Game-Based Intervention for HPV Vaccination
Recruiting in Palo Alto (17 mi)
Overseen byANGELA CHEN, PhD
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Michigan State University
Disqualifiers: Cognitive issues
No Placebo Group
Approved in 5 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
46789How 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.
24101112Eligibility Criteria
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 over 18, the parent/guardian of the child in the study, speak English or Spanish, own a smartphone, and agree to participate and receive texts.
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
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: HPV game groupExperimental Treatment1 Intervention
Parent-child dyads receive a HPV game intervention
Group II: Usual careActive Control1 Intervention
Parent-child dyads receive child's usual care
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Michigan State UniversityEast Lansing, MI
Loading ...
Who Is Running the Clinical Trial?
Michigan State UniversityLead Sponsor
Arizona State UniversityCollaborator
References
Effectiveness of decision support for families, clinicians, or both on HPV vaccine receipt. [2022]To improve human papillomavirus (HPV) vaccination rates, we studied the effectiveness of targeting automated decision support to families, clinicians, or both.
Optimising HPV vaccination communication to adolescents: A discrete choice experiment. [2021]Human Papillomavirus (HPV) vaccine coverage in France is below 30%, despite proven effectiveness against HPV infections and (pre-)cancerous cervical lesions. To optimise vaccine promotion among adolescents, we used a discrete choice experiment (DCE) to identify optimal statements regarding a vaccination programme, including vaccine characteristics.
Evaluating societal preferences for human papillomavirus vaccine and cervical smear test screening programme. [2022]Cervical cancer and genital warts are diseases associated with human papillomavirus (HPV) infection. Cervical smear testing is used as a cervical cancer screening tool in most countries worldwide. The newly introduced vaccines that prevent HPV infections are the quadrivalent vaccine (Gardasil), which prevents genital warts and cervical cancer, and the bivalent vaccine (Cervarix), which prevents cervical cancer only. Public preferences for HPV vaccines and smear test screening were determined using a discrete choice experiment.
Human papillomavirus vaccines. [2015]To review the pharmacology, efficacy, safety, tolerability, and pharmacoeconomics of Cervarix and Gardasil, 2 human papillomavirus (HPV) vaccines.
Using financial incentives to increase initial uptake and completion of HPV vaccinations: protocol for a randomised controlled trial. [2021]HPV vaccination reduces the risk of cervical cancer. Uptake however, of the 'catch-up' campaign in England for 17-18 year old girls is below the 80% NHS target. The aim of this randomized controlled trial is to assess the impact of financial incentives on (a) the uptake and completion of an HPV vaccination programme and (b) the quality of the decisions to undertake the vaccination.
OAE-based data mining and modeling analysis of adverse events associated with three licensed HPV vaccines. [2022]Three licensed human papillomavirus (HPV) vaccines (Cervarix, Gardasil, and Gardasil 9) have been effectively used to prevent infection with oncogenic HPV types; however, many adverse events (AEs) have also been reported following their vaccinations. We assessed AE profiles after receiving the HPV vaccines based on the reported data from Vaccine Adverse Event Reporting System (VAERS).
Prophylactic papillomavirus vaccines. [2022]Human papillomaviruses (HPV) are the causative agents of cervical cancer, the third most common cancer in women. The development of prophylactic HPV vaccines Gardasil® and Cervarix® targeting the major oncogenic HPV types is now the frontline of cervical cancer prevention. Both vaccines have been proven to be highly effective and safe although there are still open questions about their target population, cross-protection, and long-term efficacy. The main limitation for a worldwide implementation of Gardasil® and Cervarix® is their high cost. To develop more affordable vaccines research groups are concentrated in new formulations with different antigens including capsomeres, the minor capsid protein L2 and DNA. In this article we describe the vaccines' impact on HPV-associated disease, the main open questions about the marketed vaccines, and current efforts for the development of second-generation vaccines.
Postlicensure safety evaluation of human papilloma virus vaccines. [2015]A summary of postlicensure safety information of HPV vaccines from three sources: VigiBase, the global database of WHO's Programme for International Drug Monitoring, the VAERS report on Gardasil and the RIVM report on Cervarix.
Strategies for continuous evaluation of the benefit-risk profile of HPV-16/18-AS04-adjuvanted vaccine. [2014]The HPV types 16/18-AS04-adjuvanted cervical cancer vaccine, Cervarix(®) (HPV-16/18-vaccine, GlaxoSmithKline, Belgium) was first approved in 2007 and is licensed in 134 countries for the prevention of persistent infection, premalignant cervical lesions and cervical cancer caused by oncogenic HPV. Benefit-risk status requires continual re-evaluation as vaccine uptake increases, as the epidemiology of the disease evolves and as new information becomes available. This paper provides an example of benefit-risk considerations and risk-management planning. Evaluation of the benefit-risk of HPV-16/18-vaccine post-licensure includes studies with a range of designs in many countries and in collaboration with national public agencies and regulatory authorities. The strategy to assess benefit versus risk will continue to evolve and adapt to the changing HPV-16/18-vaccine market.
Integrating epidemiology, psychology, and economics to achieve HPV vaccination targets. [2021]Human papillomavirus (HPV) vaccines provide an opportunity to reduce the incidence of cervical cancer. Optimization of cervical cancer prevention programs requires anticipation of the degree to which the public will adhere to vaccination recommendations. To compare vaccination levels driven by public perceptions with levels that are optimal for maximizing the community's overall utility, we develop an epidemiological game-theoretic model of HPV vaccination. The model is parameterized with survey data on actual perceptions regarding cervical cancer, genital warts, and HPV vaccination collected from parents of vaccine-eligible children in the United States. The results suggest that perceptions of survey respondents generate vaccination levels far lower than those that maximize overall health-related utility for the population. Vaccination goals may be achieved by addressing concerns about vaccine risk, particularly those related to sexual activity among adolescent vaccine recipients. In addition, cost subsidizations and shifts in federal coverage plans may compensate for perceived and real costs of HPV vaccination to achieve public health vaccination targets.
Economic evaluation of human papillomavirus vaccination in developed countries. [2014]With promising efficacy results from randomized control trials of human papillomavirus (HPV) vaccines and the availability of new screening paradigms, policymakers are being asked to make recommendations and decisions regarding the optimal strategies to reduce HPV infection and disease. Such decisions are increasingly being made with significant input from mathematical and economic models. The demand for modeling has resulted in the publication of numerous mathematical models looking at the cost-effectiveness of HPV vaccination.
[Did the recommendation of the French public health council modify the antipapillomavirus vaccines' prescription level?]. [2022]In France, two vaccines are approved for prevention of papillomavirus infection: Cervarix(®) and Gardasil(®). The 17th of December 2010 the French High Committee of Public Hearth changed its recommendation about Cervarix(®) and decided that no scientific element justified a preference using Gardasil(®). This notification was published the 25th of January 2011. Our study aimed to determine whether this decision changed medical prescriptions.