AFIX to Improve HPV Vaccination

NCT ID: NCT02370459

Last Updated: 2017-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

223 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Papillomavirus Vaccines Adolescent Health Services

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

AFIX in-person consultation

Intervention Type 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.

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.

Group Type EXPERIMENTAL

AFIX webinar consultation

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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

Eligibility Criteria

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Inclusion Criteria

* at least 500 active records for patients, ages 11-17, in their states' immunization information systems.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Robert Wood Johnson Foundation

OTHER

Sponsor Role collaborator

Washington State, Department of Health

OTHER_GOV

Sponsor Role collaborator

Illinois Department of Public Health

OTHER

Sponsor Role collaborator

Michigan Department of Community Health

OTHER

Sponsor Role collaborator

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Melissa B Gilkey, PhD

Role: PRINCIPAL_INVESTIGATOR

Harvard Medical School (HMS and HSDM)

Noel T Brewer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

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Illinois Department of Public Health

Springfield, Illinois, United States

Site Status

Michigan Department of Community Health

Lansing, Michigan, United States

Site Status

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Washington State Department of Health

Olympia, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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71272

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

13-3599

Identifier Type: -

Identifier Source: org_study_id

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