<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/NCT01681706</url>
  </required_header>
  <id_info>
    <org_study_id>HIDES</org_study_id>
    <nct_id>NCT01681706</nct_id>
  </id_info>
  <brief_title>HIV Indicator Diseases Across Europe Study</brief_title>
  <acronym>HIDES</acronym>
  <official_title>HIV Indicator Diseases Across Europe Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jesper Grarup</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Copenhagen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this non-interventional study is to implement a survey initiative to assess&#xD;
      HIV prevalence for one or more diseases and/or conditions within a specific segment of the&#xD;
      population not yet diagnosed with HIV, who presents for care with the specific&#xD;
      disease/condition.&#xD;
&#xD;
      The list of diseases below is not indicative of the most important indicator diseases for HIV&#xD;
      but rather a list of diseases suggested for surveillance.&#xD;
&#xD;
      This study will enrol patients presenting with the following diseases/conditions:&#xD;
&#xD;
        1. Presenting for care of malignant lymphoma, irrespective of type&#xD;
&#xD;
        2. Presenting for care of cervical or anal dysplasia or cancer, (Cervical CIN II and above)&#xD;
&#xD;
        3. Presenting for care of Hepatitis B or C virus infection (acute or chronic - and&#xD;
           irrespective of time of diagnosis relative to time of survey),&#xD;
&#xD;
        4. Presenting with ongoing mononucleosis-like illness&#xD;
&#xD;
        5. Presenting with unexplained leukocytopenia or thrombocytopenia lasting at least 4 weeks&#xD;
&#xD;
        6. Presenting with seborrheic dermatitis / exanthema&#xD;
&#xD;
        7. Presenting with pneumonia, admitted to hospital for at least 24h&#xD;
&#xD;
        8. Presenting with unexplained lymphadenopathy&#xD;
&#xD;
        9. Presenting with peripheral neuropathy of unknown cause (diagnosed by neurologist)&#xD;
&#xD;
       10. Presenting with primary lung cancer&#xD;
&#xD;
       11. Presenting with severe or recalcitrant psoriasis (newly diagnosed)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Most patients infected with HIV across the European continent remain undiagnosed; although&#xD;
      this percentage varies markedly from 15-80% across the continent. Undiagnosed HIV is harmful&#xD;
      to the person infected as appropriate health interventions are then delayed until the HIV&#xD;
      infection is diagnosed. It is also detrimental to society as persons unaware of their HIV&#xD;
      infection may transmit more frequently to others than persons that are aware of their HIV&#xD;
      status.&#xD;
&#xD;
      An important public health issue is hence how to diagnose more HIV-infected persons earlier&#xD;
      in the course of their infection. In the US, the Centers for Disease Control and Prevention&#xD;
      (CDC) has introduced testing guidelines where all persons are tested upon entry into the&#xD;
      hospital system (the &quot;opt-out&quot; testing guidelines).&#xD;
&#xD;
      At the &quot;HIV in Europe&quot; conference held in November 2007, the general sense was that such an&#xD;
      approach would not be suitable for Europe. Conversely, the conference recommended further&#xD;
      development of focused HIV testing in patients presenting with certain clinical conditions&#xD;
      and/or diseases (i.e. indicator condition guided testing).&#xD;
&#xD;
      Cost effectiveness analyses suggests cost savings if a population with a HIV prevalence of 1%&#xD;
      or more are tested although this rate may be as low as 0.1%. However, there is very little -&#xD;
      if any - evidence on HIV prevalence for various conditions and diseases in specific and easy&#xD;
      to identify sections of society. This is true in general and particularly across the European&#xD;
      continent.&#xD;
&#xD;
      Surveys will be undertaken by the investigators:&#xD;
