AFIX to Improve HPV Vaccination (AFIX)

• ClinicalTrials.gov Identifier: NCT02370459
• Recruitment Status: Completed
• First Posted: February 25, 2015
• Last Update Posted: February 24, 2017
• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Robert Wood Johnson Foundation; Washington State, Department of Health; Illinois Department of Public Health; Michigan Department of Community Health; Harvard Medical School (HMS and HSDM)
• Information provided by (Responsible Party): University of North Carolina, Chapel Hill

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Papillomavirus Vaccines; Adolescent Health Services	Other: AFIX in-person consultation; Other: AFIX webinar consultation	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 223 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Adolescent AFIX: A Multi-state RCT to Increase Adolescent Vaccination by Facilitating Providers' Adoption of Best Practices
• Study Start Date: April 2015
• Actual Primary Completion Date: November 2016
• Actual Study Completion Date: November 2016

Arms and Interventions

Arm	Intervention/treatment
No Intervention: control; 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: AFIX in-person consultation; 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.	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.; Other Name: AFIX, Assessment, Feedback, Incentives, and eXchange Program
Experimental: AFIX webinar consultation; 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.	Other: 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.; Other Name: AFIX, Assessment, Feedback, Incentives, and eXchange Program

Outcome Measures

Primary Outcome Measures :

1. HPV vaccination (≥1 dose), 11-12 year olds [ Time Frame: Six months ]
   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

Secondary Outcome Measures :

1. HPV vaccination (≥1 dose), 11-12 year olds [ Time Frame: Six months ]
   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.
2. HPV vaccination (≥1 dose), 11-12 year olds [ Time Frame: Six months ]
   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).
3. HPV vaccination (≥1 dose), 11-12 year olds [ Time Frame: Twelve months ]
   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.
4. HPV vaccination (≥1 dose), 11-12 year olds [ Time Frame: Twelve months ]
   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).
5. HPV vaccination (3 doses), 11-12 year olds [ Time Frame: Six months ]
   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.
6. Tetanus, diphtheria, and acellular pertussis (Tdap) vaccination, 11-12 year olds [ Time Frame: Six months ]
   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.
7. Meningococcal vaccination (≥1 dose), 11-12 year olds [ Time Frame: Six months ]
   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.
8. HPV vaccination (≥1 dose), 13-17 year olds [ Time Frame: Six months ]
   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.
9. HPV vaccination (3 doses), 13-17 year olds [ Time Frame: Six months ]
   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.
10. Tdap vaccination, 13-17 year olds [ Time Frame: Six months ]
    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.
11. Meningococcal vaccination (≥1 dose), 13-17 year olds [ Time Frame: Six months ]
    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.
12. HPV vaccination (≥1 dose), 11-12 year olds [ Time Frame: Twelve months ]
    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.
13. HPV vaccination (3 doses), 11-12 year olds [ Time Frame: Twelve months ]
    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.
14. Tdap vaccination, 11-12 year olds [ Time Frame: Twelve months ]
    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.
15. Meningococcal vaccination (≥1 dose), 11-12 year olds [ Time Frame: Twelve months ]
    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.
16. HPV vaccination (≥1 dose), 13-17 year olds [ Time Frame: Twelve months ]
    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.
17. HPV vaccination (3 doses), 13-17 year olds [ Time Frame: Twelve months ]
    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.
18. Tdap vaccination, 13-17 year olds [ Time Frame: Twelve months ]
    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.
19. Meningococcal vaccination (≥1 dose), 13-17 year olds [ Time Frame: Twelve months ]
    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.
20. HPV vaccination (≥1 dose), 11-12 year olds [ Time Frame: Six months ]
    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.
21. HPV vaccination (3 doses), 11-12 year olds [ Time Frame: Six months ]
    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.
22. Tdap vaccination, 11-12 year olds [ Time Frame: Six months ]
    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.
23. Meningococcal vaccination (≥1 dose), 11-12 year olds [ Time Frame: Six months ]
    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.
24. HPV vaccination (≥1 dose), 13-17 year olds [ Time Frame: Six months ]
    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.
25. HPV vaccination (3 doses), 13-17 year olds [ Time Frame: Six months ]
    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.
26. Tdap vaccination, 13-17 year olds [ Time Frame: Six months ]
    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.
27. Meningococcal vaccination (≥1 dose), 13-17 year olds [ Time Frame: Six months ]
    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.
28. HPV vaccination (≥1 dose), 11-12 year olds [ Time Frame: Twelve months ]
    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.
29. HPV vaccination (3 doses), 11-12 year olds [ Time Frame: Twelve months ]
    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.
30. Tdap vaccination, 11-12 year olds [ Time Frame: Twelve months ]
    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.
31. Meningococcal vaccination (≥1 dose), 11-12 year olds [ Time Frame: Twelve months ]
    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.
32. HPV vaccination (≥1 dose), 13-17 year olds [ Time Frame: Twelve months ]
    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.
33. HPV vaccination (3 doses), 13-17 year olds [ Time Frame: Twelve months ]
    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.
34. Tdap vaccination, 13-17 year olds [ Time Frame: Twelve months ]
    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.
35. Meningococcal vaccination (≥1 dose), 13-17 year olds [ Time Frame: Twelve months ]
    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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Illinois

Illinois Department of Public Health

Springfield, Illinois, United States, 62761

United States, Michigan

Michigan Department of Community Health

Lansing, Michigan, United States, 48909

United States, North Carolina

University of North Carolina

Chapel Hill, North Carolina, United States, 27599

United States, Washington

Washington State Department of Health

Olympia, Washington, United States, 98504

Sponsors and Collaborators

University of North Carolina, Chapel Hill

Robert Wood Johnson Foundation

Washington State, Department of Health

Illinois Department of Public Health

Michigan Department of Community Health

Harvard Medical School (HMS and HSDM)

Investigators

• Principal Investigator: Melissa B Gilkey, PhD; Harvard Medical School (HMS and HSDM)
• Principal Investigator: Noel T Brewer, PhD; University of North Carolina

More Information

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT02370459
• Other Study ID Numbers: 13-3599; 71272 ( Other Grant/Funding Number: Robert Wood Johnson Foundation )
• First Posted: February 25, 2015
• Last Update Posted: February 24, 2017
• Last Verified: February 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: No raw data will be shared with the general public or other researchers.

Keywords provided by University of North Carolina, Chapel Hill:

Papillomavirus Vaccines; Immunization; Quality Improvement; Adolescent Health Services