2232 Participants Needed

HPV Vaccine for Increasing Vaccination Rates

(HPV Trial)

RK
Overseen ByRamneek Kahlon, BS
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Davis
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the HPV vaccine treatment?

Research shows that HPV vaccines are highly effective, with close to 100% efficacy in preventing HPV infections and cervical cancer when given in a three-dose schedule to young women who have not been previously infected with HPV.12345

Is the HPV vaccine generally safe for humans?

The HPV vaccine has been linked to some adverse events, with a small percentage being serious. However, most studies have not found these events to be directly caused by the vaccine, and it is generally considered safe based on pre-licensure and post-marketing data.678910

How is the HPV vaccine treatment unique compared to other treatments for HPV-related conditions?

The HPV vaccine is unique because it is a preventive measure that effectively stops the transmission of HPV, which can lead to cancers, rather than treating existing infections. It is recommended for individuals aged 9 to 26 and has a strong safety profile, but it does not offer therapeutic benefits for those already infected.1112131415

What is the purpose of this trial?

Develop, implement, and evaluate a culturally tailored multilevel intervention to increase uptake of the HPV vaccine among eligible patients ages 10-12 of the University of California, Davis Health Community Physician (UCDH CP) primary care practices using a randomized controlled trial design.

Research Team

JH

Julie HT Dang, PhD

Principal Investigator

University of California, Davis

Eligibility Criteria

This trial is for eligible patients aged 10-12 within the UC Davis Health Community Physician primary care practices, aiming to increase HPV vaccine uptake. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

I am between 10-12 years old and eligible for the HPV vaccine.

Exclusion Criteria

I have received the HPV vaccine.
I cannot receive the HPV vaccine due to health reasons.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Implementation

Implementation of a multilevel intervention including tailored education, appointment scheduling assistance, and primary care team trainings

12 months

Follow-up

Participants are monitored for the completion of the HPV vaccine series

12 months

Treatment Details

Interventions

  • HPV Vaccine
Trial Overview The study is testing a culturally tailored intervention designed to boost HPV vaccination rates among young patients. It's set up as a randomized controlled trial, meaning participants will be randomly assigned to receive this new approach or continue with standard practices.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ArmExperimental Treatment1 Intervention
These clinics will receive the multilevel intervention which will include tailored parent/patient education, appointment scheduling assistance, and primary care team trainings.
Group II: Control ArmActive Control1 Intervention
These clinics will not receive any intervention and will continue with care as usual.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials
958
Recruited
4,816,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

While clinical trials have shown that HPV vaccines are highly effective, their effectiveness in the general population is still not fully understood, highlighting the need for further research.
A comprehensive review of HPV-related clinical outcomes suggests that tracking these outcomes at the population level is crucial for evaluating the real-world effectiveness of HPV vaccines, as many large trials are nearing completion.
Evaluating the impact of human papillomavirus vaccines.Chang, Y., Brewer, NT., Rinas, AC., et al.[2009]
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]
Expanding HPV vaccination to adults, particularly at cervical cancer screening visits for women and during STI consultations for both sexes, could lead to significant reductions in HPV infection rates, with reductions of about 20% for women and even greater reductions (63% for HPV-16 and 84% for HPV-18) when including male vaccination.
The study suggests that while the impact of vaccinating adult women alone is modest, combining vaccination strategies for both genders during key health consultations is a highly efficient approach to improve HPV prevention and reduce the incidence of related cancers.
Public Health Benefits of Routine Human Papillomavirus Vaccination for Adults in the Netherlands: A Mathematical Modeling Study.Matthijsse, SM., Hontelez, JA., Naber, SK., et al.[2018]

References

Evaluating the impact of human papillomavirus vaccines. [2009]
Human papillomavirus (HPV) vaccination: from clinical studies to immunization programs. [2020]
Effectiveness of decision support for families, clinicians, or both on HPV vaccine receipt. [2022]
HPV and HPV vaccine education intervention: effects on parents, healthcare staff, and school staff. [2022]
Public Health Benefits of Routine Human Papillomavirus Vaccination for Adults in the Netherlands: A Mathematical Modeling Study. [2018]
Human papillomavirus vaccine safety in pediatric patients: an evaluation of the Vaccine Adverse Event Reporting System. [2019]
Safety of HPV vaccines in the age of nonavalent vaccination. [2018]
OAE-based data mining and modeling analysis of adverse events associated with three licensed HPV vaccines. [2022]
Serious adverse events after HPV vaccination: a critical review of randomized trials and post-marketing case series. [2022]
Lessons learnt in Japan from adverse reactions to the HPV vaccine: a medical ethics perspective. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Human Papillomavirus Vaccines. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Implementing a Multipartner HPV Vaccination Assessment and Feedback Intervention in an Integrated Health System. [2018]
The Role of Physician Recommendations and Public Policy in Human Papillomavirus Vaccinations. [2017]
14.United Statespubmed.ncbi.nlm.nih.gov
Increasing HPV vaccination through policy for public health benefit. [2018]
15.United Statespubmed.ncbi.nlm.nih.gov
Interventions to Improve HPV Vaccine Uptake: A Systematic Review. [2018]
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