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

Not Applicable

Completed

• Conditions: Measles

• Registration Number: NCT02904642
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

Brief Summary

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.

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 Timeline

• Study First Submitted: 2016-09-08
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-19
• Study Start: 2016-12-06
• Primary Completion: 2017-04-04
• Study Completion: 2017-04-04
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-27
• Last Update Posted: 2018-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 537

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Measles vaccination coverage	10 months	Proportion of children receiving measles vaccination by 10 months of age by study arm

Secondary Outcome Measures

Name	Time	Method
Proportion of children who receive measles vaccination stratified by demographic variables	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
Time to measles vaccination (in days) using Kaplan-Meier Survival Analysis	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.
Measles vaccination coverage at 12 months	12 months	Proportion of children who receive measles vaccination by twelve months of age by study arm
Vaccination coverage for second dose of measles vaccine at 24 months.	24 months	This outcome is dependent on receiving more funding