<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/NCT04449107</url>
  </required_header>
  <id_info>
    <org_study_id>2019-1534-5556</org_study_id>
    <nct_id>NCT04449107</nct_id>
  </id_info>
  <brief_title>Evaluate the Role of a Personalized Smartphone Based Application to Improve Childhood Immunization Coverage</brief_title>
  <official_title>To Evaluate the Role of a Personalized Smartphone-based Application to Improve Childhood Immunization Coverage and Timelines Among Children in Pakistan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aga Khan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>NED University of Engineering and Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Surrey</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aga Khan University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The vision of the investigators is to build capacity in technology-driven healthcare&#xD;
      innovation in LMCIs. The programme will be initiated by a feasibility and proof-of-concept&#xD;
      (POC) study to tackle the lack of awareness around immunization, which is a major health&#xD;
      issue in developing countries. Mobile apps and social media have been shown to be effective&#xD;
      in various programmes worldwide, but there is limited data from LMICs on the use of digital&#xD;
      technologies in improving routine immunization (RI) coverage.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pakistan is one of the countries with the highest rates of child death in the world. It ranks&#xD;
      4th in child mortality, with 60% deaths due to vaccine-preventable diseases (VPDs). The&#xD;
      immunization coverage in Pakistan is estimated to be 59%, which is still well below the&#xD;
      desired level, leading to continued polio transmission, large measles outbreaks, and&#xD;
      thousands of deaths from vaccine-preventable illnesses. In addition, Pakistan is a major&#xD;
      polio epidemic country and among 3 countries in the world requiring proof of polio&#xD;
      vaccination for international travel. Pakistan demographic and health survey in 2017-2018&#xD;
      suggests 88% percent of children had received BCG vaccine due at birth, 86% and 95% had&#xD;
      received the first dose of pentavalent and polio vaccine respectively due at the 6th week.&#xD;
      Furthermore, 75% and 86% of children had received the third dose of the pentavalent and polio&#xD;
      vaccines, respectively, due at 14th week and measles vaccination was 73%, which is due at 9&#xD;
      months. However, these rates are at 1 year of age and much higher than vaccination coverage&#xD;
      rate at scheduled time and among conflict hits and displaced populations. Improved RI&#xD;
      coverage is recommended as the priority public health strategy to reduce VPDs and eradicate&#xD;
      polio in Pakistan and worldwide.&#xD;
&#xD;
      According to immunization coverage surveys, 1 in 5 children are unimmunized. A major reason&#xD;
      for poor childhood vaccine coverage is low immunization uptake, when parents are unable to&#xD;
      complete the entire series of vaccines in accordance with the scheduled timelines. Some of&#xD;
      the reasons include: (1) the family is not in favor of getting their child immunized, (2) low&#xD;
      trust in vaccines provided through Expanded Programme on Immunization (EPI) and government&#xD;
      health care providers, and (3) caregivers have forgotten their child's next vaccination due&#xD;
      date or child's EPI card is misplaced. These barriers may be modified with additional support&#xD;
      through education and behavior change strategies. In addition, with more pressing issues of&#xD;
      food and shelter, preventive health often takes the back seat, and parents and caregivers&#xD;
      forget or ignore the subsequent doses of vaccines for their children. There is an immense&#xD;
      need to encourage parents' care seeking and collaboration with the health care providers to&#xD;
      improve initial vaccine uptake and the completion of all doses according to the schedule. New&#xD;
      innovative and cost-effective techniques are necessary for practical solutions to improve&#xD;
      vaccination uptake and coverage.&#xD;
&#xD;
      Mobile phones offer a new medium to provide education and advocate families or caregivers to&#xD;
      enable behavior change so as to improve immunization uptake. Mobile phone use has also&#xD;
      increased in countries with low RI coverage and a high risk of VPDs. Good examples are&#xD;
      Nigeria and Pakistan, where there were around 170 and 140 million mobile phone subscribers,&#xD;
      respectively, in 2014. There are limited data from LMICs set up on the role of SMS-based&#xD;
      interventions for improvement of RI coverage, and conventional 1-way reminder SMS text&#xD;
      messages were used by most of the studies as the intervention. Overall, very few studies&#xD;
      compared reminders, educational, and interactive SMS messages related to childhood&#xD;
      vaccination uptake. Although some of the studies have shown some behavior change for&#xD;
      improvement in vaccination coverage, more rigorous application of health behavior change&#xD;
      model needs to be applied to understand the impact of reminder, educational, and interactive&#xD;
      messages on behavior change related to improvement in RI coverage. However, data from&#xD;
      developing countries regarding the role of automated calls in improving vaccine coverage are&#xD;
