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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02904642
Acronym
M-SIMI
Enrollment
537
Registered
2016-09-19
Start date
2016-12-06
Completion date
2017-04-04
Last updated
2018-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Measles

Keywords

SMS reminder, incentive, mobile phone, Immunization

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.

Interventions

BEHAVIORALSMS reminder

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

BEHAVIORALUnconditional 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

Sponsors

Kenya Medical Research Institute
CollaboratorOTHER
Bill and Melinda Gates Foundation
CollaboratorOTHER
Johns Hopkins Bloomberg School of Public Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Measles vaccination coverage10 monthsProportion of children receiving measles vaccination by 10 months of age by study arm

Secondary

MeasureTime frameDescription
Time to measles vaccination (in days) using Kaplan-Meier Survival Analysis12 monthsAs 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.
Proportion of children who receive measles vaccination stratified by demographic variables10 monthsA 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
Measles vaccination coverage at 12 months12 monthsProportion 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 monthsThis outcome is dependent on receiving more funding

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026