Replacement of Insecticides to Control Visceral Leishmaniasis (VL)
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|ClinicalTrials.gov Identifier: NCT01644682|
Recruitment Status : Completed
First Posted : July 19, 2012
Last Update Posted : August 29, 2017
Visceral leishmaniasis (VL) is a public health problem in Bangladesh, India and Nepal. To control the disease in these three countries a National kala-azar elimination program is ongoing. One of the major pillars of the elimination program is VL vector control. Currently there is a no public VL vector control program in Bangladesh. In India the program is depending on Indoor Residual Spraying with insecticides. IRS with DDT and in Nepal on Alpha-cypermethrin. The sand fly, vector of VL is already resistant to DDT and hurdles related with IRS i.e. funds, logistics and human resources make IRS unsustainable VL vector control method in Nepal. Thus alternative to IRS for VL vector control is highly desirable for the success of national kala-azar elimination program in these three countries.
Through current research activities we will compare the effectiveness of three effective VL vector control methods. They are 1) Plastering of household walls with lime (a traditional method known in the study areas),treatment of possible sand-fly breeding places with lime and bleaching powder; 2) Installing durable wall lining containing deltamethrin in the main living room(s) of households; 3) Impregnation of existing bed-nets with slow release insecticide tablet containing deltamethrin.
The study finding will be important for the national elimination program of the three countries through discovering the most effective VL vector control method.
|Condition or disease||Intervention/treatment||Phase|
|Cost-effective and Sustainable Vector Control Methods Will be Established to Reduce VL in India, Bangladesh and Nepal||Other: IWFPL Other: IDWL Other: ITN||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3600 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Replacement of Insecticides to Control Visceral Leishmaniasis|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
In each country, this arm constitute with 6 clusters where 2 from high, 2 from medium and 2 from low shadfly destiny. Each cluster has 50 households. It will receive IWFPL intervention.
Indoor house walls and floors will be plastered with lime (a traditional method known in the study areas) including treatment of outdoor breeding places with lime and bleaching powder to inhibit sandfly breeding
Other Name: Insecticide
In each country, this arm constitute with 6 clusters where 2 from high, 2 from medium and 2 from low shadfly destiny. Each cluster has 50 households. It will receive IDWL intervention.
Install durable wall lining containing deltamethrin to kill immature stage and as well as adult sand flies
Other Name: Insecticide
In each country, this arm constitute with 6 clusters where 2 from high, 2 from medium and 2 from low shadfly destiny. Each cluster has 50 households. It will receive ITN intervention.
Impregnation of existing bed-nets available in the community with slow release insecticide, deltamethrin
Other Name: Insecticide
No Intervention: Control
In each country, this arm constitute with 6 clusters where 2 from high, 2 from medium and 2 from low shadfly destiny. Each cluster has 50 households. It will not receive any intervention, Control group
- Measurement of efficacy of interventions [ Time Frame: 12 months ]Efficacy will be measured by the reduction of sand-fly density by intervention compared to control measured by sand-fly density at 4 weeks, 12 weeks, 24 weeks and 12 months after intervention; percentage mortality of sand-fly assessed by WHO Cone Bioassay test on wall and impregnated net compared to control at 4 weeks, 12 weeks, 24 weeks and 12 months after intervention.
- Estimation of intervention costs and its acceptability [ Time Frame: 12 months ]
Fixed costs (equipment/accessories, apportioned staff salary, non-recurrent training, social mobilization etc.) and variable costs (lime, bleaching powder, K0 tab 123, wall lining, labor charge, transportation, travel cost etc.) data will be collected through projects financial database, household level inventory that received intervention(s), key informant interview with field supervisors/technicians, and record review. Relationship between cost and effectiveness of corresponding intervention(s) will be represented by cost and effectiveness ratio for comparison.
Acceptability survey will be carried out through structure questionnaire in all the experimental arms. The survey will be conducted at 6 weeks after intervention.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01644682
|Rajshahi, Bangladesh, 6205|