&#xD;
      Zangerle, Kitchen, U H Innsbruck, Vassilenko, Minsk Municipal Infectious Diseases Hospital,&#xD;
      Necsoi, Clumeck, Saint-Pierre U H Hadziosmanovic, U of Sarajevo Begovac, U Hospital of&#xD;
      Infectious Diseases Pedersen, Mogensen, Abildgaard, Titlestad, Odense U H Dragsted, Roskilde&#xD;
      H Späth, U of Bonn Sthoeger, Neve-Or AIDS Centre d'Armino Monforte, Mareo, Comi, Centanni,&#xD;
      San Paolo H Grzeszczuk, Medical U of Bialystok Maltez, H Curry Cabral Castro, HU A&#xD;
      Coruna-Hospital Juan Canalejo Masia, HU Elche Estrada, HCU San Carlos Iribarren, H. Donostia&#xD;
      Ortega, CH General de Valencia Ocampo, H Xeral-Cies Vernazza, Kantonsspital St. Gallen Perry,&#xD;
      Fisher, Elton John Centre, Morris, RIDU Minton, St James's U H Palfreeman, Leicester Royal&#xD;
      Infirmary Gazzard, Sullivan, ChelseaWestminster H Winston, Walsh, St Mary's H Anderson,&#xD;
      Millett, Homerton H NHS Trust Farazmand, Huddersfield Royal Infirmary Ong, Krasnov, Kharkov&#xD;
      Regional Clinic of Infectious Diseases Kutsyna, State Medical U&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2012</start_date>
  <completion_date type="Anticipated">June 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2013</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>Prevalence of HIV</measure>
    <time_frame>Participants are surveyed once up to month 23 for presenting indicator disease and result of the HIV test performed. Per site 100 participants are included in each survey - in total the single survey requires minimum 400 participants from all sites</time_frame>
    <description>To assess the HIV prevalence for the identified diseases and/or conditions within a specific segment of the population not yet diagnosed with HIV and that present for care with the specific disease/condition.</description>
  </primary_outcome>
  <enrollment type="Anticipated">14000</enrollment>
  <condition>HIV</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Participants between the age of 18 and 64 years old, presenting with 1 of the 11 indicator&#xD;
        diseases surveyed&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HIV status unknown&#xD;
&#xD;
          -  Presenting for care with 1 of the 11 indicator diseases surveyed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known HIV positive&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jens D Lundgren, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Copenhagen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dorthe Raben</last_name>
    <phone>0045 3545 5757</phone>
    <phone_ext>5782</phone_ext>
    <email>dra@cphiv.dk</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Copenhagen, Panum Institute, Health faculty,</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dorthe Raben</last_name>
      <phone>0045 3545 5757</phone>
      <phone_ext>5782</phone_ext>
      <email>dra@cphiv.dk</email>
    </contact>
    <investigator>
      <last_name>Jens Lundgren, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>September 5, 2012</last_update_submitted>
  <last_update_submitted_qc>September 5, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 10, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Copenhagen</investigator_affiliation>
    <investigator_full_name>Jesper Grarup</investigator_full_name>
    <investigator_title>Director of Administration</investigator_title>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>Indicator disease</keyword>
  <!-- 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/NCT01681706
org study id: HIDES
nct id: NCT01681706
lead sponsor: 
has dmc: No
The purpose of this non-interventional study is to implement a survey initiative to assess
      HIV prevalence for one or more diseases and/or conditions within a specific segment of the
      population not yet diagnosed with HIV, who presents for care with the specific
      disease/condition.

