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
  Purpose

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).


Condition Intervention
Malaria
Other: Hammocks with LLIN
Other: Standard vector control measures

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Cluster Randomized Trial to Evaluate the Effectiveness of Long Lasting Insecticidal Hammocks for Controlling Forest Malaria in Central Vietnam

Resource links provided by NLM:


Further study details as provided by Institute of Tropical Medicine, Belgium:

Primary Outcome Measures:
  • Reduction of malaria prevalence and incidence [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction of malaria sero-prevalence [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 18646
Study Start Date: March 2004
Study Completion Date: June 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other: Hammocks with LLIN
Locally-made hammocks covered with long lasting insecticidal nel (LLIN)
Other Name: Oliset(R)
Active Comparator: ITN
Standard vector control measures (insectice-treated net or ITN)
Other: Standard vector control measures
Insectice-treated net
Other Name: ITN

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00853281

Locations
Vietnam
Ninh Thuan Provincial Malaria Station
Phan Rang, Ninh Thuan, Vietnam
Sponsors and Collaborators
Institute of Tropical Medicine, Belgium
National Institute of Malariology, Parasitology and Entomology, Vietnam
London School of Hygiene and Tropical Medicine
Investigators
Study Director: Annette Erhart, MD Institute of Tropical medicine
  More Information

No publications provided by Institute of Tropical Medicine, Belgium

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Umberto D'Alessandro, MD, Institute of Tropical Medicine
ClinicalTrials.gov Identifier: NCT00853281     History of Changes
Other Study ID Numbers: LLIH
Study First Received: February 27, 2009
Last Updated: September 12, 2010
Health Authority: Vietnam: Ministry of Health

Keywords provided by Institute of Tropical Medicine, Belgium:
Forest malaria prevention
Long-lasting insecticidal hammocks
Cluster randomized trial
Central Vietnam

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on October 01, 2014