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

Malaria Clinical Trial

Official title:

A Cluster Randomized Trial to Evaluate the Effectiveness of Long Lasting Insecticidal Hammocks for Controlling Forest Malaria in Central Vietnam

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00853281
• Other study ID #: LLIH
• Status: Completed
• Phase: N/A
• First received: February 27, 2009
• Last updated: September 12, 2010
• Start date: March 2004
• Est. completion date: June 2007

Study information

• Verified date: September 2010
• Source: Institute of Tropical Medicine, Belgium
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18646
• Est. completion date: June 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria

Intervention

Other:
• Hammocks with LLIN
Locally-made hammocks covered with long lasting insecticidal nel (LLIN)
• Standard vector control measures
Insectice-treated net

Locations

Country	Name	City	State
Vietnam	Ninh Thuan Provincial Malaria Station	Phan Rang	Ninh Thuan

Sponsors (3)

Lead Sponsor	Collaborator
Institute of Tropical Medicine, Belgium	London School of Hygiene and Tropical Medicine, National Institute of Malariology, Parasitology and Entomology, Vietnam

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of malaria prevalence and incidence		24 months	No
Secondary	Reduction of malaria sero-prevalence		24 months	No