Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05872373 |
| Other study ID # |
D02550 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2022 |
| Est. completion date |
August 30, 2024 |
Study information
| Verified date |
May 2023 |
| Source |
Toxicology Society of Bangladesh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
General Objective:
To determine the impact of community engagement/awareness on snakebite prevention and
appropriate first aid practices after snakebite in Bangladesh.
Specific Objective:
1. To depict the snakebite scenario in the study areas.
2. To conduct formative research for designing the intervention for the prevention and
management of snakebites in rural Bangladesh.
3. To design and strategize the implementation framework for awareness building, community
engagement, and developing community based SBSG for prevention and proper management of
snakebites in rural Bangladesh.
4. To implement the implementation programme according to the designed strategies.
5. To evaluate the impact of the implementation programme in increasing awareness for the
prevention of snakebites and improving the management practice for snakebites.
Methodology
Methodological framework:
This study will be a community trial. The overall research process, interventions and
evaluation methods are provided below:
1. Formative research will be performed to better understand the community perception
regarding the snakebite prevention and management. Data gathered through this assessment
will contribute to intervention design, message development, intervention
implementation, monitoring, and evaluation. In this phase, In-depth Interviews (IDI)
will be conducted among the healthcare professionals to comprehend the perception of
snakebite treatment. There will be Focus Group Discussion (FGD) sessions among the
community people, volunteers, and community leaders to understand their level of
knowledge about snakebite prevention and first aid management.
2. Finalization of Intervention: After the formative research the development of
interventions will be in process. The intervention package will be developed utilizing
(a) findings of the baseline survey and formative research, (b) a review of existing
literature including recommendations of 'Guidelines for the Management of Snakebites'
World Health Organization (WHO) South East Asia Region (SEAR) Office 2016 which was
prepared by a team of experts where one of us (MAF, Principal Investigator- PI) was
involved; adopted recommendations in the National Guideline for Management of snakebite
2019 and training modules prepared by Non Communicable Disease Control (NCDC),
Directorate General of Health Services (DGHS), Government of Bangladesh (GOB) for
providing training to the community health workers (in Bengali) and medical doctors (in
English). The investigators were involved in the development of the guidelines and the
learner's guide by organizing a workshop involving key stakeholders.
3. Implementation of Interventions
After the finalization of interventions, the next steps would be implementation of the
interventions for better community engagement and creating awareness for first aid
management. The following work packages will be implemented at the community level:
Work package 1: IEC material development and demonstration
The preparation of intervention processes; the information, education, and communication
(IEC) materials for creating community awareness will be developed in Bengali through
participatory involvement of the relevant stakeholders including program personnel,
health managers, health care professionals and the community. The work steps and IEC
materials will include the following:
1.1 Collection of existing IEC materials (if any) on snakebite prevention and first aid
1.2 Identification of IEC materials for snakebite prevention and first aid with methods
of delivery to the community through the lens of anthropology 1.3 Development of IEC
materials in Bengali 1.3.1 Possible IEC materials: 1.3.1.1 Posters 1.3.1.2 Flip chart
1.3.1.3 Leaflet and pamphlet 1.3.1.4 Video film 1.3.1.5 Radio talk and short radio
advertisements (with special note to local community radio) 1.3.1.6 Popular writing
1.3.1.7 Traditional song- as for example 'Boyati', 'Gambira' 1.3.1.8 Laminated picture
of common venomous and non-venomous snakes Community engagement through small group
discussion (Courtyard Meeting) will be arranged using the relevant IEC materials
developed by the health care staff/SBSG working in the intervention area of a community
clinic.
Community engagement through multi-stakeholder involvement centring the community clinic
of the intervention area.
Work package 2: Community engagement through multi-stakeholder involvement centring the
community clinic of the intervention area. 2.1 Identification of stakeholders relevant
to prevention and providing first aid following snakebite. Relevant stakeholders will be
identified for prevention and providing first aid following snakebite.
2.2 Engagement of stakeholders (community group, two representatives of three community
support groups + others including Health Assistant, Assistant Health Inspector, Family
Welfare Assistant) for prevention and providing first aid following snakebite at the
community level (scene) through community education, thus engaging the community
centring on the community clinic (self-organized first aid/primary care for snakebite).
