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临床试验/NCT06470919
NCT06470919已完成不适用

The Next Generation Vaccine Card: Innovative Technology to Improve Vaccine Equity in Rural and Urban Settings in East Africa

University of Michigan3 个研究点 分布在 2 个国家目标入组 3,522 人开始时间: 2024年11月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,522
试验地点
3
主要终点
Diphtheria, pertussis, and tetanus first dose (DPT1) coverage

研究概览

简要总结

The research team of investigators from University of Michigan and the African Population and Health Research Center will implement and evaluate a newly-developed digital vaccine card and accompanying mobile application and electronic immunization registry. This will take place in rural Uganda and urban Kenya Health and Demographic Surveillance Systems (HDSS) and the study team will analyze its feasibility, impacts, cost through process, and economic evaluations. The study team will also assess the data quality and equity of the digital vaccine registry and card system.

详细描述

This study design has three parts or aims for this project, however, only the third aim is considered to be the trial portion and is included in this registration.

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
None

入排标准

年龄范围
1 Day 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 1 day to 24 months old

排除标准

  • Sites not included in the study

结局指标

主要结局

Diphtheria, pertussis, and tetanus first dose (DPT1) coverage

时间窗: 18 months of the intervention period

Percent (%) of all children born in the intervention period that received the first dose of DPT vaccine (Continuous measure, 0-100%).

Diphtheria, pertussis, and tetanus first dose (DPT3) coverage

时间窗: 15 months of the intervention period (last 15 months of the intervention period)

Percent of all children born in the first 15 months of the intervention period that received the third dose of DPT vaccine (Continuous measure, 0-100%).

Dropout rate from DPT1 to DPT3

时间窗: 15 months of the intervention period (last 15 months of the intervention period)

Difference in the proportion of children born in the first 15 months of the intervention period that received the first and third doses of the DPT vaccine (Continuous measure, 0-100%)

次要结局

  • Measles coverage(9 months of the intervention period (second half of the intervention))
  • Completion of basic immunizations(9 months of the intervention period (second half of the intervention))
  • Timeliness of BCG vaccination(18 months of the intervention period (full intervention period))
  • Timeliness of DPT3 vaccination(15 months of the intervention period (last 15 months of the intervention period))
  • Dropout rate from DPT1 to Measles(9 months of the intervention period (second half of the intervention))
  • Timeliness of Measles vaccination(9 months of the intervention period (second half of the intervention))
  • Bacillus Calmette-Guerin (BCG) coverage(18 months of the intervention period (full intervention period))
  • Timeliness of DPT1 vaccination(15 months of the intervention period (last 15 months of the intervention period))

研究者

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

Emily Treleaven

Research Assistant Professor

University of Michigan

研究点 (3)

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