The STOP-HPV Trial 6: Single Arm Evaluation of the Maintenance of the STOP-HPV Bundle (STOP-HPV)

January 25, 2023 updated by: Peter G Szilagyi, MD MPH, University of California, Los Angeles

Improving HPV Vaccination Delivery in Pediatric Primary Care: The STOP-HPV Trial 6. Single Arm Evaluation of the Maintenance of the STOP-HPV Bundle

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 single arm evaluation (embedded within arm 1 of a 2-arm cluster randomized clinical trial (RCT)) will test the sustainability of improvement made in response to a bundled intervention including HPV vaccine communication, performance feedback and provider prompts to reduce MOs and increase HPV vaccination rates.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

HPV vaccine rates remain lower than rates for other adolescent vaccines. Missed opportunities (MOs) are healthcare visits during which a patient is eligible, but does not receive a vaccine. MOs for vaccination contribute strongly to low HPV vaccination rates. This single arm evaluation (embedded within arm 1 of a 2-arm cluster RCT) will test the sustainability of improvement made in repose to a bundled intervention including HPV vaccine communication (done through online educational modules and live office practice sessions), performance feedback reports (that pull from electronic health record (EHR) data, and compare participants performance to their own previous performance and those of others) and provider prompts (via EHR and also office staff prompts, e.g., placing Vaccine Information Statements (VISs) on desk) to reduce MOs and increase HPV vaccination rates.

Study Type

Interventional

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

  • United States
    • 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

No

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single arm
These practices, which previously received the addition of performance feedback and provider prompts in the presence of communication skills training, will receive The STOP-HPV Trial 6: Maintenance
Behavioral: The STOP-HPV Trial 6: Maintenance
In this period, study team support will be withdrawn after previous bundled intervention (including HPV vaccine communication, performance feedback and provider prompts) was given to reduce MOs and increase HPV vaccination rates.

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) through month 27 (end of maintenance period), 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 maintenance period among all clinicians, with a focus on the contrast between the end of the bundled intervention and the maintenance period.
Monthly from months 0 (baseline) through month 27 (end of maintenance period), 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) through month 27 (end of maintenance period), 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 maintenance period among consenting clinicians, with a focus on the contrast between the end of the bundled intervention and the maintenance period.
Monthly from months 0 (baseline) through month 27 (end of maintenance period), 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.

Sponsor

University of California, Los Angeles

Collaborators

National Cancer Institute (NCI)
Children's Hospital of Philadelphia
University of Pennsylvania
National Institutes of Health (NIH)
University of Rochester
American Academy of Pediatrics

Investigators

  • Principal Investigator: Peter Szilagry, MD, University of California, Los Angeles

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 (Anticipated)

March 1, 2021

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

June 29, 2018

First Submitted That Met QC Criteria

July 23, 2018

First Posted (Actual)

August 1, 2018

Study Record Updates

Last Update Posted (Actual)

January 27, 2023

Last Update Submitted That Met QC Criteria

January 25, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 6R01CA202261 (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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