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临床试验/NCT02175849
NCT02175849已完成不适用

Contact Tracing by Social Network Analysis to Enhance Multi-Drug Resistant Tuberculosis Case Finding in Hanoi, Vietnam

Oxford University Clinical Research Unit, Vietnam1 个研究点 分布在 1 个国家目标入组 596 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
596
试验地点
1
主要终点
Yield of MDR-TB case detection through SNA

研究概览

简要总结

Tuberculosis burden in Vietnam increasing with contribution from low detection rates and increased drug resistance. There is a need to identify MDR-TB (MultiDrug Resistant Tuberculosis) among both notified TB cases and their contacts in the community. Traditional contact tracing often focuses on household contacts while strains of TB circulate in homes, schools, workplaces, and beyond. Social network Analysis (SNA) is a comprehensive approach which includes a set of persons and the connections among them used for analysis of structure of disease transmission.

In this study, SNA will be used to collect network data from 60 newly detected Rifampicin resistant TB patients including an expected 50 MDR-TB patients living in Hanoi, and to identify and test potential MDR-TB cases.

详细描述

The study will identify and recruit 60 newly detected Rifampicin resistant TB patients including an expected 50 MDR-TB patients living in Hanoi (index cases) who will undergo SNA of contacts and places they have stayed during 3 months preceding their TB diagnosis including residence, travel history, places of social aggregation in relation with their risk behaviour.

Patients will be interviewed to investigate contacts before the confirmation of MDR-TB (for early contact detection and minimize the risk of information lost due to patient default during treatment). Data analysis will focus on MDR-TB social networks using Cytoscape software.

After the first two enrolled Rifampicin resistant MDR-TB cases, social network data will be analyzed to identify close contacts, mutual contacts, mutual places and high risk locations. The Social Network Questionnaire (SNQ) will be contextualized to the Vietnamese setting and validated in a pilot study. Eligible contacts and locations will undergo MDR-TB screening.

Approximately 720 contacts will undergo active screening (on 2 occasions per individual: at the time of contact identification and 6 months later). Contacts will include household contacts, close contacts, mutual contacts and symptomatic individuals with significant exposure to the index case at mutual locations within a closed environment.

Contact screening will involve clinical assessment, chest X-ray and sputum or gastric aspirate collection for TB culture, molecular techniques and microbiological identification.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • PATIENTS: Newly detected rifampicin resistant TB or MDR-TB patients living in Hanoi for at least 3 months preceding a diagnosis made between 2013-
  • CONTACTS: During the 3 months before the patient's TB or MDR-TB diagnosis: all persons who spend an average of >4 hours per day in the same residence as the patient AND/OR any individual who has had frequent and prolonged contact with the patient AND/OR anyone who has spent time in a closed environment with an MDR-TB patient
  • PATIENTS AND CONTACTS: All ages
  • PATIENTS AND CONTACTS: Living in Hanoi during the study period.

排除标准

  • PATIENTS AND CONTACTS: Lack of informed consent for participation.

结局指标

主要结局

Yield of MDR-TB case detection through SNA

时间窗: Six months

The number of MDR-TB cases notified from contacts identified by SNA and who would not have been detected by routine screening.

次要结局

  • MDR-TB incidence among rifampicin resistant TB cases(Six months)
  • MDR-TB incidence among subgroups of contacts(Six months)
  • MDR-TB genotype(Six months)
  • Cost-effectiveness ratio of SNA and passive case finding strategies(Six months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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