants. Quantitative data collected from this study will be made available to qualified scientists for research purposes following acceptance for publication of the main findings derived from the final data set.
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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. This study is not recruiting at the moment.
ANGELA CHEN, PhD principal investigator
Michigan State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV game in people with HPV Infection and Vaccine-Preventable Diseases, run by Michigan State University at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of eligible individuals agreeing to participate (time frame: 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06162676, which also lists 1 linked publication.
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 20 May 2026.