Increasing Optimal Use of HPV Vaccination in Primary Care

Not Applicable

Completed

• Conditions: Human Papillomavirus Vaccines
• Interventions: Other: Practice Facilitation; Other: Education; Other: Audit and Feedback; Other: Communication Strategy

• Registration Number: NCT04180462
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-11-26
• Study First Submitted QC: 2019-11-26
• Study First Posted: 2019-11-27
• Study Start: 2020-01-07
• Primary Completion: 2023-02-14
• Results First Submitted: 2024-01-26
• Results First Submitted QC: 2024-01-26
• Results First Posted: 2024-02-20
• Study Completion: 2024-04-29
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Education	Practices randomly assigned to this arm will receive the multi-component intervention.
Intervention Group	Audit and Feedback	Practices randomly assigned to this arm will receive the multi-component intervention.
Intervention Group	Communication Strategy	Practices randomly assigned to this arm will receive the multi-component intervention.
Intervention Group	Practice Facilitation	Practices randomly assigned to this arm will receive the multi-component intervention.

Primary Outcome Measures

Name	Time	Method
Initiation of the HPV Vaccine 2-dose Series.	24 months	The proportion of eligible preteens who initiate the HPV vaccine before their 13th birthday, at 24 months, post randomization
Completion of the HPV Vaccine 2-dose Series.	24 months	The proportion of eligible preteens who complete the HPV vaccine before their 13th birthday, at 24 months, post randomization.

Secondary Outcome Measures

Name	Time	Method
Sustainability of the Intervention Benefit for Initiation of the HPV Vaccine.	36 months	The proportion of eligible preteens who receive the 1st dose of HPV vaccine before their 13th birthday at 36 months, post randomization
Sustainability of the Intervention Benefit for Completion of the HPV Vaccine.	36 months	The proportion of eligible preteens who complete the HPV vaccine before their 13th birthday, at 36 months, post randomization

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States