Cost-effective and Sustainable Vector Control Methods Will be Established to Reduce VL in India, Bangladesh and NepalPhase 3NCT01644682
Replacement of Insecticides to Control Visceral Leishmaniasis (VL)
A Phase 3 study testing IWFPL, IDWL and ITN in people with Cost-effective and Sustainable Vector Control Methods Will be Established to Reduce VL in India, Bangladesh and Nepal, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cost-effective and Sustainable Vector Control Methods Will be Established to Reduce VL in India, Bangladesh and Nepal
- What is being tested?
- IWFPL, IDWL and ITN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,600 participants
- Where
- 1 siteBangladesh
- Study dates
- May 2012to Dec 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Household head who agree to participate in the study
Who cannot join
- Household head who does not agree to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Replacement of Insecticides to Control Visceral Leishmaniasis
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.
Read the detailed description
Visceral leishamniasis (VL; known as kala-azar in the Indian Sub-continent) is a deadly parasitic disease if left untreated. The disease is reported from 109 districts (Bangladesh-45, India-52 and Nepal-12). VL elimination programme was launched in 2005 between the three countries with the set target to reduce the cases one in 10,000 populations. Toward this set target, vector control will play a significant role. Based on the experiences in the past during malaria eradication period Indoor residual spraying (IRS) with insecticides is taken as the main pillar of VL vector control. Operation like IRS is expensive, labour-intensive, require sustainable infrastructures, supplies of insecticide, spraying equipment, trained personnel and funding over a long-term of period. These doubts about the sustainability of IRS in poor resource settings like Bangladesh. Thus alternative of IRS other vector control tool is highly desired. Current research activities will explore for the alternatives of IRS (here defined as "insecticide"). The proposed three different types of alternative of IRS 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 will include three different types of intervention arm and one control arm; Arm: 1) 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 sand fly breeding. Arm: 2) Installing of durable wall lining containing deltamethrin to kill immature stage of sand flies. Arm: 3) Impregnation of existing bed-nets with slow release insecticide, deltamethrin and 4) Control group, no intervention. VL endemic areas with 1200 households will be selected and identified 24 clusters based on geographic characteristics. Minimum distance between each cluster will be about 50 meters. Each cluster will have 50 households (HHs) where the different interventions will be applied. Five HHs will be selected randomly from each cluster to measure the intervention effect on sandfly density on 2 consecutive nights using CDC light traps at 4, 12, 24 and 52 weeks after intervention. Baseline sand fly densities will be measured at 2 weeks before introducing the intervention. Based on base line sandfly data the clusters will be ranked as high, moderate and low and from them equal number of clusters will be assigned for each intervention arm as well as control arm. Control HHs will receive commercial insecticide treated bed-nets after the study is over. This study will be a multi-centre cluster randomized trial with three vector control methods and will be carried out in ICDDR,B, Bangladesh, RMRI, India and in BPKIHS, Dahran, Nepal simultaneously during a 12 months period. A total of 3600 households in the three countries (Bangladesh-1200, India-1200 and Nepal-1200 HHs) will be included in the study.
The cost of interventions will be assessed applying a combination of bottom-up and top-down costing approach from the provider's perspective only. Costs attributable to effectiveness of the interventions (i.e. reduction of sandfly density by intervention) will be calculated separately for comparison among three types of intervention. Firstly; all inputs to be mobilized for implementing each of the intervention will be identified, quantified and valued in local currency separately. Based on the relationship of the inputs to outputs, costs will be broadly classified into fixed cost and variable cost. Standard procedure will be followed for annualization of capital costs using replacement cost, useful lifetime, discounting rate and corresponding annualization factor taken from the standard table.
Shadow pricing will be considered for inputs to be donated for the study purpose by partner agencies. Allocation factors (e.g. % time spent by staff, % used etc) will be applied to apportion joint costs. Summing-up the fixed and variable costs over all total cost of each intervention will be calculated separately. Average or unit cost will be calculated dividing total cost of each intervention by the corresponding number of households that received the intervention. Finally relationship between cost and effectiveness of corresponding intervention(s) will be represented by cost and effectiveness ratio for comparison.
- Being tested
- IWFPL, IDWL, ITN
- Keywords
- Visceral leishmaniasis, insecticide, wall lining, KO TAB123, Household, Kala-azar endemic area
- Medical subject headings
- Leishmaniasis, Visceral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IWFPLOther
Also called Insecticide
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
IDWLOther
Also called Insecticide
Install durable wall lining containing deltamethrin to kill immature stage and as well as adult sand flies
ITNOther
Also called Insecticide
Impregnation of existing bed-nets available in the community with slow release insecticide, deltamethrin
| Study group | Role | What they receive |
|---|---|---|
| Arm-1 | Experimental | 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. Receives: Other: IWFPL |
| Arm-2 | Experimental | 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. Receives: Other: IDWL |
| Arm-3 | Experimental | 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. Receives: Other: ITN |
| Control | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of efficacy of interventions
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.
