<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/NCT03271424</url>
  </required_header>
  <id_info>
    <org_study_id>15-1361a</org_study_id>
    <secondary_id>5R01HD083033</secondary_id>
    <nct_id>NCT03271424</nct_id>
  </id_info>
  <brief_title>Innovations in HIV Testing (TI)</brief_title>
  <official_title>Innovations in HIV Testing to Enhance Care for Young Women and Their Peers and Partners</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Witwatersrand, South Africa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators propose to improve HIV prevention and care through expanding HIV testing&#xD;
      options to include self-testing for young women, their peers and their sex partners, and by&#xD;
      facilitating linkage to care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Description Brief Summary: The investigators propose to improve HIV prevention and care&#xD;
      through expanding HIV testing options to include self-testing for young women, their peers&#xD;
      and their sex partners, and by facilitating linkage to care.&#xD;
&#xD;
      Detailed Description: The investigators propose to improve HIV prevention and care through&#xD;
      expanding HIV testing options to include self-testing for young women, their peers and their&#xD;
      sex partners, and by facilitating linkage to care. In this study the investigators proposed&#xD;
      two phases. The first phase, explained in this submission, is formative and involved two&#xD;
      parts: 1) conducting formative qualitative research to understand perceptions of HIV testing&#xD;
      and HIV self-testing in the study population and 2) conducting observed HIV self-testing to&#xD;
      better understand any challenges with self-testing and the materials needed to make the&#xD;
      process clear. The second phase of the study is a randomized controlled trial where the&#xD;
      investigators will randomize approximately 400 young women to receive either 1) CHOICE of&#xD;
      self-testing or clinic-based HIV Counseling and Testing (HCT) or 2) clinic based HCT. Once&#xD;
      young women have been randomized, they will be asked to recruit up to 4 peers or male sex&#xD;
      partners to test with the method of their randomization group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2015</start_date>
  <completion_date type="Actual">June 1, 2016</completion_date>
  <primary_completion_date type="Actual">June 1, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Qualitative focus group discussions (FGDs) with male and female community members aged 18 - 24&#xD;
In-clinic observation of HIV self-testing and completion of a brief CAPI/ACASI interview with male and female community members aged 18 - 24</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Qualitative Summaries of Participant Experience in Focus Group Discussions</measure>
    <time_frame>6 months post study start</time_frame>
    <description>Qualitative Summaries for recruitment of peers/sex partners, issues related to privacy and spaces for testing, options for post-test counseling, optimizing return visits, and preferences for contact</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quantitative Summaries of Participants Experience in Observation Sessions</measure>
    <time_frame>12 month post study start</time_frame>
    <description>Frequency counts of clarity of instructions, comfort using the test, confidence in test result, difficulty performing the test and reading results</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">95</enrollment>
  <condition>Human Immunodeficiency Virus</condition>
  <arm_group>
    <arm_group_label>Focus Group Discussions</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Focus group discussions (FGD) with young women (n=2 FGDs) and young men (n=2 FGDs) in the study area to determine the best way to offer self-testing to study participants.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>In Clinic Observation-Both</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>10 young women and 10 young men were assigned and conducted BOTH of the HIV self-tests. Participants tried two different self-testing kits, one that is oral fluid based (saliva), Oraquick HIV Self Test, and one that is blood based via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test and Atomo HIV Self Test - Both</description>
  </arm_group>
  <arm_group>
    <arm_group_label>In Clinic Observation-Subject Choice</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 young women and 20 young men were assigned and conducted EITHER of the HIV self-tests. Investigators asked them to choose which test they would prefer to use, one that is oral fluid based (saliva), Oraquick HIV Self Test, or one that requires the use blood via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test - Choice; Atomo HIV Self Test - choice</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Oraquick HIV Self Test - Choice</intervention_name>
    <description>This is an oral swab in home HIV test.</description>
    <arm_group_label>In Clinic Observation-Subject Choice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Atomo HIV Self Test - Choice</intervention_name>
    <description>This is a blood finger prick in home HIV test.</description>
    <arm_group_label>In Clinic Observation-Subject Choice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Oraquick HIV Self Test and Atomo HIV Self Test - Both</intervention_name>
    <description>This is an oral swab in home HIV test and this is a blood finger prick in home HIV test.</description>
    <arm_group_label>In Clinic Observation-Both</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        FGD Inclusion Criteria:&#xD;
&#xD;
          -  Females and males aged 18 - 24&#xD;
&#xD;
          -  Able and willing to provide informed consent&#xD;
&#xD;
          -  Residing in the selected villages&#xD;
&#xD;
        Observation Inclusion Criteria:&#xD;
&#xD;
          -  Females and males aged 18 -24&#xD;
&#xD;
          -  Able and willing to provide informed consent&#xD;
&#xD;
          -  Residing in the selected villages&#xD;
&#xD;
          -  Not known to be HIV positive (not reporting a previous positive test)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Enrolled participants need to self-identify as female or female for their respective data collection.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Audrey Pettifor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit</name>
