<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/NCT02987270</url>
  </required_header>
  <id_info>
    <org_study_id>2380</org_study_id>
    <nct_id>NCT02987270</nct_id>
  </id_info>
  <brief_title>Evaluation of Community-based Mass Screening and Treatment for Malaria in Western Kenya</brief_title>
  <acronym>MSaT</acronym>
  <official_title>Evaluation of Community-based Screening and Treatment for Malaria in the KEMRI/CDC Health and Demographic Surveillance System (HDSS) in Western Kenya</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Simon Kariuki</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Kenya Medical Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a cluster-randomized controlled trial to evaluate the efficacy of&#xD;
      community-based mass screening with a malaria rapid diagnostic test, and treatment of&#xD;
      participants with positive tests with an appropriate antimalarial for reducing malaria&#xD;
      transmission indices.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators purposively selected ten health facilities in Siaya County, western Kenya&#xD;
      based on malaria case loads. All villages whose midpoint was located within a 3 kilometer&#xD;
      radius of each of the ten health facilities were included in the study. Contiguous villages&#xD;
      were merged to form two clusters around each health facility. Clusters were randomly assigned&#xD;
      to the control or intervention arm such that there was one control and one intervention&#xD;
      cluster around each health facility. Approximately 30,000 and 60,000 people resided in&#xD;
      intervention and control arms, respectively.&#xD;
&#xD;
      Once a year during the peak malaria transmission season in July, starting at baseline, the&#xD;
      investigators selected a simple random sample of compounds within the study area for a&#xD;
      cross-sectional survey to determine risk factors for malaria acquisition and parasite&#xD;
      prevalence. Every person in each selected compound was consented into the cross-sectional&#xD;
      survey. Community health volunteers (CHV) were trained to perform malaria rapid diagnostic&#xD;
      tests, collect dried blood spots on filter papers, and provide treatment and referral&#xD;
      recommendations for participants. Three times a year, in September, January, and April, for&#xD;
      two years, CHVs visited every household in the intervention arm and tested and treated every&#xD;
      consenting household member who was positive for malaria by rapid diagnostic test. Throughout&#xD;
      the study period, malaria case counts from individuals located within the study clusters were&#xD;
      recorded at each of the study health facilities. During the first two cross-sectional surveys&#xD;
      we randomly selected 660 individuals to enter into an incidence cohort, 330 per arm. Cohort&#xD;
      members were definitively treated for malaria at recruitment with artemether-lumefantrine,&#xD;
      and were asked to visit a study health facility once a month for blood draws for malaria&#xD;
      testing.&#xD;
&#xD;
      Every month, 18 households were randomly selected for entomological monitoring; 12 in the&#xD;
      control arm, and 6 in the intervention arm. Pyrethrum spray catches were performed in each&#xD;
      household. Live catches were performed one week in each month of the study. During live&#xD;
      collection weeks, as many households were visited as possible, and prokopak aspirators were&#xD;
      used to collect mosquitoes from the inner walls of houses.&#xD;
&#xD;
      Prior to the first round of mass screening and treatment and then again after the first&#xD;
      round, 36 focus group discussions were conducted to evaluate community acceptance of&#xD;
      community-based mass screening and treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <phase>Phase 3</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of malaria infection</measure>
    <time_frame>After year 1 and after year 2</time_frame>
    <description>Incidence of malaria infection as determined by malaria blood smear microscopy in members of the cohort after year 1 and year 2 of mass screening and treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of malaria infection</measure>
    <time_frame>After year 1 and after year 2</time_frame>
    <description>Prevalence of malaria infections diagnosed by blood smear microscopy were determined during three cross-sectional studies at baseline, after year 1, and after year 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinical malaria</measure>
    <time_frame>After year 1 and after year 2</time_frame>
    <description>Incidence of clinical malaria as determined by passive surveillance in the ten study health facilities, after year 1 and after year 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Entomological indices of transmission</measure>
