<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/NCT03810014</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00100425</org_study_id>
    <secondary_id>1R01AI141444-01</secondary_id>
    <nct_id>NCT03810014</nct_id>
  </id_info>
  <brief_title>Malaria Diagnostic Testing and Conditional Subsidies to Target ACTs in the Retail Sector: the TESTsmART Trial AIM 1</brief_title>
  <acronym>TESTsmART</acronym>
  <official_title>Malaria Diagnostic Testing and Conditional Subsidies to Target ACTs in the Retail Sector: the TESTsmART Trial AIM 1</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>
    <collaborator>
      <agency>Clinton Health Access Initiative, Nigeria</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</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>
      The TESTsmART Trial consists of two main aims. The overall goal of the two aims is to&#xD;
      investigate the impact of malaria rapid diagnostic test (mRDT) subsidies and conditional&#xD;
      artemisinin combination therapy (ACT) subsidies on the testing and treatment behavior of&#xD;
      participants seeking care for their febrile illness in the private retail sector. Conditional&#xD;
      ACT subsidies are discounts on quality-assured ACTs which are linked to the results of a&#xD;
      malaria rapid diagnostic test administered at the retail outlet; only participants with a&#xD;
      positive test will have access to an additional discount on a quality-assured ACT.&#xD;
&#xD;
      The main objective of Aim 1 of this study is to identify a combination of conditional ACT and&#xD;
      RDT subsidies that maximizes the proportion of participants that choose to have a malaria&#xD;
      diagnostic test before taking a drug. The investigators will test two levels of conditional&#xD;
      ACT subsidy (100% subsidy versus ~67% subsidy) and two levels of RDT subsidy (0% subsidy and&#xD;
      50% subsidy) in a factorial designed experiment. Because dose size and therefore the price of&#xD;
      an ACT course are dependent upon patient age, the ACT subsidy amount will also be scaled with&#xD;
      patient age. These subsidy levels were chosen to keep the estimated program cost of the&#xD;
      combined subsidy within $0.30-0.60 USD per person (assuming 100% testing uptake and between&#xD;
      20-40% of participants having a positive RDT). These estimates represent an upper bound since&#xD;
      testing is unlikely to reach 100%. Current subsidy levels for ACT costs the program between&#xD;
      1.30-2.50 USD per treatment, with more than a third of that investment spent on individuals&#xD;
      without malaria.&#xD;
&#xD;
      Individuals presenting to a retail outlet for a treatment of a fever or suspected malaria&#xD;
      illness will be randomized to one of the four groups in equal proportions. A total of 840&#xD;
      participants will be enrolled (210 per arm). Their choices concerning uptake of testing and&#xD;
      drug purchase will be recorded. The main outcome will be the proportion of participants that&#xD;
      choose to take a test. Secondary outcomes include the proportion of participants who adhered&#xD;
      to the results of the RDT among those who were tested (used ACT when positive and did not use&#xD;
      an ACT when negative or without a test). The results of this study will be used to inform the&#xD;
      subsidy levels in the intervention for Aim 2 of this trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      RATIONALE:&#xD;
&#xD;
      From previous studies and implementation experiences, we know that consumption of ACTs&#xD;
      increases as the price declines. Declining prices of ACTs create a trade-off between access&#xD;
      and targeting; lower prices improve uptake of effective therapies by those with malaria but&#xD;
      also increase inappropriate use by those without malaria. Curbing inappropriate use and&#xD;
      targeting ACTs to malaria cases requires parasitological diagnosis which is virtually absent&#xD;
      in the retail sector. It has also been shown that RDTs can be safely deployed in the retail&#xD;
      sector. Most clients will agree to have an RDT if it is free. However, uptake of RDTs is&#xD;
      sensitive to the price of the RDT. Previous work has not specifically evaluated the&#xD;
      relationship between the price of the drug and the price of the test, but available evidence&#xD;
      suggests that uptake of the RDT is sensitive to the price of the ACT as well.&#xD;
&#xD;
      In this work, we will link these two commodities through a diagnosis-dependent ACT subsidy.&#xD;
      Access to the additional ACT subsidy depends on having a positive RDT. What we need to&#xD;
      understand before scaling up a conditional subsidy is how the price of these two commodities&#xD;
      should be related. Should the conditionally-subsidized ACT be less expensive than the RDT?&#xD;
      Must the RDT be considerably less expensive than the retail price of ACT in order to motivate&#xD;
      people to purchase a test?&#xD;
&#xD;
      OBJECTIVES:&#xD;
&#xD;
      In this study (Aim 1) we will use an individually-randomized experiment conducted among&#xD;
      customers at medicine retail outlets to identify the combination of RDT subsidy-level and&#xD;
      conditional ACT subsidy-level that maximizes uptake of diagnostic testing. We choose to focus&#xD;
      on diagnostic testing because this is the first step to achieving the downstream goals of ACT&#xD;
      targeting and rational use.&#xD;
&#xD;
      STUDY DESIGN:&#xD;
&#xD;
      We will use a factorial design to test two ACT subsidy levels and two RDT subsidy levels. The&#xD;
      unit of randomization will be the individual customer.&#xD;
&#xD;
      STUDY POPULATION:&#xD;
&#xD;
      This study will be carried out in a sample of retail shops that carry quality-assured ACTs in&#xD;
      our study area in western Kenya. Ten shops will be randomly selected to participate in the&#xD;
      study. The study population will be any individual presenting to the shop with a malaria-like&#xD;
      illness. Children older than 1 year of age are eligible to be enrolled provided they are&#xD;
      physically present and accompanied by a parent or legal guardian. Customers with a&#xD;
      prescription from a health facility, who have already received a malaria diagnostic test or&#xD;
      who have already taken antimalarials prior to coming to the outlet will be excluded.&#xD;
      Individuals who have signs of severe disease will be excluded and referred immediately to a&#xD;