      <address>
        <city>Agincourt</city>
        <state>Mpumalanga</state>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>South Africa</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <results_first_submitted>October 19, 2017</results_first_submitted>
  <results_first_submitted_qc>December 18, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">January 19, 2018</results_first_posted>
  <last_update_submitted>December 18, 2017</last_update_submitted>
  <last_update_submitted_qc>December 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>In Clinic Observation-Both</title>
          <description>10 young women and 10 young men were assigned and conducted BOTH of the HIV self-tests. Participants tried two different self-testing kits, one that is oral fluid based (saliva), Oraquick HIV Self Test, and one that is blood based via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test and Atomo HIV Self Test - Both&#xD;
Oraquick HIV Self Test and Atomo HIV Self Test - Both: This is an oral swab in home HIV test and this is a blood finger prick in home HIV test.</description>
        </group>
        <group group_id="P2">
          <title>Focus Group Discussions</title>
          <description>Focus group discussions (FGD) with young women (n=2 FGDs) and young men (n=2 FGDs) in the study area to determine the best way to offer self-testing to study participants.</description>
        </group>
        <group group_id="P3">
          <title>In Clinic Observation-Subject Choice</title>
          <description>20 young women and 20 young men were assigned and conducted EITHER of the HIV self-tests. Investigators asked them to choose which test they would prefer to use, one that is oral fluid based (saliva), Oraquick HIV Self Test, or one that requires the use blood via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test - Choice; Atomo HIV Self Test - choice&#xD;
Oraquick HIV Self Test - Choice: This is an oral swab in home HIV test.&#xD;
Atomo HIV Self Test - Choice: This is a blood finger prick in home HIV test.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>November 2015</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>December 2015</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="35"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="35"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>April-May 2016</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Focus Group Discussions</title>
          <description>Focus group discussions (FGD) with young women (n=2 FGDs) and young men (n=2 FGDs) in the study area to determine the best way to offer self-testing to study participants.</description>
        </group>
        <group group_id="B2">
          <title>In Clinic Observation-Both</title>
          <description>10 young women and 10 young men were assigned and conducted BOTH of the HIV self-tests. Participants tried two different self-testing kits, one that is oral fluid based (saliva), Oraquick HIV Self Test, and one that is blood based via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test and Atomo HIV Self Test - Both&#xD;
Oraquick HIV Self Test and Atomo HIV Self Test - Both: This is an oral swab in home HIV test and this is a blood finger prick in home HIV test.</description>
        </group>
        <group group_id="B3">
          <title>In Clinic Observation-Subject Choice</title>
          <description>20 young women and 20 young men were assigned and conducted EITHER of the HIV self-tests. Investigators asked them to choose which test they would prefer to use, one that is oral fluid based (saliva), Oraquick HIV Self Test, or one that requires the use blood via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test - Choice; Atomo HIV Self Test - choice&#xD;
Oraquick HIV Self Test - Choice: This is an oral swab in home HIV test.&#xD;
Atomo HIV Self Test - Choice: This is a blood finger prick in home HIV test.</description>
        </group>
        <group group_id="B4">
          <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="35"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="40"/>
            <count group_id="B4" value="95"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                    <measurement group_id="B4" value="95"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20" lower_limit="18" upper_limit="24"/>
                    <measurement group_id="B2" value="20" lower_limit="18" upper_limit="24"/>
                    <measurement group_id="B3" value="20" lower_limit="18" upper_limit="24"/>
                    <measurement group_id="B4" value="20" lower_limit="18" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="49"/>
                  </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>South Africa</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                    <measurement group_id="B4" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Qualitative Summaries of Participant Experience in Focus Group Discussions</title>
        <description>Qualitative Summaries for recruitment of peers/sex partners, issues related to privacy and spaces for testing, options for post-test counseling, optimizing return visits, and preferences for contact</description>
        <time_frame>6 months post study start</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Focus Group Discussions</title>
            <description>Focus group discussions (FGD) with young women (n=2 FGDs) and young men (n=2 FGDs) in the study area to determine the best way to offer self-testing to study participants.</description>
          </group>
        </group_list>
        <measure>
          <title>Qualitative Summaries of Participant Experience in Focus Group Discussions</title>
          <description>Qualitative Summaries for recruitment of peers/sex partners, issues related to privacy and spaces for testing, options for post-test counseling, optimizing return visits, and preferences for contact</description>
          <units>number of times reported in FGD</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HIV Self Test (HST) Acceptability</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HST Context</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HST Kit Preference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HST motivation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HST Recommendations</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supportive resources</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Quantitative Summaries of Participants Experience in Observation Sessions</title>
