<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/NCT04426656</url>
  </required_header>
  <id_info>
    <org_study_id>19-3481</org_study_id>
    <secondary_id>R01AI114310</secondary_id>
    <nct_id>NCT04426656</nct_id>
  </id_info>
  <brief_title>The Development of a Mobile-based App to Increase Uptake of Pre-Exposure Prophylaxis (PrEP) by Men Who Have Sex With Men in China</brief_title>
  <official_title>IGHID 12001 - The Development of a Mobile-based App to Increase Uptake of Pre-Exposure Prophylaxis (PrEP) by Men Who Have Sex With Men in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to use a mini-application on the popular Chinese social media mobile&#xD;
      platform, WeChat, to improve HIV pre-exposure prophylaxis (PrEP) uptake among at-risk men who&#xD;
      have sex with men (MSM). UNC investigators will work in close partnership with a&#xD;
      well-established HIV special hospital and the local MSM community to understand key barriers&#xD;
      to PrEP use, and develop a mobile-based intervention to increase PrEP uptake among young MSM&#xD;
      in Guangzhou, China.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study includes two parts. Before the start of Part 1, a mini-app prototype for promoting&#xD;
      HIV pre-exposure prophylaxis (PrEP) uptake will have been developed from a prior MSM&#xD;
      community-driven hackathon contest. PrEP is an antiretroviral medicines-based prevention&#xD;
      strategy against HIV infection, which has been proved save and effective.&#xD;
&#xD;
      Part 1 includes in-depth interviews with 40 HIV-negative young MSM (18 and above) with a&#xD;
      brief survey to collect demographic data. The interview topics include PrEP-related&#xD;
      perceptions and feedback on the design of a mini-app prototype. Findings from Part 1 will&#xD;
      inform refining the mini-app before the start of Part 2.&#xD;
&#xD;
      In Part 2, a small two-arm randomized control trial with 70 young MSM (18 and above) will be&#xD;
      conducted to evaluate the preliminary efficacy of the mini-app in improving PrEP-related&#xD;
      perceptions and actual PrEP uptake, compared to a control group of standard of care.&#xD;
&#xD;
      Participants in Part 2 will be followed up for 12 weeks (8 week intervention and&#xD;
      after-intervention follow-up at 12th week). A subgroup of participants (n=15) from both the&#xD;
      intervention arm and the control arm will receive two rounds of in-depth interviews,&#xD;
      separately at the 4th and 8th week, to share their experience of using the app and changed&#xD;
      perceptions and/or behaviors related to PrEP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 8, 2020</start_date>
  <completion_date type="Actual">April 2, 2021</completion_date>
  <primary_completion_date type="Actual">April 2, 2021</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>
    <intervention_model_description>Mixed methods study, including a 2-arm randomized controlled trial.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Intention to Use PrEP Score</measure>
    <time_frame>Baseline and up to 12 weeks</time_frame>
    <description>Individual perceived likelihood to start using PrEP, measured by a one-item question with a bipolar response scale (-3 to 3). Higher score indicates higher intention to use.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Initiate PrEP by Week 8</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>Individual's self-reported whether starting use of PrEP medication (binary: Yes/No)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants at Different Change Stages to PrEP Initiation at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants at Different Change Stages to PrEP Initiation at Week 4</measure>
    <time_frame>Week 4</time_frame>
    <description>Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants at Different Change Stages to PrEP Initiation at Week 8</measure>
    <time_frame>Week 8</time_frame>
    <description>Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants at Different Change Stages to PrEP Initiation at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in PrEP Knowledge Score at Week 4, 8 and 12</measure>
    <time_frame>Baseline and up to 12 weeks</time_frame>
    <description>Individual's understanding of PrEP, measured by a 5-item True/False quiz. Values range from 0-5. Higher score indicates better PrEP knowledge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>Willingness to pay for PrEP ranging from 0-100% of monthly income. Amount spent will be assessed at Baseline, Weeks 4, 8, and 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PrEP Self-Efficacy Score</measure>
    <time_frame>Baseline and up to 12 weeks</time_frame>
    <description>Self-Efficacy will be assessed at Baseline, Weeks 4, 8, and 12 using an 8-item PrEP self-efficacy scale. Values range from 0-5. Higher scores indicate higher self-efficacy to use PrEP.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PrEP Attitude Score</measure>
    <time_frame>Baseline and up to 12 weeks</time_frame>
    <description>Individual's attitude towards PrEP, measured by a 5-item scale. Values range from 0-5. Higher scores indicate more positive attitude toward PrEP. The PrEP Attitude will be assessed at Baseline, Weeks 4, 8, and 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PrEP Stigma Score</measure>
    <time_frame>Baseline and up to 12 weeks</time_frame>
    <description>Individual's perceived stigma related to PrEP, measured by 5-item PrEP stigma scale. Values range from 0-5. Higher score indicates higher perceived stigma related to PrEP. The PrEP Stigma will be assessed at Baseline, Weeks 4, 8, and 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Ordered At-home HIV/Syphilis Tests</measure>
    <time_frame>12 weeks</time_frame>
    <description>Number of participants who ordered at-home HIV/syphilis tests through the mini-app based on the study record. Values range from 0 to greater than 0. Higher indicates higher frequency of participants who ordered HIV/syphilis tests completed through the study.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>HIV</condition>
  <condition>Pre-exposure Prophylaxis</condition>
  <arm_group>
    <arm_group_label>Part 2 Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STI(sexually transmitted infections) testing and referrals to local HIV/STI testing sites and prevention services.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2 mini-app</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Phone application</intervention_name>
