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临床试验/NCT06017843
NCT06017843招募中不适用

Impact Evaluation of Use of MATCH AI Predictive Modelling for Identification of Hotspots for TB Active Case Finding in Pakistan: a Pragmatic Stepped Wedge Cluster Randomized Trial

Centre for Global Public Health Pakistan1 个研究点 分布在 1 个国家目标入组 180,000 人开始时间: 2023年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
180,000
试验地点
1
主要终点
Camp positivity yield

研究概览

简要总结

The aim of this pragmatic, stepped wedge cluster-randomized trial is to measure the comparative yield (number of incident TB cases diagnosed during active case-finding camps) using a site selection approach based on predictions generated via an artificial intelligence software called MATCH-AI (intervention group) versus the conventional approach of camp site selection using field-staff knowledge and experience (control group). The trial will help inform whether a targeted approach towards screening for TB using artificial-intelligence can improve yields of TB cases detected through community-based active case-finding.

详细描述

Despite significant progress over the past decades, an estimated 10.6 million individuals fell ill with tuberculosis (TB) in 2021 and the disease caused 1.6 million deaths globally. Pakistan is ranked as the 5th highest TB burden country in the world and TB causes 42,000 deaths annually in the country. A key challenge in the Pakistan's response to TB is ensuring diagnosis and treatment of all individuals with TB. In 2020, out of the 573,000 cases, a total of 276,736 (48%) were notified. Bridging this case-detection gap is a critical objective for the National TB Program (NTP). Active case-finding (ACF), is a potential strategy to increase case-detection by systematic screening of communities for TB. Recent evidence, indicates that ACF can also reduce population-level TB incidence and prevalence through early detection. While ACF interventions have demonstrated effectiveness in community-trials and are now being conducted at scale in Pakistan, concerns remain regarding their yields and cost-effectiveness in programmatic settings.

The primary aim of this study is to investigate whether a targeted approach towards community-based screening using MATCH-AI, an artificial intelligence software that models sub-district TB prevalence, can improve the yield of ACF interventions in Pakistan. In the intervention arm, field-team will conduct community-based ACF activities (called chest camps) primarily in locations predicted by MATCH-AI to have a higher prevalence of TB. In the control arm, field-teams will continue to utilize existing approaches towards camp site-selection. The trial will be conducted in 65 districts of Pakistan in collaboration with implementation partners of the NTP.

研究设计

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

盲法说明

Individuals visiting camps will be masked to the intervention status.

入排标准

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

入选标准

  • •All individuals >15 years of age presenting to camp sites
  • •Individuals with previous history of TB disease

排除标准

  • •Children and adolescents <15 years of age
  • •Pregnant women

研究组 & 干预措施

Intervention

Experimental

Camps site selection for active case finding for TB using MATCH-AI

干预措施: Camps site selection for active case finding for TB using MATCH-AI (Other)

Control

No Intervention

Camps site selection for active case finding for TB using existing approaches.

结局指标

主要结局

Camp positivity yield

时间窗: 12 months

Counts of bacteriologically confirmed TB (B+) cases diagnosed in each camp

次要结局

  • Camp positivity rate(12 months)
  • Camp All-Forms yield(12 months)
  • Camp All-Forms TB rate(12 months)

研究者

发起方
Centre for Global Public Health Pakistan
申办方类型
Other
责任方
Sponsor

研究点 (1)

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