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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 (m-SIMU)

This study has been completed.
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Kenya Medical Research Institute
Centers for Disease Control and Prevention
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: September 21, 2016
Last verified: September 2016
  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
Diphtheria
Tetanus
Pertussis
Hepatitis B
Haemophilus Influenzae Type b
Measles
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 ]

Secondary Outcome Measures:
  • Percent of fully immunized children (FIC) by study arm [ Time Frame: 10 months of age ] [ Designated as safety issue: No ]
    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 [ Time Frame: Within 2 weeks of each scheduled vaccine date ] [ Designated as safety issue: No ]
    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

  • Proportion of children dropping out between doses [ Time Frame: Age 24 weeks ] [ Designated as safety issue: No ]
    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

  • Proportion of children receiving measles and pentavalent vaccines by study arm [ Time Frame: Age 24 weeks (pentavalent only), 10 months and age 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Age 12 months ] [ Designated as safety issue: No ]
    Vaccine coverage analysis stratified by mobile phone ownership and residential distance

  • Height-for-age,to evaluate if the interventions had impact on other health status indicators [ Time Frame: Age 12 months ] [ Designated as safety issue: No ]
    Using regression, average height for age in each group will be compared across study groups

  • Direct costs for each intervention arm [ Time Frame: 25 months, approximate time period for deploying interventions ] [ Designated as safety issue: No ]
    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

  • Bed-net usage, to evaluate if the interventions had impact on other indicators of health status [ Time Frame: Age 12 months ]
    Proportion 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 status [ Time Frame: Age 12 months ]
    Proportion of children who have received vitamin A supplementation will be compared across study groups


Enrollment: 2018
Study Start Date: October 2013
Study Completion Date: February 2016
Primary Completion Date: February 2016 (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   (Child)
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

Locations
Kenya
Gem and Asembo Area
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
Centers for Disease Control and Prevention
  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: September 21, 2016
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
vaccination
immunization
mHealth

Additional relevant MeSH terms:
Hepatitis B
Diphtheria
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2016