Increasing Optimal Use of HPV Vaccination in Primary Care

Human Papillomavirus Vaccines Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04180462
• Other study ID #: 201911030
• Secondary ID: 1R01CA235615-01A
• Status: Completed
• Phase: N/A
• Start date: January 7, 2020
• Est. completion date: April 29, 2024

Study information

• Verified date: May 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 29, 2024
• Est. primary completion date: February 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Human Papillomavirus Vaccines

Intervention

Other:
• Practice Facilitation
Practice facilitation to support quality improvement methods to effect practice change to develop a sustainable HPV vaccine delivery system.
• Education
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
Audit and feedback of vaccine coverage to increase motivation to engage in practice change.
• Communication Strategy
A communication strategy to improve the provider's communication skills and their self-efficacy to address parental hesitation.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Initiation of the HPV Vaccine 2-dose Series.	The proportion of eligible preteens who initiate the HPV vaccine before their 13th birthday, at 24 months, post randomization	24 months
Primary	Completion of the HPV Vaccine 2-dose Series.	The proportion of eligible preteens who complete the HPV vaccine before their 13th birthday, at 24 months, post randomization.	24 months
Secondary	Sustainability of the Intervention Benefit for Initiation of the HPV Vaccine.	The proportion of eligible preteens who receive the 1st dose of HPV vaccine before their 13th birthday at 36 months, post randomization	36 months
Secondary	Sustainability of the Intervention Benefit for Completion of the HPV Vaccine.	The proportion of eligible preteens who complete the HPV vaccine before their 13th birthday, at 36 months, post randomization	36 months

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
•   Washington University: Pediatric & Adolescent Ambulatory Research Consortium