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Polio NID and Routine EPI Integration Trial Pakistan

Primary Purpose

Polio

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Vaccine promotion messages
Vaccination Verification.
Distribution of Plastic Pouches to retain vaccination card
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Polio focused on measuring Polio supplementary immunization activities, Routine EPI vaccine, Integration of polio NID and routine EPI

Eligibility Criteria

3 Months - 14 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Thatta, Hyderabad

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Educational messages only

Immunization status verification only

Education and vaccine verification

Status quo

Arm Description

EPI vaccinators/volunteers will educate mothers/care-providers of infants less than 12 months old months about the benefits of routine immunization

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.

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.

No interventional activity will take place in this group. Therefore, the status quo (routine services) will be maintained during Polio NID

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 2, 2012
Last Updated
January 15, 2014
Sponsor
Aga Khan University
Collaborators
World Health Organization
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1. Study Identification

Unique Protocol Identification Number
NCT01697280
Brief Title
Polio NID and Routine EPI Integration Trial Pakistan
Official Title
Improving Routine Immunization Coverage Through Educational Messages Delivered During Polio NIDs in Pakistan: A Cluster Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University
Collaborators
World Health Organization

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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: 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polio
Keywords
Polio supplementary immunization activities, Routine EPI vaccine, Integration of polio NID and routine EPI

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
4560 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Educational messages only
Arm Type
Experimental
Arm Description
EPI vaccinators/volunteers will educate mothers/care-providers of infants less than 12 months old months about the benefits of routine immunization
Arm Title
Immunization status verification only
Arm Type
Experimental
Arm Description
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.
Arm Title
Education and vaccine verification
Arm Type
Experimental
Arm Description
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.
Arm Title
Status quo
Arm Type
No Intervention
Arm Description
No interventional activity will take place in this group. Therefore, the status quo (routine services) will be maintained during Polio NID
Intervention Type
Behavioral
Intervention Name(s)
Vaccine promotion messages
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Vaccination Verification.
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Distribution of Plastic Pouches to retain vaccination card
Intervention Description
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.
Primary Outcome Measure Information:
Title
age appropriate vaccination of children 3 - 14 months old at the time of the endline survey
Description
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.
Time Frame
03 months after intervention (polio NID)
Secondary Outcome Measure Information:
Title
Maternal knowledge about routine immunization
Description
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.
Time Frame
03 months after intervention
Title
Retention of immunization cards
Description
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.
Time Frame
03 months after intervention (polio NID)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
14 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anita KM Zaidi, MBBS, FAAP
Organizational Affiliation
The Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thatta, Hyderabad
City
Thatta, Hyderabad
State/Province
Sindh
Country
Pakistan

12. IPD Sharing Statement

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Polio NID and Routine EPI Integration Trial Pakistan

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