- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03599557
The STOP-HPV Trial 1: Communication Intervention (STOP-HPV)
November 21, 2019 updated by: Peter G Szilagyi, MD MPH, University of California, Los Angeles
Improving HPV Vaccination Delivery in Pediatric Primary Care: The STOP-HPV Trial 1. Comparison of Communication Skills and Standard of Care for Uptake of the HPV Vaccine
Most adolescents who receive human papillomavirus (HPV) vaccine are vaccinated in pediatric practices, yet missed opportunities (MOs) for HPV vaccination occur often and lead to low HPV vaccination rates.
This cluster randomized clinical trial (RCT) will test the effectiveness (and cost-effectiveness) of training providers on HPV vaccine communication to reduce MOs and increase HPV vaccination rates.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
As highlighted by NCI, low HPV vaccination rates represent a major lost opportunity for population-wide cancer prevention.
Pediatric primary care office visits are the main site for HPV vaccination, yet many missed opportunities (MOs) for vaccination occur in primary care and contribute to low vaccination rates.
MOs are office visits during which a patient is eligible for a vaccine, but does not receive it.
Many factors cause MOs - provider factors (e.g., time-constrained visits, lack of communication skills, and giving vaccinations only at preventive visits) and parent factors (e.g., vaccine hesitancy).
This cluster randomized clinical trial will test the effectiveness (and cost-effectiveness) of training providers in HPV vaccine communication to reduce MOs and increase HPV vaccination rates.
This training will be done through online educational modules (sent via text or email), weekly mini lessons and live office practice sessions.
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Itasca, Illinois, United States, 60143
- American Academy of Pediatrics
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 17 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Practice Inclusion Criteria:
- The practice provides HPV vaccination services to adolescents.
- The practice is part of Physician's Computer Company (PCC), Office Practicum (OP) or (a) yet-to-be selected health system(s).
- The practice has had the same EHR system in place for a year or more (with special consideration on a case by case basis if they are close to but not do not reach a year).
- The practice agrees to not participate in other HPV-related QI projects or research interventions during the study period (with special consideration on a case by case basis).
Practice Exclusion Criteria:
- The practice plans to change EHR systems in the next three years.
- The practice participated in the last year, is currently engaged in, or plans to participate in an office-based HPV-related quality improvement (QI) project or research intervention during the study period (with special consideration on a case by case basis).
- Estimated 20% or more of adolescents at the practice receive HPV vaccinations at schools or health department clinics (given standard practice and published data, the investigators expect that few to no practices will need to be excluded based on this restriction).
Patient inclusion criteria:
-All patients of participating practices (intervention and comparison) aged 11-17 years who have at least 1 visit to the practice within the past two years.
Patient exclusion criteria:
-None apart from age of patients (above).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Arm 2 will receive standard of care
|
|
Experimental: Intervention
Arm 1 will receive the STOP-HPV communication intervention
|
This intervention will be communication skills training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the rate of missed vaccination opportunities among all clinicians
Time Frame: Monthly from months 0 (baseline) to month 6, and also aggregated over the 6-month period from month 0, where month 0 is site specific and depends on completion of site staff training and readiness to proceed.
|
Change in the rate of missed vaccination opportunities from baseline through the end of the communication intervention period among all clinicians.
|
Monthly from months 0 (baseline) to month 6, and also aggregated over the 6-month period from month 0, where month 0 is site specific and depends on completion of site staff training and readiness to proceed.
|
Change in the rate of missed vaccination opportunities among consenting clinicians
Time Frame: Monthly from months 0 (baseline) to month 6, and also aggregated over the 6-month period from month 0, where month 0 is site specific and depends on completion of site staff training and readiness to proceed.
|
Change in the rate of missed vaccination opportunities from baseline through the end of the communication intervention period among consenting clinicians.
|
Monthly from months 0 (baseline) to month 6, and also aggregated over the 6-month period from month 0, where month 0 is site specific and depends on completion of site staff training and readiness to proceed.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Peter Szilagyi, MD, University of California, Los Angeles
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Fiks AG, Hannan C, Localio R, Kelly MK, Stephens-Shields AJ, Grundmeier RW, Shone LP, Steffes J, Breck A, Wright M, Rand CM, Albertin C, Humiston SG, McFarland G, Abney DE, Szilagyi PG. HPV Vaccinations at Acute Visits and Subsequent Adolescent Preventive Visits. Pediatrics. 2022 Nov 1;150(5):e2022058188. doi: 10.1542/peds.2022-058188. No abstract available.
- Szilagyi PG, Humiston SG, Stephens-Shields AJ, Localio R, Breck A, Kelly MK, Wright M, Grundmeier RW, Albertin C, Shone LP, Steffes J, Rand CM, Hannan C, Abney DE, McFarland G, Kominski GF, Seixas BV, Fiks AG. Effect of Training Pediatric Clinicians in Human Papillomavirus Communication Strategies on Human Papillomavirus Vaccination Rates: A Cluster Randomized Clinical Trial. JAMA Pediatr. 2021 Sep 1;175(9):901-910. doi: 10.1001/jamapediatrics.2021.0766.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 7, 2018
Primary Completion (Actual)
July 30, 2019
Study Completion (Actual)
October 21, 2019
Study Registration Dates
First Submitted
June 29, 2018
First Submitted That Met QC Criteria
July 23, 2018
First Posted (Actual)
July 26, 2018
Study Record Updates
Last Update Posted (Actual)
November 25, 2019
Last Update Submitted That Met QC Criteria
November 21, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1R01CA202261 (U.S. NIH Grant/Contract)
- R01CA202261 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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