<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/NCT03025165</url>
  </required_header>
  <id_info>
    <org_study_id>HPTN 071c</org_study_id>
    <nct_id>NCT03025165</nct_id>
  </id_info>
  <brief_title>A Comparison of Different Community Models of ART Delivery Amongst Stable HIV+ Patients in Two Urban Settings in Zambia</brief_title>
  <official_title>A Comparison of Different Community Models of ART Delivery Amongst Stable HIV+ Patients in Two Urban Settings in Zambia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HIV Prevention Trials Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HIV Prevention Trials Network</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the virological and clinical outcomes of patients&#xD;
      participating in community models of ART delivery to the standard of care in an urban setting&#xD;
      in Zambia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The outcomes of this study will be measured in a prospective cohort of adult patients&#xD;
      enrolled into ART care in two urban communities participating in the HPTN 071 (PopART) trial.&#xD;
      The two community models are: 1) adherence clubs, groups of 20-25 stable patients who receive&#xD;
      ART care in the community every 3 months, and 2) home-based ART delivery in which a community&#xD;
      health worker delivers ART care to an individual at home every 3 months. The standard of care&#xD;
      is delivery of ART care at the local clinic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">July 22, 2019</completion_date>
  <primary_completion_date type="Actual">July 22, 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Viral Suppression</measure>
    <time_frame>One year after beginning participation in the program</time_frame>
    <description>Viral suppression at 12 months measured using the standard of care viral load testing equipment currently in place. Viral suppression will be defined according to National guidelines.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Viral suppression at 24 months</measure>
    <time_frame>Two years after beginning participation in the program</time_frame>
    <description>Undetectable HIV viral load 24 months after entry into the models of care. This will be done as part of routine laboratory monitoring and measured using routine programmatic data.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">2526</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>Community Adherence Clubs</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ART adherence support, symptom screening and dispensation of pre-packed medications by community health worker to a club meeting of 20-25 HIV+ patients every three months, with two clinic visits every year for clinical review and laboratory monitoring</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Home-Based ART Delivery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individuals receive ART adherence support, symptom screening and dispensation of pre-packed medications by community health worker at their household every three months, with two clinic visits every year for clinical review and laboratory monitoring</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Delivery of ART adherence support, symptom screening and dispensation of medications at the local clinic according to local guidelines.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Community Adherence Clubs</intervention_name>
    <description>Provision of ART care in the community to a club of 20-25 HIV+ patients</description>
    <arm_group_label>Community Adherence Clubs</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Home-Based ART Delivery</intervention_name>
    <description>Provision of ART care to an individual at their home</description>
    <arm_group_label>Home-Based ART Delivery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>Delivery of ART adherence support, symptom screening and dispensation of medications at the local clinic according to local guidelines.</description>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        18 years or older On first-line ART and retained in care for more than 6 months&#xD;
        Virologically suppressed World Health Organization (WHO) stage I and II at time of&#xD;
        screening Reside within the clinic catchment area Willing to provide written informed&#xD;
        consent and accept Community HIV-care Provider (CHiPs) intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</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>Mohammed Limbada, MBCHB, MScID</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zambart</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zambart</name>
      <address>
        <city>Lusaka</city>
        <country>Zambia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Zambia</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>August 25, 2022</last_update_submitted>
  <last_update_submitted_qc>August 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03025165
org study id: HPTN 071c
nct id: NCT03025165
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare the virological and clinical outcomes of patients
      participating in community models of ART delivery to the standard of care in an urban setting
      in Zambia.
The outcomes of this study will be measured in a prospective cohort of adult patients
      enrolled into ART care in two urban communities participating in the HPTN 071 (PopART) trial.
      The two community models are: 1) adherence clubs, groups of 20-25 stable patients who receive
      ART care in the community every 3 months, and 2) home-based ART delivery in which a community
      health worker delivers ART care to an individual at home every 3 months. The standard of care
      is delivery of ART care at the local clinic.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Viral Suppression
time frame: One year after beginning participation in the program
description: Viral suppression at 12 months measured using the standard of care viral load testing equipment currently in place. Viral suppression will be defined according to National guidelines.
measure: Viral suppression at 24 months
time frame: Two years after beginning participation in the program
description: Undetectable HIV viral load 24 months after entry into the models of care. This will be done as part of routine laboratory monitoring and measured using routine programmatic data.
arm group label: Community Adherence Clubs
arm group type: Experimental
description: ART adherence support, symptom screening and dispensation of pre-packed medications by community health worker to a club meeting of 20-25 HIV+ patients every three months, with two clinic visits every year for clinical review and laboratory monitoring
arm group label: Home-Based ART Delivery
arm group type: Experimental
description: Individuals receive ART adherence support, symptom screening and dispensation of pre-packed medications by community health worker at their household every three months, with two clinic visits every year for clinical review and laboratory monitoring
arm group label: Standard of Care
arm group type: Other
description: Delivery of ART adherence support, symptom screening and dispensation of medications at the local clinic according to local guidelines.
intervention type: Other
intervention name: Community Adherence Clubs
description: Provision of ART care in the community to a club of 20-25 HIV+ patients
arm group label: Community Adherence Clubs
intervention type: Other
intervention name: Home-Based ART Delivery
description: Provision of ART care to an individual at their home
arm group label: Home-Based ART Delivery
intervention type: Other
intervention name: Standard of Care
description: Delivery of ART adherence support, symptom screening and dispensation of medications at the local clinic according to local guidelines.
arm group label: Standard of Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mohammed Limbada, MBCHB, MScID
role: Principal Investigator
affiliation: Zambart
facility: 
country: Zambia
responsible party type: Sponsor
mesh term: HIV Infections
sharing ipd: No