<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03269006</url>
  </required_header>
  <id_info>
    <org_study_id>PR-14087</org_study_id>
    <nct_id>NCT03269006</nct_id>
  </id_info>
  <brief_title>Improved Case Detection and Vector Control for Visceral Leishmaniasis</brief_title>
  <official_title>Improved Visceral Leishmaniasis (VL) Case Detection and Vector Control to Support the VL Elimination Initiative in Bangladesh</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>International Centre for Diarrhoeal Disease Research, Bangladesh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>International Centre for Diarrhoeal Disease Research, Bangladesh</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Visceral leishmaniasis (VL) also known as kala-azar is a public health problem in Bangladesh.&#xD;
      Since 2005 a national kala-azar elimination program is going on in the country. The program&#xD;
      has preparatory, attack, consolidation and maintenance phases. The target of the program is&#xD;
      to reduce the VL incidence less than 1 per 10,000 people at upazila (sub-district) level in&#xD;
      VL endemic upazilas of the country. The program is heading successfully to its consolidation&#xD;
      phase.&#xD;
&#xD;
      During attack phase house to house search for VL suspects and also suspects with&#xD;
      Post-kala-azar Dermal Leishmaniasis (PKDL) was the tool for early diagnosis of VL and PKDL&#xD;
      cases. Indoor residual spraying with insecticide (Deltamethrin) was the method for sand fly&#xD;
      control to reduce the transmission of the disease. Since in the consolidation phase the VL&#xD;
      case load is many times less than that in the attack phase, house to house search for VL and&#xD;
      PKDL cases and IRS for vector control is no more cost-effective for the program. Therefore&#xD;
      there is a need for alternative methods for active search of VL and PKDL cases and method for&#xD;
      sand fly control, appropriate for the consolidation phase.&#xD;
&#xD;
      In the present study the investigators propose to investigate the efficacy of Inesfly 5AIGRNG&#xD;
      TM containing Alphacypermethrin 0.7%; D-Allethin 1.0% and Pyriproxyphen (0.063%), commercial&#xD;
      available durable wall lining (DWL), impregnated of existing bed-net with insecticide tablet,&#xD;
      KO TAB 123, indoor residual spraying (IRS) with Delthamethrin against a control group&#xD;
      Methods: A cluster randomized controlled design to measure sand fly density reduction at&#xD;
      intervention household as well as sand fly mortality by entomological methods.&#xD;
&#xD;
      Outcome measures/variables: reduction of sand fly density at intervention household and sand&#xD;
      fly corrected mortality on intervention surfaces compare to control households/conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to test the efficacy Inesfly 5AIGRNG TM containing&#xD;
      Alphacypermethrin 0.7%; D-Allethin 1.0% and Pyriproxyphen (0.063%), and other intervention&#xD;
      with control group. The formulation is vinyl paint with an aqueous base, with the active&#xD;
      ingredients residing within Ca CO3 and resin microcapsules, allowing a gradual release of&#xD;
      active ingredients. Microcapsules range from one to several hundred micrometers in size.&#xD;
      Inesfly has been tested for control of malaria and chagas disease vector with encouraging&#xD;
      results. The product is effective even against vectors, resistant to pyrethroids.&#xD;
&#xD;
      A randomized control trial will be performed with Inesfly 5AIGRNG TM containing&#xD;
      Alphacypermethrin 0.7%; D-Allethin 1.0% and Pyriproxyphen (0.063%), commercial available&#xD;
      durable wall lining (DWL), impregnated of existing bed-net with insecticide tablet, KO TAB&#xD;
      123, indoor residual spraying (IRS) with Delthamethrin against a control group (study with 5&#xD;
      arms). The study will be carried out in villages located in Mymensingh District , one of the&#xD;
      high VL endemic district in Bangladesh. The VL burden of the villages will be estimated using&#xD;
      the VL case reports in the last 12 months. Four high endemic villages will be selected for&#xD;
      the study. As per sample size calculation the investigators need minimum 31 households to see&#xD;
      the efficacy of the interventions (see sample size calculation part below). The investigators&#xD;
      will include 50 households for each intervention and 50 for control (No intervention).&#xD;
      Twenty-five households (HHs) from each village will be selected randomly which will be&#xD;
      considered as a cluster. Field Research Assistant will be listed all the study households.&#xD;
      Only subjects who agree to participate and freely signed the consent form will be included in&#xD;
      the study. Household roster and household head interview for socio-demographic,&#xD;
      socio-economic and knowledge about VL and VL vectors will be done. Based on sample size&#xD;
      calculation, 18 HHs from each cluster will be selected randomly for entomological analysis&#xD;
      which includes sand fly density measurement (base line and 1, 3, 6, 9,12, 15, 18, 21 and 24&#xD;
      months after intervention), WHO Cone bioassay on the intervention surfaces and control&#xD;
      surfaces at 1, 3, 6, 9,12, 15, 18, 21 and 24 months after intervention After performing&#xD;
      baseline sand fly density measurements, clusters will be redefined with High density (sand&#xD;