    <description>The mini-app (used in Part 2) has four main functions:&#xD;
a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;&#xD;
an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);&#xD;
an asynchronous message function that allows users to chat with a study staff (C.Li); and&#xD;
a user profile page where users can manage all HIV test orders.</description>
    <arm_group_label>Part 2 mini-app</arm_group_label>
    <other_name>mini-app</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Part 1: HIV-negative men who have sex with men (MSM): must self-report: being assigned&#xD;
             male sex at birth, HIV-negative, age 18 and above, ever having had anal sex with&#xD;
             another man, identify as a Chinese citizen, own a smartphone, able to being willing to&#xD;
             sign written informed consent and participate in the study as procedures required.&#xD;
&#xD;
        Part 2: HIV-negative men who have sex with men (MSM): same characteristics as in Part 1.&#xD;
&#xD;
        AND, they must report :&#xD;
&#xD;
          -  Having a smartphone with WeChat installed.&#xD;
&#xD;
          -  Being assigned male sex at birth, HIV-negative, age 18 and above, ever having had anal&#xD;
             sex with another man, currently reside in Guangzhou, China, identifying as a Chinese&#xD;
             citizen, able to sign written informed consent and participate in the study as&#xD;
             procedures require. AND&#xD;
&#xD;
          -  At least one criterion associated with high risk of HIV infection in the past 6 months&#xD;
             prior to enrollment as follows:&#xD;
&#xD;
               -  Unprotected (condomless) anal intercourse with male partner(s)&#xD;
&#xD;
               -  More than two male partners (regardless of condom use and HIV serostatus)&#xD;
&#xD;
               -  Reported STI, such as syphilis, Herpes Simplex Virus-2 (HSV-2), gonorrhea,&#xD;
                  chlamydia, chancroid, or lymphogranuloma venereum.&#xD;
&#xD;
               -  Reported use of post-exposure prophylaxis (PEP)&#xD;
&#xD;
               -  Have a sexual partner living with HIV&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Part 1: Individuals who report any following status will be excluded from&#xD;
             participating Part 1:&#xD;
&#xD;
               -  HIV-positive&#xD;
&#xD;
               -  Mental health issues which may compromise participant adherence or safety,&#xD;
                  including memory loss, cognitive impairment, intellectual disability, or&#xD;
                  communication disorders.&#xD;
&#xD;
          -  Part 2:&#xD;
&#xD;
               -  HIV-positive (self-report or lab-confirmed)&#xD;
&#xD;
               -  Currently taking oral PrEP based on self-report&#xD;
&#xD;
               -  Symptoms of acute HIV infection within the prior 30 days&#xD;
&#xD;
               -  Contradictions to taking oral PrEP&#xD;
&#xD;
               -  Personal diagnosis or family history of hemophilia&#xD;
&#xD;
               -  Chronic Hepatitis B (self-report)&#xD;
&#xD;
               -  Participating in another research study related to HIV and antiretroviral therapy&#xD;
                  or other intervention study&#xD;
&#xD;
               -  Having serious chronic disease, including metabolic diseases (such as diabetes),&#xD;
                  neurological, and psychiatric disorders&#xD;
&#xD;
               -  Mental health issues which may compromise participant adherence or safety,&#xD;
                  including memory loss, cognitive impairment, intellectual disability, or&#xD;
                  communication disorders&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>This is a tailored intervention pilot study for MSM in China</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chunyan Li, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joseph D Tucker, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of North Carolina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Guangzhou No. 8 People's Hospital</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <results_first_submitted>January 31, 2022</results_first_submitted>
  <results_first_submitted_qc>February 28, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">March 2, 2022</results_first_posted>
  <last_update_submitted>February 28, 2022</last_update_submitted>
  <last_update_submitted_qc>February 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>PrEP</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Beginning 9 and ending 36 months following article publication.</ipd_time_frame>
    <ipd_access_criteria>Investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 2, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT04426656/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 27, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT04426656/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Part 2 Standard of Care</title>
          <description>Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.</description>
        </group>
        <group group_id="P2">
          <title>Part 2 Mini-app</title>
          <description>In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.&#xD;
Phone application: The mini-app (used in Part 2) has four main functions:&#xD;
a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;&#xD;
an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);&#xD;
an asynchronous message function that allows users to chat with a study staff (C.Li); and&#xD;
a user profile page where users can manage all HIV test orders.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Part 2 Standard of Care</title>
          <description>Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.</description>
        </group>
        <group group_id="B2">
          <title>Part 2 Mini-app</title>
          <description>In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.&#xD;
Phone application: The mini-app (used in Part 2) has four main functions:&#xD;
a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;&#xD;
an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);&#xD;
an asynchronous message function that allows users to chat with a study staff (C.Li); and&#xD;
a user profile page where users can manage all HIV test orders.</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="24"/>
            <count group_id="B2" value="46"/>
            <count group_id="B3" value="70"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.5" spread="4.6"/>
