HPV Vaccination Strategies for Cervical Cancer Prevention
(IVaccinate Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The trial aims to evaluate how different strategies increase the number of children and young adults starting and completing the HPV vaccine series. By using educational materials and reminders, the researchers aim to boost vaccine rates, ultimately helping to prevent cervical cancer. The trial involves two groups: one receives the educational materials and reminders immediately, while the other receives them after 12 months. It suits clinics in certain Appalachian counties that provide immunizations to patients aged 11 to 26. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance public health strategies.
Do I have to stop taking my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It focuses on improving HPV vaccine uptake in children and young adults.
What prior data suggests that these interventions are safe for improving HPV vaccine uptake?
Research has shown that the HPV vaccine, such as Gardasil 9, has undergone careful safety studies. The FDA approved this vaccine in 2014, and it has been monitored for over 15 years. Studies find that recipients generally tolerate it well. Side effects, if they occur, are usually mild, such as soreness at the injection site or a mild fever. Serious side effects are rare. This extensive history of use and monitoring instills confidence in the vaccine's safety for preventing cervical cancer and other diseases caused by HPV.12345
Why are researchers excited about this trial?
Researchers are excited about the HPV vaccination strategies because these approaches aim to enhance cervical cancer prevention through innovative educational interventions. Unlike the standard of care, which typically involves vaccination without additional support, these strategies incorporate educational materials and reminder systems to boost vaccine uptake. By engaging both health providers and patients with tailored information and timely reminders, this method could significantly increase the effectiveness of existing HPV vaccines, making cervical cancer prevention more proactive and comprehensive.
What evidence suggests that this trial's treatments could be effective for preventing cervical cancer?
Research has shown that the HPV vaccine, studied in this trial, effectively prevents cervical cancer. Studies have found that over 98% of vaccinated individuals develop strong immunity against the targeted virus types. Real-world evidence indicates that the vaccine is most effective when administered to girls under 20, significantly reducing cervical cancer rates. The 9-valent HPV vaccine protects against nine virus types and has successfully lowered infection rates. More than 15 years of research confirms the HPV vaccine's safety and long-lasting protection. Participants in this trial will receive educational interventions and reminders to enhance vaccination uptake.56789
Who Is on the Research Team?
Electra D. Paskett, PhD
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for healthcare providers and office staff in certain Appalachian states who care for patients aged 11-26, provide immunizations, and are involved in the vaccine process. Participants must be able to speak, read, and write English.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Early Intervention
Health systems receive educational materials, providers complete surveys and educational sessions, and patients receive educational materials and reminder letters for HPV vaccination.
Delayed Intervention
Health systems, providers, and patients receive usual care for 12 months, then receive the multi-level intervention as in the early intervention phase.
Follow-up
Participants are monitored for changes in HPV vaccination rates, knowledge, and attitudes of providers.
What Are the Treatments Tested in This Trial?
Interventions
- Educational Intervention
- HPV Vaccine
- Reminder
Trial Overview
The study tests if using educational materials, promotional efforts, and electronic health record reminders can increase HPV vaccination rates among children and young adults within four Appalachian state health systems.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Health systems, providers, and patients receive usual care for 12 months, then receive multi-level intervention as in Arm I.
Health systems receive educational materials consisting of posters, brochures and handouts. Providers complete survey about HPV knowledge, participate in educational session over 1 hour and receive educational handouts on the HPV vaccine. Patients receive educational materials about HPV vaccine and reminder letters for HPV vaccination
HPV Vaccine is already approved in United States, European Union, Canada, Switzerland for the following indications:
- Prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58
- Prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11
- Prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58
- Prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11
- Prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58
- Prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11
- Prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58
- Prevention of genital warts (condyloma acuminata) caused by HPV types 6 and 11
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University Comprehensive Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
HPV Vaccine Efficacy
HPV vaccines are highly immunogenic. More than 98% of recipients develop an antibody response to HPV types included in the respective vaccines 1 month after ...
Real-World Effectiveness of Human Papillomavirus ...
HPV vaccine effectiveness against cervical cancer at the population level is high among girls vaccinated younger than age 20 years.
HPV Vaccine Safety and Effectiveness Data
More than 15 years of monitoring and research have accumulated reassuring evidence that HPV vaccination provides safe, effective, and long-lasting protection.
Update on the new 9-valent vaccine for human ...
The 9-valent HPV vaccine, which protects against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, is safe and effective and will further reduce the incidence ...
Clinical effectiveness of HPV vaccine by age at vaccination
HPV vaccines were licensed based on pre-licensure placebo-controlled trials that found them to be safe and efficacious (>95%) at preventing HGCL ...
Human Papillomavirus (HPV) Vaccine Safety
Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant; 9vHPV) was approved by FDA for use in 2014. The safety of Gardasil 9 was studied in clinical ...
GARDASIL 9 safety and side effects
GARDASIL 9 does not prevent all types of cervical, vulvar, vaginal, anal, or head and neck cancers. Vaccination does not remove the need for recommended cancer ...
Package Insert - GARDASIL 9
GARDASIL 9 has not been demonstrated to provide protection against disease caused by: • HPV types not covered by the vaccine [see Description (11)],. • HPV ...
GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, ...
GARDASIL 9 is a vaccine indicated in females 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and ...
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