2.3 Formation of Snakebite Support Group (SBSG): 5-member team, 3 SBSG in each community
clinic area one for each ward. The SBSG will arrange the health education session (at
least five in each ward, a total of 450 such sessions in the intervention upazila) on
prevention and first aid; will arrange a team of three-wheeler vehicle drivers
(CNG/battery operated auto rickshaw) with mobile phone number known to the community who
volunteer to transport bite victims in case of any snakebite; exact cost of transport
through volunteer drivers will be reimbursed; community may also travel by other
preferable means of transportation that is quickly available to them (for example
ambulance).
Work package 3: Providing community education utilizing the developed IEC materials 3.1
Conducting 450 'Uthan Boithok' (courtyard meeting) using flip-chart materials to be
developed (1.3) on prevention and appropriate first aid, and to show photos of relevant
venomous vs. non-venomous snakes occurring in the area. Public health measures will be
taken.
Key topics of 'Uthan Boithok ' will include prevention by promoting the use of - 'cot &
bed net', torch-light, boots, cleaning the surroundings and interior of houses, avoiding
risky behavior, avoiding poultry keeping in the house; and first aid by knowing the
'Do's and Don'ts' based on current evidence and practicing appropriate first aid
measures as well as required skills. 'Uthan Boithok ' will be organized by the SBSGs
with the support of community health workers/Multi-purpose Health Volunteers (MPHV) of
the area and an action plan to be developed by the Upazila coordinator.
3.2 Conducting regular (bi-weekly) health education at the community clinic by Community
Health Care Provider (CHCP) using the flipchart.
3.3 Utilization of the developed posters on snakebite prevention and first aid
developed.
3.4 Conducting school/college-based seminars and symposia: at least one in each
intervention community clinic area.
Work package 4: Best practice model establishment: Establishing a best-practice model
for the clinical management of snakebites in the UzHC of both control and intervention
areas. This is essential for ensuring that snakebite patients coming to the UzHC are
managed appropriately in the context.
4.1 Providing training or retraining to a team of health professionals (doctors, nurses,
sub-assistant community medical officers) at selected Upazila Health Complex (UzHC) on
the clinical management of snakebites.
4.2 Arranging essential logistics including supply of antivenom and other drugs needed
for the management of snakebite envenoming, from the government sources through
coordination with relevant Operational Plans (OPs) 4.3 Providing health education by
health care professionals on snakebite prevention and appropriate first aid following
snakebite to the snakebite victims, their families and the public attending the UzHC.
4.4 Providing supportive supervision to the health care professionals of UzHC ('spoke')
for managing snakebites through a 24/7 online connection with a dedicated medical
college or district hospital ('hub'). The implementation of this activity will involve
the participation of a pool of volunteers having specialist knowledge of snakebite
management from the 'hub' hospital or elsewhere providing telemedicine support to the
UzHC staff.
4.5 Study of the perceptions of snakebite treatment including anti-venom (AV) delivery
among the health care professionals in the UzHC, using IDI/Key informant interview
(KII).
Work Package 5: Community and hospital surveillance of snakebites 5.1 Establishing a
community surveillance system for snakebite: to record all the cases of snakebite in
humans and domesticated animals (e.g., poultry, cattle, goat, pig [if any], dog, cat)
happening in the community through a structured questionnaire and house to house search
during the survey. Any case of snakebite occurring in the community will be notified to
the CHCP of the community clinic by all (including SBSG, community health workers) for
monthly onward transfer of basic snakebite data to UzHC covering age, sex, date, and
locality of bite.
5.2. Hospital Surveillance: Recording all the human cases of snakebite attending the
UzHC keeping a 'snakebite register' and replicating this for snakebite cases on
domesticated animals seen at the veterinary hospital of the upazila and the district (if
any). All patients of snakebite attending the UzHC in intervention areas will be
reimbursed for availing the quick transport arranged by the SBSG at the community level.
Arrangements will be made for keeping the brought killed snake specimen if brought by
the victims or their attendants and for appropriately labeling and preserving them in
the facility.