      The list of diseases below is not indicative of the most important indicator diseases for HIV
      but rather a list of diseases suggested for surveillance.

      This study will enrol patients presenting with the following diseases/conditions:

        1. Presenting for care of malignant lymphoma, irrespective of type

        2. Presenting for care of cervical or anal dysplasia or cancer, (Cervical CIN II and above)

        3. Presenting for care of Hepatitis B or C virus infection (acute or chronic - and
           irrespective of time of diagnosis relative to time of survey),

        4. Presenting with ongoing mononucleosis-like illness

        5. Presenting with unexplained leukocytopenia or thrombocytopenia lasting at least 4 weeks

        6. Presenting with seborrheic dermatitis / exanthema

        7. Presenting with pneumonia, admitted to hospital for at least 24h

        8. Presenting with unexplained lymphadenopathy

        9. Presenting with peripheral neuropathy of unknown cause (diagnosed by neurologist)

       10. Presenting with primary lung cancer

       11. Presenting with severe or recalcitrant psoriasis (newly diagnosed)
Most patients infected with HIV across the European continent remain undiagnosed; although
      this percentage varies markedly from 15-80% across the continent. Undiagnosed HIV is harmful
      to the person infected as appropriate health interventions are then delayed until the HIV
      infection is diagnosed. It is also detrimental to society as persons unaware of their HIV
      infection may transmit more frequently to others than persons that are aware of their HIV
      status.

      An important public health issue is hence how to diagnose more HIV-infected persons earlier
      in the course of their infection. In the US, the Centers for Disease Control and Prevention
      (CDC) has introduced testing guidelines where all persons are tested upon entry into the
      hospital system (the "opt-out" testing guidelines).

      At the "HIV in Europe" conference held in November 2007, the general sense was that such an
      approach would not be suitable for Europe. Conversely, the conference recommended further
      development of focused HIV testing in patients presenting with certain clinical conditions
      and/or diseases (i.e. indicator condition guided testing).

      Cost effectiveness analyses suggests cost savings if a population with a HIV prevalence of 1%
      or more are tested although this rate may be as low as 0.1%. However, there is very little -
      if any - evidence on HIV prevalence for various conditions and diseases in specific and easy
      to identify sections of society. This is true in general and particularly across the European
      continent.

      Surveys will be undertaken by the investigators:

      Zangerle, Kitchen, U H Innsbruck, Vassilenko, Minsk Municipal Infectious Diseases Hospital,
      Necsoi, Clumeck, Saint-Pierre U H Hadziosmanovic, U of Sarajevo Begovac, U Hospital of
      Infectious Diseases Pedersen, Mogensen, Abildgaard, Titlestad, Odense U H Dragsted, Roskilde
      H Späth, U of Bonn Sthoeger, Neve-Or AIDS Centre d'Armino Monforte, Mareo, Comi, Centanni,
      San Paolo H Grzeszczuk, Medical U of Bialystok Maltez, H Curry Cabral Castro, HU A
      Coruna-Hospital Juan Canalejo Masia, HU Elche Estrada, HCU San Carlos Iribarren, H. Donostia
      Ortega, CH General de Valencia Ocampo, H Xeral-Cies Vernazza, Kantonsspital St. Gallen Perry,
      Fisher, Elton John Centre, Morris, RIDU Minton, St James's U H Palfreeman, Leicester Royal
      Infirmary Gazzard, Sullivan, ChelseaWestminster H Winston, Walsh, St Mary's H Anderson,
      Millett, Homerton H NHS Trust Farazmand, Huddersfield Royal Infirmary Ong, Krasnov, Kharkov
      Regional Clinic of Infectious Diseases Kutsyna, State Medical U
time perspective: Prospective
measure: Prevalence of HIV
time frame: Participants are surveyed once up to month 23 for presenting indicator disease and result of the HIV test performed. Per site 100 participants are included in each survey - in total the single survey requires minimum 400 participants from all sites
description: To assess the HIV prevalence for the identified diseases and/or conditions within a specific segment of the population not yet diagnosed with HIV and that present for care with the specific disease/condition.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: Jens D Lundgren, Prof.
role: Principal Investigator
affiliation: University of Copenhagen
last name: Dorthe Raben
phone: 0045 3545 5757
phone ext: 5782
email: dra@cphiv.dk
facility: 
status: Recruiting
contact: 
investigator: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: University of Copenhagen
investigator full name: Jesper Grarup
investigator title: Director of Administration