NCT02370459

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
223

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 25, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

1.6 years

First QC Date

February 5, 2015

Last Update Submit

February 23, 2017

Conditions

Papillomavirus VaccinesAdolescent Health Services

Keywords

Papillomavirus VaccinesImmunizationQuality ImprovementAdolescent Health Services

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (35)

  • HPV vaccination (≥1 dose), 11-12 year olds

    Six months

  • HPV vaccination (≥1 dose), 11-12 year olds

    Six months

  • HPV vaccination (≥1 dose), 11-12 year olds

    Twelve months

  • HPV vaccination (≥1 dose), 11-12 year olds

    Twelve months

  • HPV vaccination (3 doses), 11-12 year olds

    Six months

  • +30 more secondary outcomes

Study Arms (3)

control

NO INTERVENTION

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.

AFIX in-person consultation

EXPERIMENTAL

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

AFIX webinar consultation

EXPERIMENTAL

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

Interventions

AFIX in-person consultationOTHER

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.

Also known as: AFIX, Assessment, Feedback, Incentives, and eXchange Program
AFIX in-person consultation
AFIX webinar consultationOTHER

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.

Also known as: AFIX, Assessment, Feedback, Incentives, and eXchange Program
AFIX webinar consultation

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Illinois Department of Public Health

Springfield, Illinois, 62761, United States

Location

Michigan Department of Community Health

Lansing, Michigan, 48909, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Washington State Department of Health

Olympia, Washington, 98504, United States

Location

MeSH Terms

Interventions

Restraint, Physical

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Melissa B Gilkey, PhD

    Harvard Medical School (HMS and HSDM)

    PRINCIPAL INVESTIGATOR

  • Noel T Brewer, PhD

    University of North Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2015

First Posted

February 25, 2015

Study Start

April 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

February 24, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

No raw data will be shared with the general public or other researchers.

Locations

US(4)