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MeaslesM-SIMINCT02904642

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

A study testing SMS reminder and Unconditional Incentive in people with Measles, run by Johns Hopkins Bloomberg School of Public Health.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Measles
What is being tested?
SMS reminder and Unconditional Incentive
Could I receive a placebo?
No, everyone receives an active treatment
How many people
537 participants
Where
No sites listed yet
Study dates
6 Dec 2016to 4 Apr 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

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

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.

Read the 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.
Conditions
Measles
Being tested
SMS reminder, Unconditional Incentive
Keywords
SMS reminder, incentive, mobile phone, Immunization
Medical subject headings
Measles

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SMS reminderBehavioural

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

  • Unconditional IncentiveBehavioural

    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

Study groups in NCT02904642
Study groupRoleWhat they receive
ControlNo interventionAll 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.
SMS reminderExperimentalAt 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.
Receives: Behavioral: SMS reminder
SMS reminder + Unconditional IncentiveExperimentalParticipants 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.
Receives: Behavioral: SMS reminder; Behavioral: Unconditional Incentive

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measles vaccination coverage

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

    Measured: 10 months

Secondary outcomes (4)

  1. 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.

    Measured: 12 months

  2. 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

    Measured: 10 months

  3. Measles vaccination coverage at 12 months

    Proportion of children who receive measles vaccination by twelve months of age by study arm

    Measured: 12 months

  4. Vaccination coverage for second dose of measles vaccine at 24 months.

    This outcome is dependent on receiving more funding

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2016 (estimated)
  2. Study start6 Dec 2016
  3. Primary completion4 Apr 2017
  4. Study completion4 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
537 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02904642
Sponsor's protocol ID
KEMRI SERU-3311
Acronym
M-SIMI
Status last verified
Feb 2018
First submitted
8 Sep 2016
Last updated
1 Mar 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33509838

  • 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.

    PubMed 32813276

  • 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.

    PubMed 31290405

Questions about this trial

What is this clinical trial studying?

A study testing SMS reminder and Unconditional Incentive in people with Measles, run by Johns Hopkins Bloomberg School of Public Health.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measles vaccination coverage (time frame: 10 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02904642, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2018.

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