Skip to main content
OpenTrials
Completed

NCT Number: 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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diphtheria Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Bordetella Infections Clostridium Infections Communicable Diseases Corynebacterium Infections DNA Virus Infections Digestive System Diseases Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Haemophilus Infections Haemophilus Influenzae Type b Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Measles Mononegavirales Infections Morbillivirus Infections Paramyxoviridae Infections Pasteurellaceae Infections Pertussis RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Tetanus Virus Diseases Whooping Cough

Age range

0 week–5 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gem and Asembo Area

Gem and Asembo Area, Siaya County, Kenya

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mother of infant aged 0-4 weeks during the study period
  • Current resident of one of the study villages
  • Willing to sign informed consent for the study

Exclusion criteria

  • Plans to move out of the study area in the next 6 months
  • Resides in a village with active immunization intervention/program
  • Has already received immunizations other than birth dose of BCG or polio

Treatment and study plan

SMS reminder

Other

Travel subsidy

Other

Travel subsidy 2

Other

Primary outcomes

  1. Percent of children immunized

    Time frame: Up to 12 months of age

Secondary outcomes

  1. Percent of fully immunized children (FIC) by study arm

    Time frame: 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

  2. Proportion of children vaccinated by study arm

    Time frame: 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

  3. Proportion of children dropping out between doses

    Time frame: 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

  4. Proportion of children receiving measles and pentavalent vaccines by study arm

    Time frame: Age 24 weeks (pentavalent only), 10 months and age 12 months

    Comparison of vaccine coverage (pentavalent3 and measles, separately) between intervention and control arms

  5. Proportion in each arm vaccinated by mobile phone ownership and by residential distance from a health facility

    Time frame: Age 12 months

    Vaccine coverage analysis stratified by mobile phone ownership and residential distance

  6. Height-for-age,to evaluate if the interventions had impact on other health status indicators

    Time frame: Age 12 months

    Using regression, average height for age in each group will be compared across study groups

  7. Direct costs for each intervention arm

    Time frame: 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

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • Centers for Disease Control and Prevention
  • Kenya Medical Research Institute

Registry information

Acronym: m-SIMU

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 17, 2013
Registry last updated
Oct 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.