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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05984849
Enrollment
180
Registered
2023-08-09
Start date
2025-10-27
Completion date
2027-08-31
Last updated
2026-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HPV, Vaccine-Preventable Diseases

Keywords

adolescent, game intervention

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.

Interventions

BEHAVIORALvaccination game

A health game to promote HPV vaccination among youth

Sponsors

Michigan State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
11 Years to 14 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of eligible individuals agreeing to participateT0 (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-upT2 (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 assessmentsT2 (occurs two months after completion of the intervention)Assessed by the % of participants who complete the intervention and assessments
Participant satisfaction with the projectT2 (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 HPVT0 (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

Secondary

MeasureTime frameDescription
Children receives the first dose of HPV vaccineT2 (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

Countries

United States

Contacts

CONTACTANGELA CHEN, PhD
VaccineHealthGame@msu.edu(517) 884-4645
CONTACTNouran Ghonaim, BS
VaccineHealthGame@msu.edu(517) 884-4645
PRINCIPAL_INVESTIGATORANGELA C CHEN, PhD

Michigan State University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 21, 2026