SnakebiteNCT06124872
Mapping Snakebite Risk in Kenya and Eswatini
An observational study of Snakebite and Epidemiology, run by Liverpool School of Tropical Medicine at 1 site in Kenya.
Trial summary
The goal of this observational study is to learn about how snakebite risk varies in different environments in Kenya and understand how this information can be used to support decision makers. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Snakebite, Epidemiology
- What is being tested?
- Survey questionnaire and Key informant interview
- How many people
- 70,000 participants
- Where
- 1 siteKenya
- Study dates
- 1 Jun 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Community surveys * Populations resident within selected counties. Key informant interviews: * Those with power and/or influence in healthcare decision making or research with relation to Neglected Tropical Diseases/snakebite.
Who may be able to join
- Household Screening Questionnaire:
- All heads of household from randomly selected households.
- To account for all household members
- Snakebite Details Questionnaire:
- All household members with a history of snakebite. If the household member is deceased, a responsible adult from the household will be asked to complete the questionnaire.
- Key informant interviews:
- Key informants identified through a stakeholder mapping exercise as having power and/or influence in healthcare decision making or research with relation to Neglected Tropical Diseases/snakebite.
- Willing and motivated to be interviewed
Who cannot join
- Household Screening Questionnaire:
- Households where the household head/a responsible adult is not present at first visit or revisit.
- Household where the household head/responsible adult is unable or unwilling to give consent
- Snakebite Details Questionnaire:
- The household member is unable/unwilling to give consent and (in the case of the former) there is no responsible adult available/willing to complete the questionnaire on their behalf
- Key informant interviews:
- A participant whose role and organisation has already been represented in the key informant interviews
- Participant declines to be interviewed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mapping Snakebite Risk in Kenya and Eswatini: Using Primary Data Collection and Geostatistical Techniques to Develop an Approach to Remote Risk Estimation for Snakebite
The goal of this observational study is to learn about how snakebite risk varies in different environments in Kenya and understand how this information can be used to support decision makers.
The main questions it aims to answer are:
Read more
- To what extent can information on snakebite cases and data on geographic, climatic and sociodemographic factors be used to predict geographical variation in snakebite risk in Kenya and Eswatini?
- What is the most effective means of presenting outputs from spatial analysis of snakebite risk to ensure its effective use in research and healthcare decision making?
Participants in the community survey will be asked survey questions about the history of snakebite in their household. Participants in the key informant interviews will be interviewed to understand how data on snakebite risk can be best presented to support their work.
Read the detailed description
This study aims to understand whether spatial analysis methods can support the assessment and prediction of geographical variation in snakebite risk.
The investigators will analyse data collected from community and health facility surveys conducted in geographically, ecologically and demographically diverse areas of Kenya and Eswatini. Data sources will comprise existing snakebite incidence data from both countries and prospective data collected through adding snakebite questions to planned health/demographic survey platforms where feasible and conducting a small number of stand-alone cluster-sampled surveys to complement this. Selected households will be invited to complete short questionnaires covering sociodemographic details and snakebite history. Survey data will be compared with health facility data collected in the same locations to assess the value and relative bias of different data sources to snakebite risk assessment. Data will be analysed using geostatistical techniques, and predicted risk will be mapped within and beyond sampled locations where appropriate. Our findings will build knowledge on spatial determinants of snakebite within these countries and support development of a risk mapping methodology for snakebite. Identification of high-risk locations will also support advocacy for resources and guide treatment and prevention activities.
Interviews will also be conducted with key stakeholders in healthcare and research fields in Kenya to help us understand the healthcare decision-making process and how outputs from spatial analysis of snakebite data can be best presented to support this. Interview results will aid development of recommendations for the optimal presentation of snakebite data to support programmatic decision making.
