Clinical trial NCT02812732: DOSE HPV: Development of Systems and Education to Improve HPV Vaccination Rates
Official title: DOSE HPV: Development of Systems and Education to Improve HPV Vaccination Rates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior
Keywords: HPV vaccination
provider education
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Boston University
name: American Cancer Society, Inc.
First posted: 2016-06-24
Enrollment: 382
Sex: ALL
Minimum age (years): 9
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: BACKGROUND

Human Papillomavirus (HPV) causes cervical, vaginal, vulvar, anal, and oral cancers, which disproportionately affect low-income and minority populations. Universal HPV vaccination has the potential to decrease burdens and to reduce disparities in these diseases. However, HPV vaccination rates for U.S. adolescents remain low. Clinician recommendation is the most important factor influencing HPV vaccine uptake; thus enhancing clinician communication about HPV vaccines is a critically important target for interventions to prevent cancer.

OBJECTIVE

In the past six years, the investigators' research has identified factors affecting HPV vaccine communication and utilization. the investigators recently piloted a communication intervention with clinicians, and 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 investigators aim to demonstrate the effectiveness of this intervention in a randomized trial, and to directly examine its effects on communication.

SPECIFIC AIMS

Aim 1. To evaluate intervention effectiveness on raising HPV vaccination rates using a stepped wedge randomized trial in federally qualified health centers.

Aim 2: To conduct a process evaluation that examines barriers and facilitators to intervention implementation and intervention sustainability, and to assess intervention fidelity.

Aim 3. To describe specific effects of the intervention on clinician-parent communication about HPV vaccination.

STUDY DESIGN

To address Aim 1, the investigators will perform a stepped wedge randomized trial in five community health centers to determine the effectiveness of the intervention. The intervention consists of a seven session Performance Improvement Continuing Medical Education (PI CME) program that employs HPV education and training in motivational interviewing to improve clinicians' HPV vaccine communication, and allows clinicians to improve the quality of vaccine care while fulfilling board certification requirements. To address Aim 2, the investigators will individually interview a selected group of providers and clinical leaders using the Promoting Action on Research Implementation in Health Services (PARiHS) model of process evaluation, and will analyze audio recordings of clinical interactions to measure intervention fidelity. Aim 3, an exploration of the intervention's effects on parent-clinician communication, will be conducted by surveying parents and clinicians and observing clinical encounters.

CANCER RELEVANCE

Rates of HPV related cancers have been increasing, but vaccination rates have remained stagnant since 2011. Recognizing the potential impact of HPV vaccination, the President's Cancer Panel stated in 2014 that raising HPV vaccination rates was a national priority. The proposed intervention represents an innovative and scalable model for promoting cancer prevention and screening activities by clinicians.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* do not receive primary care
* outside age range

Primary outcomes:
measure: Intervention effectiveness on increasing HPV vaccination rates using a stepped wedge randomized trial in federally qualified health centers.
timeFrame: Outcomes are assessed up to 36 months from the start of the study.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Boston Medical Center/ Boston University School of Medicine
name: Rebecca Perkins, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.