NCT01773759

Brief Summary

Ensuring that all children are fully immunized against vaccine-preventable diseases is a critical public health issue. Child care programs are critical targets for efforts to increase the proportion of infants and young children who are fully immunized. The primary objective of this proposal is to rigorously examine current state, local government, and child care providers' efforts and barriers to ensuring that all enrolled children are up-to-date for required immunizations and to evaluate strategies to improve immunization coverage in child care programs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

2.9 years

First QC Date

January 13, 2013

Last Update Submit

April 12, 2017

Conditions

Up-to-date Immunization Status for Children in Child Care

Keywords

ImmunizationsChild careSchool health promotion

Outcome Measures

Primary Outcomes (1)

  • Children enrolled in child care program up-to-date for required immunizations

    Proportion of children up-to-date for all state required childhood immunizations in the Utah State Immunization Information System (USIIS)

    Up to 2 years

Study Arms (2)

Intervention child care programs

EXPERIMENTAL

Intervention child care programs will receive immunization outreach and education.

Behavioral: Intervention child care programs

Control child care programs

NO INTERVENTION

Control programs will receive no more than usual training regarding childhood immunization requirements.

Interventions

Intervention child care programsBEHAVIORAL

Interventions will be designed based on findings from Aims 1 and 2, will include outreach and education, and may include on-site demonstration and USIIS training or peer tutoring.

Intervention child care programs

Eligibility Criteria

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

You may qualify if:

  • Child care programs not currently registered to use the Utah State Immunization Information System (USIIS) in Utah counties with acceptable USIIS coverage will be included.

You may not qualify if:

  • Child care programs in Utah counties with lower than acceptable USIIS coverage will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Study Officials

  • Julie H. Shakib, DO, MPH

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Julie H. Shakib, DO, MPH

Study Record Dates

First Submitted

January 13, 2013

First Posted

January 23, 2013

Study Start

September 1, 2011

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

April 13, 2017

Record last verified: 2017-04

Locations

US(1)