- Conditions
- Snakebite, Epidemiology
- Being tested
- Survey questionnaire, Key informant interview
- Medical subject headings
- Snake Bites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey questionnaireOther
Household screening questionnaire Snakebite details questionnaire where a history of snakebite is reported
Key informant interviewOther
Semi-structured interview with selected key informants
| Study group | Role | What they receive |
|---|---|---|
| Community survey 1 (planned demographic/health survey) | Households included in a planned demographic and health survey (DSS).
All participants included in this survey will be invited to respond to snakebite questions. Receives: Other: Survey questionnaire | |
| Community survey 2 (Stand alone survey) | 25 households randomly selected for inclusion within each survey cluster.
Survey clusters will be randomly selected enumeration units within study Counties. Receives: Other: Survey questionnaire | |
| Community survey 3 (Stand alone survey) | 25 households randomly selected for inclusion within each survey cluster.
Survey clusters will be randomly selected enumeration units within study Counties. Receives: Other: Survey questionnaire | |
| Key informant interviews | Stakeholders in the process of healthcare decision making and research relevant to snakebite and snakebite envenoming Receives: Other: Key informant interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geostatistical model of snakebite risk in Kenya and Eswatini
A geostatistical model of snakebite risk, detailing the statistical association between selected covariates and snakebite risk, based on analysis of data on snakebite incidence collected from contrasting locations in Kenya and Eswatini.
Measured: Through study completion, estimated end of 2024
An assessment of the accuracy of snakebite incidence data reported from routine surveillance systems relative to community survey estimates
An assessment of the accuracy of routine surveillance data sources in relation to community survey incidence estimates (the gold standard measure) in each study location.
Measured: Through study completion, estimated end of 2024
Recommendations
A thematic analysis of key informant interviews on the potential role of and key features needed in snakebite risk maps in order for them to provide utility in healthcare decision making and a set of recommendations to guide presentation of spatial outputs on snakebite risk.
Measured: Through study completion, estimated end of 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start1 Jun 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SnakebiteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 70,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool School of Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Medical Research Institute, Institute of Primate Research
- Responsible party
- Sponsor
- Investigators
- Collinson, Principal investigator, Liverpool School of Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124872
- Sponsor's protocol ID
- 22_060
- Status last verified
- Oct 2023
- First submitted
- 3 May 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised quantitative datasets (excluding household GPS) and the R code used for analysis will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping Snakebite Risk in Kenya and Eswatini: Using Primary Data Collection and Geostatistical Techniques to Develop an Approach to Remote Risk Estimation for Snakebite
- ClinicalTrials.gov ID
- NCT06124872
- Acronym / sponsor ID
- 22_060
- Conditions
- Snakebite, Epidemiology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70,000 participants (estimated)
- Lead sponsor
- Liverpool School of Tropical MedicineUniversity, hospital or other
- Collaborators
- Kenya Medical Research Institute, Institute of Primate Research
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about how snakebite risk varies in different environments in Kenya and understand how this information can be used to support decision makers.
The main questions it aims to answer are:
- To what extent can information on snakebite cases and data on geographic, climatic and sociodemographic factors be used to predict geographical variation in snakebite risk in Kenya and Eswatini?
- What is the most effective means of presenting outputs from spatial analysis of snakebite risk to ensure its effective use in research and healthcare decision making?
Participants in the community survey will be asked survey questions about the history of snakebite in their household. Participants in the key informant interviews will be interviewed to understand how data on snakebite risk can be best presented to support their work.
Detailed description
This study aims to understand whether spatial analysis methods can support the assessment and prediction of geographical variation in snakebite risk.
The investigators will analyse data collected from community and health facility surveys conducted in geographically, ecologically and demographically diverse areas of Kenya and Eswatini. Data sources will comprise existing snakebite incidence data from both countries and prospective data collected through adding snakebite questions to planned health/demographic survey platforms where feasible and conducting a small number of stand-alone cluster-sampled surveys to complement this. Selected households will be invited to complete short questionnaires covering sociodemographic details and snakebite history. Survey data will be compared with health facility data collected in the same locations to assess the value and relative bias of different data sources to snakebite risk assessment. Data will be analysed using geostatistical techniques, and predicted risk will be mapped within and beyond sampled locations where appropriate. Our findings will build knowledge on spatial determinants of snakebite within these countries and support development of a risk mapping methodology for snakebite. Identification of high-risk locations will also support advocacy for resources and guide treatment and prevention activities.
