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CTRI Number  CTRI/2021/11/038137 [Registered on: 18/11/2021] Trial Registered Prospectively
Last Modified On: 16/11/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Capacity building of health system on prevention and management of snakebite envenomation 
Scientific Title of Study   ICMR National Snakebite Project (INSP) on capacity building of health system on prevention and management of snakebite envenomation including its complications 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rahul Gajbhiye  
Designation  Scientist D  
Affiliation  ICMR-NIRRH  
Address  Clinical Research Lab, ICMR-NIRRH J M Street Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224192036  
Fax    
Email  gajbhiyer@nirrh.res.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rahul Gajbhiye  
Designation  Scientist D  
Affiliation  ICMR-NIRRH  
Address  Clinical Research Lab, ICMR-NIRRH J M Street Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224192036  
Fax    
Email  gajbhiyer@nirrh.res.in  
 
Details of Contact Person
Public Query
 
Name  Dr Rahul Gajbhiye  
Designation  Scientist D  
Affiliation  ICMR-NIRRH  
Address  Clinical Research Lab, ICMR-NIRRH J M Street Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224192036  
Fax    
Email  gajbhiyer@nirrh.res.in  
 
Source of Monetary or Material Support  
Indian Council of Medical Research National Task Force on Snakebite  
 
Primary Sponsor  
Name  Indian Council of Medical Research  
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shashikant Shambharkar  Aheri Block Gandchiroli  Aheri Block, Gadchiroli District Maharashtra
Gadchiroli
MAHARASHTRA 
9422141016

shashishambharkar@gmail.com 
Dr Amarendra Mahapatra  Kasipur Block   Kasipur Block, Rayagada District
Rayagada
ORISSA 
9437694368

amarmaha@gmail.com 
Dr Amarendra Mahapatra  Khordha Block   Khurdha Block,Orissa
Khordha
ORISSA 
9437694368

amarmaha@gmail.com 
Dr Manohar Vitthalrao Bansode  Shahapur Block   Sub District Hospital Shahapur District Thane
Thane
MAHARASHTRA 
8424057421

drmvbansode1969aug@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
ICMR-RMRC Instituttional Human Ethics Commitee  Approved 
NIRRH Ethics Committee for Clinical Studies  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: T630||Toxic effect of snake venom,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  IEC materials, community lectures   IEC materials in local language for the community, snake rescuers (Sarpa Mitra/snake friends) school teachers, panchayat members, and traditional healers. The IEC materials will include the following information: - Pictures of the venomous snakes commonly found in the study area - Knowledge about venomous and non-venomous snakes - Symptoms of snakebite envenomation in simple non-medical terms in regional language - Prevention of snakebites and first aid treatment - Nearest health facility for snakebite treatment (distance in kms, contact numbers of health facilities), ambulance services 102,108 information The IEC materials will be displayed at Schools, Gram Panchayat in villages, Anganawadi, Tribal Residential Schools, Block panchayat Office, Sub Centers, PHCs, CHCs. Community meetings and Public talks: - ICMR snakebite project staff, and primary health care workers (ASHA, ANM and MPW) will be trained to educate community through community meetings for creating awareness on prevention, first aid and early transport of snakebite patients to nearest health facility  
Intervention  Training of healthcare workers   Capacity building of Medical Officers (PHC, CHC, District Hospital): - Team of National experts for snakebite management (Expert group STG, 2017) will provide training to master trainers and also provide technical support for regional training. [Dr Himmatrao Bawaskar and other experts who contributed for the development of STG, 2017 will provide training] - Region wise snakebite experts will train the master trainers from each study site in Maharashtra and Odisha. - Total 6 Master Trainers from each study site: 2 Master Trainers from State Public Health Department (Two Senior MOs from District Hospital and two MOs from CHC , 2 Senior faculties Medicine Department of linked Medical College will be trained.  Periodic training of all Medical Officers working in public health system in study area will be conducted every 6 months.  All medical officers will be provided copies of Training modules prepared as per the Standardized Treatment Guidelines (STG, 2017) - Quick reference guide - Snakebite treatment flyer Capacity building of outreach health staff (ASHA, ANM, MPW other healthcare providers): - Periodic Training (every 6 months for 2 years) of health care providers will be conducted on snakebite prevention, diagnosis and management - Training will also focus on first aid skills, immobilization techniques, cardiopulmonary resuscitation (CPR) etc. - Medical Officers trained by Master trainers will conduct the training program for ASHA, ANM, MPW and other healthcare providers at their respective health facilities. - Training manuals for ASHA, ANM, MPW, and other healthcare providers developed by ICMR- NIRRH will be translated into regional languages - Pre and post training evaluation to assess knowledge retention and assess impact of training Quick reference charts as per STG (2017) on first aid and management of snakebite in English and regional languages will be displayed in OPD and indoor wards of PHC, CHC, in study area.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  62.00 Year(s)
Gender  Both 
Details  Community Members
Medical Officers
Front line Health Workers  
 
