- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01811784
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
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Rebeca Sultana, MSS in Anthropology
- Phone Number: 2548 +88029827001-10
- Email: rebeca@icddrb.org
Study Contact Backup
- Name: Stephen P Luby, MD
- Email: sluby@stanford.edu
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:
- Rebeca Sultana, MSS
- Phone Number: 2548 +88029827001-10
- Email: rebeca@icddrb.org
-
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PR-12053
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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