CTRI/2025/12/098338 [Registered on: 02/12/2025] Trial Registered Prospectively
Last Modified On:
02/12/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Preventive Process of Care Changes Behavioral
Study Design
Single Arm Study
Public Title of Study
Snakebite Awareness, Response, Prevention and Action (SARPA)
Scientific Title of Study
Zero snakebite death initiative; community empowerment and engagement for mitigation of snakebite envenoming. SARPA (Snakebite Awareness, Response, Prevention and Action)
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Jaideep C Menon
Designation
Professor
Affiliation
Amrita Institute of Medical Sciences, Kochi
Address
Department of Cardiology, Amrita Institute of Medical Sciences, Ponekkara P.O , kochi, Ernakulam, Kerala
Ernakulam KERALA 682041 India
Phone
9895122099
Fax
Email
menon7jc@gmail.com
Details of Contact Person Scientific Query
Name
Jaideep C Menon
Designation
Professor
Affiliation
Amrita Institute of Medical Sciences, Kochi
Address
Department of Cardiology, Amrita Institute of Medical Sciences, Ponekkara P.O , kochi, Ernakulam, Kerala
KERALA 682041 India
Phone
9895122099
Fax
Email
menon7jc@gmail.com
Details of Contact Person Public Query
Name
Jaideep C Menon
Designation
Professor
Affiliation
Amrita Institute of Medical Sciences, Kochi
Address
Department of Cardiology, Amrita Institute of Medical Sciences, Ponekkara P.O , kochi, Ernakulam, Kerala
KERALA 682041 India
Phone
9895122099
Fax
Email
menon7jc@gmail.com
Source of Monetary or Material Support
Indian Council of Medical Research, Department of Health and Research, V.Ramalingaswami Bhawan, Ansari nagar, Post Box No-4911, New Delhi, India. Pin: 110029
Primary Sponsor
Name
Indian Council of Medical Research
Address
V.Ramalingaswami Bhawan, Ansari nagar, Post Box No-4911, New Delhi-110029
Type of Sponsor
Government funding agency
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 7
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Sunil Kumar Panigrahi
All India Institute of Medical Sciences, Deoghar
Cabin 2- Assistant Professor, Department of Community & Family Medicine, First floor, Academic Billing,
AIIMS, Deoghar, Devipur, Jharkhand 814152 Deoghar JHARKHAND
8424017937
sunil.cfm@aiimsdeoghar.edu.in
Jaideep C Menon
Amrita Institute of Medical Sciences, Kochi
Room No.06, 6th floor - Nalanda block (Department of Public Health), Amrita Institute of Medical Sciences, Ponekkara P.O,Kochi, Pin;682041,Kerala. Ernakulam KERALA
9895122099
menon7jc@gmail.com
Surajit Giri
Demow CHC cum Model Hospital
Room No.02, Operation Theatre Complex, First floor, Department of Anaesthesia,Demow CHC cum Model Hospital, Demow, Sivasagar district, Pin:785662 Sibsagar ASSAM
9435056627
drsurajitgiri@gmail.com
Srikanta Kanungo
ICMR- Regional Medical Research Centre, Bhubaneswar
State Institute of Health and Family Welfare, Parimahal
Office of State Epidemiologist,
Department of Health & Family Welfare, SIHFW
Kasumpti Shimla- India-171009. Kangra HIMACHAL PRADESH
9418120302
bhartiomesh@yahoo.com
Details of Ethics Committee
No of Ethics Committees= 7
Name of Committee
Approval Status
Ethics Committe of Amrita School of Medicine
Approved
Ethics Committe of Amrita School of Medicine
Approved
Ethics Committe of Amrita School of Medicine
Approved
Human Research Ethics Committee at MANT
Approved
ICMR-NIRRCH Ethics Committe for Human Studies
Approved
IEC OF AIIMS DEOGHAR
Approved
Institutional Human Ethics Committe, ICMR-RMRC, Bhubaneswar
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Snakebite envenomation
Intervention / Comparator Agent
Type
Name
Details
Intervention
Behavioral interventions
Use of a well tucked mosquito net.
Use of toilets and avoid open defecation.
Situational use of boots and gloves.
Use of torchlights or mobiles flashlight at night while walking in the dark.
Deploy signages with visual snakebite prevention cues in high-risk zones like agricultural fields, plantations, saw-mills, brick-kilns etc.
Intervention
Community awareness
Information, education, communication (IEC) material in digital and analogue formats for community awareness on snakes of the region. Audio-visual narrowcasting and community screening of videos in the regional language.
IEC material on preventive aspects, integrate behavioural nudges like reminders to use torch, boots, mosquito nets, and culturally adapted storytelling to aid prevention.
