Normalizing HPV Vaccination in Preteens With a Serious Video Game

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Normalizing Preteen HPV Vaccination With Practice-based Communication Strategies

Conditions
-----------------
Human Papillomavirus

Intervention / Treatment
-----------------
* Behavioral: educational video game for preteens to support HPV vaccination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: preteens who had received at least one dose of HPV vaccine

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Random assignment to intervention or comparison
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Video Game<br>This arm tests use of video game to help preteens in the decision to pursue HPV vaccination. Participants in the intervention group are asked to play the Land of Secret Gardens game and complete 3 tasks: (1) play a shield game with blue spikey virus balls, (2) find hidden objects in 4 different garden sheds, and (3) create a potion (vaccine). Participants in the intervention arm are asked to respond to surveys about HPV and HPV vaccine knowledge, vaccination self-efficacy and decisional balance, the Physical/Emotional/Narrative Presence Scale (PENS) to gauge preteens' immersion in the game, and game play experience. | Behavioral: educational video game for preteens to support HPV vaccination<br>* An educational video game developed for 11-12 year olds to increase interest in and decision to pursue HPV vaccination.<br>|
| No Intervention: No Video Game<br>This arm does not test the video game. Participants in the comparison arm are asked to respond to surveys about HPV and HPV vaccine knowledge, vaccination self-efficacy and decisional balance. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Initiating vaccination with one dose of HPV vaccine | HPV immunization records are obtained for all preteen participants from their primary care practices | approximately 9 months post intervention for each cohort total | 
| Number of Participants completing HPV vaccination series with either 2 or 3 doses of HPV vaccine in accordance with vaccination schedule for participant | HPV immunization records are obtained for all preteen participants from their primary care practices | approximately 9 months post intervention for each cohort total | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Five items ask whether HPV vaccination can prevent genital warts, prevent cervical cancer, prevent anal cancer, prevent throat cancer, is recommended for 11-12 year old boys and girls | Baseline and postintervention surveys 4 months apart | 
| 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 | Eight items ask how confident was participant in getting the HPV vaccine when consider side effects, pain, parental decision, faintness or dizziness, expense, inconvenience, weak recommendation from doctor, friends' knowledge of 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 | Four items asked how important is the decision to get HPV vaccination (protection from HPV, protection from cancers and warts, protection from a sexually transmitted infection, and less likely to spread HPV); 5 items asked reasons for not getting HPV vaccination (too much time, too embarrassing to talk to parents, too embarrassing to talk to doctor, parents would not approve, parents would think participant was having sex) | 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 | Twenty seven items asked about participant immersion in the story: in-game autonomy, in-game competence, PENS questions related to immersion in the game, PENS questions related to intuitive controls, and interest and enjoyment | 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 | Eighteen tasks are described in the video game, including playing a shield game with virus like balls, finding hidden objects in garden sheds, creating a vaccine potion | Postintervention survey (4 months after completing baseline survey) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vaccination, preteen, serious video game, human papillomavirus