Increasing Optimal Use of HPV Vaccination in Primary Care

NCT04180462 | Completed Results

• 2 other identifiers: 2019110301R01CA235615-01A1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Human Papillomavirus Vaccines

Keywords

Implementation Strategy; Quality Improvement

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

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

  36 months

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

  36 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Other: Practice Facilitation; Other: Education; Other: Audit and Feedback; Other: Communication Strategy

Wait list control group

NO INTERVENTION

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

Interventions

Practice Facilitation OTHER

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

Intervention Group

Education OTHER

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

Intervention Group

Audit and Feedback OTHER

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

Intervention Group

Communication Strategy OTHER

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

Intervention Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Practices and providers may be excluded at the discretion of the PI.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Results Point of Contact

• Title: Allison King, M.D., Ph.D., MPH
• Organization: Washington University School of Medicine

king_a@wustl.edu

314-454-4291

Study Officials

• Allison King, M.D., Ph.D., MPH

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: November 27, 2019
• Study Start: January 7, 2020
• Primary Completion: February 14, 2023
• Study Completion: April 29, 2024
• Last Updated: March 25, 2025
• Results First Posted: February 20, 2024

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)