HPVNCT05984849
Playing Game to Learn About Children's Vaccine Project
A study testing vaccination game in people with HPV and Vaccine-Preventable Diseases, run by Michigan State University at 1 site in United States.
Trial summary
This proposed study aims to conduct timely research that promotes vaccine confidence and vaccination of one strongly recommended vaccine with suboptimal uptake rates: Human papillomavirus (HPV) in vulnerable and underserved youth aged 11-14. Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- HPV, Vaccine-Preventable Diseases
- What is being tested?
- vaccination game
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2025to 31 Aug 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 11 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child sample: (1) 11-14 years old, (2) speaks and reads English, (3) has never received any doses of the HPV vaccine, (4) is not currently enrolled in another project that involves HPV-related education, and (5) agrees and provides assent to participate in research activities.
- Parent sample: (1) parent or legal guardian of the participating child, (2) speak and read English, (3) own a smartphone, (4) agree to receive email and text messages, (5) is not currently enrolled in another project that involves HPV-related education, and (6) agree and provide consent to participate in research activities.
- Exclusion Criteria: Individuals who do not meet inclusion criteria or refuse to provide consent/assent.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Community
Chandler, Arizona, 85224
ANGELA CHEN, (480) 253-9098, Healthandgame@gmail.com
About this study
Official title: A Pilot Randomized Controlled Study to Examine Feasibility and Preliminary Effectiveness of a Game-based Intervention in Promoting HPV Vaccination Among Vulnerable Youth to Prevent Cancers
This proposed study aims to conduct timely research that promotes vaccine confidence and vaccination of one strongly recommended vaccine with suboptimal uptake rates: Human papillomavirus (HPV) in vulnerable and underserved youth aged 11-14.
Read the detailed description
The study objectives are:
Objective 1: Assess feasibility (participation rate, retention, involvement, satisfaction) of one game-based interventions targeting HPV vaccination.
Objective 2: Conduct a pilot RCT with three conditions (Arm 1: HPV game-based intervention; Arm 2: usual care). The investigators will explore patterns of pre- to post-intervention change in theoretical mediators and vaccine intent, and explore levels of vaccine intent and uptake in 90 parent-child dyads of unvaccinated youth aged 11-14.
- Conditions
- HPV, Vaccine-Preventable Diseases
- Being tested
- vaccination game
- Keywords
- adolescent, game intervention
- Medical subject headings
- Vaccine-Preventable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaccination gameBehavioural
A health game to promote HPV vaccination among youth
| Study group | Role | What they receive |
|---|---|---|
| HPV game group | Experimental | parent-child dyads receive HPV game intervention Receives: Behavioral: vaccination game |
| Usual care | No intervention | parent-child dyads receive usual care (no intervention) |
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: T0 (occurs after consenting and before assigning to different study conditions)
Proportion of participants who are retained through follow-up
Assessed by the % of participants who are retained through follow-up
Measured: T2 (occurs two months after completion of the intervention)
Percentage of participants who complete the intervention and assessments
Assessed by the % of participants who complete the intervention and assessments
Measured: T2 (occurs two months after completion of the intervention)
Participant satisfaction with the project
Assessed by two Likert scale questions: (1) are you satisfied with the program? (2) Will you recommend this program to others? Responses: from (1) very dissatisfied/definitely not to (5) very satisfied/definitely yes)
Measured: T2 (occurs two months after completion of the intervention)
Intention to vaccinate the children against HPV
Assessed by a Likert scale question: How likely will you (parent) vaccinate your child against HPV? Responses: (0) no; (1) maybe; (2) yes
Measured: T0 (occurs after consenting and before assigning to different study conditions); T1 (occurs immediately post intervention);T2 (occurs two months after completion of the intervention)
Secondary outcomes (1)
Children receives the first dose of HPV vaccine
Assessed by one binary question regarding whether or not the child has received the first dose of HPV vaccine. Responses: yes, no
Measured: T2 (occurs two months after completion of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start27 Oct 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Aug 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.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Chia-Chen Chen, Michigan State University
- Investigators
- ANGELA C CHEN, PhD, Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984849
- Sponsor's protocol ID
- FP00033005
- Status last verified
- May 2026
- First submitted
- 25 Jul 2023
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified, non-sensitive data will be deposited in Dryad no later than the date of publication.
