Playing Game to Learn About Children's Vaccine Project

Michigan State University

Status: Enrolling

Conditions: Vaccine-Preventable Diseases; HPV

Treatments: Behavioral: vaccination game

Study type: Interventional

Funder types: Other

Identifiers

NCT05984849

FP00033005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 11 to 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

HPV game group

Experimental group

Description:

parent-child dyads receive HPV game intervention

Treatment:

Behavioral: vaccination game

Usual care

No Intervention group

Description:

parent-child dyads receive usual care (no intervention)