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

NCT04722822 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3100

Last updated 2026-04-22

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

(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 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.

BEHAVIORAL

(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).

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Allison Kempe, MD, MPH · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-23
Primary Completion
2026-04-01
Completion
2027-04-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04722822 on ClinicalTrials.gov