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Normalizing HPV Vaccination in Preteens With a Serious Video Game

NCT ID: NCT04627298

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-09

Study Completion Date

2019-04-16

Brief Summary

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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

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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.

Conditions

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Human Papillomavirus

Keywords

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vaccination preteen serious video game human papillomavirus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Random assignment to intervention or comparison
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
On enrollment, participants randomly assigned to condition.

Study Groups

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Video Game

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.

Group Type ACTIVE_COMPARATOR

educational video game for preteens to support HPV vaccination

Intervention Type BEHAVIORAL

An educational video game developed for 11-12 year olds to increase interest in and decision to pursue HPV vaccination.

No Video Game

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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educational video game for preteens to support HPV vaccination

An educational video game developed for 11-12 year olds to increase interest in and decision to pursue HPV vaccination.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bernard F. Fuemmeler, PhD

Role: STUDY_DIRECTOR

Virginia Commonwealth University

Jamie L. Crandell, PhD

Role: STUDY_DIRECTOR

University of North Carolina, Chapel Hill

Joan Cates, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Sandra J Diehl, MPH

Role: STUDY_DIRECTOR

University of North Carolina, Chapel Hill

Locations

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Joan R, Cates

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 29161529 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33270028 (View on PubMed)

Other Identifiers

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1R01AI113305

Identifier Type: NIH

Identifier Source: secondary_id

View Link

14-1891

Identifier Type: -

Identifier Source: org_study_id