Active — Not RecruitingNot Applicable

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

United States3,100 participantsStarted 2019-12-23

Plain-language 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.

Who can participate

Age range9 Years – 13 Years

SexALL

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Practices: Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

Age at completion of two dose HPV series

Timeframe: post-intervention assessed in year 5 of study, year 4 of trial

Trial details

NCT IDNCT04722822

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-01

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