Overview

This trial has been completed.

Conditions papillomavirus vaccines, adolescent health services
Treatments afix in-person consultation, afix webinar consultation
Sponsor University of North Carolina, Chapel Hill
Collaborator Robert Wood Johnson Foundation
Start date April 2015
End date November 2016
Trial size 225 participants
Trial identifier NCT02370459, 13-3599, 71272

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(No Intervention)
This arm includes 30 high-volume primary care clinics in each of three states (Washington, Illinois, Michigan) for a total of 90 clinics. Clinics randomly assigned to this arm will receive no AFIX consultation.
(Experimental)
This arm includes 30 high-volume primary care clinics in each of three states (Washington, Illinois, Michigan) for a total of 90 clinics. Clinics randomly assigned to this arm will receive an in-person AFIX consultation. Consultations will be delivered by state health department staff.
afix in-person consultation AFIX, Assessment, Feedback, Incentives, and eXchange Program
The adolescent AFIX (Assessment, Feedback, Incentives, and eXchange) Program is a quality improvement strategy developed by the CDC to improve the immunization practices and vaccination coverage levels of public and private health care providers. It has four main components: 1) Assessment of a provider's current immunization practices and vaccination levels, 2) Feedback of the assessment results and strategies to improve coverage levels, 3) Incentives to improve coverage levels, and 4) eXchange of information and resources necessary to facilitate improvement. Relevant AFIX information will be communicated to vaccine providers using several intervention and quality improvement components.
(Experimental)
This arm includes 30 high-volume primary care clinics in each of three states (Washington, Illinois, Michigan) for a total of 90. Clinics randomly assigned to this arm will receive an AFIX consultation via interactive webinar. Consultations will be delivered by state health department staff.
afix webinar consultation AFIX, Assessment, Feedback, Incentives, and eXchange Program
The adolescent AFIX (Assessment, Feedback, Incentives, and eXchange) Program is a quality improvement strategy developed by the CDC to improve the immunization practices and vaccination coverage levels of public and private health care providers. It has four main components: 1) Assessment of a provider's current immunization practices and vaccination levels, 2) Feedback of the assessment results and strategies to improve coverage levels, 3) Incentives to improve coverage levels, and 4) eXchange of information and resources necessary to facilitate improvement. Relevant AFIX information will be communicated to vaccine providers using several intervention and quality improvement components.

Primary Outcomes

Measure
HPV vaccination (≥1 dose), 11-12 year olds
time frame: Six months

Secondary Outcomes

Measure
HPV vaccination (≥1 dose), 11-12 year olds
time frame: Six months
HPV vaccination (≥1 dose), 11-12 year olds
time frame: Six months
HPV vaccination (≥1 dose), 11-12 year olds
time frame: Twelve months
HPV vaccination (≥1 dose), 11-12 year olds
time frame: Twelve months
HPV vaccination (3 doses), 11-12 year olds
time frame: Six months
Tetanus, diphtheria, and acellular pertussis (Tdap) vaccination, 11-12 year olds
time frame: Six months
Meningococcal vaccination (≥1 dose), 11-12 year olds
time frame: Six months
HPV vaccination (≥1 dose), 13-17 year olds
time frame: Six months
HPV vaccination (3 doses), 13-17 year olds
time frame: Six months
Tdap vaccination, 13-17 year olds
time frame: Six months
Meningococcal vaccination (≥1 dose), 13-17 year olds
time frame: Six months
HPV vaccination (≥1 dose), 11-12 year olds
time frame: Twelve months
HPV vaccination (3 doses), 11-12 year olds
time frame: Twelve months
Tdap vaccination, 11-12 year olds
time frame: Twelve months
Meningococcal vaccination (≥1 dose), 11-12 year olds
time frame: Twelve months
HPV vaccination (≥1 dose), 13-17 year olds
time frame: Twelve months
HPV vaccination (3 doses), 13-17 year olds
time frame: Twelve months
Tdap vaccination, 13-17 year olds
time frame: Twelve months
Meningococcal vaccination (≥1 dose), 13-17 year olds
time frame: Twelve months
HPV vaccination (≥1 dose), 11-12 year olds
time frame: Six months
HPV vaccination (3 doses), 11-12 year olds
time frame: Six months
Tdap vaccination, 11-12 year olds
time frame: Six months
Meningococcal vaccination (≥1 dose), 11-12 year olds
time frame: Six months
HPV vaccination (≥1 dose), 13-17 year olds
time frame: Six months
HPV vaccination (3 doses), 13-17 year olds
time frame: Six months
Tdap vaccination, 13-17 year olds
time frame: Six months
Meningococcal vaccination (≥1 dose), 13-17 year olds
time frame: Six months
HPV vaccination (≥1 dose), 11-12 year olds
time frame: Twelve months
HPV vaccination (3 doses), 11-12 year olds
time frame: Twelve months
Tdap vaccination, 11-12 year olds
time frame: Twelve months
Meningococcal vaccination (≥1 dose), 11-12 year olds
time frame: Twelve months
HPV vaccination (≥1 dose), 13-17 year olds
time frame: Twelve months
HPV vaccination (3 doses), 13-17 year olds
time frame: Twelve months
Tdap vaccination, 13-17 year olds
time frame: Twelve months
Meningococcal vaccination (≥1 dose), 13-17 year olds
time frame: Twelve months

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title Adolescent AFIX: A Multi-state RCT to Increase Adolescent Vaccination by Facilitating Providers' Adoption of Best Practices
Principal investigator Melissa B Gilkey, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill.