<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/NCT03794245</url>
  </required_header>
  <id_info>
    <org_study_id>R01MH105534</org_study_id>
    <nct_id>NCT03794245</nct_id>
  </id_info>
  <brief_title>Bringing South African Men Into HIV Counseling and Testing and Care</brief_title>
  <official_title>Bringing South African Men Into HIV Counseling (HCT) and Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Human Sciences Research Council</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Charles University, Czech Republic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial seeks to determine if male-centered recruitment increases men's testing&#xD;
      for HIV and whether or not individualized introduction to clinics increases male engagement&#xD;
      in treatment for HIV. The study is being conducted in rural KwaZulu Natal.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study combines structural and individual level interventions for HIV and integrates the&#xD;
      two to address the study's objective of identifying South African men in KwaZulu Natal with&#xD;
      HIV and maintaining those diagnosed with HIV in care to the point of viral suppression.&#xD;
&#xD;
      The cluster-randomized design will randomize 8 communities to intervention or control to test&#xD;
      the hypothesis whether male-centered mobilization and testing increases the population-level&#xD;
      percentage of men who have been tested within the past 12 months by more than 10 absolute&#xD;
      percentage points.&#xD;
&#xD;
      The individually randomized design will test whether individualized case management will&#xD;
      effectively link HIV-positive men to treatment to the point of viral suppression.&#xD;
&#xD;
      The study will also examine the incremental cost-effectiveness of the interventions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 7, 2015</start_date>
  <completion_date type="Actual">April 30, 2022</completion_date>
  <primary_completion_date type="Actual">December 1, 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>Men-Centered HIV Testing vs. Clinic-Based HIV Testing; Personalized Linkage to Care for HIV+ Men vs. Clinic Referral for HIV+ Men.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
    <masking_description>The Care Provider and Outcomes Assessors do not know the arms to which an individual has been assigned</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of men tested for HIV</measure>
    <time_frame>Tested within the past 12 months</time_frame>
    <description>Percentage of men in the community, selected through probability sampling, who report being tested for HIV</description>
  </primary_outcome>
  <other_outcome>
    <measure>Percentage of HIV+ men initiating treatment for HIV</measure>
    <time_frame>Within 6 months of receiving HIV diagnosis</time_frame>
    <description>Percentage of men HIV+ enrolling in treatment centers and starting treatment for HIV</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of men with suppressed viral load</measure>
    <time_frame>12 months after initiating treatment</time_frame>
    <description>Percentage of men with HIV viral load &lt;50 copies/ml</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">1806</enrollment>
  <condition>Human Immunodeficiency Virus</condition>
  <arm_group>
    <arm_group_label>Men-Centered HIV Testing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mobile HIV testing is conducted at sites in the community where men gather.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clinic-based HIV Testing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Men are referred to the nearest clinic for HIV counseling and testing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Linkage to Care for HIV+ Men</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patient coordinator arranges an appointment time at the clinic and accompanies the patient to the initial visit</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clinic Referral for HIV+ Men</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Men diagnosed with HIV are referred to the nearest clinic for treatment of HIV</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Men-Centered HIV Testing</intervention_name>
    <description>The intervention involves bringing mobile HIV testing to venues where men congregate, talking to them as a group about HIV testing, and then providing testing at that venue.</description>
    <arm_group_label>Men-Centered HIV Testing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Linkage to Care for HIV+ Men</intervention_name>
    <description>Men diagnosed with HIV are accompanied to the clinic and registered there with the help of a community health worker.</description>
    <arm_group_label>Linkage to Care for HIV+ Men</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Clinic-based HIV Testing</intervention_name>
    <description>Individuals present to a clinic and request HIV counseling and testing</description>
    <arm_group_label>Clinic-based HIV Testing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Clinic Referral for HIV+ Men</intervention_name>
    <description>Individuals diagnosed with HIV are referred to the nearest clinic for treatment of HIV</description>
    <arm_group_label>Clinic Referral for HIV+ Men</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men residing in the target communities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Men outside of the target communities&#xD;
&#xD;
          -  Men who report being tested and HIV+&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>THOMAS J COATES, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Heidi Van Rooyen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Human Sciences Research Council</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Human Sciences Research Council</name>
      <address>
        <city>Pietermaritzburg</city>
        <state>KwaZulu-Natal</state>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>South Africa</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>October 9, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>July 6, 2023</last_update_submitted>
  <last_update_submitted_qc>July 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Thomas J. Coates</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Prevention</keyword>
  <keyword>Testing and Diagnosis</keyword>
  <keyword>Treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <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/NCT03794245
org study id: R01MH105534
nct id: NCT03794245
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This clinical trial seeks to determine if male-centered recruitment increases men's testing
      for HIV and whether or not individualized introduction to clinics increases male engagement
      in treatment for HIV. The study is being conducted in rural KwaZulu Natal.
This study combines structural and individual level interventions for HIV and integrates the
      two to address the study's objective of identifying South African men in KwaZulu Natal with
      HIV and maintaining those diagnosed with HIV in care to the point of viral suppression.

      The cluster-randomized design will randomize 8 communities to intervention or control to test
      the hypothesis whether male-centered mobilization and testing increases the population-level
      percentage of men who have been tested within the past 12 months by more than 10 absolute
      percentage points.

      The individually randomized design will test whether individualized case management will
      effectively link HIV-positive men to treatment to the point of viral suppression.

      The study will also examine the incremental cost-effectiveness of the interventions.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Men-Centered HIV Testing vs. Clinic-Based HIV Testing; Personalized Linkage to Care for HIV+ Men vs. Clinic Referral for HIV+ Men.
primary purpose: Prevention
masking: Double (Care Provider, Outcomes Assessor)
masking description: The Care Provider and Outcomes Assessors do not know the arms to which an individual has been assigned
measure: Percentage of men tested for HIV
time frame: Tested within the past 12 months
description: Percentage of men in the community, selected through probability sampling, who report being tested for HIV
measure: Percentage of HIV+ men initiating treatment for HIV
time frame: Within 6 months of receiving HIV diagnosis
description: Percentage of men HIV+ enrolling in treatment centers and starting treatment for HIV
measure: Percentage of men with suppressed viral load
time frame: 12 months after initiating treatment
description: Percentage of men with HIV viral load <50 copies/ml
arm group label: Men-Centered HIV Testing
arm group type: Experimental
description: Mobile HIV testing is conducted at sites in the community where men gather.
arm group label: Clinic-based HIV Testing
arm group type: Active Comparator
description: Men are referred to the nearest clinic for HIV counseling and testing
arm group label: Linkage to Care for HIV+ Men
arm group type: Experimental
description: The patient coordinator arranges an appointment time at the clinic and accompanies the patient to the initial visit
arm group label: Clinic Referral for HIV+ Men
arm group type: Active Comparator
description: Men diagnosed with HIV are referred to the nearest clinic for treatment of HIV
intervention type: Behavioral
intervention name: Men-Centered HIV Testing
description: The intervention involves bringing mobile HIV testing to venues where men congregate, talking to them as a group about HIV testing, and then providing testing at that venue.
arm group label: Men-Centered HIV Testing
intervention type: Behavioral
intervention name: Linkage to Care for HIV+ Men
description: Men diagnosed with HIV are accompanied to the clinic and registered there with the help of a community health worker.
arm group label: Linkage to Care for HIV+ Men
intervention type: Behavioral
intervention name: Clinic-based HIV Testing
description: Individuals present to a clinic and request HIV counseling and testing
arm group label: Clinic-based HIV Testing
intervention type: Behavioral
intervention name: Clinic Referral for HIV+ Men
description: Individuals diagnosed with HIV are referred to the nearest clinic for treatment of HIV
arm group label: Clinic Referral for HIV+ Men
criteria: 
gender: Male
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: THOMAS J COATES, PhD
role: Principal Investigator
affiliation: University of California, Los Angeles
last name: Heidi Van Rooyen, PhD
role: Principal Investigator
affiliation: Human Sciences Research Council
facility: 
country: South Africa
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Thomas J. Coates
investigator title: Principal Investigator
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
sharing ipd: No