Mobile and Scalable Innovations for Measles Immunization: a Randomized Controlled Trial (M-SIMI)

February 27, 2018 updated by: Dustin Gibson, Johns Hopkins Bloomberg School of Public Health

Randomized Controlled Trial of the Impact of Mobile Phone Delivered Reminders and Unconditional Travel Subsidies on Measles Vaccination in Western Kenya: The Mobile and Scalable Innovations for Measles Immunization (M-SIMI) Trial

The overall objective is to test the impact of short message service (SMS) reminders, with or without unconditionally provided mobile-money incentives, can improve measles vaccination coverage in rural western Kenyan infants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary Objective The primary objective is to determine if text message reminders, with or without unconditionally provided incentives, can increase the proportion of children who receive measles vaccination by 15% at age ten months as compared to control arm children.

Secondary Objectives

  1. To conduct a secondary analysis of the primary outcome using survival analysis and time-to-immunization curves.
  2. To determine if there is a differential effect on measles vaccine coverage based on mobile phone ownership and distance to the clinic.
  3. To examine the effect of the interventions on measles coverage measured at twelve months of age.
  4. To examine the completeness and costs of identifying children through a CHW approach versus the standard HDSS approach.
  5. To evaluate the effect of the interventions on coverage of second dose of measles vaccine at 24 months. This secondary objective is contingent on receiving additional funding.

Study Type

Interventional

Enrollment (Anticipated)

537

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Caregiver of infant aged 6-8 months at time of enrollment
  • Self-reported resident of one of the study villages; where the definition of a resident is defined by caregiver
  • Willing to sign informed consent for the study

Exclusion Criteria:

  • Child of enrolled caregiver has already received one dose of measles vaccine, not including any supplemental measles vaccines
  • Caregiver plans to move away in the next 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
All enrolled caregivers will receive a congratulatory text message at enrollment which indicates who is conducting the study and which also includes a general-health related saying, "The greatest wealth is health". No additional text messages or travel subsidies will be sent to caregivers randomized to the control arm.
Experimental: SMS reminder
At enrollment, participants will be told to expect 2 SMS reminders for measles vaccine; first, at 3 days before and second, on the day before the scheduled measles vaccine at 9 months of age. At most, enrolled caregivers will receive three text messages (two for the measles vaccine and one for welcoming mother to the study). Text messages will be sent in English, Kiswahili or Dholuo language, according to the mother's preference. These reminders will have information about the child's scheduled immunization date.
Behavioral: SMS reminder
Caregivers will receive two text message reminders for their child's measles immunization scheduled for 9 months of age
Experimental: SMS reminder + Unconditional Incentive
Participants will receive SMS reminders as described in the SMS reminder arm. Additionally, participants will be sent a 150 Kenyan Shillings (KES) incentive to the mobile phone number they provided at enrollment. The incentive will be delivered three days before the child turns nine months (i.e. sent on the same day as the first SMS reminder). Caregivers will receive the mobile-money incentive unconditionally. The intent of the incentive is to help offset the costs associated with transportation to the clinic. The transaction costs associated with mobile-money transactions will be borne by the study such that mothers will receive the full 150 KES.
Behavioral: SMS reminder
Caregivers will receive two text message reminders for their child's measles immunization scheduled for 9 months of age
Behavioral: Unconditional Incentive
A mobile-money incentive in the amount of 150 Kenyan Shillings will be transferred to the enrolled caregiver's mobile phone when the child reaches nine months of age

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measles vaccination coverage
Time Frame: 10 months
Proportion of children receiving measles vaccination by 10 months of age by study arm
10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to measles vaccination (in days) using Kaplan-Meier Survival Analysis
Time Frame: 12 months
As a secondary analysis of the primary outcome, time-to-measles immunization curves will be constructed using the Kaplan-Meier method and study arms will be compared using the Cox model. The 25th, 50th, and 75th percentiles for time to immunization and the number of days delayed, in relation to the measles due date, will also be reported for each vaccine and by study arm.
12 months
Proportion of children who receive measles vaccination stratified by demographic variables
Time Frame: 10 months
A priori we will conduct sub group analyses of the primary outcome for mobile phone ownership, birth order of the enrolled caregiver's child, and time to clinic. Additional variables for subgroup analyses will come from a risk factor analysis of not receiving measles vaccination in the control arm
10 months
Measles vaccination coverage at 12 months
Time Frame: 12 months
Proportion of children who receive measles vaccination by twelve months of age by study arm
12 months
Vaccination coverage for second dose of measles vaccine at 24 months.
Time Frame: 24 months
This outcome is dependent on receiving more funding
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

Bill and Melinda Gates Foundation
Kenya Medical Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2016

Primary Completion (Actual)

April 4, 2017

Study Completion (Actual)

April 4, 2017

Study Registration Dates

First Submitted

September 8, 2016

First Submitted That Met QC Criteria

September 13, 2016

First Posted (Estimate)

September 19, 2016

Study Record Updates

Last Update Posted (Actual)

March 1, 2018

Last Update Submitted That Met QC Criteria

February 27, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEMRI SERU-3311

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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