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Vaccine

Early Initiation of HPV Vaccination for Human Papillomavirus

N/A

Recruiting

Led By Allison Kempe, MD, MPH

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Practice must have at least 100 eligible patients age 9-13 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-intervention assessed in year 5 of study, year 4 of trial

Awards & highlights

Study Summary

This trial will test whether earlier vaccination for HPV will result in less parental refusal and higher rates of full vaccination.

Who is the study for?

This trial is for medical practices in Metro Denver, Colorado and Metro Los Angeles, California that have a patient base of kids aged 9-13. At least 60% of providers at the practice must agree to participate, and they should not already be recommending HPV vaccination at ages 9-10.Check my eligibility

What is being tested?

The study is testing if suggesting the HPV vaccine earlier, at ages 9-10 instead of the usual recommendation at ages 11-12, leads to higher vaccination rates and less parental refusal. The goal is to increase protection against HPV before early sexual activity begins.See study design

What are the potential side effects?

While this trial focuses on vaccine timing rather than side effects, generally known side effects of the HPV vaccine can include pain or swelling where the shot was given, fever, headache or feeling tired.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My practice serves over 100 patients aged 9-13.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-intervention assessed in year 5 of study, year 4 of trial

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-intervention assessed in year 5 of study, year 4 of trial

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-intervention assessed in year 5 of study, year 4 of trial for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Age at completion of two dose HPV series

Secondary outcome measures

Age at initiation of the HPV series

HPV completion by age 13 years

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Providers recommending HPV vaccine at age 9-10 years of ageExperimental Treatment1 Intervention

Providers in this arm will routinely recommend HPV vaccine starting at 9-10 years of age.

Group II: Providers recommending HPV vaccine at age 11-12 years of ageActive Control1 Intervention

Providers in this arm will routinely recommend HPV vaccine starting at 11-12 years of age.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,732 Previous Clinical Trials

2,142,923 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,007 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,951,919 Total Patients Enrolled

Media Library

HPV Vaccine (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04722822 — N/A

Human Papillomavirus Research Study Groups: Providers recommending HPV vaccine at age 11-12 years of age, Providers recommending HPV vaccine at age 9-10 years of age

Human Papillomavirus Clinical Trial 2023: HPV Vaccine Highlights & Side Effects. Trial Name: NCT04722822 — N/A

HPV Vaccine (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04722822 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being enrolled in this investigation?

"As per the clinicaltrials.gov listing, recruitment for this trial is currently ongoing; it was initially posted on December 23rd 2019 and most recently updated on June 29th 2022."

Answered by AI

What is the eventual enrollment goal of this clinical trial?

"Affirmative. The clinicaltrials.gov database indicates that this experiment is actively searching for volunteers, having first been posted on December 23rd 2019 and most recently updated June 29th 2022. 660 participants are needed from two sites for proper data collection."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "The HPV 9-10 Trial: Early Initiation of HPV Vaccination". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04722822.

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