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

Sponsor

London School of Hygiene and Tropical Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT00318721

Collaborator

Institute of Tropical Medicine, Belgium (Other), University Hospital, Geneva (Other), Rajendra Memorial Research Institute of Medical Sciences (Other), Institute of Medical Sciences of the Banaras Hindu University (BHU),India (Other), International Centre for Diarrhoeal Disease Research, Bangladesh (Other), B.P. Koirala Institute of Health Sciences (Other)

20,000

Enrollment

Locations

Arms

Duration (Months)

10000

Patients Per Site

243.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Visceral Leishmaniasis Kala Azar	Device: Long Lasting Impregnated Nets (LLIN)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20000 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jun 1, 2006

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention	Device: Long Lasting Impregnated Nets (LLIN) Distribution of LLIN in selected clusters
No Intervention: control	Device: Long Lasting Impregnated Nets (LLIN) Distribution of LLIN in selected clusters

Arm

Intervention/Treatment

Experimental: Intervention

Device: Long Lasting Impregnated Nets (LLIN)

Distribution of LLIN in selected clusters

No Intervention: control

Device: Long Lasting Impregnated Nets (LLIN)

Distribution of LLIN in selected clusters

Outcome Measures

Primary Outcome Measures

L. donovani infection [yearly]

Secondary Outcome Measures

Kala Azar cases [quarterly]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion criteria (Clusters):

at least have seen 1 case per year in each of the last 3 years
An average of at least 1% Incidence rate over the period of past 3 years.

Exclusion criteria (Clusters):

Minimum 500 people
Maximum 2000 people
Distance between clusters 2000 meters (distance between borders)
Houses in tola/ward not sprayed (DDT, other) in 2006
Accessibility

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kala Azar Medical Research Center	Muzaffarpur	Bihar	India
2	B P Koirala Institute of Health Sciences	Dharan		Nepal

Sponsors and Collaborators

London School of Hygiene and Tropical Medicine
Institute of Tropical Medicine, Belgium
University Hospital, Geneva
Rajendra Memorial Research Institute of Medical Sciences
Institute of Medical Sciences of the Banaras Hindu University (BHU),India
International Centre for Diarrhoeal Disease Research, Bangladesh
B.P. Koirala Institute of Health Sciences

Investigators

Principal Investigator: Marleen Boelaert, Dr, Prince Leopold Institute of Tropical Medicine in Antwerp (ITM), Belgium
Principal Investigator: Clive Davies, Dr., London School of Hygiene and Tropical Medicine, UK
Principal Investigator: Jean Claude Dujardin, Dr, Prince Leopold Institute of Tropical Medicine in Antwerp (ITM), Belgium
Principal Investigator: Suman Rijal, Dr., B.P. Koirala Institute of Heath Sciences, Nepal
Principal Investigator: Shyam Sundar, Dr, Institute of Medical Sciences of the Banaras Hindu University (BHU),India
Principal Investigator: Francois Chappuis, Dr., University Hospital, Geneva
Principal Investigator: Beena Varghese, Dr, Centre for Health and Population Research (ICDDR,B), Dhaka, Bangladesh
Principal Investigator: Marc Coosemans, Dr, Prince Leopold Institute of Tropical Medicine in Antwerp (ITM), Belgium.
Principal Investigator: Veerle Vanlerberghe, Dr., Prince Leopold Institute of Tropical Medicine in Antwerp (ITM), Belgium.
Principal Investigator: Diwarkar Dinesh, Dr, Rajendra Memorial Research Institute of Medical Sciences