NCT02904642

Brief Summary

The overall objective is to test the impact of short message service (SMS) reminders, with or without unconditionally provided mobile-money incentives, can improve measles vaccination coverage in rural western Kenyan infants.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
537

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

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

September 8, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

December 6, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2017

Completed
Last Updated

March 1, 2018

Status Verified

February 1, 2018

Enrollment Period

4 months

First QC Date

September 8, 2016

Last Update Submit

February 27, 2018

Conditions

Keywords

SMS reminderincentivemobile phoneImmunization

Outcome Measures

Primary Outcomes (1)

  • Measles vaccination coverage

    Proportion of children receiving measles vaccination by 10 months of age by study arm

    10 months

Secondary Outcomes (4)

  • Time to measles vaccination (in days) using Kaplan-Meier Survival Analysis

    12 months

  • Proportion of children who receive measles vaccination stratified by demographic variables

    10 months

  • Measles vaccination coverage at 12 months

    12 months

  • Vaccination coverage for second dose of measles vaccine at 24 months.

    24 months

Study Arms (3)

Control

NO INTERVENTION

All enrolled caregivers will receive a congratulatory text message at enrollment which indicates who is conducting the study and which also includes a general-health related saying, "The greatest wealth is health". No additional text messages or travel subsidies will be sent to caregivers randomized to the control arm.

SMS reminder

EXPERIMENTAL

At enrollment, participants will be told to expect 2 SMS reminders for measles vaccine; first, at 3 days before and second, on the day before the scheduled measles vaccine at 9 months of age. At most, enrolled caregivers will receive three text messages (two for the measles vaccine and one for welcoming mother to the study). Text messages will be sent in English, Kiswahili or Dholuo language, according to the mother's preference. These reminders will have information about the child's scheduled immunization date.

Behavioral: SMS reminder

SMS reminder + Unconditional Incentive

EXPERIMENTAL

Participants will receive SMS reminders as described in the SMS reminder arm. Additionally, participants will be sent a 150 Kenyan Shillings (KES) incentive to the mobile phone number they provided at enrollment. The incentive will be delivered three days before the child turns nine months (i.e. sent on the same day as the first SMS reminder). Caregivers will receive the mobile-money incentive unconditionally. The intent of the incentive is to help offset the costs associated with transportation to the clinic. The transaction costs associated with mobile-money transactions will be borne by the study such that mothers will receive the full 150 KES.

Behavioral: SMS reminderBehavioral: Unconditional Incentive

Interventions

SMS reminderBEHAVIORAL

Caregivers will receive two text message reminders for their child's measles immunization scheduled for 9 months of age

SMS reminderSMS reminder + Unconditional Incentive

A mobile-money incentive in the amount of 150 Kenyan Shillings will be transferred to the enrolled caregiver's mobile phone when the child reaches nine months of age

SMS reminder + Unconditional Incentive

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Caregiver of infant aged 6-8 months at time of enrollment
  • Self-reported resident of one of the study villages; where the definition of a resident is defined by caregiver
  • Willing to sign informed consent for the study

You may not qualify if:

  • Child of enrolled caregiver has already received one dose of measles vaccine, not including any supplemental measles vaccines
  • Caregiver plans to move away in the next 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Kagucia EW, Ochieng B, Were J, Hayford K, Obor D, O'Brien KL, Gibson DG. Impact of mobile phone delivered reminders and unconditional incentives on measles-containing vaccine timeliness and coverage: a randomised controlled trial in western Kenya. BMJ Glob Health. 2021 Jan;6(1):e003357. doi: 10.1136/bmjgh-2020-003357.

  • Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.

  • Gibson DG, Kagucia EW, Were J, Obor D, Hayford K, Ochieng B. Text Message Reminders and Unconditional Monetary Incentives to Improve Measles Vaccination in Western Kenya: Study Protocol for the Mobile and Scalable Innovations for Measles Immunization Randomized Controlled Trial. JMIR Res Protoc. 2019 Jul 9;8(7):e13221. doi: 10.2196/13221.

MeSH Terms

Conditions

Measles

Condition Hierarchy (Ancestors)

Morbillivirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Scientist

Study Record Dates

First Submitted

September 8, 2016

First Posted

September 19, 2016

Study Start

December 6, 2016

Primary Completion

April 4, 2017

Study Completion

April 4, 2017

Last Updated

March 1, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share