131 Participants Needed

Game-Based Intervention for HPV Vaccination

AC
RM
NG
Overseen ByNouran Ghonaim, BS
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Michigan State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will examine the feasibility and acceptability of an innovative game-based intervention designed for families of youth aged 11-14 to promote HPV vaccination; will explore changes in key outcomes and related measures; and will identify factors contributing to or impeding effective implementation in health clinic settings. The intervention and its approach have the potential to reduce health disparities in HPV-associated cancers in youth via low-cost technology and timely intervention.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

Is the HPV vaccine safe for humans?

The HPV vaccines, including Gardasil, Cervarix, and Gardasil 9, have been shown to be generally safe for humans, although some adverse events (unwanted side effects) have been reported. These vaccines are widely used to prevent HPV infections that can lead to cervical cancer, and their safety is continuously monitored by health organizations.12345

How does the game-based intervention for HPV vaccination differ from other treatments?

The game-based intervention for HPV vaccination is unique because it uses an interactive approach to educate and engage individuals, potentially improving vaccination rates by addressing public perceptions and concerns, unlike traditional methods that rely solely on medical recommendations and information dissemination.26789

What data supports the effectiveness of the treatment for HPV vaccination?

Research shows that HPV vaccines like Gardasil and Cervarix are effective in preventing HPV infections and related cervical cancer. Studies also highlight the importance of communication and decision support to improve vaccination rates.29101112

Who Is on the Research Team?

AC

ANGELA CHEN, PhD

Principal Investigator

Michigan State University

Are You a Good Fit for This Trial?

This trial is for families with kids aged 11-14 who haven't had their first HPV shot. The child must understand English, and the parent should be over 18, speak English or Spanish, own a smartphone, and agree to participate in study activities and receive texts. Healthcare providers involved need to be over 20 and work at the study sites.

Inclusion Criteria

I am a healthcare provider, over 20, and speak English or Spanish.
I am 11-14 years old, have not had the HPV vaccine, and I speak and read English.

Exclusion Criteria

Individuals are unable to comprehend the consent or assent forms due to cognitive issues

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Parent-youth dyads in the intervention group play the HPV Detective game at the clinic prior to healthcare provider visits

1 visit
1 visit (in-person)

Usual Care

Parent-child dyads receive the child's usual care without the game intervention

1 visit
1 visit (in-person)

Follow-up

Participants are monitored for changes in vaccine intent, uptake, and acceptability of the intervention

2 years

What Are the Treatments Tested in This Trial?

Interventions

  • HPV game
Trial Overview The trial is testing an innovative game designed to encourage HPV vaccination among youth. It will assess how well this game works in health clinics, its acceptance by families, any changes it brings about regarding vaccinations, and what factors affect its success.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: HPV game groupExperimental Treatment1 Intervention
Group II: Usual careActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Michigan State University

Lead Sponsor

Trials
202
Recruited
687,000+

Arizona State University

Collaborator

Trials
311
Recruited
109,000+

Published Research Related to This Trial

A study involving 22,486 girls aged 11 to 17 showed that a combined intervention targeting both clinicians and families significantly increased HPV vaccination rates by 9, 8, and 13 percentage points for doses 1, 2, and 3, respectively.
The clinician-focused approach was particularly effective for starting the HPV vaccination series, while the family-focused approach helped in completing the series, highlighting the importance of a dual strategy for optimal vaccination outcomes.
Effectiveness of decision support for families, clinicians, or both on HPV vaccine receipt.Fiks, AG., Grundmeier, RW., Mayne, S., et al.[2022]
A study involving 1,458 adolescents in France found that emphasizing protection against cancer significantly increased the likelihood of accepting the HPV vaccine, while protection against genital warts did not motivate acceptance.
Communicating that over 80% of young people in other countries are vaccinated was highly effective in encouraging vaccine uptake, whereas mentioning serious side effects had a strong negative impact on acceptance.
Optimising HPV vaccination communication to adolescents: A discrete choice experiment.Chyderiotis, S., Sicsic, J., Raude, J., et al.[2021]
A survey of 1157 participants in Canada revealed a strong preference for the quadrivalent HPV vaccine, which protects against both cervical cancer and genital warts, and a vaccination program that targets both boys and girls.
Participants expressed a willingness to pay more to reduce their risk of cervical cancer and genital warts, indicating a societal support for HPV vaccination over frequent cervical smear testing.
Evaluating societal preferences for human papillomavirus vaccine and cervical smear test screening programme.Oteng, B., Marra, F., Lynd, LD., et al.[2022]

Citations

Effectiveness of decision support for families, clinicians, or both on HPV vaccine receipt. [2022]
Optimising HPV vaccination communication to adolescents: A discrete choice experiment. [2021]
Evaluating societal preferences for human papillomavirus vaccine and cervical smear test screening programme. [2022]
Human papillomavirus vaccines. [2015]
Using financial incentives to increase initial uptake and completion of HPV vaccinations: protocol for a randomised controlled trial. [2021]
OAE-based data mining and modeling analysis of adverse events associated with three licensed HPV vaccines. [2022]
Prophylactic papillomavirus vaccines. [2022]
Postlicensure safety evaluation of human papilloma virus vaccines. [2015]
Strategies for continuous evaluation of the benefit-risk profile of HPV-16/18-AS04-adjuvanted vaccine. [2014]
10.United Statespubmed.ncbi.nlm.nih.gov
Integrating epidemiology, psychology, and economics to achieve HPV vaccination targets. [2021]
Economic evaluation of human papillomavirus vaccination in developed countries. [2014]
[Did the recommendation of the French public health council modify the antipapillomavirus vaccines' prescription level?]. [2022]
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