      limited.&#xD;
&#xD;
      The vision of the investigators is to build capacity in technology-driven healthcare&#xD;
      innovation in LMCIs. The programme will be initiated by a feasibility and proof-of-concept&#xD;
      (POC) study to tackle the lack of awareness around immunization, which is a major health&#xD;
      issue in developing countries. Mobile apps and social media have been shown to be effective&#xD;
      in various programmes worldwide, but there is limited data from LMICs on the use of digital&#xD;
      technologies in improving routine immunization (RI) coverage.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">February 27, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2020</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>
    <intervention_model_description>A mixed methods study will be conducted in which a smart phone application will be developed based on the findings of qualitative component of the study, which will have features for text, voice, video and pictorial messages for the participant caregivers to improve RI on 10th and 14th week of child age.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>improvement in RI coverage</measure>
    <time_frame>12 weeks</time_frame>
    <description>to see a 10 percent increase in RI through personalized smart mobile phone-based application at 10 and 14 weeks of age according to the EPI schedule versus standard care</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improvement in timeline</measure>
    <time_frame>12 weeks</time_frame>
    <description>To see a 10 percent increase in RI within 1 week of the original timeline at 10, and 14 weeks versus standard care</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perceptions and barriers related to routine immunization (Interview guide in form of in depth interview will be administered).</measure>
    <time_frame>6 weeks</time_frame>
    <description>Perceptions regarding risks of infectious diseases preventable by vaccines and vaccine safety and efficacy.&#xD;
Perceptions and barriers to vaccinating children including difficulties in visiting RI centers.&#xD;
This will help us in understanding the types of (1) barriers perceived by caregivers, (2) designing the Randomized Controlled Trial and study methodology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>perceptions and barriers of a mobile phone based application to improve immunization coverage (interview guide in form of in depth interview will be administered)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Perceptions and barriers that may affect the use of mobile phone application in implementing the phone-based intervention to improve immunization coverage&#xD;
Usability and preferences of mobile phone app to improve routine immunization coverage&#xD;
This will help in developing personalized mobile phone application and content of the messages according to the barriers of the participants to bring in behavior change in order to improve immunization coverage and timelines&#xD;
Measurement tool is the 14 weeks vaccination as per EPI schedule.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">328</enrollment>
  <condition>Mobile Application</condition>
  <condition>Routine Childhood Immunization</condition>
  <arm_group>
    <arm_group_label>Intervention Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention arm in addition to the standard counselling will include receiving text messages, voice messages, pictorial messages and video messages regarding vaccination once a week till the child turns 14 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will receive one-time standard verbal counselling at the time of initial visit for on-time EPI vaccines at 10 and 14 weeks of age as recommended by EPI, government of Pakistan.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Android based mobile phone application</intervention_name>
    <description>An android based mobile application will be developed. The application will have features and capacity for text messages, voice messages, pictorial messages and video messages. The content of the messages will be according to the findings of Paigham e sehat project and the four messages domains would be educational, reminder, religious and adverse effects. In addition, pictorial and video messages would be used as per freely available through EPI programme Pakistan.</description>
    <arm_group_label>Intervention Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  parent or guardian or at least one person in the household has a working android based&#xD;
             smart mobile phone&#xD;
&#xD;
          -  ability to use android based smart phone&#xD;
&#xD;
          -  Parent or guardian providing consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  If the family will not be visiting AKU for 10- and 14-week RI.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Weeks</minimum_age>
    <maximum_age>2 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Aga Khan University</name>
      <address>
        <city>Karachi</city>
        <state>Sindh</state>
        <zip>74800</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>April 14, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>June 25, 2020</last_update_submitted>
  <last_update_submitted_qc>June 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aga Khan University</investigator_affiliation>
    <investigator_full_name>Dr Abdul Momin Kazi</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Mobile application</keyword>
