Back to resultsRandomized 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)
Primary Purpose
Diphtheria, Tetanus, Pertussis
Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
SMS reminder
Travel subsidy
Travel subsidy 2
Sponsored by
About this trial
This is an interventional other trial for Diphtheria focused on measuring Short Message System, SMS reminder, mobile phone, cell phone, vaccination, immunization, mHealth
Eligibility Criteria
Inclusion Criteria:
- Mother of infant aged 0-4 weeks during the study period
- Current resident of one of the study villages
- Willing to sign informed consent for the study
Exclusion Criteria:
- Plans to move out of the study area in the next 6 months
- Resides in a village with active immunization intervention/program
- Has already received immunizations other than birth dose of BCG or polio
Sites / Locations
- Gem and Asembo Area
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
No Intervention
Experimental
Arm Label
SMS reminder
SMS reminder and Travel subsidy
Control
SMS reminder and Travel subsidy 2
Arm Description
Outcomes
Primary Outcome Measures
Percent of children immunized
Secondary Outcome Measures
Percent of fully immunized children (FIC) by study arm
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
Proportion of children vaccinated by study arm
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
Proportion of children dropping out between doses
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
Proportion of children receiving measles and pentavalent vaccines by study arm
Comparison of vaccine coverage (pentavalent3 and measles, separately) between intervention and control arms
Proportion in each arm vaccinated by mobile phone ownership and by residential distance from a health facility
Vaccine coverage analysis stratified by mobile phone ownership and residential distance
Height-for-age,to evaluate if the interventions had impact on other health status indicators
Using regression, average height for age in each group will be compared across study groups
Direct costs for each intervention arm
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
Bed-net usage, to evaluate if the interventions had impact on other indicators of health status
Proportion of children using bed-nets will be compared across study groups
Vitamin A coverage, o evaluate if the interventions had impact on other indicators of health status
Proportion of children who have received vitamin A supplementation will be compared across study groups
Full Information
NCT ID
NCT01878435
First Posted
June 10, 2013
Last Updated
October 25, 2022
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Bill and Melinda Gates Foundation, Kenya Medical Research Institute, Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT01878435
Brief Title
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
Acronym
m-SIMU
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Bill and Melinda Gates Foundation, Kenya Medical Research Institute, Centers for Disease Control and Prevention
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Measles
Keywords
Short Message System, SMS reminder, mobile phone, cell phone, vaccination, immunization, mHealth
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2018 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SMS reminder
Arm Type
Experimental
Arm Title
SMS reminder and Travel subsidy
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Arm Title
SMS reminder and Travel subsidy 2
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
SMS reminder
Intervention Type
Other
Intervention Name(s)
Travel subsidy
Intervention Type
Other
Intervention Name(s)
Travel subsidy 2
Primary Outcome Measure Information:
Title
Percent of children immunized
Time Frame
Up to 12 months of age
Secondary Outcome Measure Information:
Title
Percent of fully immunized children (FIC) by study arm
Description
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
Time Frame
10 months of age
Title
Proportion of children vaccinated by study arm
Description
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
Time Frame
Within 2 weeks of each scheduled vaccine date
Title
Proportion of children dropping out between doses
Description
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
Time Frame
Age 24 weeks
Title
Proportion of children receiving measles and pentavalent vaccines by study arm
Description
Comparison of vaccine coverage (pentavalent3 and measles, separately) between intervention and control arms
Time Frame
Age 24 weeks (pentavalent only), 10 months and age 12 months
Title
Proportion in each arm vaccinated by mobile phone ownership and by residential distance from a health facility
Description
Vaccine coverage analysis stratified by mobile phone ownership and residential distance
Time Frame
Age 12 months
Title
Height-for-age,to evaluate if the interventions had impact on other health status indicators
Description
Using regression, average height for age in each group will be compared across study groups
Time Frame
Age 12 months
Title
Direct costs for each intervention arm
Description
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
Time Frame
25 months, approximate time period for deploying interventions
Title
Bed-net usage, to evaluate if the interventions had impact on other indicators of health status
Description
Proportion of children using bed-nets will be compared across study groups
Time Frame
Age 12 months
Title
Vitamin A coverage, o evaluate if the interventions had impact on other indicators of health status
Description
Proportion of children who have received vitamin A supplementation will be compared across study groups
Time Frame
Age 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Weeks
Maximum Age & Unit of Time
5 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Mother of infant aged 0-4 weeks during the study period
Current resident of one of the study villages
Willing to sign informed consent for the study
Exclusion Criteria:
Plans to move out of the study area in the next 6 months
Resides in a village with active immunization intervention/program
Has already received immunizations other than birth dose of BCG or polio
Facility Information:
Facility Name
Gem and Asembo Area
City
Gem And Asembo Area
State/Province
Siaya County
Country
Kenya
12. IPD Sharing Statement
Citations:
PubMed Identifier
23246258
Citation
Wakadha H, Chandir S, Were EV, Rubin A, Obor D, Levine OS, Gibson DG, Odhiambo F, Laserson KF, Feikin DR. The feasibility of using mobile-phone based SMS reminders and conditional cash transfers to improve timely immunization in rural Kenya. Vaccine. 2013 Jan 30;31(6):987-93. doi: 10.1016/j.vaccine.2012.11.093. Epub 2012 Dec 13.
Results Reference
background
PubMed Identifier
27189422
Citation
Gibson DG, Kagucia EW, Ochieng B, Hariharan N, Obor D, Moulton LH, Winch PJ, Levine OS, Odhiambo F, O'Brien KL, Feikin DR. The Mobile Solutions for Immunization (M-SIMU) Trial: A Protocol for a Cluster Randomized Controlled Trial That Assesses the Impact of Mobile Phone Delivered Reminders and Travel Subsidies to Improve Childhood Immunization Coverage Rates and Timeliness in Western Kenya. JMIR Res Protoc. 2016 May 17;5(2):e72. doi: 10.2196/resprot.5030.
Results Reference
background
PubMed Identifier
28288747
Citation
Gibson DG, Ochieng B, Kagucia EW, Were J, Hayford K, Moulton LH, Levine OS, Odhiambo F, O'Brien KL, Feikin DR. Mobile phone-delivered reminders and incentives to improve childhood immunisation coverage and timeliness in Kenya (M-SIMU): a cluster randomised controlled trial. Lancet Glob Health. 2017 Apr;5(4):e428-e438. doi: 10.1016/S2214-109X(17)30072-4.
Results Reference
derived
Learn more about this trial
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
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