<?xml version="1.0" encoding="UTF-8"?>
<clinical_study rank="373">
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<required_header>
<download_date>ClinicalTrials.gov processed this data on November 07, 2013</download_date>
<link_text>Link to the current ClinicalTrials.gov record.</link_text>
<url>http://clinicaltrials.gov/show/NCT01811784</url>
</required_header>
<id_info>
<org_study_id>PR-12053</org_study_id>
<nct_id>NCT01811784</nct_id>
</id_info>
<brief_title>Community Intervention to Prevent Nipah Spillover</brief_title>
<official_title>A Community Intervention Trial Utilizing Behavior Change to Reduce the Risk of Nipah Spillover Through Date Palm Sap in Bangladesh</official_title>
<sponsors>
<lead_sponsor>
<agency>International Centre for Diarrhoeal Disease Research, Bangladesh</agency>
<agency_class>Other</agency_class>
</lead_sponsor>
<collaborator>
<agency>FHI 360</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>IEDCR, DGHS, Bangladesh</agency>
<agency_class>Other</agency_class>
</collaborator>
<collaborator>
<agency>Stanford University</agency>
<agency_class>Other</agency_class>
</collaborator>
</sponsors>
<source>International Centre for Diarrhoeal Disease Research, Bangladesh</source>
<oversight_info>
<authority>Bangladesh: Ethical Review Committee</authority>
<has_dmc>Yes</has_dmc>
</oversight_info>
<brief_summary>
<textblock>
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.
</textblock>
</brief_summary>
<detailed_description>
<textblock>
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.
</textblock>
</detailed_description>
<overall_status>Recruiting</overall_status>
<start_date>November 2012</start_date>
<completion_date type="Anticipated">December 2014</completion_date>
<primary_completion_date type="Anticipated">May 2014</primary_completion_date>
<phase>Phase 1/Phase 2</phase>
<study_type>Interventional</study_type>
<study_design>Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention</study_design>
<primary_outcome>
<measure>Phase one: Proportion of people who continue drinking raw date palm sap.</measure>
<time_frame>16 months</time_frame>
<safety_issue>No</safety_issue>
</primary_outcome>
<primary_outcome>
<measure>Phase two: Proportion of people who stop drinking sap or who drink sap from skirt protected trees.</measure>
<time_frame>10 months</time_frame>
<safety_issue>No</safety_issue>
</primary_outcome>
<secondary_outcome>
<measure>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.</measure>
<time_frame>16 months</time_frame>
<safety_issue>No</safety_issue>
</secondary_outcome>
<number_of_arms>4</number_of_arms>
<enrollment type="Anticipated">7696</enrollment>
<condition>Human NiV Infection</condition>
<arm_group>
<arm_group_label>Use skirt on raw sap consumption</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>Phase one: Test the effectiveness of a single message of "do not drink raw sap".</description>
</arm_group>
<arm_group>
<arm_group_label>Ask people not to drink sap</arm_group_label>
<arm_group_type>Experimental</arm_group_type>
<description>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.</description>
</arm_group>
<arm_group>
<arm_group_label>Phase 1: Routine raw sap consumption among household members.</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>Test the effectiveness of a single message of "do not drink raw sap"</description>
</arm_group>
<arm_group>
<arm_group_label>Phase 2:</arm_group_label>
<arm_group_type>No Intervention</arm_group_type>
<description>Raw sap consumption from skirt protected trees</description>
</arm_group>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>Ask people not to drink raw sap</intervention_name>
<arm_group_label>Use skirt on raw sap consumption</arm_group_label>
</intervention>
<intervention>
<intervention_type>Behavioral</intervention_type>
<intervention_name>Ask people not to drink sap or drink sap from skirt protected trees</intervention_name>
<description>Behavioural</description>
<arm_group_label>Ask people not to drink sap</arm_group_label>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>No Intervention</intervention_name>
<arm_group_label>Use skirt on raw sap consumption</arm_group_label>
</intervention>
<intervention>
<intervention_type>Other</intervention_type>
<intervention_name>No Intervention</intervention_name>
<arm_group_label>Ask people not to drink sap</arm_group_label>
</intervention>
<eligibility>
<criteria>
<textblock>
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.
</textblock>
</criteria>
<gender>Both</gender>
<minimum_age>3 Years</minimum_age>
<maximum_age>70 Years</maximum_age>
<healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
</eligibility>
<overall_contact>
<last_name>Rebeca Sultana, MSS in Anthropology</last_name>
<phone>+88029827001-10</phone>
<phone_ext>2548</phone_ext>
<email>rebeca@icddrb.org</email>
</overall_contact>
<overall_contact_backup>
<last_name>Stephen P Luby, MD</last_name>
<email>sluby@stanford.edu</email>
</overall_contact_backup>
<location>
<facility>
<name>Two sub-districts in Gopalganj</name>
<address>
<city>Gopalganj</city>
<country>Bangladesh</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Rebeca Sultana, MSS in Anthropology</last_name>
<phone>+88029827001-10</phone>
<phone_ext>2548</phone_ext>
<email>rebeca@icddrb.org</email>
</contact>
</location>
<location>
<facility>
<name>Mirpur and Bheramara</name>
<address>
<city>Kushtia</city>
<country>Bangladesh</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Rebeca Sultana, MSS</last_name>
<phone>+88029827001-10</phone>
<phone_ext>2548</phone_ext>
<email>rebeca@icddrb.org</email>
</contact>
</location>
<location>
<facility>
<name>two sub-districts in Natore</name>
<address>
<city>Natore</city>
<country>Bangladesh</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Rebeca Sultana, MSS in Anthropology</last_name>
</contact>
</location>
<location>
<facility>
<name>Pangsha and Kalukhali sub-districts</name>
<address>
<city>Rajbari District</city>
<country>Bangladesh</country>
</address>
</facility>
<status>Recruiting</status>
<contact>
<last_name>Rebeca Sultana, MSS in Anthropology</last_name>
<phone>+88029827001-10</phone>
<phone_ext>2548</phone_ext>
<email>rebeca@icddrb.org</email>
</contact>
<investigator>
<last_name>Rebeca Sultana, MSS in Anthropology</last_name>
<role>Principal Investigator</role>
</investigator>
</location>
<location_countries>
<country>Bangladesh</country>
</location_countries>
<verification_date>July 2012</verification_date>
<lastchanged_date>November 7, 2013</lastchanged_date>
<firstreceived_date>March 13, 2013</firstreceived_date>
<responsible_party>
<responsible_party_type>Sponsor</responsible_party_type>
</responsible_party>
<keyword>Nipah virus infection</keyword>
<keyword>date palm sap</keyword>
<keyword>community intervention</keyword>
<keyword>capacity building</keyword>
<keyword>disease prevention</keyword>
<keyword>Bangladesh</keyword>
<keyword>Healthy Community people</keyword>
<keyword>Sap harvesters</keyword>
<keyword>Date palm three owners</keyword>
<keyword>Date palm sap consumers</keyword>
<is_fda_regulated>No</is_fda_regulated>
<has_expanded_access>No</has_expanded_access>
<!-- Results have not yet been posted for this study -->
</clinical_study>