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
- A Pilot Randomized Controlled Study to Examine Feasibility and Preliminary Effectiveness of a Game-based Intervention in Promoting HPV Vaccination Among Vulnerable Youth to Prevent Cancers
- ClinicalTrials.gov ID
- NCT05984849
- Acronym / sponsor ID
- FP00033005
- Conditions
- HPV, Vaccine-Preventable Diseases
- Keywords
- adolescent, game intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 9 Aug 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 proposed study aims to conduct timely research that promotes vaccine confidence and vaccination of one strongly recommended vaccine with suboptimal uptake rates: Human papillomavirus (HPV) in vulnerable and underserved youth aged 11-14.
Detailed description
The study objectives are:
Objective 1: Assess feasibility (participation rate, retention, involvement, satisfaction) of one game-based interventions targeting HPV vaccination.
Objective 2: Conduct a pilot RCT with three conditions (Arm 1: HPV game-based intervention; Arm 2: usual care). The investigators will explore patterns of pre- to post-intervention change in theoretical mediators and vaccine intent, and explore levels of vaccine intent and uptake in 90 parent-child dyads of unvaccinated youth aged 11-14.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HPV game group | Experimental | Behavioral: vaccination gameparent-child dyads receive HPV game intervention |
| Usual care | No intervention | –parent-child dyads receive usual care (no intervention) |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Child sample: (1) 11-14 years old, (2) speaks and reads English, (3) has never received any doses of the HPV vaccine, (4) is not currently enrolled in another project that involves HPV-related education, and (5) agrees and provides assent to participate in research activities.
- Parent sample: (1) parent or legal guardian of the participating child, (2) speak and read English, (3) own a smartphone, (4) agree to receive email and text messages, (5) is not currently enrolled in another project that involves HPV-related education, and (6) agree and provide consent to participate in research activities.
- Exclusion Criteria: Individuals who do not meet inclusion criteria or refuse to provide consent/assent.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| vaccination gameA health game to promote HPV vaccination among youth | Behavioural | HPV game group |
Primary outcome
Percentage of eligible individuals agreeing to participate
Time frame: T0 (occurs after consenting and before assigning to different study conditions)
Assessed by the % of eligible individuals agreeing to participate
Proportion of participants who are retained through follow-up
Time frame: T2 (occurs two months after completion of the intervention)
Assessed by the % of participants who are retained through follow-up
Percentage of participants who complete the intervention and assessments
Time frame: T2 (occurs two months after completion of the intervention)
Assessed by the % of participants who complete the intervention and assessments
Participant satisfaction with the project
Time frame: T2 (occurs two months after completion of the intervention)
Assessed by two Likert scale questions: (1) are you satisfied with the program? (2) Will you recommend this program to others? Responses: from (1) very dissatisfied/definitely not to (5) very satisfied/definitely yes)
Intention to vaccinate the children against HPV
Time frame: T0 (occurs after consenting and before assigning to different study conditions); T1 (occurs immediately post intervention);T2 (occurs two months after completion of the intervention)
Assessed by a Likert scale question: How likely will you (parent) vaccinate your child against HPV? Responses: (0) no; (1) maybe; (2) yes
1 secondary outcome
Children receives the first dose of HPV vaccine
Time frame: T2 (occurs two months after completion of the intervention)
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 20 May 2026.
- Individual participant dataSharing planned: Yes. De-identified, non-sensitive data will be deposited in Dryad no later than the date of publication.
Related trials for HPV
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
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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.
ANGELA C 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 vaccination game in people with HPV 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 0 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: looking for participants now, 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?
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 ANGELA CHEN, PhD ((517) 884-4645, VaccineHealthGame@msu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of eligible individuals agreeing to participate (time frame: T0 (occurs after consenting and before assigning to different study conditions)). The study lists 5 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 20 May 2026.