ClinicalTrials.gg
Status unknownNCT03341195Updated Nov 17, 2017

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

An interventional study of SMS messages and automated calls in Tuberculosis, Polio and Diphtheria, sponsored by Aga Khan University. Status unknown. Open to participants aged 1 Day to 14 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-17.

Sponsored by Aga Khan University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
3,850
Allocation
Randomized
Ages
1 Day to 14 Days
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Tuberculosis
  • Polio
  • Diphtheria
  • Pertussis
  • Tetanus
  • Haemophilus Influenzae Type b Infection
  • Hepatitis B
  • Pneumococcal Infection

Keywords

  • SMS
  • Automated calls
  • Routine immunization
  • mHealth
03

In context

Tuberculosis

1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.

This study's planned enrollment of 3,850 is above the median of 150 across 820 interventional studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

Aga Khan University is the lead sponsor of 294 studies on the registry; 43 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 14 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
3,850 participants (estimated)

Study arms

  • 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.

    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.

    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.

    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.

    Behavioral: SMS messages and automated calls

  • No intervention
    5. Control Arm

    One time counseling at the baseline survey.

Interventions

  • BehavioralSMS messages and automated calls

    The intervention consists of SMS and automated calls based messages

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What researchers measure

Primary outcomes

  1. 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

    Time frame: Vaccination status at 20th week of life of the particpants

Secondary outcomes

  1. 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

    Time frame: On-time vaccination for routine immunization scheduled at 6, 10 and 14 weeks of life

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 32813276 ↗
  • 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. PubMed 31148544 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2018; primary completion for Jul 2018, 6 months later.

Of 169 non-industry interventional studies with no phase under Tuberculosis, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 41. This study's planned 6 months is below that.

Counting every sponsor, half of 171 studies reached it within 25 months; a quarter within 14 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 7, 2017
First posted
Nov 14, 2017
StartEst.
Jan 2018
Primary completionEst.
Jul 2018
CompletionEst.
Sep 2018
Last update
Nov 17, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03341195
Collaborators
Grand Challenges Canada, University of British Columbia
Responsible party
Dr Abdul Momin Kazi (Senior Instructor Research, Aga Khan University) — Principal investigator
First posted
Nov 14, 2017
Start date
Jan 2018 (estimated)
Primary completion
Jul 2018 (estimated)
Completion
Sep 2018 (estimated)
Last update
Nov 17, 2017

Study contacts

Abdul M Kazi, MBBS,MPH
Contact
momin.kazi@aku.edu
+922134864232
Abdul M Kazi, MBBS,MPH
principal investigator · The Aga Khan University, Pakistan

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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