Quality Improvement Strategies to Increase Human Papillomavirus (HPV) Vaccination



Status:Recruiting
Conditions:Infectious Disease, Women's Studies
Therapuetic Areas:Immunology / Infectious Diseases, Reproductive
Healthy:No
Age Range:Any
Updated:3/1/2019
Start Date:May 7, 2018
End Date:March 2020
Contact:Jennifer A Heisler-MacKinnon, MPH
Email:jenmackinnon@unc.edu
Phone:919-843-8962

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Impact of AFIX and Physician-to-Physician Engagement on HPV Vaccination in Primary Care: A Randomized Controlled Trial

HPV vaccination is at lower levels than the national goals. This study will evaluate the
effectiveness of quality improvement strategies for increasing HPV vaccination coverage among
adolescents in primary care clinics. The study will also evaluate the impact of delivering
"booster" doses of the interventions one year later.

The University of North Carolina will test the effectiveness of the Center for Disease
Control and Prevention's AFIX model, physician-to-physician engagement, and both strategies
in combination, for increasing HPV vaccination coverage among adolescents in primary care
clinics. AFIX (Assessment, Feedback, Incentives and eXchange) consists of brief quality
improvement consultations that immunization specialists from state health departments deliver
to vaccine providers in primary care settings. Using immunization registry data, the
specialist evaluates the clinic's vaccination coverage and delivers education on best
practices to improve coverage. Physician-to-physician (P2P) engagement consists of physician
educators providing feedback about clinics' current HPV vaccination coverage and in-depth
training about how to make strong and effective HPV vaccination recommendations to primary
care providers via remote webinar consultations. Physician educators will also use
immunization registry data to provide feedback on clinics' vaccine coverage. The
investigators will compare changes in HPV vaccination coverage before and after intervention
for high-volume primary care clinics in four study conditions: AFIX consultations delivered
in-person by state health department immunization specialists (AFIX group),
physician-to-physician consultations delivered remotely by trained physician educators (P2P
group), both AFIX and P2P consultations in combination (AFIX + P2P group), or no HPV quality
improvement intervention (control group). In each state, 30 clinics will be randomly assigned
to each study arm, for a total of 120 clinics per state, or 360 clinics overall.
Additionally, one year after the initial intervention, half of the clinics in each state in
each intervention arm (AFIX, P2P, and AFIX + P2P) will be randomized to either a "booster" or
"no booster" control condition (45 clinics per state, 135 overall). The primary objective of
this study is to compare the change in coverage for HPV vaccine initiation among 11-12 year
old patients, from baseline to 12-month follow-up. Secondarily, the study will compare the
change in coverage for other vaccines, age groups, time periods, and booster versus no
booster conditions.

Inclusion Criteria:

- Pediatric or family medicine clinics or practices in New York, Wisconsin, or Arizona
with at least 200 active records for patients, ages 11-17, in their states'
immunization information systems.

Exclusion Criteria:

- Less than 200 active records for patients between 11-17
We found this trial at
3
sites
Madison, Wisconsin 53703
Phone: 608-264-9884
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Madison, WI
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Albany, New York 12201
Phone: 518-473-4437
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Albany, NY
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Phoenix, Arizona 85007
Phone: 602-364-3632
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Phoenix, AZ
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