      fly density =&gt;50th percentile), and low (sand fly density (&lt;50th percentile). One cluster&#xD;
      will be selected randomly from each density group for the intervention with Inesfly,&#xD;
      commercial DWL, and the control group with no intervention. All groups will receive the&#xD;
      routine vector control services by the national program. Acceptability survey of the&#xD;
      intervention will be conducted at 6 weeks since intervention to see the community acceptance&#xD;
      of the intervention.&#xD;
&#xD;
      Entomological methods:&#xD;
&#xD;
      Sand fly collection and density measurement For the entomological activities for objective 2&#xD;
      and objective 3 HH head will be informed and his/her informed, written voluntary consent will&#xD;
      be obtained before the start of any activities. HH head and members will be requested one day&#xD;
      before by the research team to make space for conduct installation of DWL / wall paining with&#xD;
      Inesfly by removing materials including furniture to a safe place. They also will be informed&#xD;
      that for entomological activities i.e. for collection of sand fly by CDC light trap research&#xD;
      team will visit the HH for two consecutive days as on day one they will visit in the evening&#xD;
      to place CDC light trap in a corner of the main room and to take it out on the following&#xD;
      morning. As sand fly collection will be done before intervention and at 1 month, 6 months and&#xD;
      12 months after intervention research team will visit the HH 4 times for sand fly collection.&#xD;
      In addition to conduct the WHO Cone bioassay test which will be done again at 1 month, 3&#xD;
      months and 12 months since intervention the HH will be visited again 3 times by the research&#xD;
      team.&#xD;
&#xD;
      Sand flies will be collected on two consecutive nights with CDC light traps by trained&#xD;
      personnel with guidance from a member of the study team. Light traps will be kept in a corner&#xD;
      from 6 pm to 6 am, 2 inch away from the wall with a distance of 6 inches between the floor&#xD;
      and the bottom of the sac. The sand fly density will be expressed as number of P. argentipes&#xD;
      per light trap per night. Sand fly identification will be done as follows:&#xD;
&#xD;
        -  Upon collection, sand flies will be segregated and labeled by batch indicating the date&#xD;
           and the pre-printed batch numbers. Sand fly numbers and sex will be identified under&#xD;
           microscope.&#xD;
&#xD;
        -  Morphological identification will be done in the field using the following criteria:&#xD;
&#xD;
      vi. Phlebotomus argentipes Pa: Black thorax+silvering shining of the tarsal tip of the&#xD;
      leg+3mm.&#xD;
&#xD;
      vii. Phlebotomus papatasi Pp: Brown to yellow thorax+3mm. viii. Sergentomyia sp Sr:I1-2mm c.&#xD;
      Sex and physiological status ix. Males: external genitalia with claspers x. Females: without&#xD;
      claspers, Blood-fed, unfed, gravid (no undigested blood).&#xD;
&#xD;
      WHO Cone Bioassay Test The WHO cone bioassays will be performed using the cone method (WHOPES&#xD;
      2005.11) on treated and non-treated bed-nets with wild caught (manually collected) sandflies&#xD;
      at 1 month, 6 months and 12 months after intervention. Bioassays will be carried out at room&#xD;
      temperature at 25o- 29oC and 75-85% humidity. Resting sandflies will be collected manually by&#xD;
      aspirator during early morning and evening. In each net, 10-12 female sand flies will be&#xD;
      introduced in each of the cones placed against the DWL / Wall for 30 minutes. The sand flies&#xD;
      will be then transferred from each cone to a paper cup for observation. They will be observed&#xD;
      over 24 hours to calculate the mortality. The mortality rates of sand flies will be corrected&#xD;
      with Abbot's formula (WHOPES 2005.11).&#xD;
&#xD;
      Measurement of efficacy of interventions: Efficacy will be defined by the reduction of&#xD;
      sandfly density by intervention compared to control measured by sandfly density at 1 months,&#xD;
      6 months and 12 months after intervention; percentage mortality of sand-fly assessed by WHO&#xD;
      Cone Bioassay test on DWL and wall after 1 months, 6 months and 12 months following&#xD;
      intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">July 30, 2019</completion_date>
  <primary_completion_date type="Actual">April 30, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>A randomized control trial will be performed with Inesfly 5AIGRNG TM, commercial available durable wall lining (DWL), impregnated of existing bed-net with insecticide tablet, KO TAB 123, indoor residual spraying (IRS) with Delthamethrin vs a control group (study with 5 arms). The study will be carried out in villages located in Mymensingh District. Four high endemic villages will be selected for the study. As per sample size calculation we need minimum 31 households to see the efficacy of the interventions. We will include 50 households for each intervention and 50 for control (No intervention). 18 households from each cluster will be selected randomly for entomological analysis which includes sand fly density measurement at base line and 1, 3, 6, 9, 12, 15, 18, 21 and 24 months after intervention, and WHO Cone bio-assay on the intervention surfaces and the control surfaces at 1, 3, 6, 9, 12, 15, 18, 21 and 24 months after intervention.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction of Vector density (CDC light trap)</measure>
