Game-Based Intervention for HPV Vaccination

Overseen By Nouran Ghonaim, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Michigan State University

Disqualifiers: Cognitive issues

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

131 Participants Needed

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. ^{1 2 3 4 5}

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. ^{2 6 7 8 9}

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. ^{2 9 10 11 12}

Who Is on the Research Team?

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?

Group I: HPV game group Experimental Treatment 1 Intervention

Parent-child dyads receive a HPV game intervention

Group II: Usual care Active Control 1 Intervention

Parent-child dyads receive child's usual care

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating societal preferences for human papillomavirus vaccine and cervical smear test screening programme. Oteng, B., Marra, F., Lynd, LD., et al.[2022]

Cervarix and Gardasil are effective HPV vaccines that prevent infections from HPV types 16 and 18, which cause 70% of cervical cancers, with Gardasil also protecting against HPV types 6 and 11, responsible for most genital warts.

Both vaccines are well tolerated with minimal side effects, primarily at the injection site, and ongoing Phase III trials aim to further assess their long-term efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human papillomavirus vaccines. Schmiedeskamp, MR., Kockler, DR.[2015]

A randomized controlled trial involving 1000 girls aged 16-18 will assess whether offering financial incentives, such as £45 vouchers, increases the uptake of the HPV vaccination among those who previously did not attend and first-time invitees.

The study will also evaluate how these financial incentives affect the quality of decision-making regarding vaccination, considering factors like socio-economic status, which may influence the effectiveness of the incentives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using financial incentives to increase initial uptake and completion of HPV vaccinations: protocol for a randomised controlled trial. Mantzari, E., Vogt, F., Marteau, TM.[2021]

A comprehensive analysis of adverse events (AEs) reported to the Vaccine Adverse Event Reporting System (VAERS) identified 3,112 AEs for Cervarix, 31,606 for Gardasil, and 6,872 for Gardasil 9, highlighting the need for ongoing monitoring of vaccine safety.

The study found 46 unique serious adverse events (SAEs) associated with the HPV vaccines, clustered around behavioral, neurological, immune, nervous, and reproductive systems, indicating that while the vaccines are effective, further research is needed to understand the cause-and-effect relationships of these AEs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OAE-based data mining and modeling analysis of adverse events associated with three licensed HPV vaccines. Zi, W., Yang, Q., Su, J., et al.[2022]

The Gardasil® and Cervarix® vaccines are highly effective and safe in preventing cervical cancer caused by human papillomaviruses (HPV), which is the third most common cancer in women.

Current research is focused on developing more affordable second-generation HPV vaccines using different formulations, as the high cost of existing vaccines limits their global implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prophylactic papillomavirus vaccines. Ribeiro-Müller, L., Müller, M.[2022]

The post-licensure safety profile of HPV vaccines Gardasil and Cervarix was evaluated using data from three sources, including VigiBase and VAERS, confirming that the reported adverse events align with existing safety data.

The analysis showed that the safety profiles of both vaccines are consistent with the information provided in their Summary of Product Characteristics (SPC), indicating that they are safe for public use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postlicensure safety evaluation of human papilloma virus vaccines. Labadie, J.[2015]

Cervarix, an HPV types 16/18 vaccine, has been approved since 2007 and is licensed in 134 countries to prevent cervical cancer and related conditions, highlighting its established efficacy in reducing HPV-related diseases.

Ongoing evaluation of the vaccine's benefit-risk profile is essential as vaccine uptake increases and new epidemiological data emerges, ensuring that risk management strategies remain effective and relevant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for continuous evaluation of the benefit-risk profile of HPV-16/18-AS04-adjuvanted vaccine. Angelo, MG., Taylor, S., Struyf, F., et al.[2014]

Public perceptions about HPV vaccines lead to significantly lower vaccination rates than what is needed to maximize community health benefits, as shown by an epidemiological game-theoretic model based on survey data from parents of vaccine-eligible children in the U.S.

To improve vaccination rates, it is crucial to address concerns about vaccine safety and its association with sexual activity, along with implementing cost subsidies and changes in federal coverage to alleviate financial barriers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating epidemiology, psychology, and economics to achieve HPV vaccination targets. Basu, S., Chapman, GB., Galvani, AP.[2021]

Vaccinating young girls against HPV is likely to be cost-effective, supporting the strategy of prioritizing this group for vaccination programs.

Vaccinating boys is generally not considered cost-effective in countries with high vaccination coverage in girls, but the effectiveness of such programs may vary in areas with lower coverage rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Economic evaluation of human papillomavirus vaccination in developed countries. Brisson, M., Van de Velde, N., Boily, MC.[2014]

Following the French High Committee of Public Health's recommendation change on January 25, 2011, there was a significant increase in the prescription of Cervarix(®) compared to Gardasil(®), indicating that medical recommendations can directly influence prescribing behavior.

The study suggests that the rapid response of prescribers to the new guidelines may be influenced by the strong involvement of pharmaceutical companies in medical education, highlighting the importance of how information is communicated to healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Did the recommendation of the French public health council modify the antipapillomavirus vaccines' prescription level?]. Birebent, J., Dupouy, J., Lempégnat, J., et al.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of decision support for families, clinicians, or both on HPV vaccine receipt. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Optimising HPV vaccination communication to adolescents: A discrete choice experiment. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Evaluating societal preferences for human papillomavirus vaccine and cervical smear test screening programme. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Human papillomavirus vaccines. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Using financial incentives to increase initial uptake and completion of HPV vaccinations: protocol for a randomised controlled trial. [2021]

6. England pubmed.ncbi.nlm.nih.gov

OAE-based data mining and modeling analysis of adverse events associated with three licensed HPV vaccines. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Prophylactic papillomavirus vaccines. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Postlicensure safety evaluation of human papilloma virus vaccines. [2015]

9. England pubmed.ncbi.nlm.nih.gov

Strategies for continuous evaluation of the benefit-risk profile of HPV-16/18-AS04-adjuvanted vaccine. [2014]

10. United States pubmed.ncbi.nlm.nih.gov

Integrating epidemiology, psychology, and economics to achieve HPV vaccination targets. [2021]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Economic evaluation of human papillomavirus vaccination in developed countries. [2014]

12. France pubmed.ncbi.nlm.nih.gov

[Did the recommendation of the French public health council modify the antipapillomavirus vaccines' prescription level?]. [2022]