100000 Participants NeededMy employer runs this trial

STOP-HPV Strategies for Human Papillomavirus Vaccines

PS
CA
Overseen ByChristina Albertin, PhD, MPH
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Los Angeles
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to help doctors discuss the HPV vaccine with parents, aiming to prevent certain cancers caused by the human papillomavirus. It evaluates whether online training for doctors, with or without additional support meetings, can boost vaccination rates among children. The trial includes three groups: one receiving only online training (STOP-HPV-Online), another receiving training plus meetings and feedback (STOP-HPV-LC), and a control group receiving regular care. Families with children visiting the doctor for routine check-ups who have not yet started the HPV vaccine may be suitable participants. As an unphased trial, this study provides a unique opportunity to enhance healthcare communication and increase vaccination rates.

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 prior data suggests that these implementation strategies are safe for increasing HPV vaccine initiation?

Research has shown that the HPV vaccine, a key component of both the STOP-HPV-LC and STOP-HPV-Online strategies, is very safe. Many studies have proven that the vaccine effectively prevents infections and cancers caused by HPV. Most side effects are mild, such as pain or swelling at the injection site. Serious health issues are extremely rare, occurring in only about 1.8 cases per 100,000 doses.

For over 15 years, ongoing research has consistently demonstrated that the HPV vaccine is safe and provides long-lasting protection. Most adverse effects are minor, and the vaccine is not associated with serious health problems. This strong safety record supports its use in preventing health issues related to HPV.12345

Why are researchers excited about this trial?

Researchers are excited about the STOP-HPV strategies because they focus on enhancing the communication skills of healthcare providers, which is a fresh approach compared to traditional vaccine delivery. Unlike the standard care that primarily revolves around administering vaccines, STOP-HPV-LC adds a layer of provider communication training and involves Learning Collaborative sessions, along with performance feedback, to improve vaccination rates. Meanwhile, STOP-HPV-Online offers a more accessible, digital method for training providers, making it unique in its delivery and potential reach. These strategies aim to address the barriers in vaccine uptake by empowering providers with better communication tools, which could lead to higher vaccination rates and better HPV prevention.

What evidence suggests that this trial's treatments could be effective for increasing HPV vaccine initiation?

This trial will compare different strategies to increase HPV vaccination rates. Research has shown that the HPV vaccine effectively prevents cervical and other cancers caused by HPV. Studies have found that vaccinating girls before age 16 can reduce their risk of developing cervical cancer by 80%. The vaccine also prevents about 90% of cervical cancer cases in teenagers. Evidence indicates that the vaccine works best when given at younger ages, with protection rates between 74% and 93% for those vaccinated between ages 9 and 14. These findings highlight the importance of increasing HPV vaccination rates to protect against cancer.46789

Who Is on the Research Team?

PS

Peter Szilagyi, MD, MPH

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for children who are patients at participating clinics, are old enough to get the HPV vaccine (usually ages 9-12), have a well child visit during the study period, and have not yet received any doses of the HPV vaccine.

Inclusion Criteria

Patient of participating practice
My child had a well child check-up in the past 12 months.
I am within the required age range for this study.
See 1 more

Exclusion Criteria

I have received at least one dose of the HPV vaccine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of STOP-HPV-Online and STOP-HPV-LC strategies to increase HPV vaccine initiation

12 months
Regular visits as per well-child care schedule

Follow-up

Participants are monitored for vaccine initiation rates and cost-effectiveness

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • STOP-HPV-LC
  • STOP-HPV-Online

Trial Overview

The study compares usual care with two ways to help doctors talk to families about starting the HPV vaccine: one uses online training only, and the other adds group learning sessions with feedback for clinic leaders. Clinics are randomly assigned to each approach.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: STOP-HPV OnlineExperimental Treatment1 Intervention
Group II: STOP-HPV LCExperimental Treatment1 Intervention
Group III: Usual CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials
1,594
Recruited
10,430,000+

American Medical Group Association

Collaborator

Trials
3
Recruited
105,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

Human papillomavirus vaccine effectiveness by age at ... - PMC

These results demonstrate that the HPV vaccine is most effective against HPV-related disease outcomes when given at younger ages.

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.

Study Confirms HPV Vaccine Prevents Cervical Cancer - NCI

Overall, 19 of the vaccinated women were diagnosed with cervical cancer during the study period, compared with 538 of the unvaccinated women.

Optimizing HPV vaccine effectiveness: impact of ...

The findings suggest that the highest vaccine effectiveness is observed in younger age groups (ages 9–14: 74–93%) and decreases with age.

Human Papillomavirus Vaccine Efficacy and Effectiveness ...

Maximal reductions of approximately 90% for HPV 6/11/16/18 infections, approximately 90% for genital warts, approximately 45% for low-grade cytological cervical ...

Human Papillomavirus (HPV) Vaccine Safety

HPV vaccine is safe and effective at preventing HPV-related infections and cancers. Vaccines, like any medicine, can have side effects. Many ...

Long-Term Effects of Human Papillomavirus Vaccination in ...

The preventive effect of HPV vaccines against anogenital and oropharyngeal cancers has been proven in both clinical trials and real-world data.

Safety of HPV vaccines

No other adverse reactions have been identified and GACVS considers HPV vaccines to be extremely safe. Further safety data have been generated recently from ...

The Facts on HPV Vaccine Safety and Effectiveness

Data from recent studies continue to confirm that the HPV vaccine is safe. • A 2022 observational study confirmed that HPV vaccination is safe. No association ...