Increasing Optimal Use of HPV Vaccination in Primary Care

Randomized Controlled Trial to Evaluate an Implementation Strategy to Increase Optimal Use of HPV Vaccine 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Human Papillomavirus Vaccines
• Intervention / Treatment: Other: Practice Facilitation; Other: Education; Other: Audit and Feedback; Other: Communication Strategy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Wait list control group; Practices randomly assigned to this arm will be placed on a waiting list to receive the intervention in the last two years of the study.
Experimental: Intervention Group; Practices randomly assigned to this arm will receive the multi-component intervention.	Other: Practice Facilitation; Practice facilitation to support quality improvement methods to effect practice change to develop a sustainable HPV vaccine delivery system.; Other: Education; An educational video to increase the provider's knowledge about guideline recommendations and patient and practice benefits of vaccination by age 13.; Other: Audit and Feedback; Audit and feedback of vaccine coverage to increase motivation to engage in practice change.; Other: Communication Strategy; A communication strategy to improve the provider's communication skills and their self-efficacy to address parental hesitation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jason Newland, M.D., M.Ed, Washington University School of Medicine

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2020
• Primary Completion (Actual): February 14, 2023
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: November 26, 2019
• First Submitted That Met QC Criteria: November 26, 2019
• First Posted (Actual): November 27, 2019

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Quality Improvement; Implementation Strategy
• Other Study ID Numbers: 201911030; 1R01CA235615-01A1 (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