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Mobile Phone SMS Messages and Automated Calls in Improving Vaccine Coverage Among Children in Pakistan

Primary Purpose

Tuberculosis, Polio, Diphtheria

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SMS messages and automated calls
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tuberculosis focused on measuring SMS, Automated calls, Routine immunization, mHealth

Eligibility Criteria

1 Day - 14 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • The inclusion criteria includes being a child from the HDSS site, being less than 14 days of age with parent/guardian or at least one person in the household having a working mobile phone connection and parent/guardian providing consent to participate in the study.

Exclusion Criteria:

  • The exclusion criteria includes a child from outside HDSS area or family plans to stay in the catchment area for less than 20 weeks

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    No Intervention

    Arm Label

    1. One way SMS messages.

    2. Two Way SMS messages

    3. One way automated calls.

    4.Two way interactive automated calls

    5. Control Arm

    Arm Description

    Parents/caregiver will receive one way educational/reminder/proactive SMS messages related to routine immunization once a week till 20 weeks of age.

    Parents/caregiver will receive two way (interactive) educational/reminder/proactive SMS messages related to routine immunization once a week till 20 weeks of age-parents will have the option to reply and receive more information related to immunization through text messages.

    Parents/caregiver will receive one way educational/reminder/proactive automated phone call related to routine immunization once a week till 20 weeks of age.

    Parents/caregiver will receive two way (interactive) educational/reminder/proactive automated phone call related to routine immunization once a week till 20 weeks of age-parents will have the option to reply and receive more information related to immunization through phone call.

    One time counseling at the baseline survey.

    Outcomes

    Primary Outcome Measures

    The primary outcome will measure the number of children who got vaccinated for routine immunization scheduled at 6, 10 and 14 weeks of life
    The final outcome of vaccine will be measured at 20 weeks of life, between control and intervention arm and between intervention arms

    Secondary Outcome Measures

    The secondary outcome will measure the mean improvement in on-time vaccination for routine immunization scheduled at 6, 10 and 14 weeks of life
    The final outcome of on-time vaccination will be measured between control and intervention arm and between intervention arms

    Full Information

    First Posted
    November 7, 2017
    Last Updated
    November 14, 2017
    Sponsor
    Aga Khan University
    Collaborators
    Grand Challenges Canada, University of British Columbia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03341195
    Brief Title
    Mobile Phone SMS Messages and Automated Calls in Improving Vaccine Coverage Among Children in Pakistan
    Official Title
    To Evaluate the Role of Mobile Phone SMS Messages and Automated Calls in Improving Vaccine Coverage Among Children in Pakistan
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2018 (Anticipated)
    Primary Completion Date
    July 2018 (Anticipated)
    Study Completion Date
    September 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Aga Khan University
    Collaborators
    Grand Challenges Canada, University of British Columbia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Routine childhood immunization (RCI) in Pakistan is well below the recommended coverage of 90% with rates as low as 16% in certain regions (Pakistan DHS 2012-3). This has led to continued polio transmission, large measles outbreaks and thousands of deaths from vaccine-preventable diseases (Kazi.Bull WHO 2016). Mobile phone communication is widespread in developing countries and has proven a potential method of directly connecting pregnant women and mothers to health services (Kharbanda. Expert Review of Vaccine 2014). The investigators propose conducting a mixed methods proof of concept cluster randomized trial (CRT) to assess the effectiveness of different types of SMS messaging and automated calls to improve RCI and understand the perceptions and barriers that may affect SMS and automated call-based interventions at participants levels. the investigators will conduct the study at urban and rural sites in Pakistan. The investigators will examine an important public health question - do low cost, automated SMS, and automated messages improve RCI coverage in resource-constrained settings? Further, investigators will compare the effectiveness of reminder, educational and interactive text messages for improving RCI and will generate socio-cultural data regarding the impact of participants health beliefs that will be important for setting up the appropriate interventions in other LMICs.
    Detailed Description
    SMS text messages have shown to be effective for mobile health or mHealth having a considerable impact on disease prevention efforts in developing countries. Mobile phone and SMS texting provide an excellent solution to challenges like travel and complex intercultural contact. SMS based interventions have been quite effective in different programs, particularly in treatment adherence, smoke cessation, health care appointment attendance, antenatal care attendance and compliance with immunization. In addition adding incentives to SMS messages have shown a positive association, however, there is a cost implication for scaling up this model at a country level. Given the mobile phone access and acceptability in the LMIC, there is great potential for SMS based intervention to improve Immunization coverage in LMIC setup. One major reservation for SMS based interventions is the level of literacy. However, there has been mixed input related to the preference of phones calls as compared to text messages in populations of low literacy and resource-constrained settings. Mobile phone text messages in local languages, pictorial messages and in combination with a phone call can further reduce this gap. Most of the studies evaluating the impact of text messages on vaccination have been conducted in the United States with a major focus on flu vaccine among children and teenagers. The participants covered in these studies are from low income background at an academic medical center and is quite different from resource constraint settings of LMICs due to poor immunization registries and electronic records. There is limited data from LMICs set up on the role of SMS based interventions for improvement of RI coverage and conventional one-way reminder text messages were used by most of the studies as the intervention. Overall very few investigators compared reminders, educational and interactive SMS messages related to childhood vaccination uptake. Although some of the investigators 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. Very few studies have compared the effect of educational, reminders and interactive messages in improving uptake and on-time routine immunization. In this study the investigators would like to examine an important public health question - do low cost, automated SMS messages and calls improve RI coverage among participants in resource-constrained settings? In this study, we would like to compare the effectiveness of reminder, educational and interactive text messages and phone calls for improving RI uptake in Pakistani participants.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tuberculosis, Polio, Diphtheria, Pertussis, Tetanus, Haemophilus Influenzae Type b Infection, Hepatitis B, Pneumococcal Infection
    Keywords
    SMS, Automated calls, Routine immunization, mHealth