    <time_frame>After year 1 and after year 2</time_frame>
    <description>Sporozoite and oocyst rates were compared in malaria vectors captured during pyrethrum spray catches and aspirations after year 1 and after year 2.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90000</enrollment>
  <condition>Malaria,Falciparum</condition>
  <arm_group>
    <arm_group_label>Mass screening and treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each member (approximately 30,000 individuals) residing within the mass screening and treatment arm were visited three times a year and tested for malaria by rapid diagnostic test; those testing positive were treated with an appropriate antimalarial- dihydroartemisinin-piperaquine was the first-line therapy. Long-lasting insecticidal net (LLIN) coverage was topped up prior to the intervention to universal coverage (one bednet for every two household participants).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Members of the control arm received standard of care, which includes universal (LLIN) coverage and standard malaria case management (laboratory confirmation prior to antimalarial treatment) at the study health facilities.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dihydroartemisinin-piperaquine</intervention_name>
    <description>Dihydroartemisinin-piperaquine is an antimalarial in the artemisinin-based combination therapy class of drugs. It is the Kenya Ministry of Health second-line treatment for malaria in Kenya.</description>
    <arm_group_label>Mass screening and treatment</arm_group_label>
    <other_name>Eurartesim</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cross sectional studies: Living within one of the study clusters, &gt;1 month of age&#xD;
&#xD;
          -  Cohort: Living within one of the study clusters, ≥1 year of age&#xD;
&#xD;
          -  Passive surveillance: Living within one of the study clusters&#xD;
&#xD;
          -  Entomological surveillance- household in either control or intervention arm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cohort study- pregnant at time of recruitment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Meghna R Desai, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centers for Disease Control and Prevention</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Simon K Kariuki, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kenya Medical Research Institute</affiliation>
  </overall_official>
  <reference>
    <citation>Shuford K, Were F, Awino N, Samuels A, Ouma P, Kariuki S, Desai M, Allen DR. Community perceptions of mass screening and treatment for malaria in Siaya County, western Kenya. Malar J. 2016 Feb 6;15:71. doi: 10.1186/s12936-016-1123-y.</citation>
    <PMID>26852227</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>December 8, 2016</last_update_submitted>
  <last_update_submitted_qc>December 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 9, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Kenya Medical Research Institute</investigator_affiliation>
    <investigator_full_name>Simon Kariuki</investigator_full_name>
    <investigator_title>Malaria Branch Chief</investigator_title>
  </responsible_party>
  <keyword>mass screen and treat</keyword>
  <keyword>malaria</keyword>
  <keyword>asymptomatic infections</keyword>
  <keyword>transmission reduction</keyword>
  <keyword>infectious reservoir</keyword>
  <keyword>kenya</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malaria</mesh_term>
    <mesh_term>Malaria, Falciparum</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Piperaquine</mesh_term>
    <mesh_term>Artenimol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02987270
org study id: 2380
nct id: NCT02987270
lead sponsor: 
collaborator: 
has dmc: No
This study is a cluster-randomized controlled trial to evaluate the efficacy of
      community-based mass screening with a malaria rapid diagnostic test, and treatment of
      participants with positive tests with an appropriate antimalarial for reducing malaria
      transmission indices.
The investigators purposively selected ten health facilities in Siaya County, western Kenya
      based on malaria case loads. All villages whose midpoint was located within a 3 kilometer
      radius of each of the ten health facilities were included in the study. Contiguous villages
      were merged to form two clusters around each health facility. Clusters were randomly assigned
      to the control or intervention arm such that there was one control and one intervention
      cluster around each health facility. Approximately 30,000 and 60,000 people resided in
      intervention and control arms, respectively.

