<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/NCT02199977</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00052602</org_study_id>
    <secondary_id>1R01AI110478-01</secondary_id>
    <nct_id>NCT02199977</nct_id>
  </id_info>
  <brief_title>Innovative Public-private Partnership to Target Subsidized Antimalarials in the Retail Sector</brief_title>
  <official_title>Innovative Public-private Partnership to Target Subsidized Antimalarials in the Retail Sector</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Moi University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There are compelling medical and public health reasons to reduce unnecessary consumption of&#xD;
      antimalarials and strong evidence to support the use of RDTs in malaria case management. The&#xD;
      primary study hypothesis to be tested is that clients who know they will receive a subsidy&#xD;
      conditional on a positive test are more likely to opt for testing before deciding which drug&#xD;
      to buy. The primary endpoint is whether subjects choose to be tested for malaria with a rapid&#xD;
      diagnostic test. The secondary endpoint is whether they purchased an artemisinin combination&#xD;
      therapy (ACT) or not. The primary outcome of interest is to compare the proportion of&#xD;
      participants who choose to receive a free malaria diagnostic test when they can receive a&#xD;
      subsidy for a discounted drug conditional on a positive test (Group A compared to Group B)&#xD;
      compared to those without the offer of a conditional subsidy. The investigators will use an&#xD;
      experimental design that randomly assigns clients to one of four groups. Field workers will&#xD;
      canvas households in the study area looking for individuals who have fever or history of&#xD;
      fever or illness in the last 24 hours (current illness) who have not yet taken drugs or&#xD;
      sought treatment outside the home. Clients who meet the inclusion criteria and give verbal&#xD;
      consent to participate will be randomly assigned to one of the four groups. They will be&#xD;
      given the location and contact information for their local community health worker who can&#xD;
      provide a malaria rapid diagnostic test if they choose to be tested. They will also complete&#xD;
      a survey tool. One week later, the field worker will return to interview the participant and&#xD;
      determine whether they were tested, what action they took for their illness, what medicine&#xD;
      they purchased and how much they paid. The investigators will summarize clients' choice by&#xD;
      the four randomized study groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of conditional drug subsidy on proportion of participants who choose to receive a free malaria diagnostic test</measure>
    <time_frame>Within two days of group assignment</time_frame>
    <description>The primary outcome of interest is to compare the proportion of participants who choose to receive a free malaria diagnostic test when they can receive a subsidy for a discounted drug conditional on a positive test compared to those without the offer of a conditional subsidy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of malaria RDT subsidy on the uptake of testing (free versus paid RDT)</measure>
    <time_frame>Within 2 days of group assignment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of a conditional ACT subsidy on uptake of testing when the RDT is not free.</measure>
    <time_frame>Within 2 days of group assignment</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Percent of clients with a negative test, a positive test or no test who choose to purchase an ACT in all four groups.</measure>
    <time_frame>Within 2 days of test results</time_frame>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">444</enrollment>
  <condition>Fever</condition>
  <condition>Malaria</condition>
  <arm_group>
    <arm_group_label>test only (free)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The participant is entitled to a free malaria rapid diagnostic test, but no ACT voucher.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>test (free) &amp; conditional ACT voucher</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The participant is entitled to a free malaria rapid diagnostic test, and an ACT voucher conditional on a positive test result.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>test only (not free)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The participant is entitled to a malaria rapid diagnostic test for a charge (i.e., not for free), but no ACT voucher.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>test (not free) &amp; conditional ACT voucher</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The participant is entitled to a malaria rapid diagnostic test for a charge (i.e., not for free), and an ACT voucher conditional on a positive test result.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Free Malaria Rapid Diagnostic Test</intervention_name>
    <description>Malaria RDT is offered free if patients choose to be tested</description>
    <arm_group_label>test (free) &amp; conditional ACT voucher</arm_group_label>
    <arm_group_label>test only (free)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conditional ACT voucher</intervention_name>
    <description>Participants will be eligible to receive a drug subsidy for a set amount (in the form of a voucher) conditional on a positive malaria test. When a conditional subsidy is offered, it is valid for use on a &quot;Green Leaf&quot; approved malaria drug.</description>
    <arm_group_label>test (free) &amp; conditional ACT voucher</arm_group_label>
    <arm_group_label>test (not free) &amp; conditional ACT voucher</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Malaria Rapid Diagnostic test for a charge</intervention_name>
    <description>Participants can receive a malaria RDT for a set amount (i.e., not for free).</description>
    <arm_group_label>test (not free) &amp; conditional ACT voucher</arm_group_label>
    <arm_group_label>test only (not free)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Client is older than 1 year&#xD;
&#xD;
          -  Client has fever or history of fever or feeling unwell with a malaria-like illness&#xD;
             within the last 24 hours&#xD;
&#xD;
