xml: <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/NCT05998499</url>
    </required_header>
    <id_info>
      <org_study_id>HUIL_MI_VIH01</org_study_id>
      <nct_id>NCT05998499</nct_id>
    </id_info>
    <brief_title>HIV-Infected Latin American Asylum Seekers in Europe: Insights From the EuroLatin HIV Cohort</brief_title>
    <acronym>ELHC</acronym>
    <official_title>HIV-Infected Latin American Asylum Seekers in Europe: Insights From the EuroLatin HIV Cohort (ELHC)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hospital Universitario Infanta Leonor</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hospital Universitario Infanta Leonor</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>
        This is a longitudinal observational study conducted in Europe that describes migrants&#xD;
        infected with HIV from Latin America who come to Europe with the intention of seeking asylum&#xD;
        or international protection. The aim of the study is to identify the barriers this population&#xD;
        faces in accessing the healthcare system and to assess disease control&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Study Design and Setting This observational study was conducted between 2022 and 2023 in&#xD;
        Madrid, Spain. Participants were recruited at the HIV outpatient clinic of Infanta Leonor&#xD;
        University Hospital (HUIL) for the study and were monitored for a period of 6 months from&#xD;
        their enrollment in the study.&#xD;
  &#xD;
        Participant Recruitment Participants were primarily identified and referred by various&#xD;
        non-governmental organizations (NGOs) working with migrants living with HIV. These NGOs,&#xD;
        which included gTt-VIH, Apoyo Positivo, Cogam, Acción Triangulo, Kif-Kif, Salud Entre&#xD;
        Culturas, and the Spanish Red Cross, played an essential role by establishing a crucial link&#xD;
        and provided a vital bridge, facilitating the patients' integration into the healthcare&#xD;
        system through an unconventional circuit.&#xD;
  &#xD;
        Medical Evaluation In the HIV unit, assessments were conducted by experienced infectious&#xD;
        disease specialists and a unit-specific nurse. The care protocol comprised a meticulous&#xD;
        collection of medical history, an exhaustive physical examination, along with a series of&#xD;
        tests. Furthermore, appointments were scheduled for a one-month and six-month follow-up to&#xD;
        ensure continuous care and monitor the effectiveness of the treatment regimen.&#xD;
  &#xD;
        Social and Psychological Evaluation An experienced social worker with a background in&#xD;
        vulnerable populations was hired to perform a social assessment. Six months post the initial&#xD;
        hospital visit, the social worker re-established contact with the patients to reassess their&#xD;
        social circumstances and their continued engagement with the HIV consultation services.&#xD;
  &#xD;
        Ethical Considerations This study adhered to the ethical principles outlined in the&#xD;
        Declaration of Helsinki and received the necessary approvals from the ethics committee at&#xD;
        Infanta Leonor Hospital. Informed consent was provided by every participant.&#xD;
  &#xD;
        Data collection In this study, the REDCap application was utilized for the collection of&#xD;
        data. The database was stored in a secure server, and only researchers and health personnel&#xD;
        of the project had access to it.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 30, 2022</start_date>
    <completion_date type="Actual">July 15, 2023</completion_date>
    <primary_completion_date type="Actual">April 30, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>6 Months</target_duration>
    <primary_outcome>
      <measure>HIV viral control</measure>
      <time_frame>At inclusion</time_frame>
      <description>Number of participants with plasma HIV-1 RNA level of more than 50 copies per mL</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Resistance Pattern</measure>
      <time_frame>At inclusion</time_frame>
      <description>Number of participants with Drug Resistance</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sexually transmited infections</measure>
      <time_frame>At inclusion</time_frame>
      <description>Number of participants with sexually transmited infections</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number and Type of Barriers to Accessing Healthcare</measure>
      <time_frame>At inclusion</time_frame>
      <description>The outcome will assess the number and type of barriers faced by study participants when trying to access healthcare, based on the presence of any of the following barriers: administrative, geographical, financial, cultural, lack of knowledge, stigma, and organizational.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>HIV viral control at 6 months</measure>
      <time_frame>6 months</time_frame>
      <description>Number of participants with plasma HIV-1 RNA level of more than 50 copies per mL</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Retention in care</measure>
      <time_frame>6 months</time_frame>
      <description>Number of participants who maintain retention to healthcare</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">631</enrollment>
    <condition>HIV-1-infection</condition>
    <condition>Sexually Transmitted Diseases</condition>
    <arm_group>
      <arm_group_label>EuroLatin HIV Cohort (ELHC)</arm_group_label>
      <description>Cohort of Latin American migrants living with HIV who were seeking international protection in Spain (Europe)</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Description</intervention_name>
      <description>This study aimed to understand the situation of Latin American HIV-positive migrants seeking asylum in Spain and identify the challenges they encounter in getting HIV treatment. The main result measured was the proportion of participants with an HIV-1 RNA level of 50 copies/mL or higher at their first clinic visit</description>
      <arm_group_label>EuroLatin HIV Cohort (ELHC)</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Latin American migrants infected with HIV&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Latin American migrants infected with HIV who arrive in Spain with the intent to seek&#xD;
               international protection and who lack access to healthcare.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Those who do not give their consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Pablo Ryan Murua, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hospital Universitario Infanta Leonor</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Hospital Universitario Infanta Leonor</name>
        <address>
          <city>Madrid</city>
          <zip>28031</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hospital Universitario Infanta Leonor</investigator_affiliation>
      <investigator_full_name>Pablo Ryan</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Asylum Seekers</keyword>
    <keyword>Migration</keyword>
    <keyword>Europe</keyword>
    <keyword>Latin America</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sexually Transmitted Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>IPD that underlie results in a publication</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>December, 2024</ipd_time_frame>
      <ipd_access_criteria>IP email</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05998499
  org study id: HUIL_MI_VIH01
  nct id: NCT05998499
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a longitudinal observational study conducted in Europe that describes migrants
        infected with HIV from Latin America who come to Europe with the intention of seeking asylum
        or international protection. The aim of the study is to identify the barriers this population
        faces in accessing the healthcare system and to assess disease control
  Study Design and Setting This observational study was conducted between 2022 and 2023 in
        Madrid, Spain. Participants were recruited at the HIV outpatient clinic of Infanta Leonor
        University Hospital (HUIL) for the study and were monitored for a period of 6 months from
        their enrollment in the study.
  
