The HPV 9-10 Trial: Early Initiation of HPV Vaccination
2 other identifiers
interventional
3,100
1 country
2
Brief Summary
Every year, thousands of Americans die from cancers related to human papillomavirus (HPV). The vast majority of those deaths could be prevented with a safe and effective vaccine, yet many parents choose not have their children vaccinated when it is recommended at age 11 or 12. In this study, we will examine in a randomized trial whether earlier initiation of the vaccine at age 9-10 years will result in less parental refusal and higher rates of full vaccination at younger ages, before early sexual activity begins.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2019
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 23, 2019
CompletedFirst Submitted
Initial submission to the registry
January 20, 2021
CompletedFirst Posted
Study publicly available on registry
January 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
ExpectedApril 22, 2026
April 1, 2026
6.3 years
January 20, 2021
April 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Age at completion of two dose HPV series
The primary outcome will be age at completion of the two dose HPV series. This is a time-to-event outcome, with the event of interest being vaccine completion. Comparisons between the intervention practices and control practices will be made. Practice electronic health records will be used to assess this outcome.
post-intervention assessed in year 5 of study, year 4 of trial
Secondary Outcomes (2)
HPV completion by age 13 years
post-intervention assessed in year 5 of study, year 4 of trial
Age at initiation of the HPV series
post-intervention assessed in year 5 of study, year 4 of trial
Study Arms (2)
Patients attributed to practices recommending HPV at age 9-10 years of age
EXPERIMENTALPatients attributed to practices routinely recommending HPV vaccine starting at 9-10 years of age.
Patients attributed to practices recommending HPV at age 11-12 years of age
ACTIVE COMPARATORPatients attributed to practices routinely recommending HPV vaccine starting at 11-12 years of age.
Interventions
Practices are randomized to receive training on how to recommend HPV vaccine, including both standardized communication strategies and strategies for switching from 11-12 years to 9-10 years including: challenges with 11-12 strategy, long-term immunity, success of other practices and tips to help standardize to age 9-10. Trainings will be a combination of online and in-person or virtual. Annual trainings will be offered and providers will receive Maintenance of Certification credits (MOC) for participating. Providers will routinely recommend HPV starting at age 9 for all patients -- which is already approved for this vaccine but is not routinely recommended at age 9 years.
Control practices will receive a training on standardized communication for HPV vaccine including: using strong recommendations, using presumptive recommendation, providing specific phrases to use with parents, answering common questions and, HPV vaccine as a cancer prevention. Annual trainings will be offered and providers will receive professional development credit (MOC).
Eligibility Criteria
You may qualify if:
- Practices in Metro Denver, Colorado and Metro Los Angeles, California (specifically UCLA medical clinics and clinics affiliated with Children's Hospital of Orange County)
- Practices that have at least 60% of providers agree to participate
- Practices do not currently recommend HPV at 9-10 years.
- Practice must have at least 100 eligible patients age 9-13 years
You may not qualify if:
- Practices with less than 100 eligible patients age 9-13 years
- Practices currently routinely recommend HPV vaccine at 9-10 years.
- Practices where less than 60% of providers agree to participate in the study.
- Patient Eligibility Criteria
- Patient age 9-13 years
- Seen at a participating practice in the last 3 years
- Due for at least 1 dose of HPV vaccine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- National Institutes of Health (NIH)collaborator
- National Cancer Institute (NCI)collaborator
Study Sites (2)
University of California at Los Angeles
Los Angeles, California, 90095, United States
University of Colorado
Aurora, Colorado, 80045, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Allison Kempe, MD, MPH
University of Colorado, Denver
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- Investigator and data analysis team will be blinded to the arms during analysis. Practices (unit of randomization) cannot be blinded; however patients who are subjects of the intervention are not aware of the group allocation of the practice in the clinical trial.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2021
First Posted
January 25, 2021
Study Start
December 23, 2019
Primary Completion
April 1, 2026
Study Completion (Estimated)
April 1, 2027
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- May 2025
- Access Criteria
- The study team intends to share study data that may be requested from other research investigators in a data-sharing agreement provided at the individual study's end. The data-sharing agreement will include requirements to protect participants' privacy and data confidentiality. It will prohibit the recipient from transferring the data to other users and will require that the data's security be protected by standard means and be used for research purposes only. The method of distribution will be by request to Dr. Kempe (UCAMC) or Dr. Szilagyi (UCLA), the study PIs. After a requestor completes the data-sharing agreement, we will upload data to a secure File Transfer Protocol (FTP) site with the limited dataset to the requestor, or email the data through our University secured email systems that require users to create an account and sign-in with a username and password in order to receive and download any type of sensitive data.
The study team guarantees that any and all data collected as part of this project will be released in accordance with standard data sharing policies and procedures to validate research findings if requested. Data will be made available in a timely manner to the broader scientific community, and will be complete, and as accurate as possible. All data released will be de-identified, with no information that could be linked to any study subjects, or participating study practices in order to ensure the confidentiality of all subjects and practices. If necessary, a data use agreement will be established.