<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/NCT03755986</url>
  </required_header>
  <id_info>
    <org_study_id>ARST001-2016</org_study_id>
    <nct_id>NCT03755986</nct_id>
  </id_info>
  <brief_title>Performance and Usability Evaluation of the Atomo HIV Self-Test</brief_title>
  <official_title>Performance and Usability Evaluation of the Atomo HIV Self-Test</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Holdsworth House Medical Practice</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Atomo Diagnostics</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Holdsworth House Medical Practice</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study seeks to enroll 501+ patients to use a HIV self testing device to test for HIV in a&#xD;
      blood sample drawn by finger prick. The purpose of the trial is to assess the usability of&#xD;
      the device by providing participants with video and written instructions on how to correctly&#xD;
      obtain a result from the device.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Questionnaire scoring each step of performing the self-test</measure>
    <time_frame>Assessed at one time point per patient (visit 1) approximately 1 hour</time_frame>
    <description>To assess the ability of typical self-test users to follow the test instructions and perform the test accurately and to identify any issues or difficulty they may experience whilst performing the test.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Questionnaire scoring each step of performing the self-test</measure>
    <time_frame>Assessed at one time point per patient (visit 1) approximately 1 hour</time_frame>
    <description>To assess the ability of typical self-test users to perform the test accurately</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Questionnaire scoring each step of performing the self-test</measure>
    <time_frame>Assessed at one time point per patient (visit 1) approximately 1 hour</time_frame>
    <description>To identify any issues or difficulty the self-test users may experience whilst performing the test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Questionnaire scoring each step of performing the self-test</measure>
    <time_frame>Assessed at one time point only per patient (visit 1)approximately 1 hour</time_frame>
    <description>To assess the ability of typical self-test users to follow the test instructions and perform the test accurately when the user knows they did not perform the steps of testing properly in their initial attempt.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of self-test user result against the standard of care laboratory test for HIV</measure>
    <time_frame>Assessed at one time point only per patient (visit 1)approximately 1 hour</time_frame>
    <description>The result obtained by the self-test user will be compared against a standard laboratory test for HIV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of self-test done in the laboratory against the standard of care laboratory blood test for HIV</measure>
    <time_frame>Assessed at one time point only per patient (visit 1)approximately 1 hour</time_frame>
    <description>The result obtained by a qualified lab technician using the participant's blood sample for the self-test will be compared against a standard laboratory blood test for HIV</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">520</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>ATOMO Diagnostic Test</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All patients will receive an ATOMO diagnostic test to use. There is no comparative arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ATOMO Diagnostic Test</intervention_name>
    <description>The ATOMO diagnostic test device is the only intervention used in this study.</description>
    <arm_group_label>ATOMO Diagnostic Test</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria The inclusion criteria are informed by the indications for HIV testing&#xD;
        contained in the National HIV Testing Policy, which states that HIV testing is indicated in&#xD;
        the following groups: MSM; people who inject drugs; people with multiple sex partners or&#xD;
        recent partner change; people having travelled to countries of high prevalence and engaged&#xD;
        in risk behavior; people from high prevalence countries; partners of the above; and&#xD;
        partners of people living with HIV infection.&#xD;
&#xD;
        Recruitment will be restricted to people who satisfy the following criteria:&#xD;
&#xD;
          1. Attending health clinic or community-based testing study sites&#xD;
&#xD;
          2. Aged 18 years or more&#xD;
&#xD;
          3. Requesting HIV testing and/or in whom HIV testing is indicated&#xD;
&#xD;
          4. Willing and able to give their own informed consent&#xD;
&#xD;
          5. Willing to participate in and comply with the study procedures&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
        The following people will be excluded from the study:&#xD;
&#xD;
          1. People in whom HIV testing is not indicated or not appropriate&#xD;
&#xD;
          2. People not fluent in English in whom provision of informed consent or compliance with&#xD;
             the study procedures may be problematic&#xD;
&#xD;
          3. People who have participated in the study previously&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Terrance J Thiel</last_name>
    <role>Study Director</role>
    <affiliation>Atomo Diagnostics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Holdsworth House Medical Practice</name>
      <address>
        <city>Darlinghurst</city>
        <state>New South Wales</state>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>February 22, 2017</study_first_submitted>
  <study_first_submitted_qc>November 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>November 25, 2018</last_update_submitted>
  <last_update_submitted_qc>November 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Holdsworth House Medical Practice</investigator_affiliation>
    <investigator_full_name>Dr. Mark Bloch</investigator_full_name>
    <investigator_title>A/Prof</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_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/NCT03755986
org study id: ARST001-2016
nct id: NCT03755986
lead sponsor: 
collaborator: 
has dmc: No
The study seeks to enroll 501+ patients to use a HIV self testing device to test for HIV in a
      blood sample drawn by finger prick. The purpose of the trial is to assess the usability of
      the device by providing participants with video and written instructions on how to correctly
      obtain a result from the device.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Questionnaire scoring each step of performing the self-test
time frame: Assessed at one time point per patient (visit 1) approximately 1 hour
description: To assess the ability of typical self-test users to follow the test instructions and perform the test accurately and to identify any issues or difficulty they may experience whilst performing the test.
measure: Questionnaire scoring each step of performing the self-test
time frame: Assessed at one time point per patient (visit 1) approximately 1 hour
description: To assess the ability of typical self-test users to perform the test accurately
measure: Questionnaire scoring each step of performing the self-test
time frame: Assessed at one time point per patient (visit 1) approximately 1 hour
description: To identify any issues or difficulty the self-test users may experience whilst performing the test.
measure: Questionnaire scoring each step of performing the self-test
time frame: Assessed at one time point only per patient (visit 1)approximately 1 hour
description: To assess the ability of typical self-test users to follow the test instructions and perform the test accurately when the user knows they did not perform the steps of testing properly in their initial attempt.
measure: Comparison of self-test user result against the standard of care laboratory test for HIV
time frame: Assessed at one time point only per patient (visit 1)approximately 1 hour
description: The result obtained by the self-test user will be compared against a standard laboratory test for HIV
measure: Comparison of self-test done in the laboratory against the standard of care laboratory blood test for HIV
time frame: Assessed at one time point only per patient (visit 1)approximately 1 hour
description: The result obtained by a qualified lab technician using the participant's blood sample for the self-test will be compared against a standard laboratory blood test for HIV
arm group label: ATOMO Diagnostic Test
arm group type: Other
description: All patients will receive an ATOMO diagnostic test to use. There is no comparative arm.
intervention type: Device
intervention name: ATOMO Diagnostic Test
description: The ATOMO diagnostic test device is the only intervention used in this study.
arm group label: ATOMO Diagnostic Test
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Terrance J Thiel
role: Study Director
affiliation: Atomo Diagnostics
facility: 
country: Australia
responsible party type: Principal Investigator
investigator affiliation: Holdsworth House Medical Practice
investigator full name: Dr. Mark Bloch
investigator title: A/Prof
mesh term: HIV Infections
sharing ipd: No