<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/NCT02197793</url>
  </required_header>
  <id_info>
    <org_study_id>14-13575</org_study_id>
    <nct_id>NCT02197793</nct_id>
  </id_info>
  <brief_title>Activating Treatment as Prevention Through Community Mobilization in South Africa</brief_title>
  <official_title>Activating Treatment as Prevention Through Community Mobilization in South Africa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Witwatersrand, South Africa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the impact of a community mobilization intervention&#xD;
      on the uptake of HIV testing, linkage to and retention in HIV care using a community, cluster&#xD;
      randomized trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eight of 16 intervention naïve communities in the Agincourt HDSS will be randomized to&#xD;
      receive the CM intervention to activate TasP based on the investigators CM conceptual&#xD;
      framework. The 16 villages will be randomized based on the &quot;restricted randomization&quot;&#xD;
      approach, a stratification method to ensure overall balance between intervention and control&#xD;
      communities.&#xD;
&#xD;
      Intervention activities will map onto the investigators six mobilization domains identified&#xD;
      in the investigators preliminary work as key components for communities to mobilize for&#xD;
      change around HIV prevention. These activities will support communities to: 1) identify a&#xD;
      shared concern around testing, linkage and retention in care; 2) enable communities to&#xD;
      develop critical consciousness around TasP; 3) facilitate identification and development of&#xD;
      structures and networks to disseminate information and activities around TasP; 4) identify&#xD;
      and engage community leadership around TasP; 5) take collection action to support TasP; and&#xD;
      6) build community cohesion to address the HIV epidemic and support access to care.&#xD;
&#xD;
      The investigators will evaluate the impact of the intervention using a linked data set&#xD;
      including electronic clinic records and the HDSS census data, which will allow us to&#xD;
      determine whether people in the intervention communities test at higher proportions than&#xD;
      those in control communities, whether individuals who test positive in the intervention&#xD;
      communities are more likely to receive CD4 testing and initiate treatment within 3 months&#xD;
      than the control communities, and whether those who are eligible and not eligible for&#xD;
      treatment are retained in care.&#xD;
&#xD;
      The investigators will implement a representative cross-sectional survey in all 16 villages&#xD;
      prior to and following the intervention in order to examine changes in CM domains across&#xD;
      villages and the mechanisms through which the intervention affects HIV testing, linkage and&#xD;
      retention.&#xD;
&#xD;
      In addition, intervention progress and dosage will be carefully monitored through a tracking&#xD;
      system to document all workshops and activities that are carried out in each village.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">August 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rates of HIV Testing</measure>
    <time_frame>3 years follow-up</time_frame>
    <description>Tested /Untested past 12 mos, among HIV-negative or unknown status residents</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rates of linkage to care CD4 within 3 months</measure>
    <time_frame>3 years follow-up</time_frame>
    <description>Received CD4 results or had clinical visit within 3 mos of testing HIV positive among recent positives</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rates of retention in care</measure>
    <time_frame>3 years follow-up</time_frame>
    <description>No treatment default (no more than a 90-day gap in medication or visit schedule)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Median CD4 of people initiating ART</measure>
    <time_frame>3 years follow-up</time_frame>
    <description>Median CD4 at entry into care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-engagement in care</measure>
    <time_frame>3 years follow-up</time_frame>
    <description>Patients out of care for ≥ 12 months who are re-engaged in care, as evidenced by a clinical visit or CD4 test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Testing Yield</measure>
    <time_frame>3 years follow-up</time_frame>
    <description>Number of new diagnoses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>First Time Testers</measure>
    <time_frame>3 years follow-up</time_frame>
    <description>Number of first time testers (in particular the number of HIV infected undiagnosed)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2338</enrollment>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>Community Mobilization Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention activities will map onto six mobilization domains identified as key components for communities to mobilize for change around testing, linkage and retention in care (Treatment as Prevention (TasP)).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control arm does not receive the Community Mobilization Intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Community Mobilization Program</intervention_name>
    <arm_group_label>Community Mobilization Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  lived in the study area for 12 months&#xD;
&#xD;
          -  age 18-49 years&#xD;
&#xD;
          -  able to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Audrey Pettifor, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MRC/Wits Rural Public Health and Heath Transitions Research Unit</name>
      <address>
        <city>Agincourt</city>
        <state>Mpumalanga</state>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>South Africa</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>September 3, 2020</last_update_submitted>
  <last_update_submitted_qc>September 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02197793
org study id: 14-13575
nct id: NCT02197793
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate the impact of a community mobilization intervention
      on the uptake of HIV testing, linkage to and retention in HIV care using a community, cluster
      randomized trial.
Eight of 16 intervention naïve communities in the Agincourt HDSS will be randomized to
      receive the CM intervention to activate TasP based on the investigators CM conceptual
      framework. The 16 villages will be randomized based on the "restricted randomization"
      approach, a stratification method to ensure overall balance between intervention and control
      communities.

      Intervention activities will map onto the investigators six mobilization domains identified
      in the investigators preliminary work as key components for communities to mobilize for
      change around HIV prevention. These activities will support communities to: 1) identify a
      shared concern around testing, linkage and retention in care; 2) enable communities to
      develop critical consciousness around TasP; 3) facilitate identification and development of
      structures and networks to disseminate information and activities around TasP; 4) identify
      and engage community leadership around TasP; 5) take collection action to support TasP; and
      6) build community cohesion to address the HIV epidemic and support access to care.

      The investigators will evaluate the impact of the intervention using a linked data set
      including electronic clinic records and the HDSS census data, which will allow us to
      determine whether people in the intervention communities test at higher proportions than
      those in control communities, whether individuals who test positive in the intervention
      communities are more likely to receive CD4 testing and initiate treatment within 3 months
      than the control communities, and whether those who are eligible and not eligible for
      treatment are retained in care.

      The investigators will implement a representative cross-sectional survey in all 16 villages
      prior to and following the intervention in order to examine changes in CM domains across
      villages and the mechanisms through which the intervention affects HIV testing, linkage and
      retention.

      In addition, intervention progress and dosage will be carefully monitored through a tracking
      system to document all workshops and activities that are carried out in each village.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Rates of HIV Testing
time frame: 3 years follow-up
description: Tested /Untested past 12 mos, among HIV-negative or unknown status residents
measure: Rates of linkage to care CD4 within 3 months
time frame: 3 years follow-up
description: Received CD4 results or had clinical visit within 3 mos of testing HIV positive among recent positives
measure: Rates of retention in care
time frame: 3 years follow-up
description: No treatment default (no more than a 90-day gap in medication or visit schedule)
measure: Median CD4 of people initiating ART
time frame: 3 years follow-up
description: Median CD4 at entry into care
measure: Re-engagement in care
time frame: 3 years follow-up
description: Patients out of care for ≥ 12 months who are re-engaged in care, as evidenced by a clinical visit or CD4 test
measure: Testing Yield
time frame: 3 years follow-up
description: Number of new diagnoses
measure: First Time Testers
time frame: 3 years follow-up
description: Number of first time testers (in particular the number of HIV infected undiagnosed)
arm group label: Community Mobilization Program
arm group type: Experimental
description: Intervention activities will map onto six mobilization domains identified as key components for communities to mobilize for change around testing, linkage and retention in care (Treatment as Prevention (TasP)).
arm group label: Control Arm
arm group type: No Intervention
description: The control arm does not receive the Community Mobilization Intervention.
intervention type: Behavioral
intervention name: Community Mobilization Program
arm group label: Community Mobilization Program
criteria: 
gender: All
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Audrey Pettifor, PhD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
country: South Africa
responsible party type: Sponsor
sharing ipd: No