Measured: 12 months
Secondary outcomes (1)
Estimation of intervention costs and its acceptability
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cost-effective and Sustainable Vector Control Methods Will be Established to Reduce VL in India, Bangladesh and NepalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 3,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- Rajendra Memorial Research Institute of Medical Sciences, B.P. Koirala Institute of Health Sciences, Directorate General of Health Services, Bangladesh
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644682
- Sponsor's protocol ID
- PR-11045
- Status last verified
- Jul 2012
- First submitted
- 17 Jul 2012
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Replacement of Insecticides to Control Visceral Leishmaniasis
- ClinicalTrials.gov ID
- NCT01644682
- Acronym / sponsor ID
- PR-11045
- Keywords
- Visceral leishmaniasis, insecticide, wall lining, KO TAB123, Household, Kala-azar endemic area
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,600 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- Rajendra Memorial Research Institute of Medical Sciences, B.P. Koirala Institute of Health Sciences, Directorate General of Health Services, Bangladesh
- Study start
- May 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 19 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Visceral leishamniasis (VL; known as kala-azar in the Indian Sub-continent) is a deadly parasitic disease if left untreated. The disease is reported from 109 districts (Bangladesh-45, India-52 and Nepal-12). VL elimination programme was launched in 2005 between the three countries with the set target to reduce the cases one in 10,000 populations. Toward this set target, vector control will play a significant role. Based on the experiences in the past during malaria eradication period Indoor residual spraying (IRS) with insecticides is taken as the main pillar of VL vector control. Operation like IRS is expensive, labour-intensive, require sustainable infrastructures, supplies of insecticide, spraying equipment, trained personnel and funding over a long-term of period. These doubts about the sustainability of IRS in poor resource settings like Bangladesh. Thus alternative of IRS other vector control tool is highly desired. Current research activities will explore for the alternatives of IRS (here defined as "insecticide"). The proposed three different types of alternative of IRS 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 will include three different types of intervention arm and one control arm; Arm: 1) 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 sand fly breeding. Arm: 2) Installing of durable wall lining containing deltamethrin to kill immature stage of sand flies. Arm: 3) Impregnation of existing bed-nets with slow release insecticide, deltamethrin and 4) Control group, no intervention. VL endemic areas with 1200 households will be selected and identified 24 clusters based on geographic characteristics. Minimum distance between each cluster will be about 50 meters. Each cluster will have 50 households (HHs) where the different interventions will be applied. Five HHs will be selected randomly from each cluster to measure the intervention effect on sandfly density on 2 consecutive nights using CDC light traps at 4, 12, 24 and 52 weeks after intervention. Baseline sand fly densities will be measured at 2 weeks before introducing the intervention. Based on base line sandfly data the clusters will be ranked as high, moderate and low and from them equal number of clusters will be assigned for each intervention arm as well as control arm. Control HHs will receive commercial insecticide treated bed-nets after the study is over. This study will be a multi-centre cluster randomized trial with three vector control methods and will be carried out in ICDDR,B, Bangladesh, RMRI, India and in BPKIHS, Dahran, Nepal simultaneously during a 12 months period. A total of 3600 households in the three countries (Bangladesh-1200, India-1200 and Nepal-1200 HHs) will be included in the study.
The cost of interventions will be assessed applying a combination of bottom-up and top-down costing approach from the provider's perspective only. Costs attributable to effectiveness of the interventions (i.e. reduction of sandfly density by intervention) will be calculated separately for comparison among three types of intervention. Firstly; all inputs to be mobilized for implementing each of the intervention will be identified, quantified and valued in local currency separately. Based on the relationship of the inputs to outputs, costs will be broadly classified into fixed cost and variable cost. Standard procedure will be followed for annualization of capital costs using replacement cost, useful lifetime, discounting rate and corresponding annualization factor taken from the standard table.
Shadow pricing will be considered for inputs to be donated for the study purpose by partner agencies. Allocation factors (e.g. % time spent by staff, % used etc) will be applied to apportion joint costs. Summing-up the fixed and variable costs over all total cost of each intervention will be calculated separately. Average or unit cost will be calculated dividing total cost of each intervention by the corresponding number of households that received the intervention. Finally relationship between cost and effectiveness of corresponding intervention(s) will be represented by cost and effectiveness ratio for comparison.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm-1 | Experimental | Other: IWFPLIn 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. |
| Arm-2 | Experimental | Other: IDWLIn 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. |
| Arm-3 | Experimental | Other: ITNIn 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. |
| Control | No intervention | –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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Household head who agree to participate in the study
Key exclusion criteria (1 listed)
- Household head who does not agree to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IWFPLAlso: InsecticideIndoor 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 | Arm-1 |
| IDWLAlso: InsecticideInstall durable wall lining containing deltamethrin to kill immature stage and as well as adult sand flies | Other | Arm-2 |
| ITNAlso: InsecticideImpregnation of existing bed-nets available in the community with slow release insecticide, deltamethrin | Other | Arm-3 |
Primary outcome
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.
1 secondary outcome
Estimation of intervention costs and its acceptability
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IWFPL, IDWL and ITN in people with Cost-effective and Sustainable Vector Control Methods Will be Established to Reduce VL in India, Bangladesh and Nepal, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of efficacy of interventions (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2017.