Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Community Intervention to Prevent Nipah Spillover

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01811784
Recruitment Status : Recruiting
First Posted : March 15, 2013
Last Update Posted : May 25, 2021
Sponsor:
Collaborators:
FHI 360
IEDCR, DGHS, Bangladesh
Stanford University
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

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

Detailed Description:

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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
Actual Study Start Date : November 10, 2012
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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".
 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.
 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"
No Intervention: Phase 2:
Raw sap consumption from skirt protected trees


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Phase one: Proportion of people who continue drinking raw date palm sap. [ Time Frame: 16 months ]
  2. Phase two: Proportion of people who stop drinking sap or who drink sap from skirt protected trees. [ Time Frame: 10 months ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Rebeca Sultana, MSS in Anthropology +88029827001-10 ext 2548 rebeca@icddrb.org
Contact: Stephen P Luby, MD sluby@stanford.edu

Locations
Layout table for location information
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, Bangladesh
Contact: Rebeca Sultana, MSS in Anthropology    +88029827001-10 ext 2548    rebeca@icddrb.org   
Principal Investigator: Rebeca Sultana, MSS in Anthropology         
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
FHI 360
IEDCR, DGHS, Bangladesh
Stanford University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT01811784    
Other Study ID Numbers: PR-12053
First Posted: March 15, 2013    Key Record Dates
Last Update Posted: May 25, 2021
Last Verified: February 2021
Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Henipavirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases