Randomized Controlled Trial of the Impact of Mobile Phone Delivered Reminders and Travel Subsidies to Improve Childhood Immunization Coverage Rates and Timeliness in Western Kenya (m-SIMU)

October 25, 2022 updated by: Johns Hopkins Bloomberg School of Public Health
The project goal is to conduct a randomized controlled trial (RCT) to test whether mobile phone short message system (SMS) reminders, either with or without mobile-phone based travel subsidies will improve timeliness, coverage, and drop-out rates of routine EPI vaccines in rural western Kenya.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2018

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
    • Siaya County
      • Gem And Asembo Area, Siaya County, Kenya
        • Gem and Asembo Area

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 1 month (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Mother of infant aged 0-4 weeks during the study period
  2. Current resident of one of the study villages
  3. Willing to sign informed consent for the study

Exclusion Criteria:

  1. Plans to move out of the study area in the next 6 months
  2. Resides in a village with active immunization intervention/program
  3. Has already received immunizations other than birth dose of BCG or polio

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
EXPERIMENTAL: SMS reminder
Other: SMS reminder
EXPERIMENTAL: SMS reminder and Travel subsidy
Other: SMS reminder
Other: Travel subsidy
EXPERIMENTAL: SMS reminder and Travel subsidy 2
Other: SMS reminder
Other: Travel subsidy 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent of children immunized
Time Frame: Up to 12 months of age
Up to 12 months of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of fully immunized children (FIC) by study arm
Time Frame: 10 months of age
FIC = One dose bacille Calmette-Guerin (BCG) vaccine, three doses pentavalent (diphtheria, pertussis, tetanus, hepatitis B, haemophilus influenzae type b) vaccine, three doses polio vaccine and one dose measles vaccine. The proportion of FIC infants by 10 months of age in each of the intervention arms (SMS only and SMS + subsidy) will be separately compared to the control arm using statistical analyses that adjust for the cluster design and any socio-demographic variables that may be unequally distributed across study arms
10 months of age
Proportion of children vaccinated by study arm
Time Frame: Within 2 weeks of each scheduled vaccine date
The proportion of intervention arm infants that receive vaccination within 2 weeks of the scheduled date will be calculated for each dose of vaccine and compared to the control arm using statistical analyses that adjust for our cluster design and any socio-demographic variables that may be unequally distributed across study arms
Within 2 weeks of each scheduled vaccine date
Proportion of children dropping out between doses
Time Frame: Age 24 weeks
Comparison of the differences in percentages of children vaccinated with pentavalent1 and pentavalent3 in the interventions arms compared to this difference in the control arm using statistical analyses that adjust for our cluster design and any socio-demographic variables that may be unequally distributed across study arms
Age 24 weeks
Proportion of children receiving measles and pentavalent vaccines by study arm
Time Frame: Age 24 weeks (pentavalent only), 10 months and age 12 months
Comparison of vaccine coverage (pentavalent3 and measles, separately) between intervention and control arms
Age 24 weeks (pentavalent only), 10 months and age 12 months
Proportion in each arm vaccinated by mobile phone ownership and by residential distance from a health facility
Time Frame: Age 12 months
Vaccine coverage analysis stratified by mobile phone ownership and residential distance
Age 12 months
Height-for-age,to evaluate if the interventions had impact on other health status indicators
Time Frame: Age 12 months
Using regression, average height for age in each group will be compared across study groups
Age 12 months
Direct costs for each intervention arm
Time Frame: 25 months, approximate time period for deploying interventions
Costs include SMS messages, the amount of travel subsidy transferred, and the tariffs and fees that are associated with using mobile-money. For each arm, these costs will be divided by the number of children vaccinated and comparisons will be made across study arms
25 months, approximate time period for deploying interventions
Bed-net usage, to evaluate if the interventions had impact on other indicators of health status
Time Frame: Age 12 months
Proportion of children using bed-nets will be compared across study groups
Age 12 months
Vitamin A coverage, o evaluate if the interventions had impact on other indicators of health status
Time Frame: Age 12 months
Proportion of children who have received vitamin A supplementation will be compared across study groups
Age 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

Bill and Melinda Gates Foundation
Centers for Disease Control and Prevention
Kenya Medical Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

February 1, 2016

Study Registration Dates

First Submitted

June 10, 2013

First Submitted That Met QC Criteria

June 12, 2013

First Posted (ESTIMATE)

June 17, 2013

Study Record Updates

Last Update Posted (ACTUAL)

October 27, 2022

Last Update Submitted That Met QC Criteria

October 25, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPP1053900

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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