NCT03379467

Brief Summary

Pakistan has one of the highest infant mortality rates in the world. One child in eleven dies before their fifth birthday. In part, this is due to the low coverage rate of routine childhood immunizations. Since Pakistan is a Low Middle Income Country (LMIC) it is essential that an immunization intervention be developed that is suitable for its socioeconomic setting. The tele-density of Pakistan exceeds 70% and the cost of SMS in Pakistan is very low. Moreover the use of SMS in the country has broadened beyond the conventional use of peer-peer chat to include social networking, SMS banking, delivery tracking, advertising, business, disaster management, and identity verification. This study will utilise this prevalence of mobile phones to assess whether simple and interactive sms reminders can serve to increase childhood immunization coverage and timeliness. The pilot study will be carried out only in 2 EPI (Extended program on Immunization) centers at Korangi. The pilot will determine whether automated text messages produce increased immunization coverage in the reminder groups compared to the control group. 656 participants will be enrolled at Penta-1 and will be followed up until measles-2 vaccination. The results of proposed pilot will provide the basis for a large scale-up study in urban and rural settings in Pakistan.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
655

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2011

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2014

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 20, 2017

Completed
Last Updated

December 21, 2017

Status Verified

December 1, 2017

Enrollment Period

2.8 years

First QC Date

December 14, 2017

Last Update Submit

December 20, 2017

Conditions

Keywords

SMS ReminderTwo-way Reminder

Outcome Measures

Primary Outcomes (1)

  • Measles - 2 Completion

    The primary outcome for the study is the proportion of infants completing measles 2 vaccine on schedule.

    When the participants reach 2 years of age

Study Arms (3)

SMS Reminder

EXPERIMENTAL

Single SMS at each of the following times: * 3 days before immunization * 1 day before immunization * Day of immunization

Other: SMS Reminder

Interactive Reminder

EXPERIMENTAL

Single SMS at each of the following times: * 3 days before immunization * 1 day before immunization * Day of immunization On the day of immunization, study participants are required to respond back through SMS notifying us that child got vaccinated or if not, the reason for delay in immunization. In case of no response, 2 additional reminders will be sent at: * 1 day after scheduled immunization date * 1 week after scheduled immunization date

Other: Interactive Reminder

Control

NO INTERVENTION

Subjects in this arm will not receive any intervention

Interventions

A text message sent as a reminder for immunization on the registered phone number

SMS Reminder

A text message sent as a reminder for immunization on the registered phone number which requires the receiver to respond back

Interactive Reminder

Eligibility Criteria

Age6 Weeks - 12 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Child presenting for pentavalent 1- vaccine
  • Caregivers who owned a cellphone or had access to one
  • Caregivers permanently residing in Korangi Town, Karachi

You may not qualify if:

  • Child presenting for a vaccine other than pentavalent -1
  • Caregivers not having access to a cell phone
  • Caregivers residing outside of Korangi or planning to move from the catchment area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Infections

Study Officials

  • Subhash Chandir, Phd

    Interactive Research and Development (IRD)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The allocation sequence will be concealed from the study staff responsible for screening and enrolling participants in serially numbered, opaque, sealed envelopes.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: This is an individually randomized, three-arm parallel group design randomized control trial with equal allocation in the two treatment groups and control group. The parents of infants in SMS and interactive reminder groups will receive 3-5 reminders for scheduled follow-up immunization visits. The difference in between SMS and interactive reminders is that parents in SMS reminders are not asked to respond back to SMS reminders. The infants in control group will carry out routine follow-ups without any added intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

December 14, 2017

First Posted

December 20, 2017

Study Start

May 23, 2011

Primary Completion

March 8, 2014

Study Completion

March 8, 2014

Last Updated

December 21, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share