IEC on ‘dos and don’ts’ if bitten and first-aid measures.
Contextual edutainment tools like the gamified version of the ‘Snakes and ladders’ game for schoolchildren.
Observing ‘World snake day’ and ‘World snakebite day’ so as to help spread awareness
IVRS in the local language to send personalized reminders on preventive aspects on the basis of state and district level assessments.
Special sessions targeting women in self-help groups, emphasizing on safe sleeping practices and use of mosquito nets.
Intervention
Community empowerment
Through empowering 5 members in each panchayat from established work-pools of ASHAs, snake rescuers, Gram Sewak’s, Kudumbasree, Haritha Sena, Disaster network recruits,forest guards or other volunteers.
Training identified members 5 for each panchayat on common venomous and non-venomous species, look-alike of the Big 4 species, dos and don’ts, first-aid, identification of sentinel symptoms of envenoming, facilitate transport and alert for transport of envenomed victims.
Awareness sessions led by the trained workers on preventive aspects for the community especially for at-risk groups with outdoor occupations and in high-burden areas.
Intervention
Digital technology
A Digital App which facilitates victim transport.
ICE material on prevention and all other aspects with regards to prevention, first-aid, therapy, transport would be available on the App. The App would also be a link to the 24-hour helpline. The App would also serve as a resource on snakes of the region, hospitals in the area treating snakebite and help facilitate transport in an ambulance.
The App would help map hot spots from incidents, snake sightings and rescues and the information gathered along with data gathered on the agro-ecological and climate parameters would help developing a score for the risk of snakebite and SBE.
Intervention
Facilitating treatment of victims
Transport of victims to tertiary centres in ambulance with staff capable of treating with ASV.
A ‘hub and spoke’ model of transfer and treatment of victims at three levels L1, L2 and L3 centres, L1 with basic care and lacking an ICU, L2, ICU without ventilatory or dialysis facilities, L3 with advanced support systems including dialysis, ventilation and plasmapheresis.
24-hour snakebite helpline guiding diagnosis and therapy.
Drones for transport of ASV in difficult to reach geographies or during natural calamities.
Ensuring stocks of ASV in treating centres through a system of radio-tagged vials.
Comparator Agent
NIL
NIL
Intervention
Strengthening health systems
Training sessions on basic life support skills for doctors and other paramedical personnel including use of the laryngeal mask, and Ambu bag and mask ventilation.
Training sessions for doctors in PHCs and CHCs (six modules – Identification, Preventive aspects, Signs and symptoms, Treatment and complications, Policy, legislation, law, compensation etc. with regards to snakebite and SBE.
IEC material and flow-charts on the syndromic approach to treatment, charts depicting the common venomous snakes of the geography in the regional language, flow-chart on treatment guidelines with ASV dosing etc in all the public and private centres of treating snakebite.
Training of pharmacists and nurses on nuances of infusing ASV during transit, first aid and basic life-support.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
80.00 Year(s)
Gender
Both
Details
The intervention targets all relevant stakeholders across the snakebite care pathway, from prevention and early response to hospital-based treatment and policy integration. Participants are grouped into the following categories:
a. Community Members: Residents of high-burden snakebite areas, particularly those whose occupations increase exposure risk, such as agricultural workers, forest gatherers, and outdoor labourers. These populations are central to both prevention and early detection strategies.
b. Community Volunteers (Sarpa Mitras): Locally identified individuals trained to serve as first responders. Sarpa Mitras will be selected from established networks such as self-help groups (SHGs) and grassroots health workers’ collectives. They will be trained in recognizing venomous species, providing correct first-aid, stabilizing victims, ensuring safe transport, and conducting community awareness sessions.
c. Healthcare Providers: A wide spectrum of providers will be engaged, including medical officers, nurses, pharmacists, ambulance personnel, Accredited Social Health Activists (ASHAs), and Auxiliary Nurse Midwives (ANMs). These individuals will receive refresher training on evidence-based snakebite management and referral protocols.
d. Policy and System-Level Stakeholders: State and district health officials, Panchayat Raj Institutions (PRIs), and NGO representatives will be involved to facilitate system-level integration, policy alignment, and sustainability planning.
For the project, the intervention will be implemented across 14 blocks in 7 states, targeting all key stakeholders along the snakebite care pathway. The study population will include (I) Community members residing in high-risk areas, sampled through household surveys at baseline and endline to capture changes in awareness and practices. Approximately 100 households per block will be surveyed, yielding about 1,400 households in total. (II) Community volunteers (Sarpa Mitras): Five Sarpa Mitras will be identified from each panchayat, with the total number varying depending on the number of panchayats within a block. This approach ensures representation across villages while creating a strong local network of trained volunteers. (III) Healthcare workers: Training will be extended to different cadres of health providers, with approximate targets per block of 15–20 medical officers, 20–25 nurses and pharmacists, 10–15 ambulance personnel, and 20–25 frontline workers (ASHAs, ANMs). The final numbers will vary according to the number of CHCs, PHCs and rural hospitals in each block, but overall coverage across all sites is expected to be comprehensive. (IV) Policy and system-level stakeholders, including district health officers, PRI members, and NGO representatives, with at least 5–6 per district engaged in workshops and consultations.