      Once a year during the peak malaria transmission season in July, starting at baseline, the
      investigators selected a simple random sample of compounds within the study area for a
      cross-sectional survey to determine risk factors for malaria acquisition and parasite
      prevalence. Every person in each selected compound was consented into the cross-sectional
      survey. Community health volunteers (CHV) were trained to perform malaria rapid diagnostic
      tests, collect dried blood spots on filter papers, and provide treatment and referral
      recommendations for participants. Three times a year, in September, January, and April, for
      two years, CHVs visited every household in the intervention arm and tested and treated every
      consenting household member who was positive for malaria by rapid diagnostic test. Throughout
      the study period, malaria case counts from individuals located within the study clusters were
      recorded at each of the study health facilities. During the first two cross-sectional surveys
      we randomly selected 660 individuals to enter into an incidence cohort, 330 per arm. Cohort
      members were definitively treated for malaria at recruitment with artemether-lumefantrine,
      and were asked to visit a study health facility once a month for blood draws for malaria
      testing.

      Every month, 18 households were randomly selected for entomological monitoring; 12 in the
      control arm, and 6 in the intervention arm. Pyrethrum spray catches were performed in each
      household. Live catches were performed one week in each month of the study. During live
      collection weeks, as many households were visited as possible, and prokopak aspirators were
      used to collect mosquitoes from the inner walls of houses.

      Prior to the first round of mass screening and treatment and then again after the first
      round, 36 focus group discussions were conducted to evaluate community acceptance of
      community-based mass screening and treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of malaria infection
time frame: After year 1 and after year 2
description: Incidence of malaria infection as determined by malaria blood smear microscopy in members of the cohort after year 1 and year 2 of mass screening and treatment
measure: Prevalence of malaria infection
time frame: After year 1 and after year 2
description: Prevalence of malaria infections diagnosed by blood smear microscopy were determined during three cross-sectional studies at baseline, after year 1, and after year 2.
measure: Incidence of clinical malaria
time frame: After year 1 and after year 2
description: Incidence of clinical malaria as determined by passive surveillance in the ten study health facilities, after year 1 and after year 2.
measure: Entomological indices of transmission
time frame: After year 1 and after year 2
description: Sporozoite and oocyst rates were compared in malaria vectors captured during pyrethrum spray catches and aspirations after year 1 and after year 2.
arm group label: Mass screening and treatment
arm group type: Experimental
description: Each member (approximately 30,000 individuals) residing within the mass screening and treatment arm were visited three times a year and tested for malaria by rapid diagnostic test; those testing positive were treated with an appropriate antimalarial- dihydroartemisinin-piperaquine was the first-line therapy. Long-lasting insecticidal net (LLIN) coverage was topped up prior to the intervention to universal coverage (one bednet for every two household participants).
arm group label: Control arm
arm group type: No Intervention
description: Members of the control arm received standard of care, which includes universal (LLIN) coverage and standard malaria case management (laboratory confirmation prior to antimalarial treatment) at the study health facilities.
intervention type: Drug
intervention name: Dihydroartemisinin-piperaquine
description: Dihydroartemisinin-piperaquine is an antimalarial in the artemisinin-based combination therapy class of drugs. It is the Kenya Ministry of Health second-line treatment for malaria in Kenya.
arm group label: Mass screening and treatment
other name: Eurartesim
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Meghna R Desai, PhD
role: Principal Investigator
affiliation: Centers for Disease Control and Prevention
last name: Simon K Kariuki, PhD
role: Principal Investigator
affiliation: Kenya Medical Research Institute
citation: Shuford K, Were F, Awino N, Samuels A, Ouma P, Kariuki S, Desai M, Allen DR. Community perceptions of mass screening and treatment for malaria in Siaya County, western Kenya. Malar J. 2016 Feb 6;15:71. doi: 10.1186/s12936-016-1123-y.
PMID: 26852227
responsible party type: Sponsor-Investigator
investigator affiliation: Kenya Medical Research Institute
investigator full name: Simon Kariuki
investigator title: Malaria Branch Chief
mesh term: Malaria
mesh term: Malaria, Falciparum
mesh term: Piperaquine
mesh term: Artenimol
sharing ipd: No