4. Evaluation through community survey: The final process will be evaluation. As the
process of evaluation, at least two community survey will be conducted. Baseline survey
will be conducted before the implementation of the interventions. Midline survey will be
undertaken as process of evaluation. Finally, endline survey will be conducted.
Baseline survey:
To evaluate the impact of implementation program in increasing awareness for prevention of
snakebite and improving the management practice for snakebite the community survey will be
conducted in both the control and intervention area. In this process, a baseline survey will
be started simultaneously with formative research.
Study Design: This baseline study will be cross sectional survey to understand the overall
scenario of snakebite prevention and first aid management.
Study Setting: This survey will be conducted in the Shibganj upazila of Chapainawabganj and
Kalapara upazila of Patuakhali district. It will be conducted in 30 randomly selected
community clinic areas of the intervention upazila in one district and control area will be
similar 30 community clinic areas in control upazila in another district.
Study population: The study population will be the community people residing in 3 wards of
the catchment areas of community clinics in control and intervention area. An eligible
participants for the household survey will be people residing in the study area for more than
six months. In case of community survey, the key participant will be considered as the head
of the family member. Moreover, if other family members can give relevant information about
the victim, they can be invited to join the interview.
Data Collection Instruments for study: The tools will be adopted and translated in Bengali
for collecting data from the study site in Bangladesh. The data collection tools will be used
in the study will be pretested before field data collection. The tools would provide
information on the indicators.
Key parameters during community surveys:
Household: Yes/No information from all households (HHs) from control and intervention areas
and details of positive cases only (Yes) will be obtained, for snakebite cases on either
humans or domesticated animals.
Key informant
Phone number of the informant:
Day after the incident:
Global positioning system (GPS) coordinates of the location where the bite occurred (or its
close vicinity):
Snakebite victim: Human/Domestic animal (name of the animal species)
Age of the victim:
Sex: Male/Female/Third gender
If female: Pregnancy status:
Bite date and time Bite site (on body) Bite scene circumstances Day time/nighttime If the
snake was seen Could you identify the offending snake: Yes/No; respondent chooses from a set
of photos of representative venomous and non-venomous snakes of the area (2 species of cobra,
3 species of krait, Russell's viper, green pit viper, non-venomous species)
The local name of the snake that caused the bite:
Snake was killed/brought to the hospital
First aid provided:
- Pressure immobilization done if the bite is on limbs: Yes/No
- Tourniquet (ligatures) applied: Yes/No, number, if yes: materials used
- Treatment sought: 'ozha'/directly to UzHC/elsewhere (please specify)
- Time taken from bite time to hospital arrival time (if taken to hospital):
- Travel time from home to hospital:
Key symptoms after the bite:
Outcome: Survived/died (verbal autopsy of any deceased/fatal cases) Any sequelae: please
specify Cost of treatment in Bangladeshi 'Taka': Direct cost:... Indirect cost:... How was
the treatment cost covered: from savings, loan, sale of material wealth, other (specify)
Key points to be recorded in case the snakebite victim is a domestic animal:
1. Snakebite in animal (species and/or type/breed) is confirmed/probable (case definition
21 will be given)
2. Type of the animal: Cattle, buffalo, goats, sheep, pig, poultry, dog, cat, others
3. Where did the bite happen: (circumstance of bite)
4. Location of bite: owner's house or farm/animal shed/field/pasture
5. The part of the body that was bitten: limb/head-neck area/abdomen/thorax/udder/tail/
unknown.
6. Treatment provided
7. Type of treatment
8. Outcome of the victim
9. Cost of treatment in Taka: Direct cost:... indirect cost:...
10. How was the treatment cost covered: from savings, loan, sale of material wealth, other
Note:
• Confirmed if the event was witnessed, and clinical signs were consistent with snakebite
envenomation (e.g., swelling, bleeding, ptosis, hypersalivation, respiratory difficulties,
paralysis, or sudden death).
Probable if the event was not witnessed but there was evidence of contact with a snake
(animal playing, fighting a snake, a snake found close to the animal) or fang marks were
found, and clinical signs were consistent with snakebite envenomation.
