<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01697280</url>
  </required_header>
  <id_info>
    <org_study_id>1952-Ped-ERC-11</org_study_id>
    <nct_id>NCT01697280</nct_id>
  </id_info>
  <brief_title>Polio NID and Routine EPI Integration Trial Pakistan</brief_title>
  <official_title>Improving Routine Immunization Coverage Through Educational Messages Delivered During Polio NIDs in Pakistan: A Cluster Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aga Khan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>World Health Organization</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aga Khan University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to assess if pictorial messages promoting routine immunization during&#xD;
      supplementary campaigns for oral polio vaccine in areas with poor DTP3 vaccine coverage can&#xD;
      improve immunization rates. A cluster randomized trial design in low literature populations&#xD;
      will be used.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall objective of this study is to assess whether supplementary immunization&#xD;
      activities (SIAs) held for polio eradication can be used to improve routine immunization&#xD;
      coverage in Pakistan.&#xD;
&#xD;
      Primary research objectives:&#xD;
&#xD;
      (i) To assess effectiveness of educational messages regarding routine immunization during&#xD;
      SIAs held for polio on improving routine immunization coverage in Pakistan.&#xD;
&#xD;
      Secondary research objectives:&#xD;
&#xD;
      (i) To assess maternal knowledge about routine immunization in the intervention and control&#xD;
      arms.&#xD;
&#xD;
      (ii) To estimate vaccination card retention in the intervention and control arms.&#xD;
&#xD;
      This study will be completed in 12 months, between March 2012 to February 2013. Overall,&#xD;
      three major operational steps have been defined for the study as follow:&#xD;
&#xD;
      Baseline vaccine coverage survey: This is a 02-months activity in which a baseline household&#xD;
      vaccine coverage survey will be carried out to independently assess the immunization coverage&#xD;
      and socio-demographic indicators in the study areas. Participation in this survey will be&#xD;
      voluntary and written consent from participants will be obtained prior to administering the&#xD;
      study questionnaire.&#xD;
&#xD;
      Training of vaccinators/volunteers and distribution of plastic pouches: The project research&#xD;
      staff (Research Associate/Senior Research Assistants) will be exclusively trained by&#xD;
      Principal Investigator/Research Supervisor on educational material. Having completed the&#xD;
      baseline coverage survey, a one-day training session will be organized by trained project&#xD;
      staff to provide trainings to participating EPI vaccinators/volunteers on the vaccine&#xD;
      promotion educational messages to be delivered during intervention. These trainings will be&#xD;
      held at a common venue (EPI center/public hospital) in the selected towns for this study. The&#xD;
      messages will be low-literacy, of very short duration, and will be delivered with the help of&#xD;
      pictorial cards which were previously developed for and used in a similar department-run&#xD;
      study in Karachi. These educational messages will include the following messages:&#xD;
&#xD;
        1. Vaccines can save a child's life&#xD;
&#xD;
        2. Children who are immunized on time are less likely to become ill&#xD;
&#xD;
        3. Unimmunized children can become disabled for life&#xD;
&#xD;
        4. Photograph of the nearest EPI center where vaccines are offered free of charge, as well&#xD;
           as its address and timings&#xD;
&#xD;
      Additionally, at the start of this project, all EPI centers in the study areas will be&#xD;
      provided with plastic pouches to be given to parents of all children coming to EPI centers&#xD;
      for vaccinations. These pouches will be used to store a child's immunization card. In order&#xD;
      to assess the likely change in vaccination card retention, we will compare the proportion of&#xD;
      vaccination cards available on pre-and-post coverage assessment in both intervention and&#xD;
      control groups.&#xD;
&#xD;
      Endline vaccine coverage survey/outcome assessment. Outcome assessment will be done through a&#xD;
      representative endline survey assessing vaccine coverage for Penta-3 and Measles-1 in the&#xD;
      study areas, 3 months after the NID was held. Participation in this survey will be voluntary&#xD;
      and written consent from study participants will be obtained prior too administering the&#xD;
      study questionnaire.&#xD;
&#xD;
      NID = National Immunization Days SNID = Sub-national Immunization Days EPI: Expanded&#xD;
      Programme on Immunization SIA - Supplementary Immunization Activity CHW = Community Health&#xD;
      Worker AKU = Aga Khan University, Karachi, Pakistan&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>age appropriate vaccination of children 3 - 14 months old at the time of the endline survey</measure>
    <time_frame>03 months after intervention (polio NID)</time_frame>
    <description>Age appropriate vaccination for the purposes of this study is defined as the administration of:&#xD;
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&#xD;
First dose of the measles vaccine (Measles-1) for children 9 - 14 months of age.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maternal knowledge about routine immunization</measure>
    <time_frame>03 months after intervention</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retention of immunization cards</measure>
    <time_frame>03 months after intervention (polio NID)</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">4560</enrollment>
  <condition>Polio</condition>
  <arm_group>