                    <measurement group_id="B2" value="28.2" spread="6.8"/>
                    <measurement group_id="B3" value="28.0" spread="6.1"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="70"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="70"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_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>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Intention to Use PrEP Score</title>
        <description>Individual perceived likelihood to start using PrEP, measured by a one-item question with a bipolar response scale (-3 to 3). Higher score indicates higher intention to use.</description>
        <time_frame>Baseline and up to 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Part 2 Standard of Care</title>
            <description>Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.</description>
          </group>
          <group group_id="O2">
            <title>Part 2 Mini-app</title>
            <description>In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.&#xD;
Phone application: The mini-app (used in Part 2) has four main functions:&#xD;
a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;&#xD;
an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);&#xD;
an asynchronous message function that allows users to chat with a study staff (C.Li); and&#xD;
a user profile page where users can manage all HIV test orders.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Intention to Use PrEP Score</title>
          <description>Individual perceived likelihood to start using PrEP, measured by a one-item question with a bipolar response scale (-3 to 3). Higher score indicates higher intention to use.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline to Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.19" spread="1.72"/>
                    <measurement group_id="O2" value="0.00" spread="2.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.57" spread="2.62"/>
                    <measurement group_id="O2" value="-0.09" spread="2.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" spread="2.59"/>
                    <measurement group_id="O2" value="-0.40" spread="2.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The comparison was made using the outcome variable measured at Week 12.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.85</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Initiate PrEP by Week 8</title>
        <description>Individual's self-reported whether starting use of PrEP medication (binary: Yes/No)</description>
        <time_frame>Up to 8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Part 2 Standard of Care</title>
            <description>Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.</description>
          </group>
          <group group_id="O2">
            <title>Part 2 Mini-app</title>
            <description>In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.&#xD;
Phone application: The mini-app (used in Part 2) has four main functions:&#xD;
a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;&#xD;
an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);&#xD;
an asynchronous message function that allows users to chat with a study staff (C.Li); and&#xD;
a user profile page where users can manage all HIV test orders.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Initiate PrEP by Week 8</title>
          <description>Individual's self-reported whether starting use of PrEP medication (binary: Yes/No)</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="24"/>
                <count group_id="O2" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.72</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants at Different Change Stages to PrEP Initiation at Baseline</title>
        <description>Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.</description>
        <time_frame>Baseline</time_frame>
        <population>Only participants with no missing data were included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2 Standard of Care</title>
            <description>Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.</description>
          </group>
          <group group_id="O2">
            <title>Part 2 Mini-app</title>
            <description>In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.&#xD;
Phone application: The mini-app (used in Part 2) has four main functions:&#xD;
a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;&#xD;
an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);&#xD;
an asynchronous message function that allows users to chat with a study staff (C.Li); and&#xD;
a user profile page where users can manage all HIV test orders.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants at Different Change Stages to PrEP Initiation at Baseline</title>
          <description>Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.</description>
          <population>Only participants with no missing data were included in this analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Pre-contemplation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Contemplation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Preparation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Action</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.318</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants at Different Change Stages to PrEP Initiation at Week 4</title>
        <description>Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.</description>
        <time_frame>Week 4</time_frame>
        <population>Only participants with no missing data were included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2 Standard of Care</title>
            <description>Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.</description>
          </group>
          <group group_id="O2">
            <title>Part 2 Mini-app</title>
            <description>In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.&#xD;
Phone application: The mini-app (used in Part 2) has four main functions:&#xD;
a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;&#xD;
an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);&#xD;
an asynchronous message function that allows users to chat with a study staff (C.Li); and&#xD;
a user profile page where users can manage all HIV test orders.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants at Different Change Stages to PrEP Initiation at Week 4</title>
