Polio NID and Routine EPI Integration Trial Pakistan

This study has been completed.
Sponsor:
Collaborator:
World Health Organization
Information provided by (Responsible Party):
Anita Kaniz Mehdi Zaidi, Aga Khan University
ClinicalTrials.gov Identifier:
NCT01697280
First received: April 2, 2012
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

This study aims to assess if pictorial messages promoting routine immunization during supplementary campaigns for oral polio vaccine in areas with poor DTP3 vaccine coverage can improve immunization rates. A cluster randomized trial design in low literature populations will be used.


Condition Intervention
Polio
Behavioral: Vaccine promotion messages
Other: Vaccination Verification.
Other: Distribution of Plastic Pouches to retain vaccination card

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Improving Routine Immunization Coverage Through Educational Messages Delivered During Polio NIDs in Pakistan: A Cluster Randomized Trial

Resource links provided by NLM:


Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • age appropriate vaccination of children 3 - 14 months old at the time of the endline survey [ Time Frame: 03 months after intervention (polio NID) ] [ Designated as safety issue: No ]

    Age appropriate vaccination for the purposes of this study is defined as the administration of:

    1. All scheduled doses of the DPT/Hepatitis-B/Hib (Penta) vaccine within 14 days of the recommended age for children 3 - 11 months of age, and
    2. First dose of the measles vaccine (Measles-1) for children 9 - 14 months of age.


Secondary Outcome Measures:
  • Maternal knowledge about routine immunization [ Time Frame: 03 months after intervention ] [ Designated as safety issue: No ]
    Maternal knowledge about nearest EPI facility, names of EPI vaccines that child is age-eligible to receive, cost of vaccination and importance about vaccination will be assessed during end line vaccine coverage survey.

  • Retention of immunization cards [ Time Frame: 03 months after intervention (polio NID) ] [ Designated as safety issue: No ]
    The number of children who received routine EPI vaccine had vaccination card available on the end-line survey. Immunization cards will help to verify dates and number of doses that child has received.


Enrollment: 4560
Study Start Date: April 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Educational messages only
EPI vaccinators/volunteers will educate mothers/care-providers of infants less than 12 months old months about the benefits of routine immunization
Behavioral: Vaccine promotion messages

The messages will be low-literacy, of very short duration, and will be delivered with the help of pictorial cards. These educational messages will include the following messages:

  1. Vaccines can save a child's life
  2. Children who are immunized on time are less likely to become ill
  3. Unimmunized children can become disabled for life
  4. Photograph of the nearest EPI center where vaccines are offered free of charge, as well as its address and timings.
Other: Distribution of Plastic Pouches to retain vaccination card
At the start of this project, all EPI centers in the study areas will be provided with plastic pouches to be given to parents of all children coming to EPI centers for vaccinations. These pouches will be used to store a child's immunization card.
Experimental: Immunization status verification only
EPI vaccinators/volunteers will identify and record details of un/under-vaccinated children less than 12 months old in households they visit during an NID, and update immunization registries maintained at the local EPI centers so these children can be reached in subsequent outreach activity.
Other: Vaccination Verification.
EPI vaccinators/volunteers will identify and record details of un/under-vaccinated children less than 12 months old in households they visit during an NID, and update immunization registries maintained at the local EPI centers so these children can be reached in subsequent outreach activity.
Other: Distribution of Plastic Pouches to retain vaccination card
At the start of this project, all EPI centers in the study areas will be provided with plastic pouches to be given to parents of all children coming to EPI centers for vaccinations. These pouches will be used to store a child's immunization card.
Experimental: Education and vaccine verification
EPI vaccinators/volunteers will educate mothers/care-providers of infants less than 12 months old months about the benefits of routine immunization, identify and record details of un/under-vaccinated children in households they visit during an NID, and update immunization registries maintained at the local EPI centers so these children can be reached in subsequent outreach activity.
Behavioral: Vaccine promotion messages

The messages will be low-literacy, of very short duration, and will be delivered with the help of pictorial cards. These educational messages will include the following messages:

  1. Vaccines can save a child's life
  2. Children who are immunized on time are less likely to become ill
  3. Unimmunized children can become disabled for life
  4. Photograph of the nearest EPI center where vaccines are offered free of charge, as well as its address and timings.
Other: Vaccination Verification.
EPI vaccinators/volunteers will identify and record details of un/under-vaccinated children less than 12 months old in households they visit during an NID, and update immunization registries maintained at the local EPI centers so these children can be reached in subsequent outreach activity.
Other: Distribution of Plastic Pouches to retain vaccination card
At the start of this project, all EPI centers in the study areas will be provided with plastic pouches to be given to parents of all children coming to EPI centers for vaccinations. These pouches will be used to store a child's immunization card.
No Intervention: Status quo
No interventional activity will take place in this group. Therefore, the status quo (routine services) will be maintained during Polio NID

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Months to 14 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Households with children aged 3-14 months
  2. Resident of selected cluster
  3. Willing to consent for participation in the study

Exclusion Criteria:

  1. Households with children aged below 3 months or above 14 months
  2. Non-resident of selected cluster
  3. Refusing to consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01697280

Locations
Pakistan
Thatta, Hyderabad
Thatta, Hyderabad, Sindh, Pakistan
Sponsors and Collaborators
Aga Khan University
World Health Organization
Investigators
Principal Investigator: Anita KM Zaidi, MBBS, FAAP The Aga Khan University
  More Information

No publications provided

Responsible Party: Anita Kaniz Mehdi Zaidi, Professor and Chair, Department of Paediatrics and Child Health, Aga Khan University
ClinicalTrials.gov Identifier: NCT01697280     History of Changes
Other Study ID Numbers: 1952-Ped-ERC-11
Study First Received: April 2, 2012
Last Updated: January 15, 2014
Health Authority: Pakistan: Research Ethics Committee

Keywords provided by Aga Khan University:
Polio supplementary immunization activities
Routine EPI vaccine
Integration of polio NID and routine EPI

Additional relevant MeSH terms:
Poliomyelitis
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on August 27, 2014