Clinical trial NCT02370459: AFIX to Improve HPV Vaccination
Official title: Adolescent AFIX: A Multi-state RCT to Increase Adolescent Vaccination by Facilitating Providers' Adoption of Best Practices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Papillomavirus Vaccines
Adolescent Health Services
Keywords: Papillomavirus Vaccines
Immunization
Quality Improvement
Adolescent Health Services
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
name: Washington State, Department of Health
name: Illinois Department of Public Health
name: Michigan Department of Community Health
name: Harvard Medical School (HMS and HSDM)
First posted: 2015-02-25
Enrollment: 223
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The University of North Carolina will test the effectiveness of the Centers for Disease Control and Prevention's AFIX model for increasing HPV vaccination coverage among adolescents. 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. We will compare changes in HPV vaccination coverage before and after consultations for high-volume pediatric and family medicine clinics across three study conditions: traditional consultations (in-person group), virtual consultations (webinar group), or no consultations (control group). In each participating state, 30 clinics will be randomly assigned to each study arm, for a total of 90 clinics per state, or 270 clinics 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 6-month follow-up. Secondarily, we will compare the change in coverage for other vaccines and age groups.


Eligibility criteria: Inclusion Criteria: Pediatric or family medicine clinics or practices in WA, IL, or MI with

* at least 500 active records for patients, ages 11-17, in their states' immunization information systems.

Primary outcomes:
measure: HPV vaccination (≥1 dose), 11-12 year olds
timeFrame: Six months
Secondary outcomes:
measure: HPV vaccination (≥1 dose), 11-12 year olds
timeFrame: Six months
measure: HPV vaccination (≥1 dose), 11-12 year olds
timeFrame: Six months
measure: HPV vaccination (≥1 dose), 11-12 year olds
timeFrame: Twelve months
measure: HPV vaccination (≥1 dose), 11-12 year olds
timeFrame: Twelve months
measure: HPV vaccination (3 doses), 11-12 year olds
timeFrame: Six months
measure: Tetanus, diphtheria, and acellular pertussis (Tdap) vaccination, 11-12 year olds
timeFrame: Six months
measure: Meningococcal vaccination (≥1 dose), 11-12 year olds
timeFrame: Six months
measure: HPV vaccination (≥1 dose), 13-17 year olds
timeFrame: Six months
measure: HPV vaccination (3 doses), 13-17 year olds
timeFrame: Six months
measure: Tdap vaccination, 13-17 year olds
timeFrame: Six months
measure: Meningococcal vaccination (≥1 dose), 13-17 year olds
timeFrame: Six months
measure: HPV vaccination (≥1 dose), 11-12 year olds
timeFrame: Twelve months
measure: HPV vaccination (3 doses), 11-12 year olds
timeFrame: Twelve months
measure: Tdap vaccination, 11-12 year olds
timeFrame: Twelve months
measure: Meningococcal vaccination (≥1 dose), 11-12 year olds
timeFrame: Twelve months
measure: HPV vaccination (≥1 dose), 13-17 year olds
timeFrame: Twelve months
measure: HPV vaccination (3 doses), 13-17 year olds
timeFrame: Twelve months
measure: Tdap vaccination, 13-17 year olds
timeFrame: Twelve months
measure: Meningococcal vaccination (≥1 dose), 13-17 year olds
timeFrame: Twelve months
measure: HPV vaccination (≥1 dose), 11-12 year olds
timeFrame: Six months
measure: HPV vaccination (3 doses), 11-12 year olds
timeFrame: Six months
measure: Tdap vaccination, 11-12 year olds
timeFrame: Six months
measure: Meningococcal vaccination (≥1 dose), 11-12 year olds
timeFrame: Six months
measure: HPV vaccination (≥1 dose), 13-17 year olds
timeFrame: Six months
measure: HPV vaccination (3 doses), 13-17 year olds
timeFrame: Six months
measure: Tdap vaccination, 13-17 year olds
timeFrame: Six months
measure: Meningococcal vaccination (≥1 dose), 13-17 year olds
timeFrame: Six months
measure: HPV vaccination (≥1 dose), 11-12 year olds
timeFrame: Twelve months
measure: HPV vaccination (3 doses), 11-12 year olds
timeFrame: Twelve months
measure: Tdap vaccination, 11-12 year olds
timeFrame: Twelve months
measure: Meningococcal vaccination (≥1 dose), 11-12 year olds
timeFrame: Twelve months
measure: HPV vaccination (≥1 dose), 13-17 year olds
timeFrame: Twelve months
measure: HPV vaccination (3 doses), 13-17 year olds
timeFrame: Twelve months
measure: Tdap vaccination, 13-17 year olds
timeFrame: Twelve months
measure: Meningococcal vaccination (≥1 dose), 13-17 year olds
timeFrame: Twelve months
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Illinois Department of Public Health
state: Illinois
city: Lansing
country: United States
facility: Michigan Department of Community Health
state: Michigan
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Olympia
country: United States
facility: Washington State Department of Health
state: Washington
Study officials:
affiliation: Harvard Medical School (HMS and HSDM)
name: Melissa B Gilkey, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina
name: Noel T Brewer, PhD
role: PRINCIPAL_INVESTIGATOR
References: