The HPV 9-10 Trial: Early Initiation of HPV Vaccination (NCT04722822) | Clinical Trial Compass
CompletedNot Applicable
The HPV 9-10 Trial: Early Initiation of HPV Vaccination
United States62,272 participantsStarted 2021-10-04
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 range
9 Years – 13 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Age at completion of two dose HPV series
Timeframe: post-intervention assessed in year 5 of study, year 4 of trial