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

Hepatitis B Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01878435
• Other study ID #: OPP1053900
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: February 2016

Study information

• Verified date: October 2022
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2018
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Weeks to 5 Weeks

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• SMS reminder

• Travel subsidy

• Travel subsidy 2

Locations

Country	Name	City	State
Kenya	Gem and Asembo Area	Gem And Asembo Area	Siaya County

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Bill and Melinda Gates Foundation, Centers for Disease Control and Prevention, Kenya Medical Research Institute

Country where clinical trial is conducted

Kenya, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of children immunized		Up to 12 months of age
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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