Game-Based Intervention to Promote HPV Vaccination

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.

Study Overview

• Status: Completed
• Conditions: HPV Infection; Vaccine-Preventable Diseases
• Intervention / Treatment: Behavioral: HPV game

Detailed Description

Guided by Social Cognitive Theory, we propose to

1. examine the feasibility and acceptability of a new HPV preventive intervention, the HPV Detective video game, designed for youth and their parents;
2. explore pre-post, intervention-related change in vaccine intent and uptake as well as change in theoretically posited intervention mediators; and
3. 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 Type: Interventional
• Enrollment (Actual): 133
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • East Lansing, Michigan, United States, 48824
      • Michigan State University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Individuals are unable to comprehend the consent or assent forms due to cognitive issues

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 a HPV game intervention	Behavioral: HPV game; A brief health game for parent-child dyads to promote child's HPV vaccination
No Intervention: Usual care; Parent-child dyads receive child's usual care

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	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	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	2 years
Parent and child acceptability of the intervention (intervention arm only)	Assessed by a 12-item Likert scale.	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	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.	2 years

Collaborators and Investigators

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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): July 30, 2025
• Study Completion (Actual): February 28, 2026

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Actual): December 8, 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, parent, game intervention, HPV prevention
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Disease Attributes; Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Tumor Virus Infections; Pathological Conditions, Signs and Symptoms; Vaccine-Preventable Diseases; Papillomavirus Infections
• Other Study ID Numbers: STUDY00009385

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: The data will be available when the award ends and following acceptance for publication of the main findings derived from the final data set. It will be available for 10 years.
• IPD Sharing Access Criteria: The data will remain the property of the provider; the recipient shall show proof of appropriate training in the responsible conduct of research; any publication resulting from use of the data will acknowledge the provider and NIH of the original project from which the data were derived; the data will not be used for commercial or for-profit purposes; the data will not be further distributed to others; the provider makes no representations and extends no warranties of any kind, either expressed or implied; the recipient shall assume all liability for claims for damages against it by third parties that may arise from the use of the data; the recipient agrees to pay the cost of preparation and distribution of the data. Availability and use of the data may be limited by additional local institutional review board policies or by local, state, and federal laws and regulations.
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No