NCT03887793

Brief Summary

HPV vaccination coverage is at lower levels than the national goal. This study will evaluate the effectiveness of quality improvement strategies for increasing HPV vaccination coverage among adolescent within the context of large integrated health care delivery systems.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2019

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 25, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

February 26, 2020

Status Verified

February 1, 2020

Enrollment Period

7 months

First QC Date

February 26, 2019

Last Update Submit

February 24, 2020

Conditions

Human Papillomavirus Infection

Keywords

quality improvementHPV vaccineintegrated healthcare delivery systems

Outcome Measures

Primary Outcomes (1)

  • HPV vaccination (≥1 dose), 11-12 year olds at 6 months

    Coverage change from baseline to 6 months in HPV vaccine initiation (≥1 dose), among 11- to 12- year old patients, as measured by states' immunization information system (IIS) records

    Six months

Secondary Outcomes (5)

  • HPV vaccination (≥1 dose), 11-12 year olds at 6 months by state

    Six months

  • HPV vaccination (completion according to the Advisory Committee on Immunization Practices (ACIP) guidelines), 11-12 year olds at six months

    Six months

  • HPV vaccination (completion according to the Advisory Committee on Immunization Practices (ACIP) guidelines), 11-12 year olds at six months by state

    Six months

  • HPV vaccination (≥1 dose), 13-17 year olds at six months

    Six months

  • HPV vaccination (completion according to ACIP guidelines), 13-17 year olds at six months

    Six months

Study Arms (2)

VACs intervention

EXPERIMENTAL

Integrated healthcare delivery systems randomly assigned to this arm will participate in the Vaccinate Adolescents against Cancers (VACs) model for HPV vaccine QI. Specific QI activities will be chosen by healthcare system leadership and healthcare providers on the systems' QI teams.

Other: VACs

Wait list control

NO INTERVENTION

Integrated healthcare delivery systems randomly assigned to this arm will be placed on a waiting list to receive the intervention after the conclusion of the study period.

Interventions

VACsOTHER

The VACs (Vaccinate Adolescents against Cancer) model for HPV vaccine quality improvement is a strategy developed by the American Cancer Society to improve HPV vaccination coverage in large integrated health care delivery systems. It includes the development of a quality improvement (QI) action plan, the formation of a QI team of health care providers, education for the QI team about HPV-related disease burden and vaccine efficacy, HPV vaccine coverage assessments at several time points that are shared with individual clinics within the health are system, and the adoption of specific QI strategies by participating clinics in the health care system.

VACs intervention

Eligibility Criteria

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

You may qualify if:

  • Integrated healthcare delivery systems headquartered in New York State or Wisconsin with at least 4 pediatric or internal medicine practices within the system.
  • All clinics within the integrated healthcare delivery system must participate in the state immunization registry.

You may not qualify if:

  • Integrated healthcare delivery systems headquartered outside of New York State or Wisconsin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

New York State Department of Health

Albany, New York, 12237, United States

Location

Wisconsin Department of Health Services

Madison, Wisconsin, 53703, United States

Location

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Noel T Brewer, PhD

    University of North Carolina

    PRINCIPAL INVESTIGATOR

  • Melissa B Gilkey, PhD

    University of North Carolina

    PRINCIPAL INVESTIGATOR
0

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 26, 2019

First Posted

March 25, 2019

Study Start

January 1, 2020

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

February 26, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)