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

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ClinicalTrials.gov Identifier: NCT02904642
Recruitment Status : Completed
First Posted : September 19, 2016
Last Update Posted : March 1, 2018
Sponsor:
Collaborators:
Kenya Medical Research Institute
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Dustin Gibson, 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.

Condition or disease Intervention/treatment Phase
Measles Behavioral: SMS reminder Behavioral: Unconditional Incentive Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 537 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
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
Actual Study Start Date : December 6, 2016
Actual Primary Completion Date : April 4, 2017
Actual Study Completion Date : April 4, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Measles Vaccines

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




Primary Outcome Measures :
  1. Measles vaccination coverage [ Time Frame: 10 months ]
    Proportion of children receiving measles vaccination by 10 months of age by study arm


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dustin Gibson, Assistant Scientist, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT02904642    
Other Study ID Numbers: KEMRI SERU-3311
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dustin Gibson, Johns Hopkins Bloomberg School of Public Health:
SMS reminder
incentive
mobile phone
Immunization
Additional relevant MeSH terms:
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Measles
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Infections