  <keyword>routine childhood immunization</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The database will reside on a central computer at AKU managed by the study staff. Mobile numbers will not be shared except to track patterns of use. Only relevant study staff will have access to study data allowed by the local ethics committee. Participants' information will be given a study code, and no personal identifiers will be shared. Data confidentiality will be maintained at all times. No personal identifiers will be used in any reports or publication of the study. No individual identifier such as names of participants and area of location will be shared. In addition, a confidentiality agreement has been signed with the universities stating that the numbers provided will only be used for the purpose of the trial.</ipd_description>
  </patient_data>
  <!-- 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/NCT04449107
org study id: 2019-1534-5556
nct id: NCT04449107
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The vision of the investigators is to build capacity in technology-driven healthcare
      innovation in LMCIs. The programme will be initiated by a feasibility and proof-of-concept
      (POC) study to tackle the lack of awareness around immunization, which is a major health
      issue in developing countries. Mobile apps and social media have been shown to be effective
      in various programmes worldwide, but there is limited data from LMICs on the use of digital
      technologies in improving routine immunization (RI) coverage.
Pakistan is one of the countries with the highest rates of child death in the world. It ranks
      4th in child mortality, with 60% deaths due to vaccine-preventable diseases (VPDs). The
      immunization coverage in Pakistan is estimated to be 59%, which is still well below the
      desired level, leading to continued polio transmission, large measles outbreaks, and
      thousands of deaths from vaccine-preventable illnesses. In addition, Pakistan is a major
      polio epidemic country and among 3 countries in the world requiring proof of polio
      vaccination for international travel. Pakistan demographic and health survey in 2017-2018
      suggests 88% percent of children had received BCG vaccine due at birth, 86% and 95% had
      received the first dose of pentavalent and polio vaccine respectively due at the 6th week.
      Furthermore, 75% and 86% of children had received the third dose of the pentavalent and polio
      vaccines, respectively, due at 14th week and measles vaccination was 73%, which is due at 9
      months. However, these rates are at 1 year of age and much higher than vaccination coverage
      rate at scheduled time and among conflict hits and displaced populations. Improved RI
      coverage is recommended as the priority public health strategy to reduce VPDs and eradicate
      polio in Pakistan and worldwide.

      According to immunization coverage surveys, 1 in 5 children are unimmunized. A major reason
      for poor childhood vaccine coverage is low immunization uptake, when parents are unable to
      complete the entire series of vaccines in accordance with the scheduled timelines. Some of
      the reasons include: (1) the family is not in favor of getting their child immunized, (2) low
      trust in vaccines provided through Expanded Programme on Immunization (EPI) and government
      health care providers, and (3) caregivers have forgotten their child's next vaccination due
      date or child's EPI card is misplaced. These barriers may be modified with additional support
      through education and behavior change strategies. In addition, with more pressing issues of
      food and shelter, preventive health often takes the back seat, and parents and caregivers
      forget or ignore the subsequent doses of vaccines for their children. There is an immense
      need to encourage parents' care seeking and collaboration with the health care providers to
      improve initial vaccine uptake and the completion of all doses according to the schedule. New
      innovative and cost-effective techniques are necessary for practical solutions to improve
      vaccination uptake and coverage.

      Mobile phones offer a new medium to provide education and advocate families or caregivers to
      enable behavior change so as to improve immunization uptake. Mobile phone use has also
      increased in countries with low RI coverage and a high risk of VPDs. Good examples are
      Nigeria and Pakistan, where there were around 170 and 140 million mobile phone subscribers,
      respectively, in 2014. There are limited data from LMICs set up on the role of SMS-based
      interventions for improvement of RI coverage, and conventional 1-way reminder SMS text
      messages were used by most of the studies as the intervention. Overall, very few studies
      compared reminders, educational, and interactive SMS messages related to childhood
      vaccination uptake. Although some of the studies have shown some behavior change for
      improvement in vaccination coverage, more rigorous application of health behavior change
      model needs to be applied to understand the impact of reminder, educational, and interactive
      messages on behavior change related to improvement in RI coverage. However, data from
      developing countries regarding the role of automated calls in improving vaccine coverage are
      limited.

