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

Measles Clinical Trial

— M-SIMI  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02904642
• Other study ID #: KEMRI SERU-3311
• Status: Completed
• Phase: N/A
• First received: September 8, 2016
• Last updated: February 27, 2018
• Start date: December 6, 2016
• Est. completion date: April 4, 2017

Study information

• Verified date: February 2018
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 537
• Est. completion date: April 4, 2017
• Est. primary completion date: April 4, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Measles

Intervention

Behavioral:
• SMS reminder
Caregivers will receive two text message reminders for their child's measles immunization scheduled for 9 months of age
• 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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Bill and Melinda Gates Foundation, Kenya Medical Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measles vaccination coverage	Proportion of children receiving measles vaccination by 10 months of age by study arm	10 months
Secondary	Time to measles vaccination (in days) using Kaplan-Meier Survival Analysis	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
Secondary	Proportion of children who receive measles vaccination stratified by demographic variables	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
Secondary	Measles vaccination coverage at 12 months	Proportion of children who receive measles vaccination by twelve months of age by study arm	12 months
Secondary	Vaccination coverage for second dose of measles vaccine at 24 months.	This outcome is dependent on receiving more funding	24 months