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AFIX to Improve HPV Vaccination

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02370459
Acronym
AFIX
Enrollment
223
Registered
2015-02-25
Start date
2015-04-30
Completion date
2016-11-30
Last updated
2017-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Health Services, Papillomavirus Vaccines

Keywords

Papillomavirus Vaccines, Immunization, Quality Improvement, Adolescent Health Services

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.

Interventions

OTHERAFIX 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.

OTHERAFIX 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.

Sponsors

Robert Wood Johnson Foundation
CollaboratorOTHER
Washington State, Department of Health
CollaboratorOTHER_GOV
Illinois Department of Public Health
CollaboratorOTHER
Michigan Department of Community Health
CollaboratorOTHER
Harvard Medical School (HMS and HSDM)
CollaboratorOTHER
University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
HPV vaccination (≥1 dose), 11-12 year oldsSix monthsCoverage 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

MeasureTime frameDescription
HPV vaccination (3 doses), 11-12 year oldsSix monthsCoverage 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.
Tetanus, diphtheria, and acellular pertussis (Tdap) vaccination, 11-12 year oldsSix monthsCoverage 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.
Meningococcal vaccination (≥1 dose), 11-12 year oldsSix monthsCoverage 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.
HPV vaccination (≥1 dose), 13-17 year oldsSix monthsCoverage 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.
HPV vaccination (≥1 dose), 11-12 year oldsSix monthsCoverage 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.
Tdap vaccination, 13-17 year oldsSix monthsCoverage 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.
Meningococcal vaccination (≥1 dose), 13-17 year oldsSix monthsCoverage 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.
Tdap vaccination, 11-12 year oldsTwelve monthsCoverage 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.
HPV vaccination (3 doses), 13-17 year oldsSix monthsCoverage 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026