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Cluster randomized trial, four intervention arm and one control arm
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    3850 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    1. One way SMS messages.
    Arm Type
    Active Comparator
    Arm Description
    Parents/caregiver will receive one way educational/reminder/proactive SMS messages related to routine immunization once a week till 20 weeks of age.
    Arm Title
    2. Two Way SMS messages
    Arm Type
    Active Comparator
    Arm Description
    Parents/caregiver will receive two way (interactive) educational/reminder/proactive SMS messages related to routine immunization once a week till 20 weeks of age-parents will have the option to reply and receive more information related to immunization through text messages.
    Arm Title
    3. One way automated calls.
    Arm Type
    Active Comparator
    Arm Description
    Parents/caregiver will receive one way educational/reminder/proactive automated phone call related to routine immunization once a week till 20 weeks of age.
    Arm Title
    4.Two way interactive automated calls
    Arm Type
    Active Comparator
    Arm Description
    Parents/caregiver will receive two way (interactive) educational/reminder/proactive automated phone call related to routine immunization once a week till 20 weeks of age-parents will have the option to reply and receive more information related to immunization through phone call.
    Arm Title
    5. Control Arm
    Arm Type
    No Intervention
    Arm Description
    One time counseling at the baseline survey.
    Intervention Type
    Behavioral
    Intervention Name(s)
    SMS messages and automated calls
    Intervention Description
    The intervention consists of SMS and automated calls based messages
    Primary Outcome Measure Information:
    Title
    The primary outcome will measure the number of children who got vaccinated for routine immunization scheduled at 6, 10 and 14 weeks of life
    Description
    The final outcome of vaccine will be measured at 20 weeks of life, between control and intervention arm and between intervention arms
    Time Frame
    Vaccination status at 20th week of life of the particpants
    Secondary Outcome Measure Information:
    Title
    The secondary outcome will measure the mean improvement in on-time vaccination for routine immunization scheduled at 6, 10 and 14 weeks of life
    Description
    The final outcome of on-time vaccination will be measured between control and intervention arm and between intervention arms
    Time Frame
    On-time vaccination for routine immunization scheduled at 6, 10 and 14 weeks of life

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Day
    Maximum Age & Unit of Time
    14 Days
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: The inclusion criteria includes being a child from the HDSS site, being less than 14 days of age with parent/guardian or at least one person in the household having a working mobile phone connection and parent/guardian providing consent to participate in the study. Exclusion Criteria: The exclusion criteria includes a child from outside HDSS area or family plans to stay in the catchment area for less than 20 weeks
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Abdul M Kazi, MBBS,MPH
    Phone
    +922134864232
    Email
    momin.kazi@aku.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Abdul M Kazi, MBBS,MPH
    Organizational Affiliation
    The Aga Khan University, Pakistan
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32813276
    Citation
    Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.
    Results Reference
    derived
    PubMed Identifier
    31148544
    Citation
    Kazi AM, Ahsan N, Khan A, Jamal S, Kalimuddin H, Ghulamhussain N, Wajidali Z, Muqeet A, Zaidi F, Subzlani M, McKellin W, Ali A, Collet JP. Personalized Text Messages and Automated Calls for Improving Vaccine Coverage Among Children in Pakistan: Protocol for a Community-Based Cluster Randomized Clinical Trial. JMIR Res Protoc. 2019 May 30;8(5):e12851. doi: 10.2196/12851.
    Results Reference
    derived

    Learn more about this trial

    Mobile Phone SMS Messages and Automated Calls in Improving Vaccine Coverage Among Children in Pakistan

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