      health facility for care.&#xD;
&#xD;
      STUDY PROCEDURES:&#xD;
&#xD;
      A research assistant (RA) will be stationed at participating outlets on random days in order&#xD;
      to avoid influencing treatment seeking behavior - in other words, to avoid attracting&#xD;
      customers because of the study team's presence. The RA will obtain consent and offer&#xD;
      participants a scratch card with a secret subsidy offer that will be revealed after the&#xD;
      participant is enrolled. Using the scratch card, the participants will be randomized, in a&#xD;
      1:1:1:1 ratio, to one of four study arms: 1) No subsidy for RDT (price to consumer=$0.40);&#xD;
      100% ACT subsidy (price to consumer=0) // 2) No subsidy for RDT (price to consumer=$0.40);&#xD;
      67% ACT subsidy (price to consumer=$0.40) // 3) 50% subsidy for RDT (price to&#xD;
      consumer=$0.20); 100% ACT subsidy (price to consumer=0) // 4) 50% subsidy for RDT (price to&#xD;
      consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-$0.40, dependent on patient age).&#xD;
&#xD;
      These four arms represent a 2x2 factorial experiment.&#xD;
&#xD;
      If the participant chooses to purchase a test at their assigned price (subsidy level), the&#xD;
      outlet will collect the money and the RA will perform the test. (RAs have been trained in&#xD;
      RDTs and blood safety and have conducted thousands of RDTs. If the test is positive, the&#xD;
      participant is entitled to an additional discount on their ACT purchase according to their&#xD;
      group identified on the scratch card. If the test is negative, the participant may purchase&#xD;
      any medicine they choose, including a regularly-priced ACT. Those who opt not to purchase an&#xD;
      RDT may continue with their transaction as they choose, including purchasing a&#xD;
      regularly-priced ACT.&#xD;
&#xD;
      The outlet attendant will sell the medicines to the customer, including a discounted ACT, if&#xD;
      eligible. The study team will reimburse the outlet the difference between the retail price&#xD;
      and the discounted price.&#xD;
&#xD;
      The RDTs selected for the study will be a World Health Organization (WHO) approved product&#xD;
      that exceed 95% sensitivity and 95% specificity for Plasmodium falciparum [Malaria Rapid&#xD;
      Diagnostic Test Performance, Round 1-5, WHO 2014].&#xD;
&#xD;
      STUDY OUTCOME MEASURES:&#xD;
&#xD;
      The primary outcome for Aim 1 is the customer's decision to purchase an RDT (yes/no). Using&#xD;
      the 2x2 factorial design we will separately evaluate the effect of RDT price (2 levels) and&#xD;
      of conditional ACT subsidies (2 levels) on the primary outcome.&#xD;
&#xD;
      The main secondary outcome is the proportion of tested participants who are adherent to the&#xD;
      test result among those tested. Adherence is defined as taking a quality-assured ACT if the&#xD;
      RDT is positive or taking another drug (or no drug) if the test is negative. We will also&#xD;
      measure the proportion of people who purchase a full-price ACT among those who do not use an&#xD;
      RDT.&#xD;
&#xD;
      SAMPLE SIZE:&#xD;
&#xD;
      We estimated the sample size required in each of the four study arms for a design with equal&#xD;
      numbers of individuals allocated to each arm and where we wish to detect a 15-percentage&#xD;
      point increase in RDT testing between an unsubsidized RDT compared to a subsidized RDT and to&#xD;
      detect a 10 percentage-point difference in testing uptake between a partially and a fully&#xD;
      subsidized ACT (conditional on a positive RDT) with at least 90% power and 5% chance of a&#xD;
      two-tailed Type I error for each of the two comparisons. To do so, we estimate that we will&#xD;
      need 210 subjects per arm (total=840).&#xD;
&#xD;
      ENROLLMENT AND FOLLOW UP:&#xD;
&#xD;
      All participants will be screened and enrolled on the day they visit the outlet. Data&#xD;
      collection will be brief and will be completed on the same day. Participants will be screened&#xD;
      as they arrive, enrolled if eligible and willing, tested if they choose and then allowed to&#xD;
      proceed with their transaction at the outlet. Upon completion, they will be briefly&#xD;
      interviewed again before leaving. Because the interaction with the participant is short and&#xD;
      completed in one encounter, we expect minimal loss to follow-up (for example, participants&#xD;
      leaving before the final questions).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 28, 2019</start_date>
  <completion_date type="Actual">October 31, 2019</completion_date>
  <primary_completion_date type="Actual">October 31, 2019</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>Factorial Assignment</intervention_model>
    <intervention_model_description>A factorial design will be used to test two ACT subsidy levels and two RDT subsidy levels. The unit of randomization will be the individual customer. Using scratch cards, participants will be randomized, in a 1:1:1:1 ratio, to one of four study arms:&#xD;
1) No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=$0) // 2) No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer= $0.10-0.40, dependent upon patient age) // 3) 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0) // 4) 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants That Purchase an mRDT (Malaria Rapid Diagnostic Test)</measure>
    <time_frame>At the end of a participant's visit to participating retail outlet, up to 1 hour</time_frame>
    <description>This outcome will be evaluated once for each customer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With a Positive mRDT That Purchased an ACT (Artemisinin-based Combination Therapy)</measure>
    <time_frame>At the end of a participant's visit to participating retail outlet, up to 1 hour</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With a Negative mRDT That Did Not Purchase an ACT</measure>
    <time_frame>At the end of a participant's visit to participating retail outlet, up to 1 hour</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants That Did Not Purchase an mRDT and Did Not Purchase an ACT</measure>
    <time_frame>At the end of a participant's visit to participating retail outlet, up to 1 hour</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">842</enrollment>
  <condition>Malaria</condition>
  <condition>Febrile Illness</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conditional ACT subsidy, Arm 1 levels</intervention_name>
