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临床试验/CTRI/2023/08/056299
CTRI/2023/08/056299尚未招募不适用

Implementation Research project to demonstrate reduction of tuberculosis in Saharia Tribe dominated region in India’

ICMR3 个研究点 分布在 1 个国家目标入组 70,888 人开始时间: 2023年8月18日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70,888
试验地点
3
主要终点
Primary outcome

研究概览

简要总结

This is an implementation research project aiming to assess impact of  innovative operational strategies on the occurrence of tuberculosis (TB) in Saharia dominated district of Madhya Pradesh and to establish mechanism and processes for enhanced and early testing and treatment of tuberculosis cases and preventive of contacts. The will be undertaken in 8 Saharia Tribe dominated districts in Madhya Pradesh and involves the qualitative component to identify reasons for the delay in diagnosis & initiation of TB treatment and delay in TPT initiation. After baseline prevelance and rapid situational analysis, in each district, the interventions will be initiated which includes intense IEC activities followed by active case detection by field teams using handheld x-rays for screening and molecular test for diagnosis and all the cases would be treated as per NTEP guidelines by District TB cell. ASHAs, village volunteers, would be responsible for ensuring treatment adherence to decrease unfavourable outcomes and to increase awareness. All the contacts would be screened to rule out TB and would be initiated on TPT. The vulnerability mapping will be done and the co-morbid conditions would be referred for appropriate management. For the smoking and alcohol cessation, the patients would be referred to NCD division of programme. The nutritional interventions for malnutrition and IFA, deworming would be done for all eligible participants.  The tele-OPD will be initiated for consultation & appropriate advice to symptomatics. The endline survey will be done at the end of the intervention. The proposed interventions in the entire saharia dominated blocks which would cover both Saharias and non-Saharia population will have impact on the occurrence of the TB cases in the entire region, thus leading to substantial reduction of TB in Saharia population. This will help in development of the suitable policy for the Saharia tribe.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
1.00 Day(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • The entire population of the selected blocks including both Saharia and non-Saharia of the selected districts will be covered and the symptomatic screening will be done to identify all presumptive PTB and EPTB case The contacts of the already identified cases will be screened for TB.

排除标准

  • Donot agree to give sputum or for X-ray.

结局指标

主要结局

Primary outcome

时间窗: 6 months, 12 months, 18 months and 24 months

-Reduction in occurrence of number of new confirmed TB cases in selected blocks over a period of time as compared to previous years

时间窗: 6 months, 12 months, 18 months and 24 months

-Reduction in occurrence of number of new confirmed TB cases over a period of time after 6 months of intervention till one year

时间窗: 6 months, 12 months, 18 months and 24 months

次要结局

  • -Reduction in number of notified TB cases as registered in Nikshay over a period of time(-Difference in reduction of TB cases in Saharia & non-Saharia population over a period of time)

研究者

发起方
ICMR
申办方类型
Government funding agency

研究点 (3)

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