NCT01878435

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,018

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 17, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

October 27, 2022

Status Verified

October 1, 2022

Enrollment Period

2.3 years

First QC Date

June 10, 2013

Last Update Submit

October 25, 2022

Conditions

DiphtheriaTetanusPertussisHepatitis BHaemophilus Influenzae Type bMeasles

Keywords

Short Message SystemSMS remindermobile phonecell phonevaccinationimmunizationmHealth

Outcome Measures

Primary Outcomes (1)

  • Percent of children immunized

    Up to 12 months of age

Secondary Outcomes (9)

  • Percent of fully immunized children (FIC) by study arm

    10 months of age

  • Proportion of children vaccinated by study arm

    Within 2 weeks of each scheduled vaccine date

  • Proportion of children dropping out between doses

    Age 24 weeks

  • Proportion of children receiving measles and pentavalent vaccines by study arm

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

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

    Age 12 months

  • +4 more secondary outcomes

Study Arms (4)

SMS reminder

EXPERIMENTAL
Other: SMS reminder

SMS reminder and Travel subsidy

EXPERIMENTAL
Other: SMS reminderOther: Travel subsidy

Control

NO INTERVENTION

SMS reminder and Travel subsidy 2

EXPERIMENTAL
Other: SMS reminderOther: Travel subsidy 2

Interventions

SMS reminderOTHER
SMS reminderSMS reminder and Travel subsidySMS reminder and Travel subsidy 2
Travel subsidyOTHER
SMS reminder and Travel subsidy
Travel subsidy 2OTHER
SMS reminder and Travel subsidy 2

Eligibility Criteria

Age0 Weeks - 5 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gem and Asembo Area

Gem and Asembo Area, Siaya County, Kenya

Location

Related Publications (3)

  • 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.

    PMID: 23246258BACKGROUND

  • 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.

    PMID: 27189422BACKGROUND

  • 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.

    PMID: 28288747DERIVED

MeSH Terms

Conditions

DiphtheriaTetanusWhooping CoughHepatitis BHaemophilus InfectionsMeasles

Condition Hierarchy (Ancestors)

Corynebacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsClostridium InfectionsBordetella InfectionsGram-Negative Bacterial InfectionsRespiratory Tract InfectionsRespiratory Tract DiseasesBlood-Borne InfectionsCommunicable DiseasesHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesPasteurellaceae InfectionsMorbillivirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus Infections

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2013

First Posted

June 17, 2013

Study Start

October 1, 2013

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

October 27, 2022

Record last verified: 2022-10

Locations

KE(1)