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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06124872
Other study ID # 22_060
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date June 1, 2023
Est. completion date December 31, 2024

Study information

Verified date October 2023
Source Liverpool School of Tropical Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 70000
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Survey questionnaire
Household screening questionnaire Snakebite details questionnaire where a history of snakebite is reported
Key informant interview
Semi-structured interview with selected key informants

Locations

Country Name City State
Kenya KSRIC Nairobi

Sponsors (3)

Lead Sponsor Collaborator
Liverpool School of Tropical Medicine Institute of Primate Research, Kenya Medical Research Institute

Country where clinical trial is conducted

Kenya, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Through study completion, estimated end of 2024
Primary 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. Through study completion, estimated end of 2024
Primary 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. Through study completion, estimated end of 2024
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