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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

NCT ID: NCT05984849Sponsor: Michigan State UniversityLast updated: 2026-05-20

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.

Arms & interventions

  • Behavioralvaccination game

    A health game to promote HPV vaccination among youth

Outcome measures

Primary

  • Percentage of eligible individuals agreeing to participate

    Assessed by the % of eligible individuals agreeing to participate

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    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)

Secondary

  • Children receives the first dose of HPV vaccine

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

Eligibility criteria

Sex: AllAge: 11 Years to 14 YearsHealthy 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.

Study locations (1)

Community

Chandler, Arizona, 85224

Recruiting
Playing Game to Learn About Children's Vaccine Project | Cancerify