- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06124872
Mapping Snakebite Risk in Kenya and Eswatini
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:
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
-
Nairobi, Kenya
- KSRIC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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.
Description
Inclusion Criteria:
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
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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. |
Household screening questionnaire Snakebite details questionnaire where a history of snakebite is reported
|
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. |
Household screening questionnaire Snakebite details questionnaire where a history of snakebite is reported
|
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. |
Household screening questionnaire Snakebite details questionnaire where a history of snakebite is reported
|
Key informant interviews
Stakeholders in the process of healthcare decision making and research relevant to snakebite and snakebite envenoming
|
Semi-structured interview with selected key informants
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
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.
|
Through study completion, estimated end of 2024
|
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.
|
Through study completion, estimated end of 2024
|
Collaborators and Investigators
Investigators
- Principal Investigator: Collinson, Liverpool School of Tropical Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22_060
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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