NCT05872373

Brief Summary

This study will be a community trial conducted in two Upazila (sub-district) of Bangladesh- Kalapara, Patuakhali district and Shibganj, Chapainawabganj district. Kalapara upazila will be the intervention area and Shibganj will be the control area. From both the control and intervention areas, 30 community clinics will be randomly selected. Each community clinic serves 6,000 people and consists of 3 'wards'. So, the sample size will be 1,80,000 in the control and intervention areas, respectively. We would first perform formative research and survey to comprehend the burden and the community's perception of managing and preventing snakebite incidents. Data gathered through this assessment will contribute to finalizing our study interventions. The major goals of these interventions are to enhance community involvement and first aid awareness. Community participation will be addressed through 'Uthan Boithok' (courtyard meeting), health education sessions in schools, community clinics, and Upazila Health Complex (UHC) by displaying/using IEC (Information, Education, and Communication) materials (posters, flip charts, leaflets etc.), traditional songs on snakebite prevention and first aid management. Other interventions will include short audiovisual clips and community radio broadcasts, the development of Snakebite Support Groups (SBSG), and speedy referral responses. These interventions will be evaluated through a baseline survey, a midline process evaluation, and an end-line survey. The final assessment process will be completed by comparing the findings of the baseline and end-line surveys as well as by using the hospital surveillance system. Estimated cases per year and the number of patients who attended the hospital for treatment will be the main assessment criteria. In this trial, the primary outcome, the incidence of snakebite cases, will be modelled using a mixed effects Poisson regression model to obtain incidence rate ratios (IRRs) comparing the intervention to the control group. Therefore, this proposed project's community participation and health system-building initiatives will also help to build community awareness and quick treatment response in rural communities which in the long run will reduce the morbidity and mortality from snakebite incidence in Bangladesh.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

2 years

First QC Date

May 14, 2023

Last Update Submit

May 14, 2023

Conditions

Keywords

Snake envenomationCommunity engagementPrevention of snakebiteFirst aid

Outcome Measures

Primary Outcomes (1)

  • People are knowledgeable about the prevention of snakebite, engaged in proper management of snakebite, communities are empowered to address snakebite in their areas.

    The outcome will be measured by the following metrics- reduce the visit to the traditional healer, reduce the use of tourniquets, increase the practice of immobilization after bites, reduce the mean time between bite to hospital, and the mean time from home to the hospital.

    2 years

Secondary Outcomes (1)

  • A comprehensive integrated snakebite prevention and management program developed

    2 years

Study Arms (1)

Intervention Group

EXPERIMENTAL

Cases are the community people in the study area where interventions will be provided to measure the outcome of the study.

Behavioral: Snakebite prevention and first aid

Interventions

The study will offer a communication strategy to develop an effective narrative by using a mix-media campaign, where IEC materials would be chiefly localized.

Intervention Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • People living within the study area

You may not qualify if:

  • People not giving consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kalapara Upazila and Upazila Health Complex

Patuakhali, 8650, Bangladesh

Location

MeSH Terms

Conditions

Snake Bites

Interventions

First Aid

Condition Hierarchy (Ancestors)

Bites and StingsPoisoningChemically-Induced DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

Emergency TreatmentTherapeutics

Study Officials

  • Aniruddha Ghose, FCPS

    Chittagong Medical College and Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: This study is a community trial for better community engagement and creating awareness of the first aid management and prevention of snakebites through different IEC materials.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President

Study Record Dates

First Submitted

May 14, 2023

First Posted

May 24, 2023

Study Start

September 1, 2022

Primary Completion

August 30, 2024

Study Completion

August 30, 2024

Last Updated

May 24, 2023

Record last verified: 2023-05

Locations