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

Not Applicable

Completed

• Conditions: Malaria
• Interventions: Other: Hammocks with LLIN; Other: Standard vector control measures

• Registration Number: NCT00853281
• Lead Sponsor: Institute of Tropical Medicine, Belgium

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.

Study Timeline

• Study Start: 2004-03
• Primary Completion: 2006-12
• Study Completion: 2007-06
• Study First Submitted: 2009-02-27
• Study First Submitted QC: 2009-02-27
• Study First Posted: 2009-03-02
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-12
• Last Update Posted: 2010-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18646

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hammocks with LLIN	Hammocks with LLIN	Locally-made hammocks covered with long-lasting insecticidal net (LLIN)- Olyset(R), used in addition to the standard vector control measures
ITN	Standard vector control measures	Standard vector control measures (insectice-treated net or ITN)

Primary Outcome Measures

Name	Time	Method
Reduction of malaria prevalence and incidence	24 months

Secondary Outcome Measures

Name	Time	Method
Reduction of malaria sero-prevalence	24 months

Trial Locations

Locations (1)

Ninh Thuan Provincial Malaria Station; 🇻🇳 Phan Rang, Ninh Thuan, Vietnam