ExclusionCriteria
Details
Individuals who are unwilling or unable to participate in the study will be excluded
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
a scalable and context specific model for snakebite prevention and management, enhanced community capacity for early recognition and first aid, improved timely referral and treatment, increased awareness and adoption of safe behaviours, reduced reliance on traditional remedies, strengthened health system capacity through refresher and structured training, improved quality of clinical snakebite care, enhanced emergency response skills, efficient three-tier referral network with digital support, reduced treatment delays, and increased survival rates.
1. Preparatory-Adaptive Phase (8 months)
2. Piloting and Model Optimization Phase (11 months)
3. Implementation Phase (24 months)
Secondary Outcome
Outcome
TimePoints
provide evidence of pre- & post-intervention changes in awareness, attitudes, & practices across stakeholders, offering insights into behaviour change at both community & health system levels.
Pre intervention survey would be conducted at baseline. this would be during the preparatory phase-. (first 8 months of the project). Post intervention assessment will be done at the end of Intevention Phase (Full intervention phase is 24 months, the post assessment will be from 22-24 months)
The development of a real-time snakebite surveillance dashboard will enable systematic tracking of snake rescues, sightings, killings, incidence, & mortality. This tool will provide timely data to inform prevention strategies, support resource allocation, & strengthen regional & national snakebite control policies
The dashboard will be developed during the piloting phase, 11 months after project initiation. Continuous monitoring will be undertaken to ensure data accuracy & completeness.
Target Sample Size
Total Sample Size="1400" Sample Size from India="1400" 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)
05/01/2026
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="4" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Yet Recruiting
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Background:
Snakebite
envenomation (SBE) is a neglected tropical disease responsible for an estimated
58,000 deaths annually in India, disproportionately affecting rural, tribal,
and marginalized populations. Despite the availability of effective treatment
with anti-snake venom (ASV), systemic gaps in awareness, timely access, and
care coordination contribute to high mortality and morbidity. Fragmented local
initiatives have demonstrated promise but lack scalability and integration. The
Snakebite Awareness, Response, Prevention and Action (SARPA) protocol
proposes an evidence-based, community-centred model to bridge these gaps
through integrated prevention, preparedness, and health system strengthening.
Objectives:
To
design, implement, and evaluate a scalable, adaptive, and community-driven
intervention for snakebite prevention and management using the RE-AIM
framework. The primary objective of the study is to co-develop, pilot and
implement a replicable composite model of community engagement and empowerment
for the prevention and mitigation of snakebite envenoming across diverse
geographical settings of India. The secondary Objectives are : 1) To assess
changes in awareness and knowledge related to snakebite envenoming (SBE) across
the entire continuum of care — from community volunteers and first responders
to doctors and paramedical staff managing SBE — using a pre- and
post-intervention evaluation design.2) To develop and operationalise an
iterative, digital snakebite dashboard for real-time documentation and
monitoring of snake rescues, kills, sightings, envenoming cases, and related
deaths across study sites, enabling data-driven decision-making and
surveillance.
Methods:
This
multicentre implementation research uses a mixed-methods approach to co-develop
and evaluate a scalable, community-engaged model for snakebite prevention and
health system strengthening in two blocks within seven states across the five
zones of India. The study comprises three phases: a preparatory-adaptive phase
(8 months), a piloting and model optimization phase (11 months), and a full
implementation phase (24 months). Interventions will combine behaviour change
communication, digital innovations (AI-assisted snake identification, real-time
surveillance dashboards, 24×7 helpline), and structured health system capacity
building. Evaluation will integrate the RE-AIM and Proctor’s frameworks to
assess reach, effectiveness, adoption, implementation fidelity, and
maintenance. Quantitative and qualitative analyses—including logistic
regression, mixed-effects modeling, and longitudinal focus group
discussions—will measure changes in awareness, preventive practices,
time-to-treatment, and mortality reduction.
Expected
Outcomes:
The
SARPA protocol is expected to generate a replicable model for snakebite
prevention and management adaptable across diverse ecological and health system
contexts. By integrating community empowerment, digital technologies, and
health system strengthening, the study aims to produce scalable evidence to
inform India’s national snakebite strategy and contribute to the WHO’s 2030
target of halving global snakebite mortality.