跳至主要内容
临床试验/NCT02904642
NCT02904642已完成不适用

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

Johns Hopkins Bloomberg School of Public Health0 个研究点目标入组 537 人开始时间: 2016年12月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
537
主要终点
Measles vaccination coverage

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: SMS reminder (Behavioral)

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.

干预措施: SMS reminder (Behavioral)

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.

干预措施: Unconditional Incentive (Behavioral)

结局指标

主要结局

Measles vaccination coverage

时间窗: 10 months

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

次要结局

  • Proportion of children who receive measles vaccination stratified by demographic variables(10 months)
  • Time to measles vaccination (in days) using Kaplan-Meier Survival Analysis(12 months)
  • Measles vaccination coverage at 12 months(12 months)
  • Vaccination coverage for second dose of measles vaccine at 24 months.(24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dustin Gibson

Assistant Scientist

Johns Hopkins Bloomberg School of Public Health

相似试验