        Participant Recruitment Participants were primarily identified and referred by various
        non-governmental organizations (NGOs) working with migrants living with HIV. These NGOs,
        which included gTt-VIH, Apoyo Positivo, Cogam, Acción Triangulo, Kif-Kif, Salud Entre
        Culturas, and the Spanish Red Cross, played an essential role by establishing a crucial link
        and provided a vital bridge, facilitating the patients' integration into the healthcare
        system through an unconventional circuit.
  
        Medical Evaluation In the HIV unit, assessments were conducted by experienced infectious
        disease specialists and a unit-specific nurse. The care protocol comprised a meticulous
        collection of medical history, an exhaustive physical examination, along with a series of
        tests. Furthermore, appointments were scheduled for a one-month and six-month follow-up to
        ensure continuous care and monitor the effectiveness of the treatment regimen.
  
        Social and Psychological Evaluation An experienced social worker with a background in
        vulnerable populations was hired to perform a social assessment. Six months post the initial
        hospital visit, the social worker re-established contact with the patients to reassess their
        social circumstances and their continued engagement with the HIV consultation services.
  
        Ethical Considerations This study adhered to the ethical principles outlined in the
        Declaration of Helsinki and received the necessary approvals from the ethics committee at
        Infanta Leonor Hospital. Informed consent was provided by every participant.
  
        Data collection In this study, the REDCap application was utilized for the collection of
        data. The database was stored in a secure server, and only researchers and health personnel
        of the project had access to it.
  observational model: Cohort
  time perspective: Prospective
  measure: HIV viral control
  time frame: At inclusion
  description: Number of participants with plasma HIV-1 RNA level of more than 50 copies per mL
  measure: Resistance Pattern
  time frame: At inclusion
  description: Number of participants with Drug Resistance
  measure: Sexually transmited infections
  time frame: At inclusion
  description: Number of participants with sexually transmited infections
  measure: Number and Type of Barriers to Accessing Healthcare
  time frame: At inclusion
  description: The outcome will assess the number and type of barriers faced by study participants when trying to access healthcare, based on the presence of any of the following barriers: administrative, geographical, financial, cultural, lack of knowledge, stigma, and organizational.
  measure: HIV viral control at 6 months
  time frame: 6 months
  description: Number of participants with plasma HIV-1 RNA level of more than 50 copies per mL
  measure: Retention in care
  time frame: 6 months
  description: Number of participants who maintain retention to healthcare
  arm group label: EuroLatin HIV Cohort (ELHC)
  description: Cohort of Latin American migrants living with HIV who were seeking international protection in Spain (Europe)
  intervention type: Other
  intervention name: Description
  description: This study aimed to understand the situation of Latin American HIV-positive migrants seeking asylum in Spain and identify the challenges they encounter in getting HIV treatment. The main result measured was the proportion of participants with an HIV-1 RNA level of 50 copies/mL or higher at their first clinic visit
  arm group label: EuroLatin HIV Cohort (ELHC)
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  last name: Pablo Ryan Murua, MD, PhD
  role: Principal Investigator
  affiliation: Hospital Universitario Infanta Leonor
  facility: 
  country: Spain
  responsible party type: Principal Investigator
  investigator affiliation: Hospital Universitario Infanta Leonor
  investigator full name: Pablo Ryan
  investigator title: Principal Investigator
  mesh term: Sexually Transmitted Diseases
  sharing ipd: Yes
  ipd description: IPD that underlie results in a publication
  ipd info type: Study Protocol
  ipd time frame: December, 2024
  ipd access criteria: IP email