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Low Cost Interventions to Improve Adherence to Childhood Immunization Schedule

This study has been completed.
Sponsor:
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00602056
First received: January 13, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  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: 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

Resource links provided by NLM:

MedlinePlus related topics: Caregivers
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   up to 365 Days
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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, X050713007
Study First Received: January 13, 2008
Last Updated: January 13, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013