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

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ClinicalTrials.gov Identifier: NCT03341195
Recruitment Status : Not yet recruiting
First Posted : November 14, 2017
Last Update Posted : November 17, 2017
Sponsor:
Collaborators:
Grand Challenges Canada
University of British Columbia
Information provided by (Responsible Party):
Dr Abdul Momin Kazi, Aga Khan University

Tracking Information
First Submitted Date  ICMJE November 7, 2017
First Posted Date  ICMJE November 14, 2017
Last Update Posted Date November 17, 2017
Estimated Study Start Date  ICMJE January 2018
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2017)
The primary outcome will measure the number of children who got vaccinated for routine immunization scheduled at 6, 10 and 14 weeks of life [ Time Frame: Vaccination status at 20th week of life of the particpants ]
The final outcome of vaccine will be measured at 20 weeks of life, between control and intervention arm and between intervention arms
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03341195 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2017)
The secondary outcome will measure the mean improvement in on-time vaccination for routine immunization scheduled at 6, 10 and 14 weeks of life [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mobile Phone SMS Messages and Automated Calls in Improving Vaccine Coverage Among Children in Pakistan
Official Title  ICMJE To Evaluate the Role of Mobile Phone SMS Messages and Automated Calls in Improving Vaccine Coverage Among Children in Pakistan
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Cluster randomized trial, four intervention arm and one control arm
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Tuberculosis
  • Polio
  • Diphtheria
  • Pertussis
  • Tetanus
  • Haemophilus Influenzae Type b Infection
  • Hepatitis B
  • Pneumococcal Infection
Intervention  ICMJE Behavioral: SMS messages and automated calls
The intervention consists of SMS and automated calls based messages
Study Arms  ICMJE
  • Active Comparator: 1. One way SMS messages.
    Parents/caregiver will receive one way educational/reminder/proactive SMS messages related to routine immunization once a week till 20 weeks of age.
    Intervention: Behavioral: SMS messages and automated calls
  • Active Comparator: 2. Two Way SMS messages
    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.
    Intervention: Behavioral: SMS messages and automated calls
  • Active Comparator: 3. One way automated calls.
    Parents/caregiver will receive one way educational/reminder/proactive automated phone call related to routine immunization once a week till 20 weeks of age.
    Intervention: Behavioral: SMS messages and automated calls
  • Active Comparator: 4.Two way interactive automated calls
    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.
    Intervention: Behavioral: SMS messages and automated calls
  • No Intervention: 5. Control Arm
    One time counseling at the baseline survey.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 10, 2017)
3850
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2018
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 14 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Abdul M Kazi, MBBS,MPH +922134864232 momin.kazi@aku.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03341195
Other Study ID Numbers  ICMJE 4320-Ped_ERC-16
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr Abdul Momin Kazi, Aga Khan University
Study Sponsor  ICMJE Aga Khan University
Collaborators  ICMJE
  • Grand Challenges Canada
  • University of British Columbia
Investigators  ICMJE
Principal Investigator: Abdul M Kazi, MBBS,MPH The Aga Khan University, Pakistan
PRS Account Aga Khan University
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP