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

NCT ID: NCT00853281

Last Updated: 2010-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18646 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2007-06-30

Brief Summary

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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

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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.

Conditions

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Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Hammocks with LLIN

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

Group Type EXPERIMENTAL

Hammocks with LLIN

Intervention Type OTHER

Locally-made hammocks covered with long lasting insecticidal nel (LLIN)

ITN

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

Group Type ACTIVE_COMPARATOR

Standard vector control measures

Intervention Type OTHER

Insectice-treated net

Interventions

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Hammocks with LLIN

Locally-made hammocks covered with long lasting insecticidal nel (LLIN)

Intervention Type OTHER

Standard vector control measures

Insectice-treated net

Intervention Type OTHER

Other Intervention Names

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Oliset(R) ITN

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Malariology, Parasitology and Entomology, Vietnam

OTHER_GOV

Sponsor Role collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role collaborator

Institute of Tropical Medicine, Belgium

OTHER

Sponsor Role lead

Responsible Party

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Institute of Tropical Medicine

Principal Investigators

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Annette Erhart, MD

Role: STUDY_DIRECTOR

Institute of Tropical Medicine

Locations

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Ninh Thuan Provincial Malaria Station

Phan Rang-Tháp Chàm, Ninh Thuan, Vietnam

Site Status

Countries

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Vietnam

References

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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.

Reference Type DERIVED
PMID: 19809502 (View on PubMed)

Other Identifiers

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LLIH

Identifier Type: -

Identifier Source: org_study_id