Human NiV InfectionPhase 1/2NCT01811784
Community Intervention to Prevent Nipah Spillover
A Phase 1/2 study testing Ask people not to drink raw sap and Ask people not to drink sap or drink sap from skirt protected trees in people with Human NiV Infection, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 4 sites in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Human NiV Infection
- What is being tested?
- Ask people not to drink raw sap and Ask people not to drink sap or drink sap from skirt protected trees
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,782 participants
- Where
- 4 sitesBangladesh
- Study dates
- 10 Nov 2012to Sep 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- For baseline and endline:
- Women: the wife of the main male income earner in the household.
- Men: the main income earner.
- Sap harvesters.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Stephen P Luby, MD contact
Bangladesh4 sites, 4 recruiting
- Recruiting
Two sub-districts in Gopalganj
Gopālganj
Rebeca Sultana, MSS in Anthropology, +88029827001-10 ext. 2548, rebeca@icddrb.org
- Recruiting
Mirpur and Bheramara
Kushtia
Rebeca Sultana, MSS, +88029827001-10 ext. 2548, rebeca@icddrb.org
- Recruiting
two sub-districts in Natore
Natore
Rebeca Sultana, MSS in Anthropology
- Recruiting
Pangsha and Kalukhali sub-districts
Rājbāri
Rebeca Sultana, MSS in Anthropology, +88029827001-10 ext. 2548, rebeca@icddrb.org
Rebeca Sultana, MSS in Anthropology
About this study
Official title: 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.
Read the 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.
- Conditions
- Human NiV Infection
- Being tested
- Ask people not to drink raw sap, Ask people not to drink sap or drink sap from skirt protected trees, No Intervention
- Keywords
- Nipah virus infection, date palm sap, community intervention, capacity building, disease prevention, Bangladesh, Healthy Community people, Sap harvesters, Date palm three owners, Date palm sap consumers
- Medical subject headings
- Henipavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ask people not to drink raw sapBehavioural
Ask people not to drink sap or drink sap from skirt protected treesBehavioural
Behavioural
No InterventionOther
No InterventionOther
| Study group | Role | What they receive |
|---|---|---|
| Use skirt on raw sap consumption | Experimental | Phase one: Test the effectiveness of a single message of "do not drink raw sap". Receives: Behavioral: Ask people not to drink raw sap; Other: 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. Receives: Behavioral: Ask people not to drink sap or drink sap from skirt protected trees; Other: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase one: Proportion of people who continue drinking raw date palm sap.
Measured: 16 months
Phase two: Proportion of people who stop drinking sap or who drink sap from skirt protected trees.
Measured: 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.
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2013 (estimated)
- Study start10 Nov 2012
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human NiV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7,782 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- FHI 360, IEDCR, DGHS, Bangladesh, Stanford University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811784
- Sponsor's protocol ID
- PR-12053
- Status last verified
- Feb 2021
- First submitted
- 13 Mar 2013
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community Intervention Trial Utilizing Behavior Change to Reduce the Risk of Nipah Spillover Through Date Palm Sap in Bangladesh
- ClinicalTrials.gov ID
- NCT01811784
- Acronym / sponsor ID
- PR-12053
- Conditions
- Human NiV Infection
- Keywords
- Nipah virus infection, date palm sap, community intervention, capacity building, disease prevention, Bangladesh, Healthy Community people, Sap harvesters
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7,782 participants (estimated)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- FHI 360, IEDCR, DGHS, Bangladesh, Stanford University
- Study start
- 10 Nov 2012 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 15 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Use skirt on raw sap consumption | Experimental | Behavioral: Ask people not to drink raw sap, Other: No InterventionPhase one: Test the effectiveness of a single message of "do not drink raw sap". |
| Ask people not to drink sap | Experimental | Behavioral: Ask people not to drink sap or drink sap from skirt protected trees, Other: No InterventionTest 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. |
| 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 |
Who may qualify
- Ages
- 3 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Women: the wife of the main male income earner in the household.
- Men: the main income earner.
- Sap harvesters.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ask people not to drink raw sap | Behavioural | Use skirt on raw sap consumption |
| Ask people not to drink sap or drink sap from skirt protected treesBehavioural | Behavioural | Ask people not to drink sap |
| No Intervention | Other | Use skirt on raw sap consumption |
| No Intervention | Other | Ask people not to drink sap |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen P Luby, MD contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ask people not to drink raw sap and Ask people not to drink sap or drink sap from skirt protected trees in people with Human NiV Infection, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 4 sites in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rebeca Sultana, MSS in Anthropology (+88029827001-10 ext. 2548, rebeca@icddrb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase one: Proportion of people who continue drinking raw date palm sap. (time frame: 16 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021.