Increasing Optimal Use of HPV Vaccination in Primary Care

NCT ID: NCT04180462

Last Updated: 2025-03-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-07

Study Completion Date

2024-04-29

Brief Summary

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Washington University will evaluate the effectiveness of a multi-component implementation strategy to increase use of HPV vaccine in primary care practices.

Detailed Description

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The investigators at Washington University will complete a cluster-randomized trial to evaluate the effectiveness of a multi-component implementation strategy (the intervention) to increase use of the HPV vaccine according to CDC guidelines. The unit of randomization is a community-based, primary care pediatric practice. Twenty practices will be randomized into two groups, the intervention group (n=10) or a wait-list control group (n=10). The intervention will be implemented over 2-years and includes: 1) an educational video for providers; 2) audit and feedback of vaccine coverage; 3) a communication strategy; and 4) practice facilitation.

The primary outcome of HPV vaccination by age 13 will be assessed at 24 months, and at 36 months to assess if change is sustained.

Conditions

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Human Papillomavirus Vaccines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention Group

Practices randomly assigned to this arm will receive the multi-component intervention.

Group Type EXPERIMENTAL

Practice Facilitation

Intervention Type OTHER

Practice facilitation to support quality improvement methods to effect practice change to develop a sustainable HPV vaccine delivery system.

Education

Intervention Type OTHER

An educational video to increase the provider's knowledge about guideline recommendations and patient and practice benefits of vaccination by age 13.

Audit and Feedback

Intervention Type OTHER

Audit and feedback of vaccine coverage to increase motivation to engage in practice change.

Communication Strategy

Intervention Type OTHER

A communication strategy to improve the provider's communication skills and their self-efficacy to address parental hesitation.

Wait list control group

Practices randomly assigned to this arm will be offered the intervention in the last two years of the study.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Practice Facilitation

Practice facilitation to support quality improvement methods to effect practice change to develop a sustainable HPV vaccine delivery system.

Intervention Type OTHER

Education

An educational video to increase the provider's knowledge about guideline recommendations and patient and practice benefits of vaccination by age 13.

Intervention Type OTHER

Audit and Feedback

Audit and feedback of vaccine coverage to increase motivation to engage in practice change.

Intervention Type OTHER

Communication Strategy

A communication strategy to improve the provider's communication skills and their self-efficacy to address parental hesitation.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Practices:

* Community-based pediatric primary care practices with 2 or more providers.
* Providers who deliver wellness care to preteens and adolescents.
* Willingness to participate in the practice facilitator-guided QI process.

Providers:

* Providers who deliver wellness care to preteens and adolescents.
* Willingness to complete study questionnaires.
* Willingness to participate in the practice facilitator-guided QI process.

Exclusion Criteria

* Practices and providers may be excluded at the discretion of the PI.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Allison King, M.D., Ph.D., MPH

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

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http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

https://paarc.wustl.edu/

Washington University: Pediatric \& Adolescent Ambulatory Research Consortium

Other Identifiers

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1R01CA235615-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

201911030

Identifier Type: -

Identifier Source: org_study_id

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