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Completed

NCT Number: NCT02904642

Mobile and Scalable Innovations for Measles Immunization: a Randomized Controlled 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

  • To conduct a secondary analysis of the primary outcome using survival analysis and time-to-immunization curves.
  • To determine if there is a differential effect on measles vaccine coverage based on mobile phone ownership and distance to the clinic.
  • To examine the effect of the interventions on measles coverage measured at twelve months of age.
  • To examine the completeness and costs of identifying children through a CHW approach versus the standard HDSS approach.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SMS Reminder

Behavioral

Caregivers will receive two text message reminders for their child's measles immunization scheduled for 9 months of age

Unconditional Incentive

Behavioral

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

Primary outcomes

  1. Measles vaccination coverage

    Time frame: 10 months

    Proportion of children receiving measles vaccination by 10 months of age by study arm

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. Vaccination coverage for second dose of measles vaccine at 24 months.

    Time frame: 24 months

    This outcome is dependent on receiving more funding

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • Kenya Medical Research Institute

Registry information

Official study title

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

Acronym: M-SIMI

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 19, 2016
Registry last updated
Mar 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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