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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01878435
Acronym
m-SIMU
Enrollment
2018
Registered
2013-06-17
Start date
2013-10-31
Completion date
2016-02-29
Last updated
2022-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Short Message System, SMS reminder, mobile phone, cell phone, vaccination, immunization, mHealth

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.

Interventions

OTHERTravel subsidy
OTHERTravel subsidy 2

Sponsors

Bill and Melinda Gates Foundation
CollaboratorOTHER
Kenya Medical Research Institute
CollaboratorOTHER
Centers for Disease Control and Prevention
CollaboratorFED
Johns Hopkins Bloomberg School of Public Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
0 Weeks to 5 Weeks
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Percent of children immunizedUp to 12 months of age

Secondary

MeasureTime frameDescription
Proportion of children vaccinated by study armWithin 2 weeks of each scheduled vaccine dateThe 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 dosesAge 24 weeksComparison 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 armAge 24 weeks (pentavalent only), 10 months and age 12 monthsComparison 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 facilityAge 12 monthsVaccine coverage analysis stratified by mobile phone ownership and residential distance
Percent of fully immunized children (FIC) by study arm10 months of ageFIC = 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
Direct costs for each intervention arm25 months, approximate time period for deploying interventionsCosts 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 statusAge 12 monthsProportion 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 statusAge 12 monthsProportion of children who have received vitamin A supplementation will be compared across study groups
Height-for-age,to evaluate if the interventions had impact on other health status indicatorsAge 12 monthsUsing regression, average height for age in each group will be compared across study groups

Countries

Kenya

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026