    <description>The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).</description>
    <arm_group_label>Arm 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conditional ACT subsidy, Arm 2 levels</intervention_name>
    <description>The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).</description>
    <arm_group_label>Arm 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conditional ACT subsidy, Arm 3 levels</intervention_name>
    <description>The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).</description>
    <arm_group_label>Arm 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conditional ACT subsidy, Arm 4 levels</intervention_name>
    <description>The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)</description>
    <arm_group_label>Arm 4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants with fever or history of fever or malaria like illness&#xD;
&#xD;
          -  Individual with malaria-like illness must be present at recruitment&#xD;
&#xD;
          -  1 year of age or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any individual with signs of severe illness requiring immediate referral&#xD;
&#xD;
          -  Individuals who have taken an antimalarial in the last seven days, including for the&#xD;
             current illness&#xD;
&#xD;
          -  Individuals who already have a prescription from a facility or medical provider&#xD;
&#xD;
          -  Pregnant women will be enrolled and offered an mRDT, but will be advised to seek&#xD;
             treatment through a health care provider.&#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 P 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>October 2020</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <results_first_submitted>October 20, 2020</results_first_submitted>
  <results_first_submitted_qc>October 20, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">November 12, 2020</results_first_posted>
  <last_update_submitted>October 20, 2020</last_update_submitted>
  <last_update_submitted_qc>October 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>rapid diagnostic test (RDT)</keyword>
  <keyword>Artemisinin combination therapy (ACT)</keyword>
  <keyword>Conditional subsidy</keyword>
  <keyword>Private retail sector</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malaria</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 20, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT03810014/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 1, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT03810014/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was carried out in a random sample of twelve retail outlets in two sub-counties of rural western Kenya. Potential participants were approached by the research assistants as they sought services at the outlets. Participants were then offered a scratch card with masked arm assignment, which randomized them to one of four study arms in a 1:1:1:1 ratio, each arm with a different combination of two different RDT prices and two different conditional ACT prices using a 2x2 factorial design.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Arm 1</title>
          <description>The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).&#xD;
Conditional ACT subsidy, Arm 1 levels: The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).</description>
        </group>
        <group group_id="P2">
          <title>Arm 2</title>
          <description>The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).&#xD;
Conditional ACT subsidy, Arm 2 levels: The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).</description>
        </group>
        <group group_id="P3">
          <title>Arm 3</title>
          <description>The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).&#xD;
Conditional ACT subsidy, Arm 3 levels: The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).</description>
        </group>
        <group group_id="P4">
          <title>Arm 4</title>
          <description>The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)&#xD;
Conditional ACT subsidy, Arm 4 levels: The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="215"/>
                <participants group_id="P2" count="204"/>
                <participants group_id="P3" count="210"/>
                <participants group_id="P4" count="213"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="213"/>
                <participants group_id="P2" count="202"/>
                <participants group_id="P3" count="210"/>
                <participants group_id="P4" count="211"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Six pregnant women were excluded from baseline characteristics and all following analysis because they didn't meet inclusion criteria.</population>
      <group_list>
        <group group_id="B1">
          <title>Arm 1</title>
          <description>The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).&#xD;
Conditional ACT subsidy, Arm 1 levels: The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).</description>
        </group>
        <group group_id="B2">
          <title>Arm 2</title>
          <description>The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).&#xD;
Conditional ACT subsidy, Arm 2 levels: The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).</description>
        </group>
        <group group_id="B3">
          <title>Arm 3</title>
          <description>The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).&#xD;
Conditional ACT subsidy, Arm 3 levels: The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).</description>
        </group>
        <group group_id="B4">
          <title>Arm 4</title>
          <description>The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)&#xD;
Conditional ACT subsidy, Arm 4 levels: The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="213"/>
            <count group_id="B2" value="202"/>
            <count group_id="B3" value="210"/>
            <count group_id="B4" value="211"/>
            <count group_id="B5" value="836"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30" lower_limit="11" upper_limit="45"/>
                    <measurement group_id="B2" value="28.5" lower_limit="11" upper_limit="45"/>
                    <measurement group_id="B3" value="30" lower_limit="16" upper_limit="43"/>
                    <measurement group_id="B4" value="31" lower_limit="15" upper_limit="45"/>
                    <measurement group_id="B5" value="30" lower_limit="13" upper_limit="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="97"/>
