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Completed

NCT Number: NCT04180462

Increasing Optimal Use of HPV Vaccination in Primary Care

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

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Key information

Conditions

Human Papillomavirus Vaccines

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Practice Facilitation

Other

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

Education

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

Other

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

Communication Strategy

Other

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

Primary outcomes

  1. Initiation of the HPV Vaccine 2-dose Series.

    Time frame: 24 months

    The proportion of eligible preteens who initiate the HPV vaccine before their 13th birthday, at 24 months, post randomization

  2. Completion of the HPV Vaccine 2-dose Series.

    Time frame: 24 months

    The proportion of eligible preteens who complete the HPV vaccine before their 13th birthday, at 24 months, post randomization.

Secondary outcomes

  1. Sustainability of the Intervention Benefit for Initiation of the HPV Vaccine.

    Time frame: 36 months

    The proportion of eligible preteens who receive the 1st dose of HPV vaccine before their 13th birthday at 36 months, post randomization

  2. Sustainability of the Intervention Benefit for Completion of the HPV Vaccine.

    Time frame: 36 months

    The proportion of eligible preteens who complete the HPV vaccine before their 13th birthday, at 36 months, post randomization

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Randomized Controlled Trial to Evaluate an Implementation Strategy to Increase Optimal Use of HPV Vaccine in Primary Care

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Nov 27, 2019
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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