Human PapillomavirusNCT04627298
Normalizing HPV Vaccination in Preteens With a Serious Video Game
A study testing educational video game for preteens to support HPV vaccination in people with Human Papillomavirus, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 12 years
- Conditions the study is for
- Human Papillomavirus
- What is being tested?
- educational video game for preteens to support HPV vaccination
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2015to 16 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- preteens who had received at least one dose of HPV vaccine
Trial locations and contacts
1 site in 1 country.
United States1 site
Joan R, Cates
Chapel Hill, North Carolina, 27599-3365
About this study
Official title: Normalizing Preteen HPV Vaccination With Practice-based Communication Strategies
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.
Read the 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.
- Conditions
- Human Papillomavirus
- Being tested
- educational video game for preteens to support HPV vaccination
- Keywords
- vaccination, preteen, serious video game, human papillomavirus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational video game for preteens to support HPV vaccinationBehavioural
An educational video game developed for 11-12 year olds to increase interest in and decision to pursue HPV vaccination.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: Postintervention survey (4 months after completing baseline survey)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start9 Jul 2015
- Primary completion16 Apr 2019
- Study completion16 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Human PapillomavirusStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random assignment to intervention or comparison
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernard F. Fuemmeler, PhD, Study director, Virginia Commonwealth UniversityJamie L. Crandell, PhD, Study director, University of North Carolina, Chapel HillJoan Cates, PhD, Principal investigator, University of North Carolina, Chapel HillSandra J Diehl, MPH, Study director, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627298
- Sponsor's protocol ID
- 14-1891
- Other IDs
- 1R01AI113305
- Status last verified
- Nov 2020
- First submitted
- 6 Nov 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29161529Cates 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.
PubMed 33270028
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normalizing Preteen HPV Vaccination With Practice-based Communication Strategies
- ClinicalTrials.gov ID
- NCT04627298
- Acronym / sponsor ID
- 14-1891
- Conditions
- Human Papillomavirus
- Keywords
- vaccination, preteen, serious video game, human papillomavirus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 9 Jul 2015 (actual)
- Primary completion
- 16 Apr 2019 (actual)
- Study completion
- 16 Apr 2019 (actual)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Random assignment to intervention or comparison
| Arm | Type | Receives |
|---|---|---|
| Video Game | Active comparator | Behavioral: educational video game for preteens to support HPV vaccinationThis 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. |
| 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. |
Who may qualify
- Ages
- 11 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- preteens who had received at least one dose of HPV vaccine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educational video game for preteens to support HPV vaccinationAn educational video game developed for 11-12 year olds to increase interest in and decision to pursue HPV vaccination. | Behavioural | Video Game |
Primary outcome
Number of Participants Initiating vaccination with one dose of HPV vaccine
Time frame: 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
Time frame: approximately 9 months post intervention for each cohort total
HPV immunization records are obtained for all preteen participants from their primary care practices
5 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Postintervention survey (4 months after completing baseline survey)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Background: PubMed 29161529Cates 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.
- Derived from this study: PubMed 33270028Cates 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.
- Individual participant dataSharing planned: No
Related trials for Human Papillomavirus
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard F. Fuemmeler, PhD study director
Virginia Commonwealth University
Jamie L. Crandell, PhD study director
University of North Carolina, Chapel Hill
Joan Cates, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational video game for preteens to support HPV vaccination in people with Human Papillomavirus, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Initiating vaccination with one dose of HPV vaccine (time frame: approximately 9 months post intervention for each cohort total). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04627298, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.