Playing Game to Learn About Children's Vaccine Project

NCT05984849 | Recruiting

• 1 other identifier: FP00033005
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HPV; Vaccine-Preventable Diseases

Keywords

adolescent; game intervention

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Children receives the first dose of HPV vaccine

  T2 (occurs two months after completion of the intervention)

Study Arms (2)

HPV game group

EXPERIMENTAL

parent-child dyads receive HPV game intervention

Behavioral: vaccination game

Usual care

NO INTERVENTION

parent-child dyads receive usual care (no intervention)

Interventions

vaccination game BEHAVIORAL

A health game to promote HPV vaccination among youth

HPV game group

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• Michigan State University: lead

Study Sites (1)

Community

Chandler, Arizona, 85224, United States

RECRUITING

MeSH Terms

Conditions

Vaccine-Preventable Diseases

Condition Hierarchy (Ancestors)

Infections

Study Officials

• ANGELA C CHEN, PhD

  Michigan State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ANGELA CHEN, PhD

CONTACT

(517) 884-4645; VaccineHealthGame@msu.edu

Nouran Ghonaim, BS

CONTACT

(517) 884-4645; VaccineHealthGame@msu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 9, 2023
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Start: no later than the date of publication End: remain publicly available for 3 years following publication
• 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.

Locations

US (1)