Community Intervention to Prevent Nipah Spillover
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ClinicalTrials.gov Identifier: NCT01811784 |
Recruitment Status :
Recruiting
First Posted : March 15, 2013
Last Update Posted : February 19, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Human NiV Infection | Behavioral: Ask people not to drink raw sap Behavioral: Ask people not to drink sap or drink sap from skirt protected trees Other: No Intervention | Phase 1 Phase 2 |
Purpose:
Objectives: To evaluate the effectiveness of a behavior change communication (BCC) intervention in changing raw sap consumption behavior to prevent human consumption of NiV contaminated sap from unprotected trees in the districts of Rajbari (Phase one) and Natore (Phase two), in NiV-affected regions in Bangladesh.
Methods: The research study will be conducted in two phases.
Phase one:
We will conduct a BCC program to test the effectiveness of a single message of "do not drink raw sap". We will conduct a baseline survey as pre-intervention assessment in two intervention upazillas in Rajbari District and two control upazillas in Kushtia District. The intervention will consist of community meetings in each of the intervention area villages as well as an awareness campaign through closed circuit television in selected village tea stalls. We will conduct endline survey to as a post intervention assessment in the same upazillas in Rajbari and Kushtia Districts.
Main outcome measures/variables: Proportion of people who continue drinking raw date palm sap.
Phase two If a substantial proportion of the population continues to consume raw date palm sap even after implementation of the "avoid drinking sap" intervention, and the Government of Bangladesh agrees, we will conduct a BCC program to test the effectiveness of a risk reduction approach, encouraging people to avoid drinking sap, but telling them that if they do, to reduce risk they should only drink sap that comes from trees protected by banas. In addition to community meetings to convey this message to the general public, we will meet with gachhis and tree owners to encourage them to use banas. We will conduct a baseline survey as pre-intervention assessment in both intervention and control areas in Natore and Gopalganj Districts respectively. The intervention will consist of meetings with gachhis, tree owners and the community in each of the intervention area villages as well as an awareness campaign through closed circuit television in village tea stalls. We will conduct endline survey to as a post intervention assessment in both intervention (Natore District) and control areas (Gopalganj District).
Main outcome measures/variables: Proportion of people who stop drinking sap or who drink sap from skirt protected trees.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 7782 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | A Community Intervention Trial Utilizing Behavior Change to Reduce the Risk of Nipah Spillover Through Date Palm Sap in Bangladesh |
Study Start Date : | November 2012 |
Estimated Primary Completion Date : | December 2019 |
Estimated Study Completion Date : | December 2019 |
Arm | Intervention/treatment |
---|---|
Experimental: Use skirt on raw sap consumption
Phase one: Test the effectiveness of a single message of "do not drink raw sap".
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Behavioral: Ask people not to drink raw sap Other: No Intervention |
Experimental: Ask people not to drink sap
Test the effectiveness of a risk reduction approach, encouraging people to avoid drinking sap, if they do, they should only drink sap from skirt protected trees.
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Behavioral: Ask people not to drink sap or drink sap from skirt protected trees
Behavioural Other: No Intervention |
No Intervention: Phase 1: Routine raw sap consumption among household members.
Test the effectiveness of a single message of "do not drink raw sap"
|
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No Intervention: Phase 2:
Raw sap consumption from skirt protected trees
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- Phase one: Proportion of people who continue drinking raw date palm sap. [ Time Frame: 16 months ]
- Phase two: Proportion of people who stop drinking sap or who drink sap from skirt protected trees. [ Time Frame: 10 months ]
- 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. [ Time Frame: 16 months ]

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Ages Eligible for Study: | 3 Years to 70 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811784
Contact: Rebeca Sultana, MSS in Anthropology | +88029827001-10 ext 2548 | rebeca@icddrb.org | |
Contact: Stephen P Luby, MD | sluby@stanford.edu |
Bangladesh | |
Two sub-districts in Gopalganj | Recruiting |
Gopalganj, Bangladesh | |
Contact: Rebeca Sultana, MSS in Anthropology +88029827001-10 ext 2548 rebeca@icddrb.org | |
Mirpur and Bheramara | Recruiting |
Kushtia, Bangladesh | |
Contact: Rebeca Sultana, MSS +88029827001-10 ext 2548 rebeca@icddrb.org | |
two sub-districts in Natore | Recruiting |
Natore, Bangladesh | |
Contact: Rebeca Sultana, MSS in Anthropology | |
Pangsha and Kalukhali sub-districts | Recruiting |
Rajbari District, Bangladesh | |
Contact: Rebeca Sultana, MSS in Anthropology +88029827001-10 ext 2548 rebeca@icddrb.org | |
Principal Investigator: Rebeca Sultana, MSS in Anthropology |
Responsible Party: | International Centre for Diarrhoeal Disease Research, Bangladesh |
ClinicalTrials.gov Identifier: | NCT01811784 History of Changes |
Other Study ID Numbers: |
PR-12053 |
First Posted: | March 15, 2013 Key Record Dates |
Last Update Posted: | February 19, 2019 |
Last Verified: | February 2019 |
Nipah virus infection date palm sap community intervention capacity building disease prevention |
Bangladesh Healthy Community people Sap harvesters Date palm three owners Date palm sap consumers |
Henipavirus Infections Paramyxoviridae Infections Mononegavirales Infections RNA Virus Infections Virus Diseases |