          <description>Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.</description>
          <population>Only participants with no missing data were included in this analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Pre-contemplation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Contemplation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Preparation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Action</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.527</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants at Different Change Stages to PrEP Initiation at Week 8</title>
        <description>Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.</description>
        <time_frame>Week 8</time_frame>
        <population>Only participants with no missing data were included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2 Standard of Care</title>
            <description>Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.</description>
          </group>
          <group group_id="O2">
            <title>Part 2 Mini-app</title>
            <description>In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.&#xD;
Phone application: The mini-app (used in Part 2) has four main functions:&#xD;
a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;&#xD;
an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);&#xD;
an asynchronous message function that allows users to chat with a study staff (C.Li); and&#xD;
a user profile page where users can manage all HIV test orders.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants at Different Change Stages to PrEP Initiation at Week 8</title>
          <description>Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.</description>
          <population>Only participants with no missing data were included in this analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Pre-contemplation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Contemplation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Preparation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Action</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.928</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants at Different Change Stages to PrEP Initiation at Week 12</title>
        <description>Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.</description>
        <time_frame>Week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Part 2 Standard of Care</title>
            <description>Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.</description>
          </group>
          <group group_id="O2">
            <title>Part 2 Mini-app</title>
            <description>In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.&#xD;
Phone application: The mini-app (used in Part 2) has four main functions:&#xD;
a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;&#xD;
an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);&#xD;
an asynchronous message function that allows users to chat with a study staff (C.Li); and&#xD;
a user profile page where users can manage all HIV test orders.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants at Different Change Stages to PrEP Initiation at Week 12</title>
          <description>Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.</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="21"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Pre-contemplation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Contemplation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Preparation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Action</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.678</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in PrEP Knowledge Score at Week 4, 8 and 12</title>
        <description>Individual's understanding of PrEP, measured by a 5-item True/False quiz. Values range from 0-5. Higher score indicates better PrEP knowledge.</description>
        <time_frame>Baseline and up to 12 weeks</time_frame>
        <population>Participants analyzed here only include those with complete data at a certain follow-up week.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2 Standard of Care</title>
            <description>Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.</description>
          </group>
          <group group_id="O2">
            <title>Part 2 Mini-app</title>
            <description>In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.&#xD;
Phone application: The mini-app (used in Part 2) has four main functions:&#xD;
a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;&#xD;
an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);&#xD;
an asynchronous message function that allows users to chat with a study staff (C.Li); and&#xD;
a user profile page where users can manage all HIV test orders.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in PrEP Knowledge Score at Week 4, 8 and 12</title>
          <description>Individual's understanding of PrEP, measured by a 5-item True/False quiz. Values range from 0-5. Higher score indicates better PrEP knowledge.</description>
          <population>Participants analyzed here only include those with complete data at a certain follow-up week.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline to Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.33" spread="0.72"/>
                    <measurement group_id="O2" value="0.13" spread="0.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.33" spread="0.66"/>
                    <measurement group_id="O2" value="0.16" spread="0.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.38" spread="0.50"/>
                    <measurement group_id="O2" value="0.19" spread="0.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The comparison test was made using the outcome variable measured at Week 12.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.26</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP</title>
        <description>Willingness to pay for PrEP ranging from 0-100% of monthly income. Amount spent will be assessed at Baseline, Weeks 4, 8, and 12.</description>
        <time_frame>Up to 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Part 2 Standard of Care</title>
            <description>Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.</description>
          </group>
          <group group_id="O2">
            <title>Part 2 Mini-app</title>
            <description>In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.&#xD;
