<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/NCT02248558</url>
  </required_header>
  <id_info>
    <org_study_id>14-1865</org_study_id>
    <nct_id>NCT02248558</nct_id>
  </id_info>
  <brief_title>Spurring Innovation to Promote HIV Testing: An RCT Evaluating Crowdsourcing</brief_title>
  <official_title>Crowdsourcing Versus Conventional HIV Testing Promotion: A Noninferiority Randomized Controlled Trial to Evaluate Promoting First-Time HIV Testing Among MSM and Transgender Individuals in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Social Entrepreneurship for Sexual Health (SESH)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>London School of Hygiene and Tropical Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guangdong Provincial Centers for Skin Diseases and STI Control</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Crowdsourcing may be a powerful tool to spur the development of innovative videos to promote&#xD;
      HIV testing among key populations such as men who have sex with men (MSM) and transgender&#xD;
      (TG) individuals. The purpose of this randomized controlled trial is to compare the effect of&#xD;
      a crowdsourced video and a conventional video on first-time HIV testing among MSM and TG in&#xD;
      China. The crowdsourced video was developed using an open contest, formal transparent&#xD;
      judging, and an incentive of marketing promotion. The hypothesis is that a crowdsourced video&#xD;
      will be equivalent (within a margin of 3%) to a conventional video in terms of self-reported&#xD;
      first-time HIV testing within 3-4 weeks of watching the video.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>First-Time HIV Testing</measure>
    <time_frame>Up to 4 weeks following the video intervention</time_frame>
    <description>All individuals enrolled in the study will receive a cell phone text message three weeks later asking if they have received an HIV test. Among those individuals who do not respond to the text message, another text will be sent at four weeks after the video. We anticipate the median duration of follow-up to be approximately 3.5 weeks following the video intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Likelihood of HIV Testing</measure>
    <time_frame>Up to one day</time_frame>
    <description>All individuals will be asked how likely they are to test for HIV soon immediately before and after watching the videos (during enrollment). Likelihood of HIV testing will be measured on a 4-point numerical Likert scale rating scale. 0 will be &quot;very unlikely&quot;, 1 will be &quot;unlikely&quot;, 2 will be likely, and 3 will be very likely. The percentage of individuals who report increased likelihood of HIV testing will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness of Developing HIV Testing Promotional Videos</measure>
    <time_frame>Up to one year</time_frame>
    <description>Cost-effectiveness of developing the crowdsourced video compared to the conventional video</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">721</enrollment>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>Conventional video</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm will receive a one-minute conventional video promoting HIV test uptake.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Crowdsourced video</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will receive a one-minute crowdsourced video promoting HIV test uptake.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Conventional Video</intervention_name>
    <description>Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development.</description>
    <arm_group_label>Conventional video</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Crowdsourced Video</intervention_name>
    <description>Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos.</description>
    <arm_group_label>Crowdsourced video</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Born biologically male or identify as transgender&#xD;
&#xD;
          -  16 years or older&#xD;
&#xD;
          -  Lifetime anal sex with another man&#xD;
&#xD;
          -  Providing informed consent and active mobile phone number&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  HIV-infected&#xD;
&#xD;
          -  HIV-tested ever in the past&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joseph Tucker</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNC Project-China</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UNC Project-China</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://www.seshglobal.org/</url>
    <description>Social Entrepreneurship for Sexual Health</description>
  </link>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <results_first_submitted>October 26, 2016</results_first_submitted>
  <results_first_submitted_qc>October 26, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 20, 2016</results_first_posted>
  <last_update_submitted>December 20, 2016</last_update_submitted>
  <last_update_submitted_qc>December 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of North Carolina, Chapel Hill</investigator_affiliation>
    <investigator_full_name>Joseph Tucker, MD, PhD, MA</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine, Director of UNC Project-China</investigator_title>
  </responsible_party>
  <keyword>Contest</keyword>
  <keyword>Crowdsourcing</keyword>
  <keyword>Innovation</keyword>
  <keyword>Randomized controlled trial</keyword>
  <keyword>China</keyword>
  <keyword>Social entrepreneurship</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Conventional Video</title>
          <description>This arm will receive a one-minute conventional video promoting HIV test uptake.&#xD;
Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development.</description>
        </group>
        <group group_id="P2">
          <title>Crowdsourced Video</title>
          <description>This arm will receive a one-minute crowdsourced video promoting HIV test uptake.&#xD;
Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="369"/>
                <participants group_id="P2" count="352"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="317"/>
                <participants group_id="P2" count="307"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
                <participants group_id="P2" count="45"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Conventional Video</title>
          <description>This arm will receive a one-minute conventional video promoting HIV test uptake.&#xD;
Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development.</description>
        </group>
        <group group_id="B2">
          <title>Crowdsourced Video</title>
          <description>This arm will receive a one-minute crowdsourced video promoting HIV test uptake.&#xD;
Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos.</description>
        </group>
        <group group_id="B3">
          <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="369"/>
            <count group_id="B2" value="352"/>
