AFIX to Improve HPV Vaccination

Papillomavirus Vaccines Clinical Trial

— AFIX  

Official title:

Adolescent AFIX: A Multi-state RCT to Increase Adolescent Vaccination by Facilitating Providers' Adoption of Best Practices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02370459
• Other study ID #: 13-3599
• Secondary ID: 71272
• Status: Completed
• Phase: N/A
• First received: February 5, 2015
• Last updated: February 23, 2017
• Start date: April 2015
• Est. completion date: November 2016

Study information

• Verified date: February 2017
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent Health Services
• Papillomavirus Vaccines

Intervention

Other:
• AFIX in-person consultation
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.
• AFIX webinar consultation
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.

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Michigan Department of Community Health	Lansing	Michigan
United States	Washington State Department of Health	Olympia	Washington
United States	Illinois Department of Public Health	Springfield	Illinois

Sponsors (6)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Harvard Medical School, Illinois Department of Public Health, Michigan Department of Community Health, Robert Wood Johnson Foundation, Washington State, Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HPV vaccination (=1 dose), 11-12 year olds	Coverage change from baseline to six months in HPV vaccine initiation (=1 dose), among 11- to 12-year old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by electronic immunization information system (IIS) records, controlling for child's sex	Six months
Secondary	HPV vaccination (=1 dose), 11-12 year olds	Coverage change from baseline to six months in HPV vaccine initiation (=1 dose), among 11- 12-year old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records, stratifying by child's sex.	Six months
Secondary	HPV vaccination (=1 dose), 11-12 year olds	Coverage change from baseline to six months in HPV vaccine initiation (=1 dose), among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records, stratifying by state (IL, MI or WA).	Six months
Secondary	HPV vaccination (=1 dose), 11-12 year olds	Coverage change from baseline to twelve months in HPV vaccine initiation (=1 dose), among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records, stratifying by child's sex.	Twelve months
Secondary	HPV vaccination (=1 dose), 11-12 year olds	Coverage change from baseline to twelve months in HPV vaccine initiation (=1 dose), among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records, stratifying by state (IL, MI or WA).	Twelve months
Secondary	HPV vaccination (3 doses), 11-12 year olds	Coverage change from baseline to six months in HPV vaccine completion (3 doses), among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.	Six months
Secondary	Tetanus, diphtheria, and acellular pertussis (Tdap) vaccination, 11-12 year olds	Coverage change from baseline to six months in Tdap vaccination among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.	Six months
Secondary	Meningococcal vaccination (=1 dose), 11-12 year olds	Coverage change from baseline to six months in meningococcal vaccination (=1 dose), among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.	Six months
Secondary	HPV vaccination (=1 dose), 13-17 year olds	Coverage change from baseline to six months in HPV vaccine initiation (=1 dose), among 13- to 17-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.	Six months
Secondary	HPV vaccination (3 doses), 13-17 year olds	Coverage change from baseline to six months in HPV vaccine completion (3 doses), among 13- to 17-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.	Six months
Secondary	Tdap vaccination, 13-17 year olds	Coverage change from baseline to six months in Tdap vaccination among 13- to 17-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.	Six months
Secondary	Meningococcal vaccination (=1 dose), 13-17 year olds	Coverage change from baseline to six months in meningococcal vaccination (=1 dose), among 13- to 17-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.	Six months
Secondary	HPV vaccination (=1 dose), 11-12 year olds	Coverage change from baseline to twelve months in HPV vaccine initiation (=1 dose), among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.	Twelve months
Secondary	HPV vaccination (3 doses), 11-12 year olds	Coverage change from baseline to twelve months in HPV vaccine completion (3 doses), among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.	Twelve months
Secondary	Tdap vaccination, 11-12 year olds	Coverage change from baseline to twelve months in Tdap vaccination among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.	Twelve months