    <time_frame>at base line and 1,3, 6, 9, 12, 15, 18, 21 and 24 months after intervention</time_frame>
    <description>Based on sample size calculation, 18 households from each cluster will be selected randomly for sand fly density measurement at base line and 1,3, 6, 9, 12, 15, 18, 21 and 24 months after intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Corrected sand fly mortality</measure>
    <time_frame>at 1,3, 6, 9, 12, 15, 18, 21 and 24 months after intervention</time_frame>
    <description>WHO Cone bio-assay will be done on the intervention surfaces and the control surfaces (at 18 households from each cluster) at 1, 3, 6, 9, 12, 15, 18, 21 and 24 months after intervention.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">202</enrollment>
  <condition>Visceral Leishmaniasis</condition>
  <arm_group>
    <arm_group_label>Inesfly Paint</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Inesfly 5AIGRNG TM containing Alphacypermethrin 0.7%; D-Allethin 1.0% and Pyriproxyphen (0.063%). The formulation is vinyl paint with an aqueous base, with the active ingredients residing within Ca CO3 and resin microcapsules, allowing a gradual release of active ingredients. Microcapsules range from one to several hundred micrometers in size.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IDWL (1m)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Install durable wall lining up to one meter from the floor of the intervention room containing deltamethrin to kill immature stage and as well as adult sand flies.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ITN (KO-Tab 123)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>impregnation of existing bed net by the insecticide tablet, K-O Tab 1-2-3 containing deltamethrin.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IRS (Delthamethrin)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>indoor residual spraying with Delthamethrin in the living rooms</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>without any study interventions</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Inesfly Paint</intervention_name>
    <description>Inesfly 5AIGRNG TM paint contain Alphacypermethrin 0.7%; D-Allethin 1.0% and Pyriproxyphen (0.063%).&#xD;
Others intervention such as IRS, ITN and IDWLcontain Delthamethrin</description>
    <arm_group_label>Inesfly Paint</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IDWL (1m)</intervention_name>
    <description>Install durable wall lining up to one meter from the floor of the intervention room containing deltamethrin to kill immature stage and as well as adult sand flies</description>
    <arm_group_label>IDWL (1m)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ITN (KO-Tab 123)</intervention_name>
    <description>Impregnation of existing bed net by the insecticide tablet, K-O Tab 1-2-3 containing deltamethrin</description>
    <arm_group_label>ITN (KO-Tab 123)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IRS (Delthamethrin)</intervention_name>
    <description>Indoor residual spraying with Delthamethrin in the living rooms</description>
    <arm_group_label>IRS (Delthamethrin)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Filed Research Assistant will be listed all the study households in the selected study&#xD;
             areas.&#xD;
&#xD;
          -  Only subjects who agree to participate and freely signed the consent form will be&#xD;
             included in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Subjects who will not agree to participate and freely signed the consent form will be&#xD;
        included in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dinesh Mondal, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Senior Scientist</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Icddr,B Field Site</name>
      <address>
        <city>Mymensingh</city>
        <country>Bangladesh</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bangladesh</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>March 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>January 13, 2020</last_update_submitted>
  <last_update_submitted_qc>January 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Visceral leishmaniasis</keyword>
  <keyword>Vector control</keyword>
  <keyword>Sand fly,</keyword>
  <keyword>Bangladesh</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leishmaniasis</mesh_term>
    <mesh_term>Leishmaniasis, Visceral</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>As per institutional (icddr,b) data sharing policy.</ipd_description>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>As per institutional (icddr,b) data sharing policy.</ipd_time_frame>
    <ipd_access_criteria>As per institutional (icddr,b) data sharing policy.</ipd_access_criteria>
    <ipd_url>http://www.icddrb.org/component/content/article/10003-data-policies/1893-data-policies</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03269006
org study id: PR-14087
nct id: NCT03269006
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Visceral leishmaniasis (VL) also known as kala-azar is a public health problem in Bangladesh.
      Since 2005 a national kala-azar elimination program is going on in the country. The program
      has preparatory, attack, consolidation and maintenance phases. The target of the program is
      to reduce the VL incidence less than 1 per 10,000 people at upazila (sub-district) level in
      VL endemic upazilas of the country. The program is heading successfully to its consolidation
      phase.

