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/NCT05981807</url>
    </required_header>
    <id_info>
      <org_study_id>2023-A00672-43</org_study_id>
      <nct_id>NCT05981807</nct_id>
    </id_info>
    <brief_title>HPV Infection, Sexually Transmitted Infections and Anal Dysplasia in the Transgender Population</brief_title>
    <acronym>PrevHPV-TG</acronym>
    <official_title>Prevalence of Genital, Anal and Oral HPV Infection and Sexually Transmitted Infections, and of Anal Dysplasia in the Transgender Population (PrevHPV-TG)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>ANRS, Emerging Infectious Diseases</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>ANRS, Emerging Infectious Diseases</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>
        The goal of this observational study is to estimate the prevalence of HPV infections anal and&#xD;
        ENT level and according to HIV status in transgender (TG) population. The main question it&#xD;
        aims to answer is:&#xD;
  &#xD;
          -  What is the prevalence of HPV lesions in transgender population (TG);&#xD;
  &#xD;
          -  What kind of high risk HPV (hrHPV) and low risk HPV (lrHPV) are detected at the genital,&#xD;
             anal and ENT level&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Context:&#xD;
  &#xD;
        The few publications with an individualized transgender (TG) population have been conducted&#xD;
        in South America (Peru, Argentina) showing very high anal or ano-genital hrHPV prevalences of&#xD;
        around 97% (dos Ramos Farias et al., 2011; Brown et al., 2016). Recently a study conducted in&#xD;
        22 TGs showed a high prevalence of anal dysplastic lesions with low grade lesions detected in&#xD;
        8 individuals and high grade in 3 individuals (Kobayashi et al., 2017). Thus, in the face of&#xD;
        this high prevalence of 50% anal dysplasia, the TG population therefore appears to be at risk&#xD;
        for developing anal dysplastic lesions and this needs to be explored in another TG&#xD;
        population. Furthermore, to our knowledge, no study has evaluated the concomitant prevalence&#xD;
        of hrHPV infection at the anogenital and ENT levels in the transgender population. The&#xD;
        Infectious and Tropical Diseases Department of Bichat-Claude Bernard Hospital is particularly&#xD;
        involved in the follow-up of transgender individuals with a large active file that&#xD;
        participates in clinical research projects (Pommier et al., 2019; Bertin et al., 2019; Phung&#xD;
        et al., 2018).&#xD;
  &#xD;
        Objectives:&#xD;
  &#xD;
        Principal objective The primary objective of this study is to determine the prevalence of HPV&#xD;
        lesions in transgender population (TG).&#xD;
  &#xD;
        Secondary objectives&#xD;
  &#xD;
        Secondary objectives include:&#xD;
  &#xD;
          1. Estimate the prevalence of HPV infections at the genital, anal and ENT level and&#xD;
             according to HIV status;&#xD;
  &#xD;
          2. To estimate the prevalence of hrHPV infections at the genital, anal and ENT levels,&#xD;
             globally and according to HIV status;&#xD;
  &#xD;
          3. To estimate the prevalence of lrHPV infections at the genital, anal and ENT level&#xD;
             globally and by HIV status;&#xD;
  &#xD;
          4. Describe the types of hrHPV and lrHPV detected at the genital, anal and ENT level;&#xD;
  &#xD;
          5. To estimate the prevalence of dysplastic lesions (low grade and high grade) by HIV&#xD;
             status;&#xD;
  &#xD;
          6. To estimate the prevalence of bacterial Sexually Transmitted Infections (STIs):&#xD;
             Neisseria gonorrhoeae, Chlamydia trachomatis and Syphilis, globally and by anatomical&#xD;
             site and HIV status.&#xD;
  &#xD;
        Methodology This is a national, non-interventional, cross-sectional, monocentric study among&#xD;
        TG people (man to woman, and woman to man)&#xD;
  &#xD;
        Estimated enrolment 200 participants&#xD;
  &#xD;
        Outcomes Primary outcome:&#xD;
  &#xD;
        The prevalence of HPV infections among TG people. Prevalence is defined as the percentage of&#xD;
        subjects with HPV infection among TG people included, regardless the site where infection was&#xD;
        detected.&#xD;
  &#xD;
        Secondary outcomes:&#xD;
  &#xD;
          1. The prevalence of HPV infections in each anatomical site (genital, anal and ENT) and by&#xD;
             HIV status.&#xD;
  &#xD;
          2. The prevalence of hrHPV infections in each anatomical site (genital, anal and ENT),&#xD;
             globally and according to HIV status.&#xD;
  &#xD;
          3. The prevalence of lrHPV infections in each anatomical site (genital, anal and ENT),&#xD;
             globally and by HIV status.&#xD;
  &#xD;
          4. The types of hrHPV and lrHPV in each anatomical site (genital, anal).&#xD;
  &#xD;
          5. The prevalence of dysplastic lesions (low grade and high grade) by HIV status.&#xD;
  &#xD;
          6. The prevalence of bacterial STIs: Neisseria gonorrhoeae, Chlamydia trachomatis and&#xD;
             Syphilis, globally, by anatomical site and HIV status.&#xD;
  &#xD;
        Eligibility Inclusion criteria&#xD;
  &#xD;
          -  Age ≥ 18 years&#xD;
  &#xD;
          -  To belong to transgender population : i.e. people who doesn't identify to the gender&#xD;
             assigned at birth&#xD;
  &#xD;
          -  To be affiliated to a social security system or be beneficiary of the Aide Médicale&#xD;
             d'Etat (AME)&#xD;
  &#xD;
        Non-inclusion criteria&#xD;
  &#xD;
          -  To have ever been vaccinated against HPV&#xD;
  &#xD;
          -  Research participation refusal&#xD;
  &#xD;
          -  People under guardianship or curatorship, or deprived of liberty by administrative or&#xD;