      The vision of the investigators is to build capacity in technology-driven healthcare
      innovation in LMCIs. The programme will be initiated by a feasibility and proof-of-concept
      (POC) study to tackle the lack of awareness around immunization, which is a major health
      issue in developing countries. Mobile apps and social media have been shown to be effective
      in various programmes worldwide, but there is limited data from LMICs on the use of digital
      technologies in improving routine immunization (RI) coverage.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A mixed methods study will be conducted in which a smart phone application will be developed based on the findings of qualitative component of the study, which will have features for text, voice, video and pictorial messages for the participant caregivers to improve RI on 10th and 14th week of child age.
primary purpose: Prevention
masking: Single (Participant)
measure: improvement in RI coverage
time frame: 12 weeks
description: to see a 10 percent increase in RI through personalized smart mobile phone-based application at 10 and 14 weeks of age according to the EPI schedule versus standard care
measure: Improvement in timeline
time frame: 12 weeks
description: To see a 10 percent increase in RI within 1 week of the original timeline at 10, and 14 weeks versus standard care
measure: Perceptions and barriers related to routine immunization (Interview guide in form of in depth interview will be administered).
time frame: 6 weeks
description: Perceptions regarding risks of infectious diseases preventable by vaccines and vaccine safety and efficacy.
Perceptions and barriers to vaccinating children including difficulties in visiting RI centers.
This will help us in understanding the types of (1) barriers perceived by caregivers, (2) designing the Randomized Controlled Trial and study methodology.
measure: perceptions and barriers of a mobile phone based application to improve immunization coverage (interview guide in form of in depth interview will be administered)
time frame: 4 weeks
description: Perceptions and barriers that may affect the use of mobile phone application in implementing the phone-based intervention to improve immunization coverage
Usability and preferences of mobile phone app to improve routine immunization coverage
This will help in developing personalized mobile phone application and content of the messages according to the barriers of the participants to bring in behavior change in order to improve immunization coverage and timelines
Measurement tool is the 14 weeks vaccination as per EPI schedule.
arm group label: Intervention Arm
arm group type: Experimental
description: The intervention arm in addition to the standard counselling will include receiving text messages, voice messages, pictorial messages and video messages regarding vaccination once a week till the child turns 14 weeks
arm group label: Control Arm
arm group type: No Intervention
description: The control group will receive one-time standard verbal counselling at the time of initial visit for on-time EPI vaccines at 10 and 14 weeks of age as recommended by EPI, government of Pakistan.
intervention type: Behavioral
intervention name: Android based mobile phone application
description: An android based mobile application will be developed. The application will have features and capacity for text messages, voice messages, pictorial messages and video messages. The content of the messages will be according to the findings of Paigham e sehat project and the four messages domains would be educational, reminder, religious and adverse effects. In addition, pictorial and video messages would be used as per freely available through EPI programme Pakistan.
arm group label: Intervention Arm
criteria: 
gender: All
minimum age: 6 Weeks
maximum age: 2 Months
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Aga Khan University
investigator full name: Dr Abdul Momin Kazi
investigator title: Assistant Professor
sharing ipd: No
ipd description: The database will reside on a central computer at AKU managed by the study staff. Mobile numbers will not be shared except to track patterns of use. Only relevant study staff will have access to study data allowed by the local ethics committee. Participants' information will be given a study code, and no personal identifiers will be shared. Data confidentiality will be maintained at all times. No personal identifiers will be used in any reports or publication of the study. No individual identifier such as names of participants and area of location will be shared. In addition, a confidentiality agreement has been signed with the universities stating that the numbers provided will only be used for the purpose of the trial.