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HPV Vaccine Optimization Strategies for Human Papillomavirus
N/A
Recruiting
Led By Noel T Brewer, PhD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 13 months to 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial studies how to increase HPV vaccine use in primary care clinics, with communication training and tools to optimize standing orders. #covid19
Who is the study for?
This trial is for primary care clinics that vaccinate children aged 9-12 against HPV but have vaccination rates below 72%. Clinics must have standing orders for the vaccine, which they either don't use routinely or are willing to adopt. Staff must complete a follow-up survey. Children and clinics not meeting these criteria are excluded.
What is being tested?
The study tests whether communication training combined with optimized standing orders increases HPV vaccination rates in clinics. Some clinics will receive only training, while others will get both training and tools to improve their standing order usage.
What are the potential side effects?
Since this trial focuses on staff training and procedural changes rather than medical interventions, there aren't direct side effects like those associated with drugs or vaccines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from 13 months to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 13 months to 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Estimated recommendation frequency, 11-12 year olds
Estimated recommendation frequency, 9-10 year olds
Estimated time spent on recommendations
+15 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: HPV vaccine communication training and standing orders optimizationExperimental Treatment1 Intervention
Staff in clinics randomized to this arm will receive the AAT and conduct a set of activities to optimize use of HPV vaccine standing orders.
Group II: HPV vaccine communication trainingExperimental Treatment1 Intervention
Staff in clinics randomized to this arm will receive an intervention called Announcement Approach Training (AAT). This training is designed to improve communication about HPV vaccination.
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Who is running the clinical trial?
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
363 Previous Clinical Trials
91,974 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,917 Previous Clinical Trials
41,014,431 Total Patients Enrolled
Noel T Brewer, PhDPrincipal InvestigatorUniversity of North Carolina
8 Previous Clinical Trials
5,574 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My clinic does not offer HPV vaccines to kids aged 9-12.My clinic approves HPV vaccination orders but doesn't always use them or is willing to start using them for the trial.My clinic is working to improve how we handle HPV vaccinations.My child is between 9-12 years old and is part of a clinic's follow-up study.My clinic offers HPV vaccines to kids aged 9-12.My clinic does not have HPV vaccination orders and won't adopt them before the trial starts.I am not between 9-12 years, not in a participating clinic, receiving end-of-life care, pregnant, or allergic to HPV vaccine.
Research Study Groups:
This trial has the following groups:- Group 1: HPV vaccine communication training
- Group 2: HPV vaccine communication training and standing orders optimization
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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