Playing Game to Learn About Children's Vaccine Project
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: vaccination game.
- Who it may be relevant to
- Registry conditions: HPV, Vaccine-Preventable Diseases. Basic parameters: 11 years — 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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
- Behavioral vaccination game
A health game to promote HPV vaccination among youth
Primary outcome measures
- Percentage 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 [Time frame: T2 (occurs two months after completion of the intervention)]
- Percentage of participants who complete the intervention and assessments [Time frame: T2 (occurs two months after completion of the intervention)]
- Participant satisfaction with the project [Time frame: T2 (occurs two months after completion of the intervention)]
- 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)]
Secondary outcome measures (1)
- Children receives the first dose of HPV vaccine [Time frame: T2 (occurs two months after completion of the intervention)]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Community — Chandler
Identifiers
NCT: NCT05984849 · FP00033005