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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 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
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
1,806 Previous Clinical Trials
2,822,217 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,017,378 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,817 Previous Clinical Trials
8,161,099 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My practice serves over 100 patients aged 9-13.You live in certain areas of Colorado or California near Denver or Los Angeles, including some medical clinics.At least 60% of doctors in the practice have agreed to take part in the study.Children aged 9-10 years old have not yet been advised to receive the HPV vaccine by medical professionals.
Research Study Groups:
This trial has the following groups:- Group 1: Providers recommending HPV vaccine at age 11-12 years of age
- Group 2: Providers recommending HPV vaccine at age 9-10 years of age
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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