Clinical trial NCT02904642: Mobile and Scalable Innovations for Measles Immunization: a Randomized Controlled Trial
Official title: Randomized Controlled Trial of the Impact of Mobile Phone Delivered Reminders and Unconditional Travel Subsidies on Measles Vaccination in Western Kenya: The Mobile and Scalable Innovations for Measles Immunization (M-SIMI) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Measles
Keywords: SMS reminder
incentive
mobile phone
Immunization
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Kenya Medical Research Institute
name: Bill and Melinda Gates Foundation
First posted: 2016-09-19
Enrollment: 537
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Measles vaccination coverage
timeFrame: 10 months
Secondary outcomes:
measure: Time to measles vaccination (in days) using Kaplan-Meier Survival Analysis
timeFrame: 12 months
measure: Proportion of children who receive measles vaccination stratified by demographic variables
timeFrame: 10 months
measure: Measles vaccination coverage at 12 months
timeFrame: 12 months
measure: Vaccination coverage for second dose of measles vaccine at 24 months.
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.