Community Intervention to Prevent Nipah Spillover

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.

Study Overview

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

Interventional

Enrollment (Anticipated)

7782

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Rebeca Sultana, MSS in Anthropology
  • Phone Number: 2548 +88029827001-10
  • Email: rebeca@icddrb.org

Study Contact Backup

Study Locations

      • Gopalganj, Bangladesh
        • Recruiting
        • Two sub-districts in Gopalganj
        • Contact:
          • Rebeca Sultana, MSS in Anthropology
          • Phone Number: 2548 +88029827001-10
          • Email: rebeca@icddrb.org
      • Kushtia, Bangladesh
        • Recruiting
        • Mirpur and Bheramara
        • Contact:
      • Natore, Bangladesh
        • Recruiting
        • two sub-districts in Natore
        • Contact:
          • Rebeca Sultana, MSS in Anthropology
      • Rajbari, Bangladesh
        • Recruiting
        • Pangsha and Kalukhali sub-districts
        • Contact:
          • Rebeca Sultana, MSS in Anthropology
          • Phone Number: 2548 +88029827001-10
          • Email: rebeca@icddrb.org
        • Principal Investigator:
          • Rebeca Sultana, MSS in Anthropology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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".
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.
Behavioural
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 10, 2012

Primary Completion (ANTICIPATED)

September 1, 2021

Study Completion (ANTICIPATED)

September 1, 2021

Study Registration Dates

First Submitted

March 13, 2013

First Submitted That Met QC Criteria

March 14, 2013

First Posted (ESTIMATE)

March 15, 2013

Study Record Updates

Last Update Posted (ACTUAL)

May 25, 2021

Last Update Submitted That Met QC Criteria

May 23, 2021

Last Verified

February 1, 2021

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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