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Low Cost Interventions to Improve Adherence to Childhood Immunization Schedule

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00602056
First Posted: January 28, 2008
Last Update Posted: January 28, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Alabama at Birmingham
  Purpose
The objective of the study was to assess the effect of 1) redesigned immunization card, 2) center-based education to mothers, and 3) redesigned card with center-based education to mothers, provided at DPT1, on DPT3 completion in a randomized controlled trial at rural Expanded Programme on Immunization (EPI) centers in Karachi, Pakistan.

Condition Intervention
Childhood Immunization Completion Childhood Immunization Dropout Immunization Card Center Based Education Other: Redesigned immunization card Other: Center based education to mothers/caregivers Other: Redesigned immunization card with center based education to mother/caregivers

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Trial of Low Cost Interventions to Improve Adherence to Childhood Immunization Schedule in a Low Literacy Population in Pakistan

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • The study outcome in each study group was the immunization status categorized into "DPT3 completed" and "DPT3 not completed". [ Time Frame: 90 day follow-up after enrollment at DPT1 visit ]

Enrollment: 1506
Study Start Date: November 2005
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Redesigned immunization card
Other: Redesigned immunization card
A low cost nad simplified redesigned immunization card
Experimental: 2
Center based education to mothers/caregivers
Other: Center based education to mothers/caregivers
A 2-3 minute center based education to mothers/caregivers
Experimental: 3
Redesigned immunization card with center based education to mothers/caregivers
Other: Redesigned immunization card with center based education to mother/caregivers
Redesigned immunization card with center based education to mother/caregivers
No Intervention: 4
Standard care only

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 365 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All children visiting the selected EPI centers for DPT1 immunization

Exclusion Criteria:

  • Not residing in the same area for last six months.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00602056


Locations
Pakistan
EPI immunization centers
Karachi, Sindh, Pakistan
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Hussain R Usman, MBBS, MS University of Alabama at Birmingham
  More Information

Responsible Party: Dr. Hussain R. Usman/Doctoral Trainee, University of Alabama at Bormingham
ClinicalTrials.gov Identifier: NCT00602056     History of Changes
Other Study ID Numbers: X050713007
First Submitted: January 13, 2008
First Posted: January 28, 2008
Last Update Posted: January 28, 2008
Last Verified: January 2008

Keywords provided by University of Alabama at Birmingham:
Immunization dropout
Immunization card
Center based education

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs