<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/NCT04434950</url>
  </required_header>
  <id_info>
    <org_study_id>MSS269R</org_study_id>
    <nct_id>NCT04434950</nct_id>
  </id_info>
  <brief_title>Promoting Repeated HIV Self-testing Among MSM in Hong Kong</brief_title>
  <official_title>A Longitudinal Study for Promotion and Implementation of Repeated HIV Self-testing With Online Real-time Counseling</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this longitudinal study, we will firstly construct a cohort of HIV negative MSM, who will&#xD;
      be exposed to an online video-based intervention promoting HIV testing in general and&#xD;
      real-time HIV self-testing with online counselling service (HIVST-online) in particular.&#xD;
      Participants will receive intervention at baseline, Month 6 and Month 12.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      500 MSM will be recruited via venue-based, online outreach, and NGO referrals. At baseline,&#xD;
      Month 6 and Month 12, participants received online intervention promoting HIV testing in&#xD;
      general and HIV testing with online real-time counseling service. Free HIV self-testing kits&#xD;
      will be mailed to participants at baseline, Month 6 and Month 12. Upon appointment, a testing&#xD;
      administrator will provide online real-time pre-test and post-test counseling service for HIV&#xD;
      self-testing users.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">July 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HIV testing of any type</measure>
    <time_frame>14 months</time_frame>
    <description>Taking up any type of HIV testing during the follow-up period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HIV self-testing</measure>
    <time_frame>14 months</time_frame>
    <description>Taking up HIV self-testing during the follow-up period</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Behavior, Health</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention group</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Promoting and implementing repeated HIV self-testing and online real-time counseling</intervention_name>
    <description>At baseline, Month 6 and Month 12, participants will view an online video clip promoting the needs for HIV testing in general and HIV self-testing with online real-time counseling. A free HIV self-testing kit will be sent to participants. An HIVST administrator will provide online real-time pre-test and post-test counseling.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hong Kong Chinese speaking men&#xD;
&#xD;
          -  ≥18 years old&#xD;
&#xD;
          -  Anal intercourse with at least one man in the last six months&#xD;
&#xD;
          -  Access to online face-to-face communication tools (e.g., Line, Skype, WhatsApp)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Self-reported to be HIV positive&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zixin Wang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zixin Wang</last_name>
    <phone>51669414</phone>
    <email>wangzx@cuhk.edu.hk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Centre for Health Behaviours Research, the Chinese University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <zip>666888</zip>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zixin Wang, PhD</last_name>
      <phone>+852 22528740</phone>
      <email>wangzx@cuhk.edu.hk</email>
    </contact>
    <contact_backup>
      <last_name>Mary Ip, BSc</last_name>
      <phone>+852 22528724</phone>
      <email>mitk@cuhk.edu.hk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>August 11, 2020</last_update_submitted>
  <last_update_submitted_qc>August 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Zixin Wang</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>HIV testing</keyword>
  <keyword>HIV self-testing</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04434950
org study id: MSS269R
nct id: NCT04434950
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
In this longitudinal study, we will firstly construct a cohort of HIV negative MSM, who will
      be exposed to an online video-based intervention promoting HIV testing in general and
      real-time HIV self-testing with online counselling service (HIVST-online) in particular.
      Participants will receive intervention at baseline, Month 6 and Month 12.
500 MSM will be recruited via venue-based, online outreach, and NGO referrals. At baseline,
      Month 6 and Month 12, participants received online intervention promoting HIV testing in
      general and HIV testing with online real-time counseling service. Free HIV self-testing kits
      will be mailed to participants at baseline, Month 6 and Month 12. Upon appointment, a testing
      administrator will provide online real-time pre-test and post-test counseling service for HIV
      self-testing users.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: HIV testing of any type
time frame: 14 months
description: Taking up any type of HIV testing during the follow-up period
measure: HIV self-testing
time frame: 14 months
description: Taking up HIV self-testing during the follow-up period
arm group label: Intervention
arm group type: Experimental
description: Intervention group
intervention type: Behavioral
intervention name: Promoting and implementing repeated HIV self-testing and online real-time counseling
description: At baseline, Month 6 and Month 12, participants will view an online video clip promoting the needs for HIV testing in general and HIV self-testing with online real-time counseling. A free HIV self-testing kit will be sent to participants. An HIVST administrator will provide online real-time pre-test and post-test counseling.
arm group label: Intervention
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Zixin Wang
role: Principal Investigator
affiliation: Chinese University of Hong Kong
last name: Zixin Wang
phone: 51669414
email: wangzx@cuhk.edu.hk
facility: 
status: Recruiting
contact: 
contact backup: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Zixin Wang
investigator title: Assistant Professor
sharing ipd: No