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 (m-SIMU)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Johns Hopkins Bloomberg School of Public Health
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Kenya Medical Research Institute
Information provided by (Responsible Party):
Katherine O'Brien, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01878435
First received: June 10, 2013
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Vaccination
Immunization
Other: SMS reminder
Other: Travel subsidy
Other: Travel subsidy 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Percent of children immunized [ Time Frame: Up to 12 months of age ] [ Designated as safety issue: No ]

Estimated Enrollment: 2800
Study Start Date: October 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SMS reminder Other: SMS reminder
Experimental: SMS reminder and Travel subsidy Other: SMS reminder Other: Travel subsidy
No Intervention: Control
Experimental: SMS reminder and Travel subsidy 2 Other: SMS reminder Other: Travel subsidy 2

  Eligibility

Ages Eligible for Study:   up to 5 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01878435

Contacts
Contact: Ben Omondi, MASc +254722245636

Locations
Kenya
Gem and Asembo Area Recruiting
Gem and Asembo Area, Siaya County, Kenya
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Bill and Melinda Gates Foundation
Kenya Medical Research Institute
  More Information

Publications:
Responsible Party: Katherine O'Brien, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01878435     History of Changes
Other Study ID Numbers: OPP1053900
Study First Received: June 10, 2013
Last Updated: December 10, 2013
Health Authority: Kenya: Ethical Review Committee
United States: Institutional Review Board

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Short Message System
SMS reminder
mobile phone
cell phone

ClinicalTrials.gov processed this record on October 20, 2014