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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
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
No Placebo-Only Group

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.
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.
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.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Age at completion of two dose HPV series
Secondary study objectives
Age at initiation of the HPV series
HPV completion by age 13 years

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,810 Previous Clinical Trials
2,919,440 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,111,457 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,840 Previous Clinical Trials
8,171,463 Total Patients Enrolled
Allison Kempe, MD, MPHPrincipal InvestigatorUniversity of Colorado, Denver
11 Previous Clinical Trials
517,125 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
~31 spots leftby Apr 2025
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