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临床试验/NCT07737275
NCT07737275尚未招募不适用

Mobilizing Innovative Strategies to Improve Tuberculosis (TB) Diagnosis and Retention in the TB Care Cascade for Migrant Communities in New York City

Columbia University0 个研究点目标入组 1,000 人开始时间: 2026年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,000
主要终点
Completion of Appropriate Clinical Referrals

研究概览

简要总结

SPOT-TB (Screening with Portable X-rays for rapid recOgniTion of TB) is a prospective study evaluating a community-based tuberculosis (TB) screening strategy for migrant populations in New York City. The screening intervention integrates mobile ultra-portable digital chest radiography with artificial intelligence-assisted image interpretation, tuberculosis symptom assessment, latent tuberculosis infection testing, and HIV testing. Participants with concerning screening findings are referred for appropriate clinical evaluation. The study will evaluate the feasibility, acceptability, and effectiveness of this integrated screening strategy for improving early identification of active pulmonary tuberculosis and linkage to care in community settings.

详细描述

Tuberculosis (TB) remains a major public health challenge in the United States, with increasing numbers of reported cases in recent years. Delayed diagnosis contributes to ongoing transmission and poorer clinical outcomes, particularly among populations facing barriers to healthcare access. Migrant populations in New York City experience a disproportionately high burden of TB infection and disease, highlighting the need for innovative community-based screening strategies.

SPOT-TB (Screening with Portable X-rays for rapid recOgniTion of TB) is a prospective study evaluating a novel community-based TB screening strategy. The intervention combines mobile ultra-portable digital chest radiography, artificial intelligence-assisted image interpretation, tuberculosis symptom assessment, latent tuberculosis infection testing, and HIV testing to provide rapid, front-loaded screening while minimizing loss to follow-up. Participants with concerning screening findings are referred for appropriate clinical evaluation according to standard clinical practice.

The study will evaluate the feasibility, acceptability, and effectiveness of this integrated screening strategy for improving early identification of active pulmonary tuberculosis, facilitating linkage to care, and informing future community-based TB screening programs. The study will also provide information on TB and latent TB infection prevalence among migrant populations and the implementation of mobile AI-assisted screening in an urban U.S. setting.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

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

  • Adult persons 18 years or older
  • Self-identifying as migrants to the US
  • Self-reporting migration within the 24 months

排除标准

  • Lack capacity for informed consent
  • Unable to perform translation/study materials not available in appropriate language
  • Unwilling to participate
  • Pregnancy

结局指标

主要结局

Completion of Appropriate Clinical Referrals

时间窗: Up to 12 weeks post-visit

Proportion of participants who complete recommended diagnostic evaluations and clinical referrals, stratified by tuberculosis risk screening group.

次要结局

未报告次要终点

研究者

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

Max O'Donnell

Associate Professor of Medicine and Associate Professor of Epidemiology

Columbia University

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