Playing Game to Learn About Children's Vaccine Project

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.

Study Overview

• Status: Recruiting
• Conditions: Vaccine-Preventable Diseases; HPV
• Intervention / Treatment: Behavioral: vaccination game

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 Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ANGELA CHEN, PhD; Phone Number: (517) 884-4645; Email: VaccineHealthGame@msu.edu
• Study Contact Backup: Name: Nouran Ghonaim, BS; Phone Number: (517) 884-4645; Email: VaccineHealthGame@msu.edu

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Recruiting
      • Community
      • Contact: ANGELA CHEN; Phone Number: (480) 253-9098; Email: Healthandgame@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HPV game group; parent-child dyads receive HPV game intervention	Behavioral: vaccination game; A health game to promote HPV vaccination among youth
No Intervention: Usual care; parent-child dyads receive usual care (no intervention)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of eligible individuals agreeing to participate	Assessed by the % of eligible individuals agreeing to participate	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	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	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)	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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	T2 (occurs two months after completion of the intervention)

Collaborators and Investigators

• Sponsor: Michigan State University
• Investigators: Principal Investigator: ANGELA C CHEN, PhD, Michigan State University

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: July 25, 2023
• First Submitted That Met QC Criteria: August 2, 2023
• First Posted (Actual): August 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: adolescent; game intervention
• Additional Relevant MeSH Terms: Infections; Vaccine-Preventable Diseases
• Other Study ID Numbers: FP00033005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified, non-sensitive data will be deposited in Dryad no later than the date of publication.
• IPD Sharing Time Frame: Start: no later than the date of publication End: remain publicly available for 3 years following publication
• IPD Sharing Access Criteria: All users will have open access to the data without restriction, consistent with Dryad's open-access model. Data can be accessed directly through Dryad's website using the assigned DOI, ensuring discoverability and persistent availability. No personally identifiable or sensitive information will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No