Efficacy, Acceptability and Cost-effectiveness of Long Lasting Insecticide Nets (LLIN) in the Prevention of Kala Azar

Summary

A cluster-randomized vector control trial in Bihar, India, and neighboring Nepal, will test the efficacy of long-lasting impregnated bednets (LLINs, Permanets) for reducing visceral leishmaniasis incidence. The intervention unit is the village (400-1000 people). The study is designed to detect a 50% reduction in Leishmania donovani incidence in intervention compared to control clusters over 2 years. 24 clusters (selected as high incidence during previous years) will be randomly allocated to intervention or control. Following health education, and with informed consent, all households in intervention villages will receive free Permanets (from September 2006). Net usage will be monitored and new nets provided if required. Control villages will not be given untreated nets, as - although commonly used in this region - their effectiveness against sandflies has not been proven. Pre-intervention infection status of villagers (\>2 yrs) will be evaluated serologically from finger-prick blood (and past/current disease status noted). Incident infections will be recorded by 3-monthly active search for clinical cases, and by annual serological diagnoses to detect subclinical infections. All villagers (\>2yrs) will be leishmanin skin tested at the end of the trial for further subclinical infection detection, and sera from a sub-sample will be tested for antibodies to sandfly saliva antigens (a measure of sandfly exposure). All clinical cases will be given free treatment. Free Permanets will be provided to control villages after the trial. Complementary studies involve entomological surveillance by light traps in a sample of houses and social/economic questionnaire surveys. The entomological surveys will test whether community-wide use of LLINs provides any mass effect, which could protect those in the community who fail to use LLIN for any reason.

Conditions

• Visceral Leishmaniasis
• Kala Azar

Interventions

DEVICE

Long Lasting Impregnated Nets (LLIN)

Distribution of LLIN in selected clusters

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium

  collaborator OTHER

• University Hospital, Geneva

  collaborator OTHER

• Rajendra Memorial Research Institute of Medical Sciences

  collaborator OTHER

• Institute of Medical Sciences of the Banaras Hindu University, India

  collaborator OTHER

• International Centre for Diarrhoeal Disease Research, Bangladesh

  collaborator OTHER

• B.P. Koirala Institute of Health Sciences

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  lead OTHER

Principal Investigators

• Marleen Boelaert, Dr · Prince Leopold Institute of Tropical Medicine in Antwerp (ITM), Belgium

• Clive Davies, Dr. · London School of Hygiene and Tropical Medicine

• Jean Claude Dujardin, Dr · Prince Leopold Institute of Tropical Medicine in Antwerp (ITM), Belgium

• Suman Rijal, Dr. · B.P. Koirala Institute of Heath Sciences, Nepal

• Shyam Sundar, Dr · Institute of Medical Sciences of the Banaras Hindu University, India

• Francois Chappuis, Dr. · University Hospital, Geneva

• Beena Varghese, Dr · Centre for Health and Population Research (ICDDR,B), Dhaka, Bangladesh

• Marc Coosemans, Dr · Prince Leopold Institute of Tropical Medicine in Antwerp (ITM), Belgium.

• Veerle Vanlerberghe, Dr. · Prince Leopold Institute of Tropical Medicine in Antwerp (ITM), Belgium.

• Diwarkar Dinesh, Dr · Rajendra Memorial Research Institute of Medical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

2 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2006-06-30

Primary Completion

2008-12-31

Completion

2009-11-30

Countries

• India
• Nepal

Study Locations