            <count group_id="B3" value="721"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>16-20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="114"/>
                    <measurement group_id="B2" value="120"/>
                    <measurement group_id="B3" value="234"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>21-25</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="130"/>
                    <measurement group_id="B2" value="136"/>
                    <measurement group_id="B3" value="266"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>26-30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>31-35</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;35</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="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>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="351"/>
                    <measurement group_id="B2" value="334"/>
                    <measurement group_id="B3" value="685"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Transgender</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>High School or below</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="105"/>
                    <measurement group_id="B2" value="108"/>
                    <measurement group_id="B3" value="213"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>College</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="239"/>
                    <measurement group_id="B2" value="231"/>
                    <measurement group_id="B3" value="470"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Graduate Education</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Annual Income (SD)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt;3000</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="128"/>
                    <measurement group_id="B2" value="113"/>
                    <measurement group_id="B3" value="241"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3000-6000</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="102"/>
                    <measurement group_id="B2" value="104"/>
                    <measurement group_id="B3" value="206"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6001-9500</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                    <measurement group_id="B2" value="84"/>
                    <measurement group_id="B3" value="169"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9501-15000</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;15000</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marital status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Never married</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="304"/>
                    <measurement group_id="B2" value="311"/>
                    <measurement group_id="B3" value="615"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Married/Engaged</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Separated/divorced/Widowed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sexual orientation disclosure</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="210"/>
                    <measurement group_id="B2" value="199"/>
                    <measurement group_id="B3" value="409"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="159"/>
                    <measurement group_id="B2" value="153"/>
                    <measurement group_id="B3" value="312"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ever used gay mobile application</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="267"/>
                    <measurement group_id="B2" value="275"/>
                    <measurement group_id="B3" value="542"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="97"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="168"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Recent Condomless anal sex</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>No recent sex</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Condomless anal sex</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anal sex with a condom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>First-Time HIV Testing</title>
        <description>All individuals enrolled in the study will receive a cell phone text message three weeks later asking if they have received an HIV test. Among those individuals who do not respond to the text message, another text will be sent at four weeks after the video. We anticipate the median duration of follow-up to be approximately 3.5 weeks following the video intervention.</description>
        <time_frame>Up to 4 weeks following the video intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Conventional Video</title>
            <description>This arm will receive a one-minute conventional video promoting HIV test uptake.&#xD;
Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development.&#xD;
111 of 317 (35%) in the health marketing arm reported testing for HIV</description>
          </group>
          <group group_id="O2">
            <title>Crowdsourced Video</title>
            <description>This arm will receive a one-minute crowdsourced video promoting HIV test uptake.&#xD;
Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos.&#xD;
In the crowdsourced intervention arm, 114 of 307 (37%) reported testing for HIV.</description>
          </group>
        </group_list>
        <measure>
          <title>First-Time HIV Testing</title>
          <description>All individuals enrolled in the study will receive a cell phone text message three weeks later asking if they have received an HIV test. Among those individuals who do not respond to the text message, another text will be sent at four weeks after the video. We anticipate the median duration of follow-up to be approximately 3.5 weeks following the video intervention.</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="317"/>
                <count group_id="O2" value="307"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="111"/>
                    <measurement group_id="O2" value="114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Likelihood of HIV Testing</title>
        <description>All individuals will be asked how likely they are to test for HIV soon immediately before and after watching the videos (during enrollment). Likelihood of HIV testing will be measured on a 4-point numerical Likert scale rating scale. 0 will be &quot;very unlikely&quot;, 1 will be &quot;unlikely&quot;, 2 will be likely, and 3 will be very likely. The percentage of individuals who report increased likelihood of HIV testing will be reported.</description>
        <time_frame>Up to one day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Conventional Video</title>
            <description>This arm will receive a one-minute conventional video promoting HIV test uptake.&#xD;
Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development.</description>
          </group>
          <group group_id="O2">
            <title>Crowdsourced Video</title>
            <description>This arm will receive a one-minute crowdsourced video promoting HIV test uptake.&#xD;
Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos.</description>
          </group>
        </group_list>
        <measure>
          <title>Likelihood of HIV Testing</title>
          <description>All individuals will be asked how likely they are to test for HIV soon immediately before and after watching the videos (during enrollment). Likelihood of HIV testing will be measured on a 4-point numerical Likert scale rating scale. 0 will be &quot;very unlikely&quot;, 1 will be &quot;unlikely&quot;, 2 will be likely, and 3 will be very likely. The percentage of individuals who report increased likelihood of HIV testing will be reported.</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="369"/>
                <count group_id="O2" value="352"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="184"/>
                    <measurement group_id="O2" value="212"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="185"/>
                    <measurement group_id="O2" value="140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cost-effectiveness of Developing HIV Testing Promotional Videos</title>
        <description>Cost-effectiveness of developing the crowdsourced video compared to the conventional video</description>
        <time_frame>Up to one year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Conventional Video</title>
            <description>This arm will receive a one-minute conventional video promoting HIV test uptake.&#xD;
Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development.&#xD;
111 of 317 (35%) in the health marketing arm reported testing for HIV</description>
          </group>
          <group group_id="O2">
            <title>Crowdsourced Video</title>
            <description>This arm will receive a one-minute crowdsourced video promoting HIV test uptake.&#xD;
Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos.&#xD;
In the crowdsourced intervention arm, 114 of 307 (37%) reported testing for HIV.</description>
          </group>
        </group_list>
        <measure>
          <title>Cost-effectiveness of Developing HIV Testing Promotional Videos</title>
          <description>Cost-effectiveness of developing the crowdsourced video compared to the conventional video</description>
          <units>USD</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="369"/>
                <count group_id="O2" value="352"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>The incremental unit cost for promoting HIV testin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="238"/>
                    <measurement group_id="O2" value="131"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>The incremental unit costs per newly diagnosed HIV</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="799"/>
                    <measurement group_id="O2" value="415"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Conventional Video</title>
          <description>This arm will receive a one-minute conventional video promoting HIV test uptake.&#xD;
Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development.</description>
        </group>
        <group group_id="E2">
          <title>Crowdsourced Video</title>
          <description>This arm will receive a one-minute crowdsourced video promoting HIV test uptake.&#xD;
Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos.</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="369"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="352"/>
              </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="369"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="352"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Weiming Tang</name_or_title>
      <organization>UNC Project-China</organization>
      <phone>+86-15920567132</phone>
      <email>weimingtangscience@gmail.com</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/NCT02248558
org study id: 14-1865
nct id: NCT02248558
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Crowdsourcing may be a powerful tool to spur the development of innovative videos to promote
      HIV testing among key populations such as men who have sex with men (MSM) and transgender
      (TG) individuals. The purpose of this randomized controlled trial is to compare the effect of
      a crowdsourced video and a conventional video on first-time HIV testing among MSM and TG in
      China. The crowdsourced video was developed using an open contest, formal transparent
      judging, and an incentive of marketing promotion. The hypothesis is that a crowdsourced video
      will be equivalent (within a margin of 3%) to a conventional video in terms of self-reported
      first-time HIV testing within 3-4 weeks of watching the video.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: First-Time HIV Testing
time frame: Up to 4 weeks following the video intervention
description: All individuals enrolled in the study will receive a cell phone text message three weeks later asking if they have received an HIV test. Among those individuals who do not respond to the text message, another text will be sent at four weeks after the video. We anticipate the median duration of follow-up to be approximately 3.5 weeks following the video intervention.
measure: Likelihood of HIV Testing
time frame: Up to one day
description: All individuals will be asked how likely they are to test for HIV soon immediately before and after watching the videos (during enrollment). Likelihood of HIV testing will be measured on a 4-point numerical Likert scale rating scale. 0 will be "very unlikely", 1 will be "unlikely", 2 will be likely, and 3 will be very likely. The percentage of individuals who report increased likelihood of HIV testing will be reported.
measure: Cost-effectiveness of Developing HIV Testing Promotional Videos
time frame: Up to one year
description: Cost-effectiveness of developing the crowdsourced video compared to the conventional video
arm group label: Conventional video
arm group type: Active Comparator
description: This arm will receive a one-minute conventional video promoting HIV test uptake.
arm group label: Crowdsourced video
arm group type: Experimental
description: This arm will receive a one-minute crowdsourced video promoting HIV test uptake.
intervention type: Behavioral
intervention name: Conventional Video
description: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development.
arm group label: Conventional video
intervention type: Behavioral
intervention name: Crowdsourced Video
description: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos.
arm group label: Crowdsourced video
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Joseph Tucker
role: Principal Investigator
affiliation: UNC Project-China
facility: 
country: China
url: http://www.seshglobal.org/
description: Social Entrepreneurship for Sexual Health
responsible party type: Principal Investigator
investigator affiliation: University of North Carolina, Chapel Hill
investigator full name: Joseph Tucker, MD, PhD, MA
investigator title: Assistant Professor of Medicine, Director of UNC Project-China
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 