Playing Game to Learn About Children's Vaccine Project

Not Applicable

Recruiting

• Conditions: HPV; Vaccine-Preventable Diseases

• Registration Number: NCT05984849
• Lead Sponsor: Michigan State University

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.

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 Timeline

• Study First Submitted: 2023-07-25
• Study First Submitted QC: 2023-08-02
• Study First Posted: 2023-08-09
• Status Verified: 2025-09
• Study Start: 2025-09-01
• Last Update Submitted: 2025-09-02
• Last Update Posted: 2025-09-08
• Primary Completion: 2027-08
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of eligible individuals agreeing to participate	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	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	T2 (occurs two months after completion of the intervention)	Assessed by the % of participants who complete the intervention and assessments
Intention to vaccinate the children against HPV	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
Participant satisfaction with the project	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)

Secondary Outcome Measures

Name	Time	Method
Children receives the first dose of HPV vaccine	T2 (occurs two months after completion of the intervention)	Assessed by one binary question regarding whether or not the child has received the first dose of HPV vaccine. Responses: yes, no

Trial Locations

Locations (1)

Community; 🇺🇸 Chandler, Arizona, United States