      During attack phase house to house search for VL suspects and also suspects with
      Post-kala-azar Dermal Leishmaniasis (PKDL) was the tool for early diagnosis of VL and PKDL
      cases. Indoor residual spraying with insecticide (Deltamethrin) was the method for sand fly
      control to reduce the transmission of the disease. Since in the consolidation phase the VL
      case load is many times less than that in the attack phase, house to house search for VL and
      PKDL cases and IRS for vector control is no more cost-effective for the program. Therefore
      there is a need for alternative methods for active search of VL and PKDL cases and method for
      sand fly control, appropriate for the consolidation phase.

      In the present study the investigators propose to investigate the efficacy of Inesfly 5AIGRNG
      TM containing Alphacypermethrin 0.7%; D-Allethin 1.0% and Pyriproxyphen (0.063%), commercial
      available durable wall lining (DWL), impregnated of existing bed-net with insecticide tablet,
      KO TAB 123, indoor residual spraying (IRS) with Delthamethrin against a control group
      Methods: A cluster randomized controlled design to measure sand fly density reduction at
      intervention household as well as sand fly mortality by entomological methods.

      Outcome measures/variables: reduction of sand fly density at intervention household and sand
      fly corrected mortality on intervention surfaces compare to control households/conditions.
The objective of this study is to test the efficacy Inesfly 5AIGRNG TM containing
      Alphacypermethrin 0.7%; D-Allethin 1.0% and Pyriproxyphen (0.063%), and other intervention
      with control group. The formulation is vinyl paint with an aqueous base, with the active
      ingredients residing within Ca CO3 and resin microcapsules, allowing a gradual release of
      active ingredients. Microcapsules range from one to several hundred micrometers in size.
      Inesfly has been tested for control of malaria and chagas disease vector with encouraging
      results. The product is effective even against vectors, resistant to pyrethroids.

