A Cluster Randomized Trial to Evaluate Long Lasting Insecticidal Hammocks to Prevent Forest Malaria in Vietnam
Primary Purpose
Malaria
Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Hammocks with LLIN
Standard vector control measures
Sponsored by
About this trial
This is an interventional prevention trial for Malaria focused on measuring Forest malaria prevention, Long-lasting insecticidal hammocks, Cluster randomized trial, Central Vietnam
Eligibility Criteria
Inclusion Criteria:
- All residents in the 20 concerned study clusters and willing to give informed consent to participate
Exclusion Criteria:
- People not willing to give informed consent to participate
Sites / Locations
- Ninh Thuan Provincial Malaria Station
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hammocks with LLIN
ITN
Arm Description
Locally-made hammocks covered with long-lasting insecticidal net (LLIN)- Olyset(R), used in addition to the standard vector control measures
Standard vector control measures (insectice-treated net or ITN)
Outcomes
Primary Outcome Measures
Reduction of malaria prevalence and incidence
Secondary Outcome Measures
Reduction of malaria sero-prevalence
Full Information
NCT ID
NCT00853281
First Posted
February 27, 2009
Last Updated
September 12, 2010
Sponsor
Institute of Tropical Medicine, Belgium
Collaborators
National Institute of Malariology, Parasitology and Entomology, Vietnam, London School of Hygiene and Tropical Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00853281
Brief Title
A Cluster Randomized Trial to Evaluate Long Lasting Insecticidal Hammocks to Prevent Forest Malaria in Vietnam
Official Title
A Cluster Randomized Trial to Evaluate the Effectiveness of Long Lasting Insecticidal Hammocks for Controlling Forest Malaria in Central Vietnam
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Institute of Tropical Medicine, Belgium
Collaborators
National Institute of Malariology, Parasitology and Entomology, Vietnam, London School of Hygiene and Tropical Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In Central Vietnam, forest malaria remains difficult to control due to the complex interactions between human, vector and environmental factors. Untreated bednets had a significantly protecting effect for villagers, except for those regularly sleeping in the forest, who suffer a significantly higher number of clinical attacks. Thus, there is need to target this high-risk group with new intervention based on long-lasting insecticidal materials. Hammocks are extensively used by people working in the forest, therefore long-lasting insecticidal hammocks (LLIH) could achieve a good individual protection.
The Investigators proposed to evaluate their effectiveness in a community-based trial, comparing them to the standard vector control methods (insecticide-treated nets).
Detailed Description
In Central Vietnam, forest malaria remains difficult to control due to the complex interactions between human, vector and environmental factors. A community-based study carried out between 1999 and 2001 showed that regular forest activity was a strong risk factor for malaria infection. Untreated bednets had a significantly protecting effect for villagers, except for those regularly sleeping in the forest, who suffered a significantly higher number of clinical attacks. Thus, there is need to target this high-risk group with new intervention based on long-lasting insecticidal materials. Hammocks are extensively used by people working in the forest, therefore long-lasting insecticidal hammocks (LLIH) could achieve a good individual protection.
The Investigators proposed to evaluate their effectiveness in a community-based trial, comparing them to the standard vector control methods (insecticide-treated nets): communities have been grouped into clusters of about 1000 înhabitants, and clusters were randomized to either the active intervention or the active control, and followed up for 24 month.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
Forest malaria prevention, Long-lasting insecticidal hammocks, Cluster randomized trial, Central Vietnam
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18646 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hammocks with LLIN
Arm Type
Experimental
Arm Description
Locally-made hammocks covered with long-lasting insecticidal net (LLIN)- Olyset(R), used in addition to the standard vector control measures
Arm Title
ITN
Arm Type
Active Comparator
Arm Description
Standard vector control measures (insectice-treated net or ITN)
Intervention Type
Other
Intervention Name(s)
Hammocks with LLIN
Other Intervention Name(s)
Oliset(R)
Intervention Description
Locally-made hammocks covered with long lasting insecticidal nel (LLIN)
Intervention Type
Other
Intervention Name(s)
Standard vector control measures
Other Intervention Name(s)
ITN
Intervention Description
Insectice-treated net
Primary Outcome Measure Information:
Title
Reduction of malaria prevalence and incidence
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Reduction of malaria sero-prevalence
Time Frame
24 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All residents in the 20 concerned study clusters and willing to give informed consent to participate
Exclusion Criteria:
People not willing to give informed consent to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annette Erhart, MD
Organizational Affiliation
Institute of Tropical Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Ninh Thuan Provincial Malaria Station
City
Phan Rang
State/Province
Ninh Thuan
Country
Vietnam
12. IPD Sharing Statement
Citations:
PubMed Identifier
19809502
Citation
Thang ND, Erhart A, Speybroeck N, Xa NX, Thanh NN, Ky PV, Hung le X, Thuan le K, Coosemans M, D'Alessandro U. Long-Lasting Insecticidal Hammocks for controlling forest malaria: a community-based trial in a rural area of central Vietnam. PLoS One. 2009 Oct 7;4(10):e7369. doi: 10.1371/journal.pone.0007369.
Results Reference
derived
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A Cluster Randomized Trial to Evaluate Long Lasting Insecticidal Hammocks to Prevent Forest Malaria in Vietnam
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