<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/NCT02191527</url>
  </required_header>
  <id_info>
    <org_study_id>EGPAF-004</org_study_id>
    <nct_id>NCT02191527</nct_id>
  </id_info>
  <brief_title>Evaluating the Effectiveness of Point-of-care Diagnostic Technologies in MCH Services in Mozambique</brief_title>
  <official_title>Evaluating the Effectiveness of Point-of-care Diagnostic Technologies in MCH Services and Their Impact on Mother and Child Health Outcomes in Cabo Delgado Province, Mozambique</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Elizabeth Glaser Pediatric AIDS Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, Mozambique</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Elizabeth Glaser Pediatric AIDS Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The general goal of the proposed study is to evaluate the cost-effectiveness of POC&#xD;
      technologies for diagnosis of syphilis, quantitative analysis for hemoglobin and CD4 counting&#xD;
      performed within MCH services to improve maternal and infant health.&#xD;
&#xD;
      A prospective, quasi-experimental study will be done in Cabo Delgado province, where health&#xD;
      facilities will be randomized in an intervention or comparison arm. Outcomes on maternal and&#xD;
      infant health will be measured.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">October 2014</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>Before and after intervention study design</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The proportion of HIV positive pregnant women initiating antiretroviral therapy among eligible women.</measure>
    <time_frame>Within 1 month</time_frame>
    <description>Number of HIV positive pregnant women initiating antiretroviral therapy divided by the number of eligible HIV positive pregnant women</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of women at first ANC visit tested and treated for syphilis</measure>
    <time_frame>Within 1 month</time_frame>
    <description>Number of women at first ANC tested and treated for syphilis divided by the number of women attending first ANC visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of pregnant women tested and treated for anemia</measure>
    <time_frame>Within 1 month</time_frame>
    <description>Number of pregnant women test and treated for anemia divided by the number of pregnant women</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of HIV infections in infants averted</measure>
    <time_frame>1-3 months of age</time_frame>
    <description>Number of HIV-positive pregnant women who accessed antiretrovial therapy in a timely manner</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1673</enrollment>
  <condition>HIV</condition>
  <condition>Syphilis</condition>
  <condition>Anemia During Pregnancy</condition>
  <arm_group>
    <arm_group_label>Point of Care Testing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The point-of-care devices will be located in the MCH services, where a trained lay counselor will do the tests.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laboratory Testing - Standard of care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Samples sent to the laboratory for analysis, (standard of care)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PIMA® for quantitative analysis of CD4-count</intervention_name>
    <arm_group_label>Point of Care Testing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hemocue® (HemoCue AB, Angelhom, Sweden) for quantitative analysis of hemoglobin</intervention_name>
    <arm_group_label>Point of Care Testing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SD Bioline® (Standard Diagnostics Inc., South-Korea) for qualitative analysis of syphilis</intervention_name>
    <arm_group_label>Point of Care Testing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  First antenatal care visit&#xD;
&#xD;
          -  Able to provide informed consent and signed consent form&#xD;
&#xD;
          -  Minimum 18 years of age&#xD;
&#xD;
          -  Diagnosed HIV positive at antenatal care visit&#xD;
&#xD;
          -  Living in the catchment area of the health facility&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years&#xD;
&#xD;
          -  No consent form signed&#xD;
&#xD;
          -  Being on ART at time of first antenatal care visit&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Caroline DeSchacht, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Elizabeth Glaser Pediatric AIDS Foundation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ilesh V Jani, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto Nacional de Saúde, Mozambique</affiliation>
  </overall_official>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>August 15, 2013</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PMTCT</keyword>
  <keyword>HIV</keyword>
  <keyword>Syphilis</keyword>
  <keyword>Anemia during pregnancy</keyword>
  <keyword>Point of care diagnostics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syphilis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chrysarobin</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02191527
org study id: EGPAF-004
nct id: NCT02191527
lead sponsor: 
collaborator: 
has dmc: No
The general goal of the proposed study is to evaluate the cost-effectiveness of POC
      technologies for diagnosis of syphilis, quantitative analysis for hemoglobin and CD4 counting
      performed within MCH services to improve maternal and infant health.

      A prospective, quasi-experimental study will be done in Cabo Delgado province, where health
      facilities will be randomized in an intervention or comparison arm. Outcomes on maternal and
      infant health will be measured.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Before and after intervention study design
primary purpose: Diagnostic
masking: None (Open Label)
measure: The proportion of HIV positive pregnant women initiating antiretroviral therapy among eligible women.
time frame: Within 1 month
description: Number of HIV positive pregnant women initiating antiretroviral therapy divided by the number of eligible HIV positive pregnant women
measure: Proportion of women at first ANC visit tested and treated for syphilis
time frame: Within 1 month
description: Number of women at first ANC tested and treated for syphilis divided by the number of women attending first ANC visit
measure: The proportion of pregnant women tested and treated for anemia
time frame: Within 1 month
description: Number of pregnant women test and treated for anemia divided by the number of pregnant women
measure: Number of HIV infections in infants averted
time frame: 1-3 months of age
description: Number of HIV-positive pregnant women who accessed antiretrovial therapy in a timely manner
arm group label: Point of Care Testing
arm group type: Experimental
description: The point-of-care devices will be located in the MCH services, where a trained lay counselor will do the tests.
arm group label: Laboratory Testing - Standard of care
arm group type: No Intervention
description: Samples sent to the laboratory for analysis, (standard of care)
intervention type: Device
intervention name: PIMA® for quantitative analysis of CD4-count
arm group label: Point of Care Testing
intervention type: Device
intervention name: Hemocue® (HemoCue AB, Angelhom, Sweden) for quantitative analysis of hemoglobin
arm group label: Point of Care Testing
intervention type: Device
intervention name: SD Bioline® (Standard Diagnostics Inc., South-Korea) for qualitative analysis of syphilis
arm group label: Point of Care Testing
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Caroline DeSchacht, MD, MSc
role: Principal Investigator
affiliation: Elizabeth Glaser Pediatric AIDS Foundation
last name: Ilesh V Jani, MD, PhD
role: Principal Investigator
affiliation: Instituto Nacional de Saúde, Mozambique
responsible party type: Sponsor
mesh term: Syphilis
mesh term: Chrysarobin