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 Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Measles

Intervention / Treatment
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* Other: SMS reminder
* Other: Travel subsidy
* Other: Travel subsidy 2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Weeks
Maximum Age: 5 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SMS reminder<br> | Other: SMS reminder<br> <br> |
| Experimental: SMS reminder and Travel subsidy<br> | Other: SMS reminder<br> <br> Other: Travel subsidy<br> <br> |
| No Intervention: Control<br> | |
| Experimental: SMS reminder and Travel subsidy 2<br> | Other: SMS reminder<br> <br> Other: Travel subsidy 2<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of children immunized |  | Up to 12 months of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 10 months of age | 
| 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 | Within 2 weeks of each scheduled vaccine date | 
| 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 | Age 24 weeks | 
| Proportion of children receiving measles and pentavalent vaccines by study arm | 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 | 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 | Using regression, average height for age in each group will be compared across study groups | Age 12 months | 
| 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 | 25 months, approximate time period for deploying interventions | 
| 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 | Age 12 months | 
| 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 | Age 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Short Message System, SMS reminder, mobile phone, cell phone, vaccination, immunization, mHealth