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临床试验/CTRI/2024/02/062556
CTRI/2024/02/062556尚未招募不适用

“One Health” approach for elimination of human anthrax from a tribal district of Odisha: a randomized control trial

Indian Council of Medical Research1 个研究点 分布在 1 个国家目标入组 1,560 人开始时间: 2024年2月19日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,560
试验地点
1
主要终点
Our primary outcome is to assess the KAP of the community across the two arms at the end of the study. So, the unit of study is a household. To achieve this, we shall do cluster sampling. Interventions will be planned and implemented in the intervention district whereas only baseline and end line survey will be carried in the control district. For qualitative inputs we shall be conducting the IDIs and FGDs till saturation of information achieved (Estimated 40 IDI & 8 FGD). We will be using purposive sampling for qualitative interviews.

研究概览

简要总结

Zoonoses are recognized as a major concern in developing nations, in need of a resolution. It is commonly agreed that the detection, management, and elimination of zoonotic diseases require joint efforts from the animal and human health sectors. Joint monitoring systems such as “One Health” strategy are the most efficient and reliable means of addressing zoonotic diseases such as anthrax in low-income countries. The One Health approach is already found to have significance when implemented to tackle the newly emerging diseases like Middle East respiratory syndrome, avian flu (H5N1), swine flu (H1N1), Ebola and Zika virus. Management and effective control of anthrax through One Health concept is described as a highly demanding approach although it needs a robust implementation globally. Over the last 15 years, 10 districts out of 30 revenue districts in Odisha have experienced outbreaks of human anthrax with 1208 cases and 436 deaths [IDSP, Odisha, 2016]. Among those affected districts, Koraput has more than 300 human anthrax cases including 10 deaths over the past 6 years. Almost all the cases came from a group of indigenous tribes involved in handling and consuming animal carcasses. Therefore, this implementation research project is planned in the district of Koraput using the "One Health" approach to demonstrate the feasibility for the elimination of human anthrax cases in three years. To compare the effectiveness of the proposed intervention we will be taking up another endemic district Sundargarh as control group.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Participants will be selected based on the eligibility criteria: a) Should be an adult (age above 18 years) and a permanent resident of Koraput district, b) willing to participate in the study.

排除标准

  • a) Cognitive impairment, b) having onset symptoms or infected with any of the communicable disease which can be spread through nasal or mouth droplets.

结局指标

主要结局

Our primary outcome is to assess the KAP of the community across the two arms at the end of the study. So, the unit of study is a household. To achieve this, we shall do cluster sampling. Interventions will be planned and implemented in the intervention district whereas only baseline and end line survey will be carried in the control district. For qualitative inputs we shall be conducting the IDIs and FGDs till saturation of information achieved (Estimated 40 IDI & 8 FGD). We will be using purposive sampling for qualitative interviews.

时间窗: Baseline at the start of the study and Endline at the end.

次要结局

  • Secondary outcome includes assessment of disease burdens, patterns, knowledge, prevalence, and practices among the identified stakeholders from the departments of health, veterinary, environment/forest, and the community; and to evaluate the effectiveness of the interventions among the study population on anthrax burden in the control and intervention district along with cost-benefit analysis of interventions.(Baseline at the start of the study and Endline at the end.)

研究者

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

Dr Debdutta Bhattacharya

ICMR Regional Medical Research Centre Bhubaneswar

研究点 (1)

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