Phone application: The mini-app (used in Part 2) has four main functions:&#xD;
a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;&#xD;
an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);&#xD;
an asynchronous message function that allows users to chat with a study staff (C.Li); and&#xD;
a user profile page where users can manage all HIV test orders.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP</title>
          <description>Willingness to pay for PrEP ranging from 0-100% of monthly income. Amount spent will be assessed at Baseline, Weeks 4, 8, and 12.</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="21"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <title>Any amount</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>30-50%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>15-25%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>10-15%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&lt; 10%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not any</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not sure</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <title>Any amount</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>30-50%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>15-25%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>10-15%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&lt; 10%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not any</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not sure</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <title>Any amount</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>30-50%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>15-25%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>10-15%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&lt; 10%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not any</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not sure</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <title>Any amount</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>30-50%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>15-25%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>10-15%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&lt; 10%</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not any</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not sure</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The comparison was made using data measured at Week 12.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.08</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in PrEP Self-Efficacy Score</title>
        <description>Self-Efficacy will be assessed at Baseline, Weeks 4, 8, and 12 using an 8-item PrEP self-efficacy scale. Values range from 0-5. Higher scores indicate higher self-efficacy to use PrEP.</description>
        <time_frame>Baseline and up to 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Part 2 Standard of Care</title>
            <description>Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.</description>
          </group>
          <group group_id="O2">
            <title>Part 2 Mini-app</title>
            <description>In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.&#xD;
Phone application: The mini-app (used in Part 2) has four main functions:&#xD;
a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;&#xD;
an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);&#xD;
an asynchronous message function that allows users to chat with a study staff (C.Li); and&#xD;
a user profile page where users can manage all HIV test orders.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in PrEP Self-Efficacy Score</title>
          <description>Self-Efficacy will be assessed at Baseline, Weeks 4, 8, and 12 using an 8-item PrEP self-efficacy scale. Values range from 0-5. Higher scores indicate higher self-efficacy to use PrEP.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline to Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05" spread="0.40"/>
                    <measurement group_id="O2" value="0.07" spread="0.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08" spread="0.50"/>
                    <measurement group_id="O2" value="0.03" spread="0.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10" spread="0.47"/>
                    <measurement group_id="O2" value="0.13" spread="0.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The comparison was made using data measured at Week 12.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.03</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in PrEP Attitude Score</title>
        <description>Individual's attitude towards PrEP, measured by a 5-item scale. Values range from 0-5. Higher scores indicate more positive attitude toward PrEP. The PrEP Attitude will be assessed at Baseline, Weeks 4, 8, and 12.</description>
        <time_frame>Baseline and up to 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Part 2 Standard of Care</title>
            <description>Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.</description>
          </group>
          <group group_id="O2">
            <title>Part 2 Mini-app</title>
            <description>In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.&#xD;
Phone application: The mini-app (used in Part 2) has four main functions:&#xD;
a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;&#xD;
an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);&#xD;
an asynchronous message function that allows users to chat with a study staff (C.Li); and&#xD;
a user profile page where users can manage all HIV test orders.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in PrEP Attitude Score</title>
          <description>Individual's attitude towards PrEP, measured by a 5-item scale. Values range from 0-5. Higher scores indicate more positive attitude toward PrEP. The PrEP Attitude will be assessed at Baseline, Weeks 4, 8, and 12.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline to Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="0.32"/>
                    <measurement group_id="O2" value="0.07" spread="0.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.23" spread="0.79"/>
                    <measurement group_id="O2" value="0.01" spread="0.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.44"/>
                    <measurement group_id="O2" value="0.02" spread="0.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>This comparison was made using data at Week 12.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.58</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in PrEP Stigma Score</title>