          -  Client or their parent/legal guardian consents to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Client has signs of severe disease or other problem requiring immediate referral to a&#xD;
             community health worker (CHW) / health facility&#xD;
&#xD;
          -  Client has already sought treatment, purchased medicine or taken medicine for the&#xD;
             current illness.&#xD;
&#xD;
        Note:&#xD;
&#xD;
        If more than one febrile person who meet the inclusion criteria are found in a single&#xD;
        household, all of the individuals will be enrolled in the same group, but only one&#xD;
        individual (the first enrolled) will be used for the purposes of the analysis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wendy O'Meara, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Moi University</name>
      <address>
        <city>Eldoret</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kenya</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>December 14, 2015</last_update_submitted>
  <last_update_submitted_qc>December 14, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 15, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Malaria</keyword>
  <keyword>Antimalarial subsidy</keyword>
  <keyword>Malaria rapid diagnostic test (RDT)</keyword>
  <keyword>public-private partnership</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malaria</mesh_term>
  </condition_browse>
  <!-- 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/NCT02199977
org study id: Pro00052602
secondary id: 1R01AI110478-01
nct id: NCT02199977
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
There are compelling medical and public health reasons to reduce unnecessary consumption of
      antimalarials and strong evidence to support the use of RDTs in malaria case management. The
      primary study hypothesis to be tested is that clients who know they will receive a subsidy
      conditional on a positive test are more likely to opt for testing before deciding which drug
      to buy. The primary endpoint is whether subjects choose to be tested for malaria with a rapid
      diagnostic test. The secondary endpoint is whether they purchased an artemisinin combination
      therapy (ACT) or not. The primary outcome of interest is to compare the proportion of
      participants who choose to receive a free malaria diagnostic test when they can receive a
      subsidy for a discounted drug conditional on a positive test (Group A compared to Group B)
      compared to those without the offer of a conditional subsidy. The investigators will use an
      experimental design that randomly assigns clients to one of four groups. Field workers will
      canvas households in the study area looking for individuals who have fever or history of
      fever or illness in the last 24 hours (current illness) who have not yet taken drugs or
      sought treatment outside the home. Clients who meet the inclusion criteria and give verbal
      consent to participate will be randomly assigned to one of the four groups. They will be
      given the location and contact information for their local community health worker who can
      provide a malaria rapid diagnostic test if they choose to be tested. They will also complete
      a survey tool. One week later, the field worker will return to interview the participant and
      determine whether they were tested, what action they took for their illness, what medicine
      they purchased and how much they paid. The investigators will summarize clients' choice by
      the four randomized study groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Effect of conditional drug subsidy on proportion of participants who choose to receive a free malaria diagnostic test
time frame: Within two days of group assignment
description: The primary outcome of interest is to compare the proportion of participants who choose to receive a free malaria diagnostic test when they can receive a subsidy for a discounted drug conditional on a positive test compared to those without the offer of a conditional subsidy.
measure: Effect of malaria RDT subsidy on the uptake of testing (free versus paid RDT)
time frame: Within 2 days of group assignment
measure: Effect of a conditional ACT subsidy on uptake of testing when the RDT is not free.
time frame: Within 2 days of group assignment
measure: Percent of clients with a negative test, a positive test or no test who choose to purchase an ACT in all four groups.
time frame: Within 2 days of test results
arm group label: test only (free)
arm group type: Other
description: The participant is entitled to a free malaria rapid diagnostic test, but no ACT voucher.
arm group label: test (free) & conditional ACT voucher
arm group type: Other
description: The participant is entitled to a free malaria rapid diagnostic test, and an ACT voucher conditional on a positive test result.
arm group label: test only (not free)
arm group type: Other
description: The participant is entitled to a malaria rapid diagnostic test for a charge (i.e., not for free), but no ACT voucher.
arm group label: test (not free) & conditional ACT voucher
arm group type: Other
description: The participant is entitled to a malaria rapid diagnostic test for a charge (i.e., not for free), and an ACT voucher conditional on a positive test result.
intervention type: Other
intervention name: Free Malaria Rapid Diagnostic Test
description: Malaria RDT is offered free if patients choose to be tested
arm group label: test (free) & conditional ACT voucher
arm group label: test only (free)
intervention type: Other
intervention name: Conditional ACT voucher
description: Participants will be eligible to receive a drug subsidy for a set amount (in the form of a voucher) conditional on a positive malaria test. When a conditional subsidy is offered, it is valid for use on a "Green Leaf" approved malaria drug.
arm group label: test (free) & conditional ACT voucher
arm group label: test (not free) & conditional ACT voucher
intervention type: Other
intervention name: Malaria Rapid Diagnostic test for a charge
description: Participants can receive a malaria RDT for a set amount (i.e., not for free).
arm group label: test (not free) & conditional ACT voucher
arm group label: test only (not free)
criteria: 
gender: All
minimum age: 1 Year
maximum age: N/A
healthy volunteers: No
last name: Wendy O'Meara, PhD
role: Principal Investigator
affiliation: Duke University
facility: 
country: Kenya
responsible party type: Sponsor
mesh term: Malaria