Secondary	Meningococcal vaccination (=1 dose), 11-12 year olds	Coverage change from baseline to twelve months in meningococcal vaccination (=1 dose), among 11- to 12-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.	Twelve months
Secondary	HPV vaccination (=1 dose), 13-17 year olds	Coverage change from baseline to twelve months in HPV vaccine initiation (=1 dose), among 13- to 17-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.	Twelve months
Secondary	HPV vaccination (3 doses), 13-17 year olds	Coverage change from baseline to twelve months in HPV vaccine completion (3 doses), among 13- to 17-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.	Twelve months
Secondary	Tdap vaccination, 13-17 year olds	Coverage change from baseline to twelve months in Tdap vaccination among 13- to 17-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.	Twelve months
Secondary	Meningococcal vaccination (=1 dose), 13-17 year olds	Coverage change from baseline to twelve months in meningococcal vaccination (=1 dose), among 13- to 17-year-old patients in the control arm versus the combined in-person and webinar intervention arms, as measured by IIS records.	Twelve months
Secondary	HPV vaccination (=1 dose), 11-12 year olds	Coverage change from baseline to six months in HPV vaccine initiation (=1 dose), among 11- to 12-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.	Six months
Secondary	HPV vaccination (3 doses), 11-12 year olds	Coverage change from baseline to six months in HPV vaccine completion (3 doses), among 11- to 12-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.	Six months
Secondary	Tdap vaccination, 11-12 year olds	Coverage change from baseline to six months in Tdap vaccination among 11- to 12-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.	Six months
Secondary	Meningococcal vaccination (=1 dose), 11-12 year olds	Coverage change from baseline to six months in meningococcal vaccination (=1 dose), among 11- to 12-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.	Six months
Secondary	HPV vaccination (=1 dose), 13-17 year olds	Coverage change from baseline to six months in HPV vaccine initiation (=1 dose), among 13- to 17-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.	Six months
Secondary	HPV vaccination (3 doses), 13-17 year olds	Coverage change from baseline to six months in HPV vaccine completion (3 doses), among 13- to 17-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.	Six months
Secondary	Tdap vaccination, 13-17 year olds	Coverage change from baseline to six months in Tdap vaccination among 13- to 17-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.	Six months
Secondary	Meningococcal vaccination (=1 dose), 13-17 year olds	Coverage change from baseline to six months in meningococcal vaccination (=1 dose), among 13- to 17-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.	Six months
Secondary	HPV vaccination (=1 dose), 11-12 year olds	Coverage change from baseline to twelve months in HPV vaccine initiation (=1 dose), among 11- to 12-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.	Twelve months
Secondary	HPV vaccination (3 doses), 11-12 year olds	Coverage change from baseline to twelve months in HPV vaccine completion (3 doses), among 11- to 12-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.	Twelve months
Secondary	Tdap vaccination, 11-12 year olds	Coverage change from baseline to twelve months in Tdap vaccination among 11- to 12-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.	Twelve months
Secondary	Meningococcal vaccination (=1 dose), 11-12 year olds	Coverage change from baseline to twelve months in meningococcal vaccination (=1 dose), among 11- to 12-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.	Twelve months
Secondary	HPV vaccination (=1 dose), 13-17 year olds	Coverage change from baseline to twelve months in HPV vaccine initiation (=1 dose), among 13- to 17-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.	Twelve months
Secondary	HPV vaccination (3 doses), 13-17 year olds	Coverage change from baseline to twelve months in HPV vaccine completion (3 doses), among 13- to 17-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.	Twelve months
Secondary	Tdap vaccination, 13-17 year olds	Coverage change from baseline to twelve months in Tdap vaccination among 13- to 17-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.	Twelve months
Secondary	Meningococcal vaccination (=1 dose), 13-17 year olds	Coverage change from baseline to twelve months in meningococcal vaccination (=1 dose), among 13- to 17-year-old patients in the webinar versus in-person intervention arm, as measured by IIS records.	Twelve months