        <description>Individual's perceived stigma related to PrEP, measured by 5-item PrEP stigma scale. Values range from 0-5. Higher score indicates higher perceived stigma related to PrEP. The PrEP Stigma will be assessed at Baseline, Weeks 4, 8, and 12.</description>
        <time_frame>Baseline and up to 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Part 2 Standard of Care</title>
            <description>Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.</description>
          </group>
          <group group_id="O2">
            <title>Part 2 Mini-app</title>
            <description>In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.&#xD;
Phone application: The mini-app (used in Part 2) has four main functions:&#xD;
a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;&#xD;
an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);&#xD;
an asynchronous message function that allows users to chat with a study staff (C.Li); and&#xD;
a user profile page where users can manage all HIV test orders.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in PrEP Stigma Score</title>
          <description>Individual's perceived stigma related to PrEP, measured by 5-item PrEP stigma scale. Values range from 0-5. Higher score indicates higher perceived stigma related to PrEP. The PrEP Stigma will be assessed at Baseline, Weeks 4, 8, and 12.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline to Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="0.32"/>
                    <measurement group_id="O2" value="-0.02" spread="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.23" spread="0.79"/>
                    <measurement group_id="O2" value="0.09" spread="0.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.44"/>
                    <measurement group_id="O2" value="0.03" spread="0.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The comparison was made using data measured at Week 12.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.85</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Ordered At-home HIV/Syphilis Tests</title>
        <description>Number of participants who ordered at-home HIV/syphilis tests through the mini-app based on the study record. Values range from 0 to greater than 0. Higher indicates higher frequency of participants who ordered HIV/syphilis tests completed through the study.</description>
        <time_frame>12 weeks</time_frame>
        <population>This outcome is only applicable to the participants in the Part 2 mini-app arm who had access to the At-home HIV/syphilis tests per protocol.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2 Standard of Care</title>
            <description>Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.</description>
          </group>
          <group group_id="O2">
            <title>Part 2 Mini-app</title>
            <description>In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.&#xD;
Phone application: The mini-app (used in Part 2) has four main functions:&#xD;
a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;&#xD;
an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);&#xD;
an asynchronous message function that allows users to chat with a study staff (C.Li); and&#xD;
a user profile page where users can manage all HIV test orders.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Ordered At-home HIV/Syphilis Tests</title>
          <description>Number of participants who ordered at-home HIV/syphilis tests through the mini-app based on the study record. Values range from 0 to greater than 0. Higher indicates higher frequency of participants who ordered HIV/syphilis tests completed through the study.</description>
          <population>This outcome is only applicable to the participants in the Part 2 mini-app arm who had access to the At-home HIV/syphilis tests per protocol.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the time of signing informed consent through the end of the study, a total of approximately 12 to 16 weeks.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Part 2 Standard of Care</title>
          <description>Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.</description>
        </group>
        <group group_id="E2">
          <title>Part 2 Mini-app</title>
          <description>In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.&#xD;
Phone application: The mini-app (used in Part 2) has four main functions:&#xD;
a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;&#xD;
an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);&#xD;
an asynchronous message function that allows users to chat with a study staff (C.Li); and&#xD;
a user profile page where users can manage all HIV test orders.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="46"/>
              </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>Chunyan Li, MSc</name_or_title>
      <organization>University of North Carolina at Chapel Hill</organization>
      <phone>919-966-6695</phone>
      <email>chunyli@live.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/NCT04426656
org study id: 19-3481
secondary id: R01AI114310
nct id: NCT04426656
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study aims to use a mini-application on the popular Chinese social media mobile
      platform, WeChat, to improve HIV pre-exposure prophylaxis (PrEP) uptake among at-risk men who
      have sex with men (MSM). UNC investigators will work in close partnership with a
      well-established HIV special hospital and the local MSM community to understand key barriers
      to PrEP use, and develop a mobile-based intervention to increase PrEP uptake among young MSM
      in Guangzhou, China.
This study includes two parts. Before the start of Part 1, a mini-app prototype for promoting
      HIV pre-exposure prophylaxis (PrEP) uptake will have been developed from a prior MSM
      community-driven hackathon contest. PrEP is an antiretroviral medicines-based prevention
      strategy against HIV infection, which has been proved save and effective.

      Part 1 includes in-depth interviews with 40 HIV-negative young MSM (18 and above) with a
      brief survey to collect demographic data. The interview topics include PrEP-related
      perceptions and feedback on the design of a mini-app prototype. Findings from Part 1 will
      inform refining the mini-app before the start of Part 2.

