Clinical trial NCT01878435: 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
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
Overall status: COMPLETED
Phase: NA
Conditions: Diphtheria
Tetanus
Pertussis
Hepatitis B
Haemophilus Influenzae Type b
Measles
Keywords: Short Message System
SMS reminder
mobile phone
cell phone
vaccination
immunization
mHealth
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
name: Kenya Medical Research Institute
name: Centers for Disease Control and Prevention
First posted: 2013-06-17
Enrollment: 2018
Sex: ALL
Minimum age (years): 0
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent of children immunized
timeFrame: Up to 12 months of age
Secondary outcomes:
measure: Percent of fully immunized children (FIC) by study arm
timeFrame: 10 months of age
measure: Proportion of children vaccinated by study arm
timeFrame: Within 2 weeks of each scheduled vaccine date
measure: Proportion of children dropping out between doses
timeFrame: Age 24 weeks
measure: Proportion of children receiving measles and pentavalent vaccines by study arm
timeFrame: Age 24 weeks (pentavalent only), 10 months and age 12 months
measure: Proportion in each arm vaccinated by mobile phone ownership and by residential distance from a health facility
timeFrame: Age 12 months
measure: Height-for-age,to evaluate if the interventions had impact on other health status indicators
timeFrame: Age 12 months
measure: Direct costs for each intervention arm
timeFrame: 25 months, approximate time period for deploying interventions
measure: Bed-net usage, to evaluate if the interventions had impact on other indicators of health status
timeFrame: Age 12 months
measure: Vitamin A coverage, o evaluate if the interventions had impact on other indicators of health status
timeFrame: Age 12 months
Other outcomes:
Locations:
city: Gem And Asembo Area
country: Kenya
facility: Gem and Asembo Area
state: Siaya County
Study officials:
References:
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.
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.
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.