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Completed

NCT Number: NCT02370459

AFIX to Improve HPV Vaccination

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.

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Key information

Conditions

Papillomavirus Vaccines Adolescent Health Services

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Illinois Department of Public Health, Springfield, Illinois, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AFIX in-person consultation

Other

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 names: AFIX, Assessment, Feedback, Incentives, and eXchange Program

AFIX webinar consultation

Other

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 names: AFIX, Assessment, Feedback, Incentives, and eXchange Program

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Harvard Medical School (HMS and HSDM)
  • Illinois Department of Public Health
  • Michigan Department of Community Health
  • Robert Wood Johnson Foundation
  • Washington State, Department of Health

Registry information

Official study title

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

Acronym: AFIX

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 25, 2015
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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