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NCT Number: NCT05984849

Playing Game to Learn About Children's Vaccine Project

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.

Recruiting

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Key information

Conditions

HPV Infections Vaccine-Preventable Diseases

Age range

11 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

vaccination game

Behavioral

A health game to promote HPV vaccination among youth

Primary outcomes

  1. Percentage of eligible individuals agreeing to participate

    Time frame: T0 (occurs after consenting and before assigning to different study conditions)

    Assessed by the % of eligible individuals agreeing to participate

  2. Proportion of participants who are retained through follow-up

    Time frame: T2 (occurs two months after completion of the intervention)

    Assessed by the % of participants who are retained through follow-up

  3. Percentage of participants who complete the intervention and assessments

    Time frame: T2 (occurs two months after completion of the intervention)

    Assessed by the % of participants who complete the intervention and assessments

  4. Participant satisfaction with the project

    Time frame: 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)

  5. Intention to vaccinate the children against HPV

    Time frame: 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

Secondary outcomes

  1. Children receives the first dose of HPV vaccine

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

ANGELA CHEN, PhD

CONTACT

[email protected]

(517) 884-4645

Nouran Ghonaim, BS

CONTACT

[email protected]

(517) 884-4645

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 9, 2023
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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