             judiciary measure&#xD;
  &#xD;
        Statistical methods Individuals' characteristics will be described for all included subjects.&#xD;
        Continuous variables will be described using mean, standard deviation, median, interquartiles&#xD;
        values, minimal and maximal values. Qualitative variables will be described using numbers and&#xD;
        percentages by modality. Prevalences will be described by proportion and their confidence&#xD;
        interval will be calculated under binomial law. All statistical tests will be performed using&#xD;
        5% as significance level. Prevalence of high risk HPV infection in each anatomical site and&#xD;
        the concordance of HPV types by anatomical site will be determined using Fleiss Kappa test.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">October 2024</completion_date>
    <primary_completion_date type="Anticipated">October 2024</primary_completion_date>
    <study_type>Observational</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>
    <primary_outcome>
      <measure>Prevalence of HPV infection in transgender population</measure>
      <time_frame>12 months</time_frame>
      <description>The prevalence of HPV infections is defined as the percentage of subjects with HPV infection among transgender people included, regardless the site of infection.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Prevalence of HPV infections at the genital, anal and ENT level and according to HIV status</measure>
      <time_frame>12 months</time_frame>
      <description>We will estimate the prevalence of HPV infections in each anatomical site (genital, anal and ENT) and according to HIV status.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prevalence of hrHPV infections at the genital, anal and ENT levels, globally and according to HIV status</measure>
      <time_frame>12 months</time_frame>
      <description>We will estimate the prevalence of hrHPV infections in each anatomical site (genital, anal and ENT), globally and according to HIV status.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prevalence of lrHPV infections at the genital, anal and ENT level globally and by HIV status</measure>
      <time_frame>12 months</time_frame>
      <description>We will estimate the prevalence of lrHPV infections in each anatomical site (genital, anal and ENT), globally and by HIV status.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Types of hrHPV and lrHPV detected at the genital, anal and ENT level</measure>
      <time_frame>12 months</time_frame>
      <description>We will describe the types of hrHPV and lrHPV detected at the genital, anal and ENT level</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prevalence of dysplastic lesions (low grade and high grade) by HIV status</measure>
      <time_frame>12 months</time_frame>
      <description>We will estimate the prevalence of dysplastic lesions (low grade and high grade) by HIV status.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prevalence of bacterial sexually transmitted infections: Neisseria gonorrhoeae, Chlamydia trachomatis and Syphilis, globally and by anatomical site and HIV status</measure>
      <time_frame>12 months</time_frame>
      <description>We will estimate the prevalence of bacterial sexually transmitted infections: Neisseria gonorrhoeae, Chlamydia trachomatis and Syphilis, globally, by anatomical site and HIV status.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Human Papillomavirus Infection</condition>
    <condition>Human Immunodeficiency Virus Infection</condition>
    <condition>Sexually Transmitted Diseases</condition>
    <arm_group>
      <arm_group_label>Transgender population</arm_group_label>
      <description>Cohort of transgender people (man to woman and woman to man)</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          The study will include people who belong to the transgender population : i.e. people who do&#xD;
          not identify to the gender assigned at birth (man to woman and woman to man).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years&#xD;
  &#xD;
            -  To belong to transgender population : i.e. people who doesn't identify to the gender&#xD;
               assigned at birth&#xD;
  &#xD;
            -  To be affiliated to a social security system or be beneficiary of AME&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  To have ever been vaccinated against HPV&#xD;
  &#xD;
            -  Research participation refusal&#xD;
  &#xD;
            -  People under guardianship or curatorship, or deprived of liberty by administrative or&#xD;
               judiciary measure&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jade GHOSN, MD PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jade GHOSN, MD PhD</last_name>
      <phone>(+33) 1 40 25 78 03</phone>
      <email>jade.ghosn@aphp.fr</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>HPV</keyword>
    <keyword>HIV</keyword>
    <keyword>Transgender</keyword>
    <keyword>Dysplasia</keyword>
    <keyword>Neisseria gonorrhoeae</keyword>
    <keyword>Chlamydia trachomatis</keyword>
    <keyword>Syphilis</keyword>
    <keyword>STI</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infections</mesh_term>
      <mesh_term>Communicable Diseases</mesh_term>
      <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
      <mesh_term>HIV Infections</mesh_term>
      <mesh_term>Sexually Transmitted Diseases</mesh_term>
      <mesh_term>Papillomavirus Infections</mesh_term>
    </condition_browse>
    <!-- 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/NCT05981807
  org study id: 2023-A00672-43
  nct id: NCT05981807
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to estimate the prevalence of HPV infections anal and
        ENT level and according to HIV status in transgender (TG) population. The main question it
        aims to answer is:
  
