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RECRUITING
NCT04722822
NA

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

Sponsor: University of Colorado, Denver

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

9 Years - 13 Years

Study Type

INTERVENTIONAL

Enrollment

3100

Start Date

2019-12-23

Completion Date

2027-04-01

Last Updated

2025-10-21

Healthy Volunteers

No

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).

Locations (2)

University of California at Los Angeles

Los Angeles, California, United States

University of Colorado

Aurora, Colorado, United States