<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/NCT03789448</url>
  </required_header>
  <id_info>
    <org_study_id>MaxART Economic Evaluation</org_study_id>
    <nct_id>NCT03789448</nct_id>
  </id_info>
  <brief_title>Early Access to ART for All in Swaziland: Effects on Economic Outcomes</brief_title>
  <official_title>MaxART: The Effect of Early Access to ART for All in Swaziland on Economic Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Till Bärnighausen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Clinton Health Access Initiative Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital Heidelberg</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>
      The purpose of this study is to evaluate the impact of offering early antiretroviral therapy&#xD;
      to HIV-positive individuals in government-managed health facilities in Swaziland on a range&#xD;
      of economic outcomes&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The MaxART study is a three-year stepped-wedge randomized trial with open enrollment for all&#xD;
      adults 18 years and older across 14 rural health facilities in Swaziland's Hhohho Region. The&#xD;
      main trial registration is accessible at:&#xD;
      https://clinicaltrials.gov/ct2/show/record/NCT02909218.&#xD;
&#xD;
      This registration is specific to the economic evaluation of the MaxART study which aims to&#xD;
      quantify the causal impacts of early ART initiation (compared to national standard care) on a&#xD;
      range of key economic outcomes, including healthcare expenditures, productivity, and&#xD;
      household wealth.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2014</start_date>
  <completion_date type="Actual">August 31, 2017</completion_date>
  <primary_completion_date type="Actual">August 31, 2017</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>Sequential Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total healthcare expenditures (for hospitalization and primary care)</measure>
    <time_frame>12 months</time_frame>
    <description>Including direct health care costs (e.g., surgery, medication, consultation) and indirect costs (e.g., transport to clinic, payment for someone to look after children, salary lost for time off...)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total productivity hours</measure>
    <time_frame>24 hours</time_frame>
    <description>Total Hours per day spent on income generation activities</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of participants with current employment</measure>
    <time_frame>At study completion, an average of 1.5 years</time_frame>
    <description>Employment rate among participants, including full-time and part-time salary work</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total sum of self-reported monthly expenditures of the participant's household</measure>
    <time_frame>12 months</time_frame>
    <description>Including food and non-food items (e.g., electricity, water, transport, personal care items, insurance, festivals, etc.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Household Assets Ownership and Living Standards Index</measure>
    <time_frame>At study completion, an average of 1.5 years</time_frame>
    <description>Aggregated index based on ownership of assets (e.g., refrigerator, TV, table, phone...) and living standards (e.g., flush toilet, cooking facilites, floor/wall/roof material...), total scale score is determined via principal component analysis and averaged around 0</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3019</enrollment>
  <condition>HIV/AIDS</condition>
  <arm_group>
    <arm_group_label>National HIV Treatment Guidelines</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>HIV-positive individuals are offered ART per Swaziland's national treatment guidelines</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Early Access to ART for All</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HIV-positive individuals who are aged 18 years or older are initiated on ART regardless of client's immunological and clinical staging (excluding pregnant or breastfeeding women)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Early Access to ART for All</intervention_name>
    <description>All HIV-positive individuals will be initiated on Swaziland's recommended first-line ART regimen, unless contraindicated when recommended alternate regimens will be used per national guidelines</description>
    <arm_group_label>Early Access to ART for All</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All HIV-positive individuals who are aged 18 years or older, are ART naïve and attend&#xD;
             the health facilities included in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All HIV-positive individuals who are &lt;18 years of age&#xD;
&#xD;
          -  All HIV-positive pregnant or breastfeeding women&#xD;
&#xD;
          -  All HIV-positive individuals who did not consent to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>January 3, 2019</last_update_submitted>
  <last_update_submitted_qc>January 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Heidelberg</investigator_affiliation>
    <investigator_full_name>Till Bärnighausen</investigator_full_name>
    <investigator_title>University Hospital Heidelberg</investigator_title>
  </responsible_party>
  <keyword>Antiretroviral 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>
  <study_docs>
    <study_doc>
      <doc_type>Study Protocol</doc_type>
      <doc_url>https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2128-8</doc_url>
    </study_doc>
  </study_docs>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 25, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT03789448/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03789448
org study id: MaxART Economic Evaluation
nct id: NCT03789448
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the impact of offering early antiretroviral therapy
      to HIV-positive individuals in government-managed health facilities in Swaziland on a range
      of economic outcomes
The MaxART study is a three-year stepped-wedge randomized trial with open enrollment for all
      adults 18 years and older across 14 rural health facilities in Swaziland's Hhohho Region. The
      main trial registration is accessible at:
      https://clinicaltrials.gov/ct2/show/record/NCT02909218.

      This registration is specific to the economic evaluation of the MaxART study which aims to
      quantify the causal impacts of early ART initiation (compared to national standard care) on a
      range of key economic outcomes, including healthcare expenditures, productivity, and
      household wealth.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Total healthcare expenditures (for hospitalization and primary care)
time frame: 12 months
description: Including direct health care costs (e.g., surgery, medication, consultation) and indirect costs (e.g., transport to clinic, payment for someone to look after children, salary lost for time off...)
measure: Total productivity hours
time frame: 24 hours
description: Total Hours per day spent on income generation activities
measure: Rate of participants with current employment
time frame: At study completion, an average of 1.5 years
description: Employment rate among participants, including full-time and part-time salary work
measure: Total sum of self-reported monthly expenditures of the participant's household
time frame: 12 months
description: Including food and non-food items (e.g., electricity, water, transport, personal care items, insurance, festivals, etc.)
measure: Household Assets Ownership and Living Standards Index
time frame: At study completion, an average of 1.5 years
description: Aggregated index based on ownership of assets (e.g., refrigerator, TV, table, phone...) and living standards (e.g., flush toilet, cooking facilites, floor/wall/roof material...), total scale score is determined via principal component analysis and averaged around 0
arm group label: National HIV Treatment Guidelines
arm group type: No Intervention
description: HIV-positive individuals are offered ART per Swaziland's national treatment guidelines
arm group label: Early Access to ART for All
arm group type: Experimental
description: HIV-positive individuals who are aged 18 years or older are initiated on ART regardless of client's immunological and clinical staging (excluding pregnant or breastfeeding women)
intervention type: Other
intervention name: Early Access to ART for All
description: All HIV-positive individuals will be initiated on Swaziland's recommended first-line ART regimen, unless contraindicated when recommended alternate regimens will be used per national guidelines
arm group label: Early Access to ART for All
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor-Investigator
investigator affiliation: University Hospital Heidelberg
investigator full name: Till Bärnighausen
investigator title: University Hospital Heidelberg
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
study doc: 
provided document: 