Interviews will also be conducted with key stakeholders in healthcare and research fields in Kenya to help us understand the healthcare decision-making process and how outputs from spatial analysis of snakebite data can be best presented to support this. Interview results will aid development of recommendations for the optimal presentation of snakebite data to support programmatic decision making.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Community survey 1 (planned demographic/health survey) | – | Other: Survey questionnaireHouseholds included in a planned demographic and health survey (DSS). All participants included in this survey will be invited to respond to snakebite questions. |
| Community survey 2 (Stand alone survey) | – | Other: Survey questionnaire25 households randomly selected for inclusion within each survey cluster. Survey clusters will be randomly selected enumeration units within study Counties. |
| Community survey 3 (Stand alone survey) | – | Other: Survey questionnaire25 households randomly selected for inclusion within each survey cluster. Survey clusters will be randomly selected enumeration units within study Counties. |
| Key informant interviews | – | Other: Key informant interviewStakeholders in the process of healthcare decision making and research relevant to snakebite and snakebite envenoming |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Community surveys * Populations resident within selected counties. Key informant interviews: * Those with power and/or influence in healthcare decision making or research with relation to Neglected Tropical Diseases/snakebite.
Key inclusion criteria (8 listed)
- All heads of household from randomly selected households.
- To account for all household members
- All household members with a history of snakebite. If the household member is deceased, a responsible adult from the household will be asked to complete the questionnaire.
- Key informants identified through a stakeholder mapping exercise as having power and/or influence in healthcare decision making or research with relation to Neglected Tropical Diseases/snakebite.
- Willing and motivated to be interviewed
Key exclusion criteria (8 listed)
- Households where the household head/a responsible adult is not present at first visit or revisit.
- Household where the household head/responsible adult is unable or unwilling to give consent
- The household member is unable/unwilling to give consent and (in the case of the former) there is no responsible adult available/willing to complete the questionnaire on their behalf
- A participant whose role and organisation has already been represented in the key informant interviews
- Participant declines to be interviewed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey questionnaireHousehold screening questionnaire Snakebite details questionnaire where a history of snakebite is reported | Other | Community survey 1 (planned demographic/health survey), Community survey 2 (Stand alone survey), Community survey 3 (Stand alone survey) |
| Key informant interviewSemi-structured interview with selected key informants | Other | Key informant interviews |
Primary outcome
Geostatistical model of snakebite risk in Kenya and Eswatini
Time frame: Through study completion, estimated end of 2024
A geostatistical model of snakebite risk, detailing the statistical association between selected covariates and snakebite risk, based on analysis of data on snakebite incidence collected from contrasting locations in Kenya and Eswatini.
An assessment of the accuracy of snakebite incidence data reported from routine surveillance systems relative to community survey estimates
Time frame: Through study completion, estimated end of 2024
An assessment of the accuracy of routine surveillance data sources in relation to community survey incidence estimates (the gold standard measure) in each study location.
Recommendations
Time frame: Through study completion, estimated end of 2024
A thematic analysis of key informant interviews on the potential role of and key features needed in snakebite risk maps in order for them to provide utility in healthcare decision making and a set of recommendations to guide presentation of spatial outputs on snakebite risk.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Individual participant dataSharing planned: Yes. Anonymised quantitative datasets (excluding household GPS) and the R code used for analysis will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Collinson principal investigator
Liverpool School of Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Snakebite and Epidemiology, run by Liverpool School of Tropical Medicine at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geostatistical model of snakebite risk in Kenya and Eswatini (time frame: Through study completion, estimated end of 2024). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.