Human NiV Infection Clinical Trial
Official title:
A Community Intervention Trial Utilizing Behavior Change to Reduce the Risk of Nipah Spillover Through Date Palm Sap in Bangladesh
Several human Nipah virus (NiV) outbreaks have occurred in Bangladesh since 2001with 71% case fatality. Outbreak investigations have repeatedly identified drinking fresh date palm sap as a risk factor for NiV transmission. Bats are the reservoir of NiV and infected bats can shed virus through both saliva and urine and can contaminate the raw sap. The virus can transmit to humans through ingestion of contaminated sap. To interrupt bats access to the sap, sap harvesters (gachhis) occasionally use skirts make by local materials. These skirts have been found to be effective to interrupt bats' access to the sap. As an indirect effect of the community level skirt promotion, some people stopped drinking raw sap. When trees have skirts, bats cannot access the sap and when people do not drink sap, they are at much lower risk of contracting Nipah virus. The purpose of this study is to design, implement and evaluate behavior change interventions to prevent human consumption of NiV contaminated sap through reducing raw sap consumption from unprotected trees in a district of the NiV affected regions in Bangladesh.
Status | Recruiting |
Enrollment | 7782 |
Est. completion date | September 2021 |
Est. primary completion date | September 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Years to 70 Years |
Eligibility | Inclusion Criteria: For baseline and endline: - Women: the wife of the main male income earner in the household. - Men: the main income earner. - Sap harvesters. Exclusion Criteria: - If the desired respondent is not in the household the team will make an appointment to return to the household. If the desired respondent will not be available within 24 hours, the household will be skipped. - Household visitors. |
Country | Name | City | State |
---|---|---|---|
Bangladesh | Two sub-districts in Gopalganj | Gopalganj | |
Bangladesh | Mirpur and Bheramara | Kushtia | |
Bangladesh | two sub-districts in Natore | Natore | |
Bangladesh | Pangsha and Kalukhali sub-districts | Rajbari |
Lead Sponsor | Collaborator |
---|---|
International Centre for Diarrhoeal Disease Research, Bangladesh | FHI 360, IEDCR, DGHS, Bangladesh, Stanford University |
Bangladesh,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Phase one: Proportion of people who continue drinking raw date palm sap. | 16 months | ||
Primary | Phase two: Proportion of people who stop drinking sap or who drink sap from skirt protected trees. | 10 months | ||
Secondary | Reduce human exposure to Nipah virus thought bat contaminated sap and increase the awareness level on prevention of Nipah virus by refraining from sap consumption. | 16 months |