Clinical trial NCT04627298: Normalizing HPV Vaccination in Preteens With a Serious Video Game
Official title: Normalizing Preteen HPV Vaccination With Practice-based Communication Strategies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papillomavirus
Keywords: vaccination
preteen
serious video game
human papillomavirus
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2020-11-13
Enrollment: 55
Sex: ALL
Minimum age (years): 11
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Random assignment to intervention or comparison
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of Participants Initiating vaccination with one dose of HPV vaccine
timeFrame: approximately 9 months post intervention for each cohort total
measure: Number of Participants completing HPV vaccination series with either 2 or 3 doses of HPV vaccine in accordance with vaccination schedule for participant
timeFrame: approximately 9 months post intervention for each cohort total
Secondary outcomes:
measure: 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
timeFrame: Baseline and postintervention surveys 4 months apart
measure: 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
timeFrame: Baseline and postintervention surveys 4 months apart
measure: 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
timeFrame: Baseline and postintervention surveys 4 months apart
measure: 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
timeFrame: Postintervention survey (4 months after completing baseline survey)
measure: 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
timeFrame: Postintervention survey (4 months after completing baseline survey)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Joan R, Cates
state: North Carolina
Study officials:
affiliation: Virginia Commonwealth University
name: Bernard F. Fuemmeler, PhD
role: STUDY_DIRECTOR
affiliation: University of North Carolina, Chapel Hill
name: Jamie L. Crandell, PhD
role: STUDY_DIRECTOR
affiliation: University of North Carolina, Chapel Hill
name: Joan Cates, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Sandra J Diehl, MPH
role: STUDY_DIRECTOR
References:
citation: Cates JR, Fuemmeler BF, Diehl SJ, Stockton LL, Porter J, Ihekweazu C, Gurbani AS, Coyne-Beasley T. Developing a Serious Videogame for Preteens to Motivate HPV Vaccination Decision Making: Land of Secret Gardens. Games Health J. 2018 Feb;7(1):51-66. doi: 10.1089/g4h.2017.0002. Epub 2017 Nov 21.
citation: Cates JR, Fuemmeler BF, Stockton LL, Diehl SJ, Crandell JL, Coyne-Beasley T. Evaluation of a Serious Video Game to Facilitate Conversations About Human Papillomavirus Vaccination for Preteens: Pilot Randomized Controlled Trial. JMIR Serious Games. 2020 Dec 3;8(4):e16883. doi: 10.2196/16883.