                    <measurement group_id="B2" value="96"/>
                    <measurement group_id="B3" value="92"/>
                    <measurement group_id="B4" value="103"/>
                    <measurement group_id="B5" value="388"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="116"/>
                    <measurement group_id="B2" value="106"/>
                    <measurement group_id="B3" value="118"/>
                    <measurement group_id="B4" value="107"/>
                    <measurement group_id="B5" value="447"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown or Not Reported</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="213"/>
                    <measurement group_id="B2" value="202"/>
                    <measurement group_id="B3" value="210"/>
                    <measurement group_id="B4" value="211"/>
                    <measurement group_id="B5" value="836"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="213"/>
                    <measurement group_id="B2" value="202"/>
                    <measurement group_id="B3" value="210"/>
                    <measurement group_id="B4" value="211"/>
                    <measurement group_id="B5" value="836"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Kenya</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="213"/>
                    <measurement group_id="B2" value="202"/>
                    <measurement group_id="B3" value="210"/>
                    <measurement group_id="B4" value="211"/>
                    <measurement group_id="B5" value="836"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants That Purchase an mRDT (Malaria Rapid Diagnostic Test)</title>
        <description>This outcome will be evaluated once for each customer</description>
        <time_frame>At the end of a participant's visit to participating retail outlet, up to 1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Arm 1</title>
            <description>The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).&#xD;
Conditional ACT subsidy, Arm 1 levels: The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).</description>
          </group>
          <group group_id="O2">
            <title>Arm 2</title>
            <description>The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).&#xD;
Conditional ACT subsidy, Arm 2 levels: The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).</description>
          </group>
          <group group_id="O3">
            <title>Arm 3</title>
            <description>The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).&#xD;
Conditional ACT subsidy, Arm 3 levels: The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).</description>
          </group>
          <group group_id="O4">
            <title>Arm 4</title>
            <description>The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)&#xD;
Conditional ACT subsidy, Arm 4 levels: The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants That Purchase an mRDT (Malaria Rapid Diagnostic Test)</title>
          <description>This outcome will be evaluated once for each customer</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="213"/>
                <count group_id="O2" value="202"/>
                <count group_id="O3" value="210"/>
                <count group_id="O4" value="211"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="205"/>
                    <measurement group_id="O2" value="195"/>
                    <measurement group_id="O3" value="207"/>
                    <measurement group_id="O4" value="211"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>(Arm 3 + Arm 4) vs (Arm 1 + Arm 2)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.01</p_value>
            <method>Generalized estimating equations</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>2.50</param_value>
            <ci_percent>98</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.20</ci_lower_limit>
            <ci_upper_limit>4.80</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>(Arm 3 + Arm 4) vs (Arm 1 + Arm 2)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.012</p_value>
            <method>Generalized estimating equations</method>
            <param_type>Risk Ratio, log</param_type>
            <param_value>1.025</param_value>
            <ci_percent>98</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.002</ci_lower_limit>
            <ci_upper_limit>1.049</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>(Arm 1 + Arm 3) vs (Arm 2 + Arm 4)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.33</p_value>
            <method>Generalized estimating equations</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>-0.60</param_value>
            <ci_percent>98</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.20</ci_lower_limit>
            <ci_upper_limit>0.90</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>(Arm 1 + Arm 3) vs (Arm 2 + Arm 4)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.332</p_value>
            <method>Generalized estimating equations</method>
            <param_type>Risk Ratio, log</param_type>
            <param_value>0.994</param_value>
            <ci_percent>98</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.979</ci_lower_limit>
            <ci_upper_limit>1.009</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With a Positive mRDT That Purchased an ACT (Artemisinin-based Combination Therapy)</title>
        <time_frame>At the end of a participant's visit to participating retail outlet, up to 1 hour</time_frame>
        <population>Participants with a positive mRDT</population>
        <group_list>
          <group group_id="O1">
            <title>Arm 1</title>
            <description>The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).&#xD;
Conditional ACT subsidy, Arm 1 levels: The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).</description>
          </group>
          <group group_id="O2">
            <title>Arm 2</title>
            <description>The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).&#xD;
Conditional ACT subsidy, Arm 2 levels: The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).</description>
          </group>
          <group group_id="O3">
            <title>Arm 3</title>
            <description>The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).&#xD;
Conditional ACT subsidy, Arm 3 levels: The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).</description>
          </group>