ExclusionCriteria 
Details  not willing to participate  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Retrospective data
Facility survey
FGDs among community
Evaluation of the basic knowledge of MOs & other Healthcare providers on snakebite management
Capacity building of MOs & Health care Providers
Impact of the Capacity building 
Baseline Retrospective data FGD Facility survey
6 month Capacity building
12 months impact evaluation  
 
Secondary Outcome  
Outcome  TimePoints 
The results of the study will help in reducing the mortality and morbidity due to snakebites in selected regions in India and also useful for phase II implementation in other states having high burden of snakebites.
- The evidence generated from the study may be useful to the Government of India for developing National Strategies to reduce burden of on snakebites.
- Model clinical snakebite management centers can be established all over country based on the outcome of the study
 
24 month  
 
Target Sample Size   Total Sample Size="900"
Sample Size from India="900" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/12/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  On request to Principal Investigator/Director NIRRH after permission from ICMR

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Snakebite is a major public health problem in India leading to nearly 50,000 deaths every year. Snakebite affects mainly poor, agricultural and migrant workers, tribals, hunters and mainly earning family member. Lack of awareness, inadequate knowledge of prevention of snakebite and first aid amongst community as well as peripheral health care workers, delay in receiving lifesaving treatment [anti-snake venom (ASV)] and non-availability of trained medical officers for management of snakebite contribute to higher number of deaths. Earlier study conducted through Model Rural Health Research Unit (MRHRU) at Sub District Hospital Dahanu, District Palghar, Maharashtra reported higher incidence of snakebites in tribal area of Dahanu, lack of awareness on snakebites, inadequate knowledge on prevention and first aid amongst community and peripheral health care workers in Dahanu block. We also observed that none of the medical officers in Dahanu block were aware about National snakebite treatment protocol and there was no uniformity in giving treatment dose of ASV. Most of the medical officers were practising ASV skin test which is not recommended leading to wastage of precious ASV. We provided training to all the Medical Officers and also implemented National snakebite treatment protocol. Intense training was provided to ASHA, ANM, MPW on prevention and first aid for snakebites. The snake rescuers, local tantriks were also provided training on prevention, first aid and timely referral of snakebite cases to the nearest public health facility having ASV and trained manpower. A  model has been established involving community, training of healthcare workers, implementation of National snakebite treatment protocol for reducing burden of snakebites. ICMR-National Task Force on snakebite recommended to upscale the model in selected districts of Maharashtra and Odisha States. The objectives of the proposed study are to empower the community on prevention, appropriate first aid,  and early transfer of snakebite patients to nearest health facility for reducing the mortality and morbidity due to snakebites in selected districts in Maharashtra and Odisha. The culturally appropriate IECs, training manuals for outreach health worker (in regional languages), Training manuals for Medical Officers will be developed. The facility check assessment will also be carried out to understand ASVs distribution and utilization in selected regions of India. Interviews of outreach health care workers (ASHA,ANM,MPW) and Medical Officers will be conducted to understand the knowledge gaps. This would be crucial for planning appropriate and effective training in order to build the capacity of the health system in different zones of India. The prospective data will be collected from health facilities in all study sites for one year period and implementation of STG for snakebite treatment will be monitored regularly. The impact evaluation of the capacity building will also be carried out. The results of this study will be useful for expansion of the study at National level. The study will be useful for providing inputs for National Snakebite Management Protocol relevant to public health system taking into consideration regional differences in India. The study will help in reducing the mortality and morbidity due to snakebites in selected regions in India. The study will empower the community and health system for prevention and improved management of snakebites in selected regions in India. The results of the study will be crucial for establishing centers of excellence for snakebite management in 2 study sites spread across two geographical zones. The evidence generated from the study may be useful to the Government of India and other agencies for developing Strategies to reduce burden of snakebites.

 
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