      In Part 2, a small two-arm randomized control trial with 70 young MSM (18 and above) will be
      conducted to evaluate the preliminary efficacy of the mini-app in improving PrEP-related
      perceptions and actual PrEP uptake, compared to a control group of standard of care.

      Participants in Part 2 will be followed up for 12 weeks (8 week intervention and
      after-intervention follow-up at 12th week). A subgroup of participants (n=15) from both the
      intervention arm and the control arm will receive two rounds of in-depth interviews,
      separately at the 4th and 8th week, to share their experience of using the app and changed
      perceptions and/or behaviors related to PrEP.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Mixed methods study, including a 2-arm randomized controlled trial.
primary purpose: Other
masking: None (Open Label)
measure: Change in Intention to Use PrEP Score
time frame: Baseline and up to 12 weeks
description: Individual perceived likelihood to start using PrEP, measured by a one-item question with a bipolar response scale (-3 to 3). Higher score indicates higher intention to use.
measure: Number of Participants Who Initiate PrEP by Week 8
time frame: Up to 8 weeks
description: Individual's self-reported whether starting use of PrEP medication (binary: Yes/No)
measure: Number of Participants at Different Change Stages to PrEP Initiation at Baseline
time frame: Baseline
description: Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.
measure: Number of Participants at Different Change Stages to PrEP Initiation at Week 4
time frame: Week 4
description: Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.
measure: Number of Participants at Different Change Stages to PrEP Initiation at Week 8
time frame: Week 8
description: Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.
measure: Number of Participants at Different Change Stages to PrEP Initiation at Week 12
time frame: Week 12
description: Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.
measure: Change in PrEP Knowledge Score at Week 4, 8 and 12
time frame: Baseline and up to 12 weeks
description: Individual's understanding of PrEP, measured by a 5-item True/False quiz. Values range from 0-5. Higher score indicates better PrEP knowledge.
measure: Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
time frame: Up to 12 weeks
description: Willingness to pay for PrEP ranging from 0-100% of monthly income. Amount spent will be assessed at Baseline, Weeks 4, 8, and 12.
measure: Change in PrEP Self-Efficacy Score
time frame: Baseline and up to 12 weeks
description: Self-Efficacy will be assessed at Baseline, Weeks 4, 8, and 12 using an 8-item PrEP self-efficacy scale. Values range from 0-5. Higher scores indicate higher self-efficacy to use PrEP.
measure: Change in PrEP Attitude Score
time frame: Baseline and up to 12 weeks
description: Individual's attitude towards PrEP, measured by a 5-item scale. Values range from 0-5. Higher scores indicate more positive attitude toward PrEP. The PrEP Attitude will be assessed at Baseline, Weeks 4, 8, and 12.
measure: Change in PrEP Stigma Score
time frame: Baseline and up to 12 weeks
description: Individual's perceived stigma related to PrEP, measured by 5-item PrEP stigma scale. Values range from 0-5. Higher score indicates higher perceived stigma related to PrEP. The PrEP Stigma will be assessed at Baseline, Weeks 4, 8, and 12.
measure: Number of Participants Who Ordered At-home HIV/Syphilis Tests
time frame: 12 weeks
description: Number of participants who ordered at-home HIV/syphilis tests through the mini-app based on the study record. Values range from 0 to greater than 0. Higher indicates higher frequency of participants who ordered HIV/syphilis tests completed through the study.
arm group label: Part 2 Standard of Care
arm group type: No Intervention
description: Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STI(sexually transmitted infections) testing and referrals to local HIV/STI testing sites and prevention services.
arm group label: Part 2 mini-app
arm group type: Experimental
description: In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.
intervention type: Behavioral
intervention name: Phone application
description: The mini-app (used in Part 2) has four main functions:
a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;
an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);
an asynchronous message function that allows users to chat with a study staff (C.Li); and
a user profile page where users can manage all HIV test orders.
arm group label: Part 2 mini-app
other name: mini-app
criteria: 
gender: Male
gender based: Yes
gender description: This is a tailored intervention pilot study for MSM in China
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Chunyan Li, MS
role: Principal Investigator
affiliation: University of North Carolina
last name: Joseph D Tucker, MD
role: Study Director
affiliation: University of North Carolina
facility: 
country: China
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
ipd info type: Study Protocol
ipd time frame: Beginning 9 and ending 36 months following article publication.
ipd access criteria: Investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 