          <group group_id="O4">
            <title>Arm 4</title>
            <description>The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)&#xD;
Conditional ACT subsidy, Arm 4 levels: The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Positive mRDT That Purchased an ACT (Artemisinin-based Combination Therapy)</title>
          <population>Participants with a positive mRDT</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="39"/>
                    <measurement group_id="O3" value="24"/>
                    <measurement group_id="O4" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With a Negative mRDT That Did Not Purchase an ACT</title>
        <time_frame>At the end of a participant's visit to participating retail outlet, up to 1 hour</time_frame>
        <population>Participants with a negative mRDT. 5 participants were not included due to missing ACT purchasing behavior; four in Arm 2 and one in Arm 3.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm 1</title>
            <description>The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).&#xD;
Conditional ACT subsidy, Arm 1 levels: The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).</description>
          </group>
          <group group_id="O2">
            <title>Arm 2</title>
            <description>The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).&#xD;
Conditional ACT subsidy, Arm 2 levels: The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).</description>
          </group>
          <group group_id="O3">
            <title>Arm 3</title>
            <description>The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).&#xD;
Conditional ACT subsidy, Arm 3 levels: The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).</description>
          </group>
          <group group_id="O4">
            <title>Arm 4</title>
            <description>The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)&#xD;
Conditional ACT subsidy, Arm 4 levels: The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Negative mRDT That Did Not Purchase an ACT</title>
          <population>Participants with a negative mRDT. 5 participants were not included due to missing ACT purchasing behavior; four in Arm 2 and one in Arm 3.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="154"/>
                <count group_id="O2" value="145"/>
                <count group_id="O3" value="175"/>
                <count group_id="O4" value="165"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144"/>
                    <measurement group_id="O2" value="132"/>
                    <measurement group_id="O3" value="166"/>
                    <measurement group_id="O4" value="155"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants That Did Not Purchase an mRDT and Did Not Purchase an ACT</title>
        <time_frame>At the end of a participant's visit to participating retail outlet, up to 1 hour</time_frame>
        <population>Participants with no mRDT</population>
        <group_list>
          <group group_id="O1">
            <title>Arm 1</title>
            <description>The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).&#xD;
Conditional ACT subsidy, Arm 1 levels: The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).</description>
          </group>
          <group group_id="O2">
            <title>Arm 2</title>
            <description>The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).&#xD;
Conditional ACT subsidy, Arm 2 levels: The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).</description>
          </group>
          <group group_id="O3">
            <title>Arm 3</title>
            <description>The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).&#xD;
Conditional ACT subsidy, Arm 3 levels: The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).</description>
          </group>
          <group group_id="O4">
            <title>Arm 4</title>
            <description>The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)&#xD;
Conditional ACT subsidy, Arm 4 levels: The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants That Did Not Purchase an mRDT and Did Not Purchase an ACT</title>
          <population>Participants with no mRDT</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>up to 1 hour</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Arm 1</title>
          <description>The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).&#xD;
Conditional ACT subsidy, Arm 1 levels: The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).</description>
        </group>
        <group group_id="E2">
          <title>Arm 2</title>
          <description>The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).&#xD;
Conditional ACT subsidy, Arm 2 levels: The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).</description>
        </group>
        <group group_id="E3">
          <title>Arm 3</title>
          <description>The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).&#xD;
Conditional ACT subsidy, Arm 3 levels: The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).</description>
        </group>
        <group group_id="E4">
          <title>Arm 4</title>
          <description>The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)&#xD;
Conditional ACT subsidy, Arm 4 levels: The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="211"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="211"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="202"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="211"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Wendy P O'Meara, PhD</name_or_title>
      <organization>Duke University</organization>
      <phone>919-681-7711</phone>
      <email>wpo@duke.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03810014
org study id: Pro00100425
secondary id: 1R01AI141444-01
nct id: NCT03810014
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The TESTsmART Trial consists of two main aims. The overall goal of the two aims is to
      investigate the impact of malaria rapid diagnostic test (mRDT) subsidies and conditional
      artemisinin combination therapy (ACT) subsidies on the testing and treatment behavior of
      participants seeking care for their febrile illness in the private retail sector. Conditional
      ACT subsidies are discounts on quality-assured ACTs which are linked to the results of a
      malaria rapid diagnostic test administered at the retail outlet; only participants with a
      positive test will have access to an additional discount on a quality-assured ACT.

