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

Primary Purpose

Measles

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SMS reminder
Unconditional Incentive
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Measles focused on measuring SMS reminder, incentive, mobile phone, Immunization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Experimental

    Arm Label

    Control

    SMS reminder

    SMS reminder + Unconditional Incentive

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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.
    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
    Measles vaccination coverage at 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.
    This outcome is dependent on receiving more funding

    Full Information

    First Posted
    September 8, 2016
    Last Updated
    February 27, 2018
    Sponsor
    Johns Hopkins Bloomberg School of Public Health
    Collaborators
    Kenya Medical Research Institute, Bill and Melinda Gates Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02904642
    Brief Title
    Mobile and Scalable Innovations for Measles Immunization: a Randomized Controlled Trial
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    December 6, 2016 (Actual)
    Primary Completion Date
    April 4, 2017 (Actual)
    Study Completion Date
    April 4, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Johns Hopkins Bloomberg School of Public Health
    Collaborators
    Kenya Medical Research Institute, Bill and Melinda Gates Foundation

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Measles
    Keywords
    SMS reminder, incentive, mobile phone, Immunization

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    537 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    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.
    Arm Title
    SMS reminder
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    SMS reminder + Unconditional Incentive
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    SMS reminder
    Intervention Description
    Caregivers will receive two text message reminders for their child's measles immunization scheduled for 9 months of age
    Intervention Type
    Behavioral
    Intervention Name(s)
    Unconditional Incentive
    Intervention Description
    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 Measure Information:
    Title
    Measles vaccination coverage
    Description
    Proportion of children receiving measles vaccination by 10 months of age by study arm
    Time Frame
    10 months
    Secondary Outcome Measure Information:
    Title
    Time to measles vaccination (in days) using Kaplan-Meier Survival Analysis
    Description
    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.
    Time Frame
    12 months
    Title
    Proportion of children who receive measles vaccination stratified by demographic variables
    Description
    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 Frame
    10 months
    Title
    Measles vaccination coverage at 12 months
    Description
    Proportion of children who receive measles vaccination by twelve months of age by study arm
    Time Frame
    12 months
    Title
    Vaccination coverage for second dose of measles vaccine at 24 months.
    Description
    This outcome is dependent on receiving more funding
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33509838
    Citation
    Kagucia EW, Ochieng B, Were J, Hayford K, Obor D, O'Brien KL, Gibson DG. Impact of mobile phone delivered reminders and unconditional incentives on measles-containing vaccine timeliness and coverage: a randomised controlled trial in western Kenya. BMJ Glob Health. 2021 Jan;6(1):e003357. doi: 10.1136/bmjgh-2020-003357.
    Results Reference
    derived
    PubMed Identifier
    32813276
    Citation
    Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.
    Results Reference
    derived
    PubMed Identifier
    31290405
    Citation
    Gibson DG, Kagucia EW, Were J, Obor D, Hayford K, Ochieng B. Text Message Reminders and Unconditional Monetary Incentives to Improve Measles Vaccination in Western Kenya: Study Protocol for the Mobile and Scalable Innovations for Measles Immunization Randomized Controlled Trial. JMIR Res Protoc. 2019 Jul 9;8(7):e13221. doi: 10.2196/13221.
    Results Reference
    derived

    Learn more about this trial

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

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