Schistosomiasis in Senegal
Primary Purpose
Schistosomiasis
Status
Active
Phase
Not Applicable
Locations
Senegal
Study Type
Interventional
Intervention
Bottom-up intervention
Sponsored by
About this trial
This is an interventional prevention trial for Schistosomiasis
Eligibility Criteria
Inclusion Criteria:
- School age children
Exclusion Criteria:
- Non-school age children
Sites / Locations
- Espoir Pour La Santé (EPLS)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Experimental
Arm Label
Status quo
Low risk
No agrochemicals
Arm Description
Status quo pesticide use
Villages shifted to low risk pesticides that don't kill prawns
Villages that eliminate agrochemicals
Outcomes
Primary Outcome Measures
Schistosomiasis reinfection rate
Schistosomiasis reinfection rate
Secondary Outcome Measures
Crop yields
Crop yields
Full Information
NCT ID
NCT03187366
First Posted
June 12, 2017
Last Updated
March 21, 2023
Sponsor
University of Notre Dame
Collaborators
Biomedical Research Center EPLS
1. Study Identification
Unique Protocol Identification Number
NCT03187366
Brief Title
Schistosomiasis in Senegal
Official Title
EID: Using Community Ecology Theory to Predict the Effects of Agricultural Expansion and Intensification on Infections of Humans: Implications for Sustainable Agriculture
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2, 2017 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Notre Dame
Collaborators
Biomedical Research Center EPLS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Schistosomiasis is a flatworm transmitted from freshwater snails to humans in the tropics. In addition to this infectious disease, tropical developing countries are faced with malnutrition. We propose to alter pesticide and compost use to reduce schistosomiasis and maintain or even improve crop production.
Detailed Description
We propose two types of manipulations. Bottom-up manipulations will affect snail resources, whereas top-down manipulations will affect snail predators. For the bottom-up manipulations, we will clear schistosoma infections in school children, then remove the primary habitat for snails, the submerged macrophyte Ceratophyllum demersum (with proper unmanipulated controls), compost it, apply it to crops, and then quantify reinfection rates and crop yields. The second bottom-up manipulation will be to clear schistosoma infections in school children, apply three agrochemical treatments (status quo control, shift to lower risk herbicides, or eliminate herbicides and fertilizers), and then quantify reinfection rates and crop yields. Farmers will be compensated for any loss in yields. For the top-down manipulations, every village will receive prawns that depredate snails. We will clear schistosoma infections in school children, apply three agrochemical treatments (status quo control, shift to lower risk insecticides that don't kill prawns, or eliminate insecticides), and then quantify reinfection rates and crop yields. Farmers will be compensated for any loss in yields.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schistosomiasis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1477 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Status quo
Arm Type
No Intervention
Arm Description
Status quo pesticide use
Arm Title
Low risk
Arm Type
Active Comparator
Arm Description
Villages shifted to low risk pesticides that don't kill prawns
Arm Title
No agrochemicals
Arm Type
Experimental
Arm Description
Villages that eliminate agrochemicals
Intervention Type
Other
Intervention Name(s)
Bottom-up intervention
Other Intervention Name(s)
Top-down intervention
Intervention Description
Some interventions are bottom-up, where we manipulate the resources of snails and some are top-down, where we manipulate the predators of snails.
Primary Outcome Measure Information:
Title
Schistosomiasis reinfection rate
Description
Schistosomiasis reinfection rate
Time Frame
One year
Secondary Outcome Measure Information:
Title
Crop yields
Description
Crop yields
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
School age children
Exclusion Criteria:
Non-school age children
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason R Rohr, PhD
Organizational Affiliation
University of South Florida, Department of Integrative Biology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Espoir Pour La Santé (EPLS)
City
Saint-Louis
Country
Senegal
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Schistosomiasis in Senegal
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