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Improved Doctor-Patient Communication for HPV Vaccination (PCOM2 Trial)
N/A
Recruiting
Led By Sean O'Leary, 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 younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up adolescent vaccination initiation status will be assessed among all "active" (seen in the last 12 months) 13-17-year-old patients at each practice during the last 12 months of the 24 month intervention period
Awards & highlights
PCOM2 Trial Summary
This trial is testing a new way to get primary care providers to better recommend the HPV vaccine to their adolescent patients, in the hope that this will lead to more teens getting the vaccine and fewer cases of HPV-associated cancers.
Who is the study for?
This trial is for parents with kids aged 9-17 receiving care at enrolled clinics, and for healthcare providers working at these practices. Parents without children in this age range or not attending the participating clinics, and providers outside these practices cannot join.Check my eligibility
What is being tested?
The study is testing two ways of talking to patients about HPV vaccines: a new virtual communication method (PCOM2-virtual) versus the standard approach (PCOM-standard). The goal is to see if the virtual version can improve vaccination rates without needing much help from research teams.See study design
What are the potential side effects?
Since this trial focuses on communication methods rather than medical treatments, there are no direct side effects related to drugs or procedures. However, participants may experience varying levels of satisfaction or effectiveness with each communication strategy.
PCOM2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ adolescent vaccination initiation status will be assessed among all "active" (seen in the last 12 months) 11 to 12-year-old patients at each practice during the last 12 months of the 24 month intervention period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~adolescent vaccination initiation status will be assessed among all "active" (seen in the last 12 months) 11 to 12-year-old patients at each practice during the last 12 months of the 24 month intervention period
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
HPV vaccination initiation status in 11-12 year olds
Secondary outcome measures
HPV series completion among 11-12 year olds
HPV series completion among 13-17 year olds
HPV vaccination initiation status in 13-17 year olds
PCOM2 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PCOM2 Virtual ArmExperimental Treatment1 Intervention
Providers participating in the PCOM2-virtual arm will receive training on this communication method through an adapted virtual model of PCOM-standard.
PCOM2-Virtual intervention will result in a "shelf ready" intervention and associated "User Manual" that can be easily incorporated into practices broadly to improve the practice's adolescent HPV vaccination rates. PCOM-Virtual arm will then be compared to that of the original PCOM-standard intervention in its efficacy for increasing HPV vaccination among adolescents.
Group II: PCOM Standard ArmActive Control1 Intervention
Providers in participating in the PCOM-standard intervention will be trained on optimizing an in-person provider communication technique about HPV vaccination by training primary care providers in a 2-step verbal communication process: 1) to start the HPV vaccine discussion using a "presumptive" format, and 2) to use motivational interviewing (MI) techniques to address parental vaccine hesitancy.
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,406 Total Patients Enrolled
University of Kansas Medical CenterOTHER
463 Previous Clinical Trials
169,150 Total Patients Enrolled
Children's Mercy Hospital Kansas CityOTHER
245 Previous Clinical Trials
935,679 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a parent of a 9-17 year old who is receiving care at an enrolled clinic.I do not have a child aged 9-17 nor is my child receiving care at an enrolled clinic.
Research Study Groups:
This trial has the following groups:- Group 1: PCOM2 Virtual Arm
- Group 2: PCOM Standard Arm
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the research study allowing new participants to join?
"Clinicialtrials.gov reveals that this clinical trial is now closed to enrollment, as its latest update was posted on October 10th 2022. The study was initially open for recruitment in January 1st 2023; however, there are 111 alternative trials currently recruiting participants."
Answered by AI
What criteria must individuals meet to participate in this research endeavor?
"This trial is recruiting 120 adolescents - aged 9 to 17 - who have preventive health services. In order for parents and providers to be eligible, they must meet the criteria outlined: Parents should have an adolescent in the specified age range receiving care at a participating clinic; Providers will need to be employed by one of the enrolled practices."
Answered by AI
Are geriatric patients eligible for this research endeavor?
"The cut-off age for this trial is 17 and the minimum age requirement is 9. Furthermore, there are 25 clinical trials specifically designed for people under 18 years old and 58 treatments available to those over 65."
Answered by AI
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