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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 : May 25, 2021
Sponsor:
Collaborators:
FHI 360
IEDCR, DGHS, Bangladesh
Stanford University
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

Tracking Information
First Submitted Date  ICMJE March 13, 2013
First Posted Date  ICMJE March 15, 2013
Last Update Posted Date May 25, 2021
Actual Study Start Date  ICMJE November 10, 2012
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2013)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 14, 2013)
Main outcome measures/variables: Proportion of people who stop drinking sap. [ Time Frame: 8 months ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2013)
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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Community Intervention to Prevent Nipah Spillover
Official Title  ICMJE A Community Intervention Trial Utilizing Behavior Change to Reduce the Risk of Nipah Spillover Through Date Palm Sap in Bangladesh
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Human NiV Infection
Intervention  ICMJE
  • Behavioral: Ask people not to drink raw sap
  • Behavioral: Ask people not to drink sap or drink sap from skirt protected trees
    Behavioural
  • Other: No Intervention
Study Arms  ICMJE
  • Experimental: Use skirt on raw sap consumption
    Phase one: Test the effectiveness of a single message of "do not drink raw sap".
    Interventions:
    • 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.
    Interventions:
    • Behavioral: Ask people not to drink sap or drink sap from skirt protected trees
    • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 5, 2017)
7782
Original Estimated Enrollment  ICMJE
 (submitted: March 14, 2013)
7696
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Rebeca Sultana, MSS in Anthropology +88029827001-10 ext 2548 rebeca@icddrb.org
Contact: Stephen P Luby, MD sluby@stanford.edu
Listed Location Countries  ICMJE Bangladesh
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01811784
Other Study ID Numbers  ICMJE PR-12053
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party International Centre for Diarrhoeal Disease Research, Bangladesh
Study Sponsor  ICMJE International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators  ICMJE
  • FHI 360
  • IEDCR, DGHS, Bangladesh
  • Stanford University
Investigators  ICMJE Not Provided
PRS Account International Centre for Diarrhoeal Disease Research, Bangladesh
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP