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A Cluster Randomized Trial to Evaluate Long Lasting Insecticidal Hammocks to Prevent Forest Malaria in Vietnam

This study has been completed.
Sponsor:
Collaborators:
National Institute of Malariology, Parasitology and Entomology, Vietnam
London School of Hygiene and Tropical Medicine
Information provided by:
Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier:
NCT00853281
First received: February 27, 2009
Last updated: September 12, 2010
Last verified: September 2010
History of Changes

February 27, 2009
September 12, 2010
March 2004
December 2006   (final data collection date for primary outcome measure)
Reduction of malaria prevalence and incidence [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00853281 on ClinicalTrials.gov Archive Site
Reduction of malaria sero-prevalence [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Cluster Randomized Trial to Evaluate Long Lasting Insecticidal Hammocks to Prevent Forest Malaria in Vietnam
A Cluster Randomized Trial to Evaluate the Effectiveness of Long Lasting Insecticidal Hammocks for Controlling Forest Malaria in Central Vietnam

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).

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Malaria
  • Other: Hammocks with LLIN
    Locally-made hammocks covered with long lasting insecticidal nel (LLIN)
    Other Name: Oliset(R)
  • Other: Standard vector control measures
    Insectice-treated net
    Other Name: ITN
  • Experimental: Hammocks with LLIN
    Locally-made hammocks covered with long-lasting insecticidal net (LLIN)- Olyset(R), used in addition to the standard vector control measures
    Intervention: Other: Hammocks with LLIN
  • Active Comparator: ITN
    Standard vector control measures (insectice-treated net or ITN)
    Intervention: Other: Standard vector control measures
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18646
June 2007
December 2006   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Vietnam
 
NCT00853281
LLIH
No
Umberto D'Alessandro, MD, Institute of Tropical Medicine
Institute of Tropical Medicine, Belgium
  • National Institute of Malariology, Parasitology and Entomology, Vietnam
  • London School of Hygiene and Tropical Medicine
Study Director: Annette Erhart, MD Institute of Tropical medicine
Institute of Tropical Medicine, Belgium
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP