Polio NID and Routine EPI Integration Trial Pakistan - Full Text View

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:

MedlinePlus related topics: Polio and Post-Polio Syndrome

U.S. FDA Resources

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.

Estimated Enrollment:	2016
Study Start Date:	September 2012
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	March 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: Vaccines can save a child's life Children who are immunized on time are less likely to become ill Unimmunized children can become disabled for life 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: Vaccines can save a child's life Children who are immunized on time are less likely to become ill Unimmunized children can become disabled for life 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:

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

Exclusion Criteria:

Households with children aged below 3 months or above 14 months
Non-resident of selected cluster
Refusing to consent

Contacts and Locations

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

Contacts

Contact: Mir MK Khan, MBA, MPhil	+922134864385 ext 4385	asghar.ali@aku.edu
Contact: Asif AR Raza, MSC.HPM	+92 213 493 0051 ext 4334	raza.asif@aku.edu

Locations

Pakistan
Thatta, Hyderabad	Recruiting
Thatta, Hyderabad, Sindh, Pakistan
Contact: Asif R Khowaja, MSc.HPM 00923458226482 raza.asif@aku.edu

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:	September 27, 2012
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 June 17, 2013