      The main objective of Aim 1 of this study is to identify a combination of conditional ACT and
      RDT subsidies that maximizes the proportion of participants that choose to have a malaria
      diagnostic test before taking a drug. The investigators will test two levels of conditional
      ACT subsidy (100% subsidy versus ~67% subsidy) and two levels of RDT subsidy (0% subsidy and
      50% subsidy) in a factorial designed experiment. Because dose size and therefore the price of
      an ACT course are dependent upon patient age, the ACT subsidy amount will also be scaled with
      patient age. These subsidy levels were chosen to keep the estimated program cost of the
      combined subsidy within $0.30-0.60 USD per person (assuming 100% testing uptake and between
      20-40% of participants having a positive RDT). These estimates represent an upper bound since
      testing is unlikely to reach 100%. Current subsidy levels for ACT costs the program between
      1.30-2.50 USD per treatment, with more than a third of that investment spent on individuals
      without malaria.

      Individuals presenting to a retail outlet for a treatment of a fever or suspected malaria
      illness will be randomized to one of the four groups in equal proportions. A total of 840
      participants will be enrolled (210 per arm). Their choices concerning uptake of testing and
      drug purchase will be recorded. The main outcome will be the proportion of participants that
      choose to take a test. Secondary outcomes include the proportion of participants who adhered
      to the results of the RDT among those who were tested (used ACT when positive and did not use
      an ACT when negative or without a test). The results of this study will be used to inform the
      subsidy levels in the intervention for Aim 2 of this trial.
RATIONALE:

