NCT01811784

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7,782

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2012

Longer than P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2013

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

May 25, 2021

Status Verified

February 1, 2021

Enrollment Period

8.8 years

First QC Date

March 13, 2013

Last Update Submit

May 23, 2021

Conditions

Human NiV Infection

Keywords

Nipah virus infectiondate palm sapcommunity interventioncapacity buildingdisease preventionBangladeshHealthy Community peopleSap harvestersDate palm three ownersDate palm sap consumers

Outcome Measures

Primary Outcomes (2)

  • Phase one: Proportion of people who continue drinking raw date palm sap.

    16 months

  • Phase two: Proportion of people who stop drinking sap or who drink sap from skirt protected trees.

    10 months

Secondary Outcomes (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.

    16 months

Study Arms (4)

Use skirt on raw sap consumption

EXPERIMENTAL

Phase one: Test the effectiveness of a single message of "do not drink raw sap".

Behavioral: Ask people not to drink raw sapOther: No Intervention

Ask people not to drink sap

EXPERIMENTAL

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 treesOther: No Intervention

Phase 1: Routine raw sap consumption among household members.

NO INTERVENTION

Test the effectiveness of a single message of "do not drink raw sap"

Phase 2:

NO INTERVENTION

Raw sap consumption from skirt protected trees

Interventions

Ask people not to drink raw sapBEHAVIORAL
Use skirt on raw sap consumption
Ask people not to drink sap or drink sap from skirt protected treesBEHAVIORAL

Behavioural

Ask people not to drink sap
No InterventionOTHER
Use skirt on raw sap consumption

Eligibility Criteria

Age3 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • For baseline and endline:
  • Women: the wife of the main male income earner in the household.
  • Men: the main income earner.
  • Sap harvesters.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Two sub-districts in Gopalganj

Gopālganj, Bangladesh

RECRUITING

Mirpur and Bheramara

Kushtia, Bangladesh

RECRUITING

two sub-districts in Natore

Natore, Bangladesh

RECRUITING

Pangsha and Kalukhali sub-districts

Rājbāri, Bangladesh

RECRUITING

MeSH Terms

Conditions

Henipavirus Infections

Condition Hierarchy (Ancestors)

Paramyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Central Study Contacts

Rebeca Sultana, MSS in Anthropology

CONTACT

+88029827001-10rebeca@icddrb.org

Stephen P Luby, MD

CONTACT

sluby@stanford.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2013

First Posted

March 15, 2013

Study Start

November 10, 2012

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

May 25, 2021

Record last verified: 2021-02

Locations

BA(4)