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

Institute of Tropical Medicine, Belgium

Status: Completed

Conditions: Malaria

Treatments: Other: Hammocks with LLIN; Other: Standard vector control measures

Study type: Interventional

Funder types: Other

Identifiers

NCT00853281

LLIH

Details and patient eligibility

About

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).

Full 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.

Enrollment: 18,646 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18,646 participants in 2 patient groups

Hammocks with LLIN

Experimental group

Description:

Locally-made hammocks covered with long-lasting insecticidal net (LLIN)- Olyset(R), used in addition to the standard vector control measures

Treatment:

Other: Hammocks with LLIN

ITN

Active Comparator group

Description:

Standard vector control measures (insectice-treated net or ITN)

Treatment:

Other: Standard vector control measures