Mobile and Scalable Innovations for Measles Immunization: a Randomized Controlled Trial

NCT ID: NCT02904642

Last Updated: 2018-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

537 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-06

Study Completion Date

2017-04-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Primary Objective The primary objective is to determine if text message reminders, with or without unconditionally provided incentives, can increase the proportion of children who receive measles vaccination by 15% at age ten months as compared to control arm children.

Secondary Objectives

1. To conduct a secondary analysis of the primary outcome using survival analysis and time-to-immunization curves.
2. To determine if there is a differential effect on measles vaccine coverage based on mobile phone ownership and distance to the clinic.
3. To examine the effect of the interventions on measles coverage measured at twelve months of age.
4. To examine the completeness and costs of identifying children through a CHW approach versus the standard HDSS approach.
5. To evaluate the effect of the interventions on coverage of second dose of measles vaccine at 24 months. This secondary objective is contingent on receiving additional funding.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Measles

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

SMS reminder

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.

Group Type EXPERIMENTAL

SMS reminder

Intervention Type BEHAVIORAL

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

SMS reminder + Unconditional Incentive

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.

Group Type EXPERIMENTAL

SMS reminder

Intervention Type BEHAVIORAL

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

Unconditional Incentive

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SMS reminder

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kenya Medical Research Institute

OTHER

Sponsor Role collaborator

Bill and Melinda Gates Foundation

OTHER

Sponsor Role collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dustin Gibson

Assistant Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 32813276 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31290405 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33509838 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KEMRI SERU-3311

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Measles Vaccine in HCW
NCT04357028 SUSPENDED PHASE3
Prophylactic Antibiotics in Measles
NCT00168532 COMPLETED PHASE3
Early Two-dose Measles Vaccination Trial
NCT00168558 COMPLETED PHASE4