Normalizing Preteen HPV Vaccination With Practice-based Communication Strategies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Number of Participants Initiating vaccination with one dose of HPV vaccine
研究概览
简要总结
Human papillomavirus (HPV) is the most common sexually transmitted infection in the United States and causes genital warts and cancers in both females and males. Vaccination against HPV is recommended for routine use in those aged 11-12 years old, yet is underutilized. The study's premise is that preteens are relevant decision makers who can be motivated to initiate and complete the HPV vaccine series (assuming parental consent and provider recommendation). This study evaluates a serious video game to engage preteens in the decision to pursue HPV vaccination. The hypothesis is that preteens who are assigned to the video game will be more likely to initiate and complete HPV vaccination than preteens who are not assigned to the video game.
详细描述
The aims of this pilot study are to (1) evaluate whether preteens who receive the video game have better self-reported outcomes related to knowledge of HPV and HPV vaccine, vaccination self-efficacy and decisional balance compared with preteens who do not receive the game; and (2) evaluate outcomes related to immersion in the video game and game play experiences of preteens who played the game. HPV vaccination initiation and completion data are collected from practices for both preteens who receive the game and a comparison group who do not receive the game.
This is a multiple baseline study based in primary care practices in North Carolina and conducted over 3 waves of 16 practices each wave. The goal is to recruit 160 boys and girls ages 11-12 and not vaccinated against HPV for each wave. Participants are recruited by their primary care providers to enroll in the study. Parents give consent and preteens give assent.
An original video game, Land of Secret Gardens, is created for the study. The game is a metaphor for protecting seedlings (body) with a potion (vaccine). Points to buy seeds and create the potion are earned by playing minigames. The minigames include several versions of finding secret objects in a garden shed and another involves playing a shield game with blue spikey balls (i.e., HPV) before they land on budding plants. Throughout the play, players are exposed to messaging about HPV and the benefits of the HPV vaccine.
Preteens are randomly assigned to an intervention group to play the video game or to a comparison group that will not play the game. Participants are asked to complete baseline and postintervention surveys. Measures included are scales for knowledge of HPV and HPV vaccine, vaccination self-efficacy and decisional balance about deciding to pursue HPV vaccination. Participants in the intervention group are also asked about story immersion and game play.
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 (Participant)
盲法说明
On enrollment, participants randomly assigned to condition.
入排标准
- 年龄范围
- 11 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preteens 11-12 who had not received any doses of HPV vaccination
- •recruited by primary care practices in North Carolina
- •parent signed HIPAA release
- •willing to take baseline and postintervention surveys
- •access to internet and mobile device or personal computer
排除标准
- •preteens who had received at least one dose of HPV vaccine
结局指标
主要结局
Number of Participants Initiating vaccination with one dose of HPV vaccine
时间窗: approximately 9 months post intervention for each cohort total
HPV immunization records are obtained for all preteen participants from their primary care practices
Number of Participants completing HPV vaccination series with either 2 or 3 doses of HPV vaccine in accordance with vaccination schedule for participant
时间窗: approximately 9 months post intervention for each cohort total
HPV immunization records are obtained for all preteen participants from their primary care practices
次要结局
- Mean HPV Vaccination Self-Efficacy Scale Score (8 items, range 1-3) is collected from both intervention and comparison group participants via Qualtrics surveys; higher score indicates greater confidence in getting HPV vaccination(Baseline and postintervention surveys 4 months apart)
- Mean HPV Vaccination Decisional Balance Scale Score (4 items pro and 5 items con, range 1-3) is collected from intervention and comparison group participants via Qualtrics surveys; higher pro mean score and lower con mean score indicate greater support(Baseline and postintervention surveys 4 months apart)
- Number of participants who evaluate video game characteristics via PENS: Physical/Emotional/Narrative Presence Scale (27 items) is collected from intervention group via Qualtrics; higher score indicates agreement with video game characteristic(Postintervention survey (4 months after completing baseline survey))
- Number of participants who self-report characteristics of video game play (18 items) is collected from intervention group via Qualtrics; higher score indicates report of video game characteristic(Postintervention survey (4 months after completing baseline survey))
- Mean HPV Vaccination Knowledge Scale Score (5 items, range 1-3) is collected from both intervention and comparison group participants via Qualtrics surveys; higher score indicates greater knowledge of HPV and HPV vaccination(Baseline and postintervention surveys 4 months apart)