      A randomized control trial will be performed with Inesfly 5AIGRNG TM containing
      Alphacypermethrin 0.7%; D-Allethin 1.0% and Pyriproxyphen (0.063%), commercial available
      durable wall lining (DWL), impregnated of existing bed-net with insecticide tablet, KO TAB
      123, indoor residual spraying (IRS) with Delthamethrin against a control group (study with 5
      arms). The study will be carried out in villages located in Mymensingh District , one of the
      high VL endemic district in Bangladesh. The VL burden of the villages will be estimated using
      the VL case reports in the last 12 months. Four high endemic villages will be selected for
      the study. As per sample size calculation the investigators need minimum 31 households to see
      the efficacy of the interventions (see sample size calculation part below). The investigators
      will include 50 households for each intervention and 50 for control (No intervention).
      Twenty-five households (HHs) from each village will be selected randomly which will be
      considered as a cluster. Field Research Assistant will be listed all the study households.
      Only subjects who agree to participate and freely signed the consent form will be included in
      the study. Household roster and household head interview for socio-demographic,
      socio-economic and knowledge about VL and VL vectors will be done. Based on sample size
      calculation, 18 HHs from each cluster will be selected randomly for entomological analysis
      which includes sand fly density measurement (base line and 1, 3, 6, 9,12, 15, 18, 21 and 24
      months after intervention), WHO Cone bioassay on the intervention surfaces and control
      surfaces at 1, 3, 6, 9,12, 15, 18, 21 and 24 months after intervention After performing
      baseline sand fly density measurements, clusters will be redefined with High density (sand
      fly density =>50th percentile), and low (sand fly density (<50th percentile). One cluster
      will be selected randomly from each density group for the intervention with Inesfly,
      commercial DWL, and the control group with no intervention. All groups will receive the
      routine vector control services by the national program. Acceptability survey of the
      intervention will be conducted at 6 weeks since intervention to see the community acceptance
      of the intervention.

      Entomological methods:

      Sand fly collection and density measurement For the entomological activities for objective 2
      and objective 3 HH head will be informed and his/her informed, written voluntary consent will
      be obtained before the start of any activities. HH head and members will be requested one day
      before by the research team to make space for conduct installation of DWL / wall paining with
      Inesfly by removing materials including furniture to a safe place. They also will be informed
      that for entomological activities i.e. for collection of sand fly by CDC light trap research
      team will visit the HH for two consecutive days as on day one they will visit in the evening
      to place CDC light trap in a corner of the main room and to take it out on the following
      morning. As sand fly collection will be done before intervention and at 1 month, 6 months and
      12 months after intervention research team will visit the HH 4 times for sand fly collection.
      In addition to conduct the WHO Cone bioassay test which will be done again at 1 month, 3
      months and 12 months since intervention the HH will be visited again 3 times by the research
      team.

      Sand flies will be collected on two consecutive nights with CDC light traps by trained
      personnel with guidance from a member of the study team. Light traps will be kept in a corner
      from 6 pm to 6 am, 2 inch away from the wall with a distance of 6 inches between the floor
      and the bottom of the sac. The sand fly density will be expressed as number of P. argentipes
      per light trap per night. Sand fly identification will be done as follows:

        -  Upon collection, sand flies will be segregated and labeled by batch indicating the date
           and the pre-printed batch numbers. Sand fly numbers and sex will be identified under
           microscope.

        -  Morphological identification will be done in the field using the following criteria:

      vi. Phlebotomus argentipes Pa: Black thorax+silvering shining of the tarsal tip of the
      leg+3mm.

      vii. Phlebotomus papatasi Pp: Brown to yellow thorax+3mm. viii. Sergentomyia sp Sr:I1-2mm c.
      Sex and physiological status ix. Males: external genitalia with claspers x. Females: without
      claspers, Blood-fed, unfed, gravid (no undigested blood).

      WHO Cone Bioassay Test The WHO cone bioassays will be performed using the cone method (WHOPES
      2005.11) on treated and non-treated bed-nets with wild caught (manually collected) sandflies
      at 1 month, 6 months and 12 months after intervention. Bioassays will be carried out at room
      temperature at 25o- 29oC and 75-85% humidity. Resting sandflies will be collected manually by
      aspirator during early morning and evening. In each net, 10-12 female sand flies will be
      introduced in each of the cones placed against the DWL / Wall for 30 minutes. The sand flies
      will be then transferred from each cone to a paper cup for observation. They will be observed
      over 24 hours to calculate the mortality. The mortality rates of sand flies will be corrected
      with Abbot's formula (WHOPES 2005.11).

