NCT04627298

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 9, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 13, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

3.8 years

First QC Date

November 6, 2020

Last Update Submit

November 6, 2020

Conditions

Human Papillomavirus

Keywords

vaccinationpreteenserious video gamehuman papillomavirus

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • 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

  • 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)

Study Arms (2)

Video Game

ACTIVE COMPARATOR

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

No Video Game

NO INTERVENTION

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.

Interventions

educational video game for preteens to support HPV vaccinationBEHAVIORAL

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

Video Game

Eligibility Criteria

Age11 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • preteens who had received at least one dose of HPV vaccine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joan R, Cates

Chapel Hill, North Carolina, 27599-3365, United States

Location

Related Publications (2)

  • 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.

    PMID: 29161529BACKGROUND

  • 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.

    PMID: 33270028DERIVED

Study Officials

  • Bernard F. Fuemmeler, PhD

    Virginia Commonwealth University

    STUDY DIRECTOR

  • Jamie L. Crandell, PhD

    University of North Carolina, Chapel Hill

    STUDY DIRECTOR

  • Joan Cates, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

  • Sandra J Diehl, MPH

    University of North Carolina, Chapel Hill

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
On enrollment, participants randomly assigned to condition.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Random assignment to intervention or comparison
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2020

First Posted

November 13, 2020

Study Start

July 9, 2015

Primary Completion

April 16, 2019

Study Completion

April 16, 2019

Last Updated

November 13, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)