        <description>Frequency counts of clarity of instructions, comfort using the test, confidence in test result, difficulty performing the test and reading results</description>
        <time_frame>12 month post study start</time_frame>
        <group_list>
          <group group_id="O1">
            <title>In Clinic Observation-Both (Oraquick Results)</title>
            <description>10 young women and 10 young men were assigned and conducted BOTH of the HIV self-tests. Participants tried two different self-testing kits, one that is oral fluid based (saliva), Oraquick HIV Self Test, and one that is blood based via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test and Atomo HIV Self Test - Both&#xD;
Oraquick HIV Self Test and Atomo HIV Self Test - Both: This is an oral swab in home HIV test and this is a blood finger prick in home HIV test.</description>
          </group>
          <group group_id="O2">
            <title>In Clinic Observation - Both (Atomo Results)</title>
            <description>10 young women and 10 young men were assigned and conducted BOTH of the HIV self-tests. Participants tried two different self-testing kits, one that is oral fluid based (saliva), Oraquick HIV Self Test, and one that is blood based via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test and Atomo HIV Self Test - Both&#xD;
Oraquick HIV Self Test and Atomo HIV Self Test - Both: This is an oral swab in home HIV test and this is a blood finger prick in home HIV test.</description>
          </group>
          <group group_id="O3">
            <title>In Clinic Observation-Subject Choice (Oraquick Results)</title>
            <description>20 young women and 20 young men conducted EITHER of the HIV self-tests. Investigators asked them to choose which test they would prefer to use, one that is oral fluid based (saliva), Oraquick HIV Self Test, or one that requires the use blood via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test - Choice; Atomo HIV Self Test - choice&#xD;
Oraquick HIV Self Test - Choice: This is an oral swab in home HIV test.&#xD;
Atomo HIV Self Test - Choice: This is a blood finger prick in home HIV test.</description>
          </group>
          <group group_id="O4">
            <title>In Clinic Observation-Subject Choice (Atomo Results)</title>
            <description>20 young women and 20 young men conducted EITHER of the HIV self-tests. Investigators asked them to choose which test they would prefer to use, one that is oral fluid based (saliva), Oraquick HIV Self Test, or one that requires the use blood via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test - Choice; Atomo HIV Self Test - choice&#xD;
Oraquick HIV Self Test - Choice: This is an oral swab in home HIV test.&#xD;
Atomo HIV Self Test - Choice: This is a blood finger prick in home HIV test.</description>
          </group>
        </group_list>
        <measure>
          <title>Quantitative Summaries of Participants Experience in Observation Sessions</title>
          <description>Frequency counts of clarity of instructions, comfort using the test, confidence in test result, difficulty performing the test and reading results</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="20"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="32"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Found Instructions Clear</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="30"/>
                    <measurement group_id="O4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Were Very Comfortable Using the Test</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="24"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Very Easy to use the Test</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="27"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Very Easy to Interpret Results</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="31"/>
                    <measurement group_id="O4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Focus Group Discussions</title>
          <description>Focus group discussions (FGD) with young women (n=2 FGDs) and young men (n=2 FGDs) in the study area to determine the best way to offer self-testing to study participants.</description>
        </group>
        <group group_id="E2">
          <title>In Clinic Observation-Both</title>
          <description>10 young women and 10 young men were assigned and conducted BOTH of the HIV self-tests. Participants tried two different self-testing kits, one that is oral fluid based (saliva), Oraquick HIV Self Test, and one that is blood based via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test and Atomo HIV Self Test - Both&#xD;
Oraquick HIV Self Test and Atomo HIV Self Test - Both: This is an oral swab in home HIV test and this is a blood finger prick in home HIV test.</description>
        </group>
        <group group_id="E3">
          <title>In Clinic Observation-Subject Choice</title>
          <description>20 young women and 20 young men were assigned and conducted EITHER of the HIV self-tests. Investigators asked them to choose which test they would prefer to use, one that is oral fluid based (saliva), Oraquick HIV Self Test, or one that requires the use blood via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test - Choice; Atomo HIV Self Test - choice&#xD;
Oraquick HIV Self Test - Choice: This is an oral swab in home HIV test.&#xD;
Atomo HIV Self Test - Choice: This is a blood finger prick in home HIV test.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
              </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="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
              </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>Dr. Audrey Pettifor</name_or_title>
      <organization>University of North Carolina Chapel Hill</organization>
      <phone>919-966-7439</phone>
      <email>apettif@email.unc.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/NCT03271424
org study id: 15-1361a
secondary id: 5R01HD083033
nct id: NCT03271424
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The investigators propose to improve HIV prevention and care through expanding HIV testing
      options to include self-testing for young women, their peers and their sex partners, and by
      facilitating linkage to care.
