NCT00853281

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18,646

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 2, 2009

Completed
Last Updated

September 14, 2010

Status Verified

September 1, 2010

Enrollment Period

2.8 years

First QC Date

February 27, 2009

Last Update Submit

September 12, 2010

Conditions

Keywords

Forest malaria preventionLong-lasting insecticidal hammocksCluster randomized trialCentral Vietnam

Outcome Measures

Primary Outcomes (1)

  • Reduction of malaria prevalence and incidence

    24 months

Secondary Outcomes (1)

  • Reduction of malaria sero-prevalence

    24 months

Study Arms (2)

Hammocks with LLIN

EXPERIMENTAL

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

ITN

ACTIVE COMPARATOR

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

Other: Standard vector control measures

Interventions

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

Also known as: Oliset(R)
Hammocks with LLIN

Insectice-treated net

Also known as: ITN
ITN

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All residents in the 20 concerned study clusters and willing to give informed consent to participate

You may not qualify if:

  • People not willing to give informed consent to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ninh Thuan Provincial Malaria Station

Phan Rang-Tháp Chàm, Ninh Thuan, Vietnam

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Annette Erhart, MD

    Institute of Tropical Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 27, 2009

First Posted

March 2, 2009

Study Start

March 1, 2004

Primary Completion

December 1, 2006

Study Completion

June 1, 2007

Last Updated

September 14, 2010

Record last verified: 2010-09

Locations