      From previous studies and implementation experiences, we know that consumption of ACTs
      increases as the price declines. Declining prices of ACTs create a trade-off between access
      and targeting; lower prices improve uptake of effective therapies by those with malaria but
      also increase inappropriate use by those without malaria. Curbing inappropriate use and
      targeting ACTs to malaria cases requires parasitological diagnosis which is virtually absent
      in the retail sector. It has also been shown that RDTs can be safely deployed in the retail
      sector. Most clients will agree to have an RDT if it is free. However, uptake of RDTs is
      sensitive to the price of the RDT. Previous work has not specifically evaluated the
      relationship between the price of the drug and the price of the test, but available evidence
      suggests that uptake of the RDT is sensitive to the price of the ACT as well.

      In this work, we will link these two commodities through a diagnosis-dependent ACT subsidy.
      Access to the additional ACT subsidy depends on having a positive RDT. What we need to
      understand before scaling up a conditional subsidy is how the price of these two commodities
      should be related. Should the conditionally-subsidized ACT be less expensive than the RDT?
      Must the RDT be considerably less expensive than the retail price of ACT in order to motivate
      people to purchase a test?

      OBJECTIVES:

      In this study (Aim 1) we will use an individually-randomized experiment conducted among
      customers at medicine retail outlets to identify the combination of RDT subsidy-level and
      conditional ACT subsidy-level that maximizes uptake of diagnostic testing. We choose to focus
      on diagnostic testing because this is the first step to achieving the downstream goals of ACT
      targeting and rational use.

      STUDY DESIGN:

      We will use a factorial design to test two ACT subsidy levels and two RDT subsidy levels. The
      unit of randomization will be the individual customer.

      STUDY POPULATION:

      This study will be carried out in a sample of retail shops that carry quality-assured ACTs in
      our study area in western Kenya. Ten shops will be randomly selected to participate in the
      study. The study population will be any individual presenting to the shop with a malaria-like
      illness. Children older than 1 year of age are eligible to be enrolled provided they are
      physically present and accompanied by a parent or legal guardian. Customers with a
      prescription from a health facility, who have already received a malaria diagnostic test or
      who have already taken antimalarials prior to coming to the outlet will be excluded.
      Individuals who have signs of severe disease will be excluded and referred immediately to a
      health facility for care.

      STUDY PROCEDURES:

      A research assistant (RA) will be stationed at participating outlets on random days in order
      to avoid influencing treatment seeking behavior - in other words, to avoid attracting
      customers because of the study team's presence. The RA will obtain consent and offer
      participants a scratch card with a secret subsidy offer that will be revealed after the
      participant is enrolled. Using the scratch card, the participants will be randomized, in a
      1:1:1:1 ratio, to one of four study arms: 1) No subsidy for RDT (price to consumer=$0.40);
      100% ACT subsidy (price to consumer=0) // 2) No subsidy for RDT (price to consumer=$0.40);
      67% ACT subsidy (price to consumer=$0.40) // 3) 50% subsidy for RDT (price to
      consumer=$0.20); 100% ACT subsidy (price to consumer=0) // 4) 50% subsidy for RDT (price to
      consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-$0.40, dependent on patient age).

      These four arms represent a 2x2 factorial experiment.

      If the participant chooses to purchase a test at their assigned price (subsidy level), the
      outlet will collect the money and the RA will perform the test. (RAs have been trained in
      RDTs and blood safety and have conducted thousands of RDTs. If the test is positive, the
      participant is entitled to an additional discount on their ACT purchase according to their
      group identified on the scratch card. If the test is negative, the participant may purchase
      any medicine they choose, including a regularly-priced ACT. Those who opt not to purchase an
      RDT may continue with their transaction as they choose, including purchasing a
      regularly-priced ACT.

