Polio NID and Routine EPI Integration Trial Pakistan

Improving Routine Immunization Coverage Through Educational Messages Delivered During Polio NIDs in Pakistan: A Cluster Randomized Trial

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.

Study Overview

• Status: Completed
• Conditions: Polio
• Intervention / Treatment: Behavioral: Vaccine promotion messages; Other: Distribution of Plastic Pouches to retain vaccination card; Other: Vaccination Verification.

Detailed Description

The overall objective of this study is to assess whether supplementary immunization activities (SIAs) held for polio eradication can be used to improve routine immunization coverage in Pakistan.

Primary research objectives:

(i) To assess effectiveness of educational messages regarding routine immunization during SIAs held for polio on improving routine immunization coverage in Pakistan.

Secondary research objectives:

(i) To assess maternal knowledge about routine immunization in the intervention and control arms.

(ii) To estimate vaccination card retention in the intervention and control arms.

This study will be completed in 12 months, between March 2012 to February 2013. Overall, three major operational steps have been defined for the study as follow:

Baseline vaccine coverage survey: This is a 02-months activity in which a baseline household vaccine coverage survey will be carried out to independently assess the immunization coverage and socio-demographic indicators in the study areas. Participation in this survey will be voluntary and written consent from participants will be obtained prior to administering the study questionnaire.

Training of vaccinators/volunteers and distribution of plastic pouches: The project research staff (Research Associate/Senior Research Assistants) will be exclusively trained by Principal Investigator/Research Supervisor on educational material. Having completed the baseline coverage survey, a one-day training session will be organized by trained project staff to provide trainings to participating EPI vaccinators/volunteers on the vaccine promotion educational messages to be delivered during intervention. These trainings will be held at a common venue (EPI center/public hospital) in the selected towns for this study. The messages will be low-literacy, of very short duration, and will be delivered with the help of pictorial cards which were previously developed for and used in a similar department-run study in Karachi. 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

Additionally, 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. In order to assess the likely change in vaccination card retention, we will compare the proportion of vaccination cards available on pre-and-post coverage assessment in both intervention and control groups.

Endline vaccine coverage survey/outcome assessment. Outcome assessment will be done through a representative endline survey assessing vaccine coverage for Penta-3 and Measles-1 in the study areas, 3 months after the NID was held. Participation in this survey will be voluntary and written consent from study participants will be obtained prior too administering the study questionnaire.

NID = National Immunization Days SNID = Sub-national Immunization Days EPI: Expanded Programme on Immunization SIA - Supplementary Immunization Activity CHW = Community Health Worker AKU = Aga Khan University, Karachi, Pakistan

• Study Type: Interventional
• Enrollment (Actual): 4560
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Thatta, Hyderabad, Sindh, Pakistan
      • Thatta, Hyderabad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 1 year (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: 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.; 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.
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: 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.; 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
age appropriate vaccination of children 3 - 14 months old at the time of the endline survey	Age appropriate vaccination for the purposes of this study is defined as the administration of: 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; First dose of the measles vaccine (Measles-1) for children 9 - 14 months of age.	03 months after intervention (polio NID)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal knowledge about routine immunization	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.	03 months after intervention
Retention of immunization cards	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.	03 months after intervention (polio NID)

Collaborators and Investigators

• Sponsor: Aga Khan University
• Collaborators: World Health Organization
• Investigators: Principal Investigator: Anita KM Zaidi, MBBS, FAAP, The Aga Khan University

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (ACTUAL): May 1, 2013
• Study Completion (ACTUAL): May 1, 2013

Study Registration Dates

• First Submitted: April 2, 2012
• First Submitted That Met QC Criteria: September 27, 2012
• First Posted (ESTIMATE): October 2, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): January 16, 2014
• Last Update Submitted That Met QC Criteria: January 15, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Polio supplementary immunization activities; Routine EPI vaccine; Integration of polio NID and routine EPI
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Neuromuscular Diseases; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; Spinal Cord Diseases; Myelitis; Poliomyelitis
• Other Study ID Numbers: 1952-Ped-ERC-11