Data collection tool: Quantitative data for this project will be collected using
Computer-aided personal interviewing (CAPI ). A structured questionnaire will be utilized to
conduct household survey. Competent use of these strategies can increase the amount of
information needed, improve data quality, and reduce the risk of bias. The above methods of
data collection will be adjusted to each of the study's objectives, considering of the
possibility of gathering information in the field and the desired indicators.
Recruitment and training of field personnel: Recruitment All the data collection personnel
will be recruited following the standard recruitment procedure. They will be recruited by
inviting applications and based on maturity, previous working experience, group cohesion,
education level and ability to collect data. The minimum educational qualification of field
personnel will be at least Bachelor's degree from a recognized university. All field
personnel will be initially recruited as trainees. A trainee will be finally appointed to a
specific post depending on his/her performance in the training. Trainees with the best
performances will be recruited as Supervisors. A greater number of persons than required will
be recruited as trainees so that those found not suitable later or those who drop out can be
replaced. Moreover, females will be included in the field teams to have easy access to the
respondents.
Training: Training of 2 days duration will be organized at the Centre for Injury Prevention
and Research, Bangladesh (CIPRB) headquarter (HQ) for all the field staff to be recruited for
the survey. The training room will be organized with maintaining social distancing. Training
for the Interviewers will include a thorough discussion on the overall methodology and each
study question, practice session, and role-playing. They will be oriented on the concept of
the project, study objectives, purpose and specified indicators and parameters through this
training. The training will cover the issues on interview techniques, the format of
questionnaires as well as data collection and record keeping procedure. Issues regarding
privacy and confidentiality will also be covered in the training. Interviewers will be
instructed not to discuss any of the details of the interviews or any of the personal
information obtained through the interviews with other persons or within themselves. A
well-experienced panel of trainers will facilitate the training sessions to fulfil the need
of administering quality data collection, quality assurance and management. All the key
personnel of the study and other senior professionals of the research team will be engaged to
impart the training.
Monitoring and evaluation:
Through the baseline survey following indicators will be measured for further evaluation and
monitoring:
- Estimated cases of snakebite for the last one year
- Estimated cases of snakebite death for the last one year
- Number (%) of patients going to hospital for treatment.
- Number (%) of patients presenting with tourniquet on admission to the health facilities.
- Number (%) of patients who visited traditional healers
- Number (%) of patients presenting with immobilization on admission to the health
facilities.
Midline Survey In the midline survey, after approaching the interventions in community level,
household survey will be conducted among the same population and after completion of one
year, midline process evaluation will be done to understand the impact of interventions.
End-line Survey All the interventions will be continued until the end of the study. After two
years, end-line survey will be conducted among the same population. The effect of the
community awareness created will be assessed by comparison of the results of a base-line
survey with survey conducted in the community's year 2 of the project and through the
hospital surveillance system.
5. Data analysis After the community survey, we will proceed for final data analysis. The
following measurable outcomes will be considered: estimated cases per 100,000 per year; the
mean time (minutes) to hospital; number of patients coming to hospital for treatment; number
(%) of patients presenting with tourniquet on admission to the health facilities; number (%)
of patients who visited traditional healers, ('ozha') and the number (%) of patients
presenting with immobilization on admission to the health facilities.
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. A hierarchical modelling approach will be employed in order to account for
nested clustering i.e., participants will be clustered in villages which are nested in the
clinic catchment area where they come from. The 95% confidence intervals for the IRRs will be
calculated and reported. A mixed effects Negative Binomial regression model will be fitted if
there will be over-dispersion in the mean of these count data. All tests of significance will
be performed at a 5% significance level. A detailed Statistical analysis plan will be
developed and approved prior to database lock. Analyses will be done in Stata or R or any
other appropriate software.
Key parameters to be analyzed Estimated cases per year Mean time to hospital
Number of patients who came to the hospital for treatment:
Number of patients having tourniquets Number of patients who visited traditional healers,
('ozha') Number of patients who arrived with immobilization in place
Risk management The risks associated with this project can be categorized into those at local
level and general contextual factors.