Study Description Brief Summary: The investigators propose to improve HIV prevention and care
      through expanding HIV testing options to include self-testing for young women, their peers
      and their sex partners, and by facilitating linkage to care.

      Detailed Description: The investigators propose to improve HIV prevention and care through
      expanding HIV testing options to include self-testing for young women, their peers and their
      sex partners, and by facilitating linkage to care. In this study the investigators proposed
      two phases. The first phase, explained in this submission, is formative and involved two
      parts: 1) conducting formative qualitative research to understand perceptions of HIV testing
      and HIV self-testing in the study population and 2) conducting observed HIV self-testing to
      better understand any challenges with self-testing and the materials needed to make the
      process clear. The second phase of the study is a randomized controlled trial where the
      investigators will randomize approximately 400 young women to receive either 1) CHOICE of
      self-testing or clinic-based HIV Counseling and Testing (HCT) or 2) clinic based HCT. Once
      young women have been randomized, they will be asked to recruit up to 4 peers or male sex
      partners to test with the method of their randomization group.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: Qualitative focus group discussions (FGDs) with male and female community members aged 18 - 24
In-clinic observation of HIV self-testing and completion of a brief CAPI/ACASI interview with male and female community members aged 18 - 24
primary purpose: Other
masking: None (Open Label)
measure: Qualitative Summaries of Participant Experience in Focus Group Discussions
time frame: 6 months post study start
description: Qualitative Summaries for recruitment of peers/sex partners, issues related to privacy and spaces for testing, options for post-test counseling, optimizing return visits, and preferences for contact
measure: Quantitative Summaries of Participants Experience in Observation Sessions
time frame: 12 month post study start
description: Frequency counts of clarity of instructions, comfort using the test, confidence in test result, difficulty performing the test and reading results
arm group label: Focus Group Discussions
arm group type: No Intervention
description: Focus group discussions (FGD) with young women (n=2 FGDs) and young men (n=2 FGDs) in the study area to determine the best way to offer self-testing to study participants.
arm group label: In Clinic Observation-Both
arm group type: Active Comparator
description: 10 young women and 10 young men were assigned and conducted BOTH of the HIV self-tests. Participants tried two different self-testing kits, one that is oral fluid based (saliva), Oraquick HIV Self Test, and one that is blood based via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test and Atomo HIV Self Test - Both
arm group label: In Clinic Observation-Subject Choice
arm group type: Active Comparator
description: 20 young women and 20 young men were assigned and conducted EITHER of the HIV self-tests. Investigators asked them to choose which test they would prefer to use, one that is oral fluid based (saliva), Oraquick HIV Self Test, or one that requires the use blood via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test - Choice; Atomo HIV Self Test - choice
intervention type: Diagnostic Test
intervention name: Oraquick HIV Self Test - Choice
description: This is an oral swab in home HIV test.
arm group label: In Clinic Observation-Subject Choice
intervention type: Diagnostic Test
intervention name: Atomo HIV Self Test - Choice
description: This is a blood finger prick in home HIV test.
arm group label: In Clinic Observation-Subject Choice
intervention type: Diagnostic Test
intervention name: Oraquick HIV Self Test and Atomo HIV Self Test - Both
description: This is an oral swab in home HIV test and this is a blood finger prick in home HIV test.
arm group label: In Clinic Observation-Both
criteria: 
gender: All
gender based: Yes
gender description: Enrolled participants need to self-identify as female or female for their respective data collection.
minimum age: 18 Years
maximum age: 24 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Audrey Pettifor
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
country: South Africa
responsible party type: Sponsor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 