    <arm_group_label>Educational messages only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EPI vaccinators/volunteers will educate mothers/care-providers of infants less than 12 months old months about the benefits of routine immunization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Immunization status verification only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Education and vaccine verification</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Status quo</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No interventional activity will take place in this group. Therefore, the status quo (routine services) will be maintained during Polio NID</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Vaccine promotion messages</intervention_name>
    <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:&#xD;
Vaccines can save a child's life&#xD;
Children who are immunized on time are less likely to become ill&#xD;
Unimmunized children can become disabled for life&#xD;
Photograph of the nearest EPI center where vaccines are offered free of charge, as well as its address and timings.</description>
    <arm_group_label>Education and vaccine verification</arm_group_label>
    <arm_group_label>Educational messages only</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vaccination Verification.</intervention_name>
    <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.</description>
    <arm_group_label>Education and vaccine verification</arm_group_label>
    <arm_group_label>Immunization status verification only</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Distribution of Plastic Pouches to retain vaccination card</intervention_name>
    <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.</description>
    <arm_group_label>Education and vaccine verification</arm_group_label>
    <arm_group_label>Educational messages only</arm_group_label>
    <arm_group_label>Immunization status verification only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Households with children aged 3-14 months&#xD;
&#xD;
          2. Resident of selected cluster&#xD;
&#xD;
          3. Willing to consent for participation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Households with children aged below 3 months or above 14 months&#xD;
&#xD;
          2. Non-resident of selected cluster&#xD;
&#xD;
          3. Refusing to consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>14 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anita KM Zaidi, MBBS, FAAP</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Aga Khan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Thatta, Hyderabad</name>
      <address>
        <city>Thatta, Hyderabad</city>
        <state>Sindh</state>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>April 2, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>January 15, 2014</last_update_submitted>
  <last_update_submitted_qc>January 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aga Khan University</investigator_affiliation>
    <investigator_full_name>Anita Kaniz Mehdi Zaidi</investigator_full_name>
    <investigator_title>Professor and Chair, Department of Paediatrics and Child Health</investigator_title>
  </responsible_party>
  <keyword>Polio supplementary immunization activities</keyword>
  <keyword>Routine EPI vaccine</keyword>
  <keyword>Integration of polio NID and routine EPI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Poliomyelitis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01697280
org study id: 1952-Ped-ERC-11
nct id: NCT01697280
lead sponsor: 
collaborator: 
has dmc: Yes
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.
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: age appropriate vaccination of children 3 - 14 months old at the time of the endline survey
time frame: 03 months after intervention (polio NID)
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.
measure: Maternal knowledge about routine immunization
time frame: 03 months after intervention
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.
measure: Retention of immunization cards
time frame: 03 months after intervention (polio NID)
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.
arm group label: Educational messages only
arm group type: Experimental
description: EPI vaccinators/volunteers will educate mothers/care-providers of infants less than 12 months old months about the benefits of routine immunization
arm group label: Immunization status verification only
arm group type: Experimental
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 group label: Education and vaccine verification
arm group type: Experimental
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 group label: Status quo
arm group type: No Intervention
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: Vaccine promotion messages
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.
arm group label: Education and vaccine verification
arm group label: Educational messages only
intervention type: Other
intervention name: Vaccination Verification.
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 group label: Education and vaccine verification
arm group label: Immunization status verification only
intervention type: Other
intervention name: Distribution of Plastic Pouches to retain vaccination card
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.
arm group label: Education and vaccine verification
arm group label: Educational messages only
arm group label: Immunization status verification only
criteria: 
gender: All
minimum age: 3 Months
maximum age: 14 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Anita KM Zaidi, MBBS, FAAP
role: Principal Investigator
affiliation: The Aga Khan University
facility: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Aga Khan University
investigator full name: Anita Kaniz Mehdi Zaidi
investigator title: Professor and Chair, Department of Paediatrics and Child Health
mesh term: Poliomyelitis