<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/NCT01716299</url>
  </required_header>
  <id_info>
    <org_study_id>msf09</org_study_id>
    <nct_id>NCT01716299</nct_id>
  </id_info>
  <brief_title>Comparison of HIV Testing Algorithms</brief_title>
  <official_title>Comparison of HIV Testing Algorithms in Two Sites in Ethiopia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medecins Sans Frontieres, Netherlands</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medecins Sans Frontieres, Netherlands</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the study is to assess whether an improved MSF HIV diagnostic&#xD;
      algorithm which includes a simple and easy to perform confirmation test has significantly&#xD;
      better positive predictive value than WHO recommended RDT testing algorithms that do not&#xD;
      include confirmatory testing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rapid Diagnostic Tests (RDT's) are essential tools in antiretroviral treatment (ART) scale&#xD;
      up. An important drawback to RDTs is the risk of false positive results. In 2005, MSF-Holland&#xD;
      has therefore changed the testing algorithm to introduce a confirmation test. This proposal&#xD;
      outlines an evaluation study of the results of the new confirmatory testing algorithm. It&#xD;
      aims to compare the confirmatory algorithm employed by MSF-OCA to the MoH serial algorithm&#xD;
      which is based on WHO recommendations. A secondary objective of the study is to determine if&#xD;
      there is a correlation between kala-azar infection and risk of false positive HIV RDT results&#xD;
      as clinicians in the projects suspect such a correlation. Furthermore, the study will look at&#xD;
      the positive predictive value of weak test lines, which have been associated with higher risk&#xD;
      of false positive results. Finally, the study aims to evaluate the results of a new&#xD;
      simplified confirmation test, the dilution testing. Clients for the study will be recruited&#xD;
      at two counseling and testing sites in Abdurafi and Humera, aiming to reach a sample size of&#xD;
      200 serial-algorithm positive and 200 negative samples in each site.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2010</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">July 2011</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>HIV result by Western Blot</measure>
    <time_frame>one week</time_frame>
  </primary_outcome>
  <enrollment type="Actual">495</enrollment>
  <condition>HIV Infection</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>application of a confirmation test</intervention_name>
    <description>Addition of confirmation test to serial testing algorithm, including dilution test</description>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>application of a confirmation test</intervention_name>
    <description>use of rapid confirmation test</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients presenting the Counseling and Testing centres in the two study sites&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Age &gt;= 59 months (to help ensure success of venepuncture)&#xD;
&#xD;
               -  Informed consent from the individual or guardian to participate in study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Inability to obtain venous blood sample&#xD;
&#xD;
               -  Withdrawal of consent to test or to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leslie Shanks, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medecins Sans Frontieres, Netherlands</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Abdurafi Health Center</name>
      <address>
        <city>Abderafi</city>
        <state>Amhara Regional State</state>
        <country>Ethiopia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Humera Hospital</name>
      <address>
        <city>Humera</city>
        <state>Tigray Regional State</state>
        <country>Ethiopia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ethiopia</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>January 20, 2014</last_update_submitted>
  <last_update_submitted_qc>January 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medecins Sans Frontieres, Netherlands</investigator_affiliation>
    <investigator_full_name>Leslie Shanks</investigator_full_name>
    <investigator_title>Medical Director, MSF-OCA</investigator_title>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>Diagnostics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_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/NCT01716299
org study id: msf09
nct id: NCT01716299
lead sponsor: 
has dmc: No
The primary objective of the study is to assess whether an improved MSF HIV diagnostic
      algorithm which includes a simple and easy to perform confirmation test has significantly
      better positive predictive value than WHO recommended RDT testing algorithms that do not
      include confirmatory testing.
Rapid Diagnostic Tests (RDT's) are essential tools in antiretroviral treatment (ART) scale
      up. An important drawback to RDTs is the risk of false positive results. In 2005, MSF-Holland
      has therefore changed the testing algorithm to introduce a confirmation test. This proposal
      outlines an evaluation study of the results of the new confirmatory testing algorithm. It
      aims to compare the confirmatory algorithm employed by MSF-OCA to the MoH serial algorithm
      which is based on WHO recommendations. A secondary objective of the study is to determine if
      there is a correlation between kala-azar infection and risk of false positive HIV RDT results
      as clinicians in the projects suspect such a correlation. Furthermore, the study will look at
      the positive predictive value of weak test lines, which have been associated with higher risk
      of false positive results. Finally, the study aims to evaluate the results of a new
      simplified confirmation test, the dilution testing. Clients for the study will be recruited
      at two counseling and testing sites in Abdurafi and Humera, aiming to reach a sample size of
      200 serial-algorithm positive and 200 negative samples in each site.
time perspective: Prospective
measure: HIV result by Western Blot
time frame: one week
intervention type: Other
intervention name: application of a confirmation test
description: Addition of confirmation test to serial testing algorithm, including dilution test
intervention type: Other
intervention name: application of a confirmation test
description: use of rapid confirmation test
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Leslie Shanks, MD
role: Principal Investigator
affiliation: Medecins Sans Frontieres, Netherlands
facility: 
facility: 
country: Ethiopia
responsible party type: Principal Investigator
investigator affiliation: Medecins Sans Frontieres, Netherlands
investigator full name: Leslie Shanks
investigator title: Medical Director, MSF-OCA
mesh term: HIV Infections