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临床试验/NCT04520113
NCT04520113已完成不适用

Innovative Contact Tracing Strategies for Detecting TB in Mobile Rural and Urban South African Populations

Johns Hopkins Bloomberg School of Public Health2 个研究点 分布在 1 个国家目标入组 10,579 人开始时间: 2020年9月1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
10,579
试验地点
2
主要终点
Effectiveness: Mean Number of Secondary TB Cases Identified and Started on Treatment Per Index Case in Each Arm

研究概览

简要总结

The purpose of this study is to characterize the role of human mobility in fueling TB epidemics and estimate the potential impact of innovative case finding interventions tailored to mobile populations

详细描述

The investigators propose a randomized trial of two novel TB case-finding interventions among household members of patients diagnosed with active TB: holiday-based screening in a rural South African province (Limpopo) and off-peak (weekend/evening) screening in an urban settlement into which many residents of Limpopo migrate for work. The investigators will enroll index cases of TB plus their household contacts in each setting and randomize them to novel versus standard contact investigation. In Specific Aim 1, investigators will use whole genome sequencing of all cases, overlaying transmission trees with data on human movement, to evaluate associations between mobility and TB transmission in this population. In Specific Aim 2, investigators will employ a multidisciplinary approach to compare novel versus standard contact investigation in each setting along the following dimensions: (a) effectiveness (number of secondary TB cases diagnosed and starting treatment); (b) implementation (reach, fidelity, and maintenance of contact investigation outside of business hours); (c) cost-effectiveness (cost per disability-adjusted life year) and budget impact; and (d) projected population-level impact on TB incidence. Successful completion of these aims will have long-term impact by characterizing the role of mobility in fueling TB epidemics and testing two tailored approaches to improve TB control in highly mobile populations - an underserved group that is increasingly recognized as playing a major role in global TB transmission.

研究设计

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

盲法说明

The principal investigators are blinded as to the assignment of treatment to participants

入排标准

年龄范围
— 至 99 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Unwilling/unable to provide informed consent
  • Unwilling/unable to comply with study procedures

结局指标

主要结局

Effectiveness: Mean Number of Secondary TB Cases Identified and Started on Treatment Per Index Case in Each Arm

时间窗: Up to 35 months

The mean number of secondary TB cases identified and started on treatment per index case for each arm.

次要结局

  • Relative Fidelity of Each Novel Strategy Compared to Standard Contact Investigation(Duration of study (30 months))
  • Sustainability of Each Novel Strategy Relative to Standard Contact Tracing(Duration of study (30 months))
  • Feasibility of Each Strategy: Proportion of Potentially Eligible Index Cases for Whom a Household Visit Was Conducted(Duration of study (30 months()
  • Relative Acceptability of Each Novel Strategy Compared to Standard Contact Investigation(Duration of study (30 months))
  • The TB Prevalence Ratio, Comparing Highly Mobile to Less Mobile Index Patients(Duration of study (30 months))
  • TB Strain Relatedness Using Maximum Likelihood Transmission Trees.(Duration of study (30 months))
  • Incremental Cost-effectiveness Ratio for Each Novel Strategy Relative to Standard Contact Tracing(Duration of study (30 months))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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