DOSE HPV: Development of Systems and Education to Improve HPV Vaccination Rates

NCT02812732 | Completed

• 1 other identifier: H-34561
• Study Type: interventional
• Target: 382
• Locations: 0 countries
• Sites: N/A

Brief Summary

After completing over 600 interviews with parents, adolescents, and clinicians to determine reasons why HPV vaccines are used or not used, the investigators recently piloted a communication-based educational intervention with healthcare clinicians to improve communication around HPV vaccination. The intervention combined education and quality improvement methods using a mechanism called Performance Improvement Continuing Medical Education. This type of intervention is attractive to clinicians because they improve their cancer prevention practices while fulfilling requirements for maintaining board certification. The intervention consists of seven education and feedback sessions along with baseline and follow-up chart reviews and facilitated group discussions of clinician and practice vaccination rates. The pilot intervention was effective: at the two pilot intervention sites, girls were 60% and boys were 15 times more likely to receive HPV vaccination than at control sites both during and after the intervention period. The goal of the proposed research is to broadly test the intervention's effectiveness in a diverse group of pediatric and family medicine practices serving low-income and minority patients. First, the investigators will perform a randomized trial in five community health centers to determine the effectiveness of the intervention. Second, the investigators will examine what made the intervention successful and identify barriers to sustainability with the goal of ensuring that the intervention can be successfully replicated in other settings. Third, the investigators will explore the effects of the intervention on parent-clinician communication by surveying parents and clinicians and observing clinical encounters when vaccination is discussed. The proposed intervention represents an innovative and scalable model for promoting cancer prevention and screening activities by clinicians. Unlike programs that increase administrative burdens on busy clinicians, the proposed intervention allows clinicians to improve cancer prevention practices while simultaneously fulfilling requirements to maintain their board certification and improving the quality of cancer prevention care. It therefore has great potential for widespread dissemination.

Conditions

Behavior

Keywords

HPV vaccination; provider education

Outcome Measures

Primary Outcomes (1)

• Intervention effectiveness on increasing HPV vaccination rates using a stepped wedge randomized trial in federally qualified health centers.

  Compare pre- and post-intervention rates of HPV vaccination

  Outcomes are assessed up to 36 months from the start of the study.

Study Arms (1)

Intervention

OTHER

Providers at each clinic will receive the intervention (DOSE HPV) on a rolling basis. Vaccination rates will be compared pre- and post-intervention at each clinic, and changes in rates will be compared across clinics.

Behavioral: DOSE HPV

Interventions

DOSE HPV BEHAVIORAL

The primary goals of the DOSE HPV intervention are to 1) change clinician HPV vaccine recommendations and responses to hesitant parents, and 2) support systems changes to improve the vaccination process. The first four sessions follow a standardized curriculum, while the last three sessions include development and implementation of tailored activities designed to meet individual practice needs. Sessions 1 and 2 generate motivation for the project through feedback of vaccination rates (Session 1) and education on HPV disease (Session 2). Brief Negotiated Interview (BNI) skills are taught in Sessions 3\&4. Action Plans are developed in Session 5. Sessions 6\&7, which follow a standard quality improvement format: plan-do-study-act (PDSA) cycles.

Intervention

Eligibility Criteria

• Age: 9 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Receive primary care at intervention sites
• ages 9-26

You may not qualify if:

• do not receive primary care
• outside age range

Sponsors & Collaborators

• Boston Medical Center: lead
• Boston University: collaborator
• American Cancer Society, Inc.: collaborator

Related Publications (4)

• Perkins RB, Zisblatt L, Legler A, Trucks E, Hanchate A, Gorin SS. Effectiveness of a provider-focused intervention to improve HPV vaccination rates in boys and girls. Vaccine. 2015 Feb 25;33(9):1223-9. doi: 10.1016/j.vaccine.2014.11.021. Epub 2014 Nov 24.

  PMID: 25448095 RESULT

• Casey SM, Jansen E, Drainoni ML, Schuch TJ, Leschly KS, Perkins RB. Long-Term Multilevel Intervention Impact on Human Papillomavirus Vaccination Rates Spanning the COVID-19 Pandemic. J Low Genit Tract Dis. 2022 Jan 1;26(1):13-19. doi: 10.1097/LGT.0000000000000648.

  PMID: 34928249 DERIVED

• Perkins RB, Legler A, Jansen E, Bernstein J, Pierre-Joseph N, Eun TJ, Biancarelli DL, Schuch TJ, Leschly K, Fenton ATHR, Adams WG, Clark JA, Drainoni ML, Hanchate A. Improving HPV Vaccination Rates: A Stepped-Wedge Randomized Trial. Pediatrics. 2020 Jul;146(1):e20192737. doi: 10.1542/peds.2019-2737. Epub 2020 Jun 15.

  PMID: 32540986 DERIVED

• Perkins RB, Banigbe B, Fenton AT, O'Grady AK, Jansen EM, Bernstein JL, Joseph NP, Eun TJ, Biancarelli DL, Drainoni ML. Effect of a multi-component intervention on providers' HPV vaccine communication. Hum Vaccin Immunother. 2020 Nov 1;16(11):2736-2743. doi: 10.1080/21645515.2020.1747923. Epub 2020 May 13.

  PMID: 32401592 DERIVED

MeSH Terms

Conditions

Behavior

Study Officials

• Rebecca Perkins, MD

  Boston Medical Center/ Boston University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: June 24, 2016
• Study Start: April 1, 2016
• Primary Completion: May 15, 2018
• Study Completion: May 15, 2018
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share