Local Level: Non-cooperation- there may arise various risks or uncertainties in the field
level implementation of such a survey on socially sensitive issues such as respondents may
avoid the team. To overcome such risk, survey teams will introduce themselves in the survey
area; local upazila health manager, UHFPO is an investigator; will acknowledge social elites
and others.
Non response; Other risks and uncertainties like non-response on the part of respondents
which will be dealt with through appropriate approaches as and when required. The common
practices are: rapport building with the respondent, taking consent from the respondent,
making aware about basic interest areas and survey objectives etc.
General Contextual Factors; Coronavirus Disease (COVID) situation- current COVID if changed
may hamper the movement of the staff including data collectors involved in this assignment.
Government instruction in this regard will be followed considering the safety of the survey
team members.
Problems with the capacity of any of the research team members; The problems with the
capacity of any of the research team members will be managed by continuous monitoring and
communication.
Dropout of the team members; any of the team members may drop out at any time during the
survey. Considering such risk, more than the required number of staff will be trained.
Data Confidentiality; maintaining the confidentiality of the data in this survey will be a
high priority. As the data will contain information on humans, safety measures will be
employed to ensure data protection and safe handling. The consent form, study tools and any
other forms linking participants' personal information will be kept in a place inaccessible
to unauthorized persons. Upon the permission of investigators, access to both hard copy and
softcopy of data will be made. During the training, a separate session will be taken to
maintain data confidentiality and management. Proper documentation and storage of the data,
files or protocols relevant to data management will be handled with utmost care. Regular
backup of the existing data will be conducted at appropriate intervals. All computers being
used in the study will have restricted access to unauthorized persons.
Quality assurance; quality assurance system will be developed. Deputy Programme Managers
(DPM), Community Based Health Care (CBHC), & Injury snakebite, DGHS, GOB and local Upazila
Health & Family Planning Officer (UHFPO) of the two study upazilas are co-investigators. The
community-led awareness meetings in the intervention upazila will be facilitated by locally
innovative multi-purpose health volunteers (MHV) of SBSG among the community group and
community support group with the support of local Community Clinic (CC) led community health
workers and elected local union members and will be monitored by the study team guided by
UHFPO. The SBSG will be motivated during community engagement training attended by senior
members of the research team including PI. The healthcare team at UzHC will be trained on the
management of snakebite through a structured existing training module and will have 24/7
contact with a 'hub' led by an investigator (Assistant Professor of Medicine) for providing
advice digitally. PI and other co-investigators will do periodic monitoring visits during the
study. Survey data will be collected on a mobile device with proper supervision and periodic
real-time monitoring. The Toxicology Society of Bangladesh (TSB) will provide administrative
and monitoring support through 2 recruited full-time managers, 1 coordinator and 1 Quality
Control Officer (quality control checking of survey data).
Data cleaning will be performed prior to database lock and statistical analyses will be done
on clean datasets.
Dissemination of results:
A dissemination meeting will be arranged at the end of the study with the relevant officials
and stakeholders in consultation with the Ministry of Health and Family Welfare (MOHFW)
(funder). The findings of the study will be published in scientific journals and presented at
conferences and may be utilized for future research. The relevant results on prevention and
first aid of snakebites will also be communicated widely in Bengali including the study.
Utilization of Results:
The principles of sustainable development goals (SDG) include 'Universal Health Coverage',
'reduction of out-of-pocket expenditure' and 'poverty alleviation. The provision of snakebite
prevention, first aid and management close to communities at UzHC directly contribute to
achieving SDGs as snakebite mainly affects marginalized, rural poor people and farming
communities and their livestock. Snakebite at nighttime in and around poor rural housing and
walking in darkness for the natural calls are risks. In addition to the health and
poverty-related SDGs, other elements of the SDG like those addressing adequate improved rural
housing (SDG 11.1), adequate access to lighting/access to electricity (SDG 7), and
elimination of outdoor open defecation (SDG 6.2) are all also linked with the problem of
snakebite envenoming and other health issues. Thus, the community engagement and health
system strengthening activities of this proposed project will also contribute to achieving
targets corresponding to these SDGs. In fact, snakebite envenoming can be regarded as a
'litmus test' for the health system to deliver services through the UzHC, and for developing
feasible strategies to optimize services at this level.
