Clinical trial NCT06124872: Mapping Snakebite Risk in Kenya and Eswatini
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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Snakebite
Epidemiology
Lead sponsor: Liverpool School of Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Kenya Medical Research Institute
name: Institute of Primate Research
First posted: 2023-11-09
Enrollment: 70000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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?
2. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Geostatistical model of snakebite risk in Kenya and Eswatini
timeFrame: Through study completion, estimated end of 2024
measure: An assessment of the accuracy of snakebite incidence data reported from routine surveillance systems relative to community survey estimates
timeFrame: Through study completion, estimated end of 2024
measure: Recommendations
timeFrame: Through study completion, estimated end of 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: KSRIC
Study officials:
affiliation: Liverpool School of Tropical Medicine
name: Collinson
role: PRINCIPAL_INVESTIGATOR
References: