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Clinical Trial NCT04722822 for HPV is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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The HPV 9-10 Trial: Early Initiation of HPV Vaccination 3,100 Vaccine Study Randomized

Recruiting
Clinical Trial NCT04722822 is an interventional study for HPV that is recruiting. It started on 23 December 2019 with plans to enroll 3,100 participants. Led by University of Colorado, Denver, it is expected to complete by 1 April 2027. The latest data from ClinicalTrials.gov was last updated on 21 October 2025.
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 ...Show More
Detailed Description
The burden of Human Papillomavirus (HPV)-related disease in the US is substantial. A safe and effective vaccine has been available for >10 years, yet the current rate of completion for the HPV series is only 49% for U.S.13-17 year olds. The Advisory Committee on Immunization Practices (ACIP) recommends routine HPV vaccination at age 11-12 years (yrs), but states that the vaccine "can be given starting at age 9 years...Show More
Official Title

The HPV 9-10 Trial: Early Initiation of HPV Vaccination

Conditions
HPV
Other Study IDs
NCT ID Number
NCT04722822
Start Date (Actual)
2019-12-23
Last Update Posted
2025-10-21
Completion Date (Estimated)
2027-04-01
Enrollment (Estimated)
3,100
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Health Services Research
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalPatients attributed to practices recommending HPV at age 9-10 years of age
Patients attributed to practices routinely recommending HPV vaccine starting at 9-10 years of age.
(Intervention) Recommending HPV vaccine for patients 9-10 years of age
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 offe...Show More
Active ComparatorPatients attributed to practices recommending HPV at age 11-12 years of age
Patients attributed to practices routinely recommending HPV vaccine starting at 11-12 years of age.
(Control) Recommending HPV vaccine for patients 11-12 years of age
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).
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
HPV completion by age 13 years
Secondary outcome will be HPV series completion rates by age 13. This will be a binary outcome. 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
Age at initiation of the HPV series
This is a time-to-event outcome, with the event of interest being vaccine initiation. 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
Participation Assistant
Eligibility Criteria

Eligible Ages
Child
Minimum Age
9 Years
Eligible Sexes
All
Practices:
  • 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

  • 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
University of Colorado, Denver logoUniversity of Colorado, Denver480 active studies to explore
Study Central Contact
Contact: Alison Saville, MPH, MSW, 720-257-4406, [email protected]
2 Study Locations in 1 Countries

California

University of California at Los Angeles, Los Angeles, California, 90095, United States
Emma Clark, Contact, [email protected]
Peter Szilagyi, MD, MPH, Principal Investigator
Recruiting

Colorado

University of Colorado, Aurora, Colorado, 80045, United States
ALISON W SAVILLE, MPH, MSW, Contact, 7202574406, [email protected]
Allison Kempe, MD, MPH, Principal Investigator
Recruiting