Actively Recruiting

Phase Not Applicable
Age: 11Years - 14Years
All Genders
Healthy Volunteers
ID05984849

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

Led by Michigan State University · Updated on 2026-05-20

180

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to promote vaccine confidence and increase vaccination rates for the Human papillomavirus (HPV) vaccine among vulnerable and underserved youth aged 11 to 14. It focuses on addressing the suboptimal uptake of this strongly recommended vaccine by assessing a game-based educational approach. The study is a pilot randomized controlled trial designed to evaluate feasibility and preliminary effectiveness in improving vaccine intent and uptake. Participants are divided into two groups: one group receives a game-based intervention designed to educate and encourage HPV vaccination, while the other group receives usual care without any intervention. The study involves parent-child dyads, with children aged 11 to 14 who have not yet received the HPV vaccine. The intervention is delivered via a health game, and the study measures changes from before to after the intervention. During the study, researchers will track participation rates, retention, involvement, and satisfaction with the intervention. They will also measure parents' intent to vaccinate their children immediately after the intervention and two months later, alongside actual vaccination uptake. Assessments occur at enrollment, immediately post-intervention, and two months afterward. The total study duration includes follow-up to monitor these outcomes and collect participant feedback.

CONDITIONS

Brief Title

Playing Game to Learn About Children's Vaccine Project

Who Can Participate

Age: 11Years - 14Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Child is 11 to 14 years old
  • Child speaks and reads English
  • Child has never received any doses of the HPV vaccine
  • Child is not currently enrolled in another project involving HPV-related education
  • Child agrees and provides assent to participate
  • Parent or legal guardian of the participating child
  • Parent speaks and reads English
  • Parent owns a smartphone
  • Parent agrees to receive email and text messages
  • Parent is not currently enrolled in another project involving HPV-related education
  • Parent agrees and provides consent to participate
Not Eligible

You will not qualify if you...

  • Individuals who do not meet inclusion criteria
  • Individuals who refuse to provide consent or assent

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or virtual) to confirm eligibility and obtain consent and assent

Outpatient Treatment

Duration - Duration of the intervention period (not explicitly specified)

Participants in the HPV game group receive the game-based intervention designed to promote HPV vaccination; participants in the usual care group do not receive an intervention.

1 baseline visit and 1 immediate post-intervention visit

Follow-up

Duration - 2 months after intervention completion

Participants are followed for 2 months after completing the intervention to assess vaccine intent, uptake, retention, and satisfaction.

1 follow-up visit approximately 2 months post intervention

Trial Site Locations

Total: 1 location

1

Community

Chandler, Arizona, United States, 85224

Actively Recruiting

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Research Team

A

ANGELA CHEN, PhD

N

Nouran Ghonaim, BS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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