      Measurement of efficacy of interventions: Efficacy will be defined by the reduction of
      sandfly density by intervention compared to control measured by sandfly density at 1 months,
      6 months and 12 months after intervention; percentage mortality of sand-fly assessed by WHO
      Cone Bioassay test on DWL and wall after 1 months, 6 months and 12 months following
      intervention.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A randomized control trial will be performed with Inesfly 5AIGRNG TM, commercial available durable wall lining (DWL), impregnated of existing bed-net with insecticide tablet, KO TAB 123, indoor residual spraying (IRS) with Delthamethrin vs a control group (study with 5 arms). The study will be carried out in villages located in Mymensingh District. Four high endemic villages will be selected for the study. As per sample size calculation we need minimum 31 households to see the efficacy of the interventions. We will include 50 households for each intervention and 50 for control (No intervention). 18 households from each cluster will be selected randomly for entomological analysis which includes sand fly density measurement at base line and 1, 3, 6, 9, 12, 15, 18, 21 and 24 months after intervention, and WHO Cone bio-assay on the intervention surfaces and the control surfaces at 1, 3, 6, 9, 12, 15, 18, 21 and 24 months after intervention.
primary purpose: Prevention
masking: None (Open Label)
measure: Reduction of Vector density (CDC light trap)
time frame: at base line and 1,3, 6, 9, 12, 15, 18, 21 and 24 months after intervention
description: Based on sample size calculation, 18 households from each cluster will be selected randomly for sand fly density measurement at base line and 1,3, 6, 9, 12, 15, 18, 21 and 24 months after intervention
measure: Corrected sand fly mortality
time frame: at 1,3, 6, 9, 12, 15, 18, 21 and 24 months after intervention
description: WHO Cone bio-assay will be done on the intervention surfaces and the control surfaces (at 18 households from each cluster) at 1, 3, 6, 9, 12, 15, 18, 21 and 24 months after intervention.
arm group label: Inesfly Paint
arm group type: Experimental
description: Inesfly 5AIGRNG TM containing Alphacypermethrin 0.7%; D-Allethin 1.0% and Pyriproxyphen (0.063%). The formulation is vinyl paint with an aqueous base, with the active ingredients residing within Ca CO3 and resin microcapsules, allowing a gradual release of active ingredients. Microcapsules range from one to several hundred micrometers in size.
arm group label: IDWL (1m)
arm group type: Experimental
description: Install durable wall lining up to one meter from the floor of the intervention room containing deltamethrin to kill immature stage and as well as adult sand flies.
arm group label: ITN (KO-Tab 123)
arm group type: Experimental
description: impregnation of existing bed net by the insecticide tablet, K-O Tab 1-2-3 containing deltamethrin.
arm group label: IRS (Delthamethrin)
arm group type: Experimental
description: indoor residual spraying with Delthamethrin in the living rooms
arm group label: Control
arm group type: No Intervention
description: without any study interventions
intervention type: Device
intervention name: Inesfly Paint
description: Inesfly 5AIGRNG TM paint contain Alphacypermethrin 0.7%; D-Allethin 1.0% and Pyriproxyphen (0.063%).
Others intervention such as IRS, ITN and IDWLcontain Delthamethrin
arm group label: Inesfly Paint
intervention type: Device
intervention name: IDWL (1m)
description: Install durable wall lining up to one meter from the floor of the intervention room containing deltamethrin to kill immature stage and as well as adult sand flies
arm group label: IDWL (1m)
intervention type: Device
intervention name: ITN (KO-Tab 123)
description: Impregnation of existing bed net by the insecticide tablet, K-O Tab 1-2-3 containing deltamethrin
arm group label: ITN (KO-Tab 123)
intervention type: Device
intervention name: IRS (Delthamethrin)
description: Indoor residual spraying with Delthamethrin in the living rooms
arm group label: IRS (Delthamethrin)
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Dinesh Mondal, PhD
role: Principal Investigator
affiliation: Senior Scientist
facility: 
country: Bangladesh
responsible party type: Sponsor
mesh term: Leishmaniasis
mesh term: Leishmaniasis, Visceral
sharing ipd: Yes
ipd description: As per institutional (icddr,b) data sharing policy.
ipd info type: Clinical Study Report (CSR)
ipd time frame: As per institutional (icddr,b) data sharing policy.
ipd access criteria: As per institutional (icddr,b) data sharing policy.
ipd url: http://www.icddrb.org/component/content/article/10003-data-policies/1893-data-policies