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

Not Applicable

Completed

• Conditions: Diphtheria; Tetanus; Pertussis; Haemophilus Influenzae Type b; Hepatitis B; Measles
• Interventions: Other: SMS reminder; Other: Travel subsidy 2; Other: Travel subsidy

• Registration Number: NCT01878435
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-10
• Study First Submitted QC: 2013-06-12
• Study First Posted: 2013-06-17
• Study Start: 2013-10
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2018

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SMS reminder and Travel subsidy 2	SMS reminder	-
SMS reminder and Travel subsidy 2	Travel subsidy 2	-
SMS reminder and Travel subsidy	SMS reminder	-
SMS reminder and Travel subsidy	Travel subsidy	-
SMS reminder	SMS reminder	-

Primary Outcome Measures

Name	Time	Method
Percent of children immunized	Up to 12 months of age

Secondary Outcome Measures

Name	Time	Method
Percent of fully immunized children (FIC) by study arm	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
Proportion of children vaccinated by study arm	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
Vitamin A coverage, o evaluate if the interventions had impact on other indicators of health status	Age 12 months	Proportion 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 indicators	Age 12 months	Using regression, average height for age in each group will be compared across study groups
Proportion of children dropping out between doses	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
Direct costs for each intervention arm	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
Proportion of children receiving measles and pentavalent vaccines by study arm	Age 24 weeks (pentavalent only), 10 months and age 12 months	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	Age 12 months	Vaccine coverage analysis stratified by mobile phone ownership and residential distance
Bed-net usage, to evaluate if the interventions had impact on other indicators of health status	Age 12 months	Proportion of children using bed-nets will be compared across study groups

Trial Locations

Locations (1)

Gem and Asembo Area; 🇰🇪 Gem And Asembo Area, Siaya County, Kenya