      The outlet attendant will sell the medicines to the customer, including a discounted ACT, if
      eligible. The study team will reimburse the outlet the difference between the retail price
      and the discounted price.

      The RDTs selected for the study will be a World Health Organization (WHO) approved product
      that exceed 95% sensitivity and 95% specificity for Plasmodium falciparum [Malaria Rapid
      Diagnostic Test Performance, Round 1-5, WHO 2014].

      STUDY OUTCOME MEASURES:

      The primary outcome for Aim 1 is the customer's decision to purchase an RDT (yes/no). Using
      the 2x2 factorial design we will separately evaluate the effect of RDT price (2 levels) and
      of conditional ACT subsidies (2 levels) on the primary outcome.

      The main secondary outcome is the proportion of tested participants who are adherent to the
      test result among those tested. Adherence is defined as taking a quality-assured ACT if the
      RDT is positive or taking another drug (or no drug) if the test is negative. We will also
      measure the proportion of people who purchase a full-price ACT among those who do not use an
      RDT.

      SAMPLE SIZE:

      We estimated the sample size required in each of the four study arms for a design with equal
      numbers of individuals allocated to each arm and where we wish to detect a 15-percentage
      point increase in RDT testing between an unsubsidized RDT compared to a subsidized RDT and to
      detect a 10 percentage-point difference in testing uptake between a partially and a fully
      subsidized ACT (conditional on a positive RDT) with at least 90% power and 5% chance of a
      two-tailed Type I error for each of the two comparisons. To do so, we estimate that we will
      need 210 subjects per arm (total=840).

      ENROLLMENT AND FOLLOW UP:

      All participants will be screened and enrolled on the day they visit the outlet. Data
      collection will be brief and will be completed on the same day. Participants will be screened
      as they arrive, enrolled if eligible and willing, tested if they choose and then allowed to
      proceed with their transaction at the outlet. Upon completion, they will be briefly
      interviewed again before leaving. Because the interaction with the participant is short and
      completed in one encounter, we expect minimal loss to follow-up (for example, participants
      leaving before the final questions).
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: A factorial design will be used to test two ACT subsidy levels and two RDT subsidy levels. The unit of randomization will be the individual customer. Using scratch cards, participants will be randomized, in a 1:1:1:1 ratio, to one of four study arms:
1) No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=$0) // 2) No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer= $0.10-0.40, dependent upon patient age) // 3) 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0) // 4) 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)
primary purpose: Health Services Research
masking: None (Open Label)
measure: Number of Participants That Purchase an mRDT (Malaria Rapid Diagnostic Test)
time frame: At the end of a participant's visit to participating retail outlet, up to 1 hour
description: This outcome will be evaluated once for each customer
measure: Number of Participants With a Positive mRDT That Purchased an ACT (Artemisinin-based Combination Therapy)
time frame: At the end of a participant's visit to participating retail outlet, up to 1 hour
measure: Number of Participants With a Negative mRDT That Did Not Purchase an ACT
time frame: At the end of a participant's visit to participating retail outlet, up to 1 hour
measure: Number of Participants That Did Not Purchase an mRDT and Did Not Purchase an ACT
time frame: At the end of a participant's visit to participating retail outlet, up to 1 hour
arm group label: Arm 1
arm group type: Experimental
description: The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).
arm group label: Arm 2
arm group type: Experimental
description: The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).
arm group label: Arm 3
arm group type: Experimental
description: The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).
arm group label: Arm 4
arm group type: Experimental
description: The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)
intervention type: Other
intervention name: Conditional ACT subsidy, Arm 1 levels
description: The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).
arm group label: Arm 1
intervention type: Other
intervention name: Conditional ACT subsidy, Arm 2 levels
description: The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).
arm group label: Arm 2
intervention type: Other
intervention name: Conditional ACT subsidy, Arm 3 levels
description: The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).
arm group label: Arm 3
intervention type: Other
intervention name: Conditional ACT subsidy, Arm 4 levels
description: The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)
arm group label: Arm 4
criteria: 
gender: All
minimum age: 1 Year
maximum age: N/A
healthy volunteers: No
last name: Wendy P O'Meara, PhD
role: Principal Investigator
affiliation: Duke University
facility: 
country: Kenya
responsible party type: Sponsor
mesh term: Malaria
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 