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

Michigan State University2 个研究点分布在 1 个国家目标入组 180 人开始时间: 2025年10月27日最近更新: 2026年5月20日

干预措施

试验速览

阶段: 不适用
状态: 招募中
发起方: Michigan State University
入组人数: 180
试验地点: 2
主要终点: Proportion of participants who are retained through follow-up

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: Single (Outcomes Assessor)

入排标准

年龄范围: 11 Years 至 14 Years（Child）
性别: All
接受健康志愿者: 是

入选标准

•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.

排除标准

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

研究组 & 干预措施

Usual care

No Intervention

parent-child dyads receive usual care (no intervention)

HPV game group

Experimental

parent-child dyads receive HPV game intervention

干预措施: vaccination game (Behavioral)

结局指标

主要结局

Proportion of participants who are retained through follow-up

时间窗: T2 (occurs two months after completion of the intervention)

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

Percentage of participants who complete the intervention and assessments

时间窗: T2 (occurs two months after completion of the intervention)

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

Participant satisfaction with the project

时间窗: 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)

Intention to vaccinate the children against HPV

时间窗: 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

Percentage of eligible individuals agreeing to participate

时间窗: T0 (occurs after consenting and before assigning to different study conditions)

Assessed by the % of eligible individuals agreeing to participate