          -  What is the prevalence of HPV lesions in transgender population (TG);
  
          -  What kind of high risk HPV (hrHPV) and low risk HPV (lrHPV) are detected at the genital,
             anal and ENT level
  Context:
  
        The few publications with an individualized transgender (TG) population have been conducted
        in South America (Peru, Argentina) showing very high anal or ano-genital hrHPV prevalences of
        around 97% (dos Ramos Farias et al., 2011; Brown et al., 2016). Recently a study conducted in
        22 TGs showed a high prevalence of anal dysplastic lesions with low grade lesions detected in
        8 individuals and high grade in 3 individuals (Kobayashi et al., 2017). Thus, in the face of
        this high prevalence of 50% anal dysplasia, the TG population therefore appears to be at risk
        for developing anal dysplastic lesions and this needs to be explored in another TG
        population. Furthermore, to our knowledge, no study has evaluated the concomitant prevalence
        of hrHPV infection at the anogenital and ENT levels in the transgender population. The
        Infectious and Tropical Diseases Department of Bichat-Claude Bernard Hospital is particularly
        involved in the follow-up of transgender individuals with a large active file that
        participates in clinical research projects (Pommier et al., 2019; Bertin et al., 2019; Phung
        et al., 2018).
  
        Objectives:
  
        Principal objective The primary objective of this study is to determine the prevalence of HPV
        lesions in transgender population (TG).
  
        Secondary objectives
  
        Secondary objectives include:
  
          1. Estimate the prevalence of HPV infections at the genital, anal and ENT level and
             according to HIV status;
  
          2. To estimate the prevalence of hrHPV infections at the genital, anal and ENT levels,
             globally and according to HIV status;
  
          3. To estimate the prevalence of lrHPV infections at the genital, anal and ENT level
             globally and by HIV status;
  
          4. Describe the types of hrHPV and lrHPV detected at the genital, anal and ENT level;
  
          5. To estimate the prevalence of dysplastic lesions (low grade and high grade) by HIV
             status;
  
          6. To estimate the prevalence of bacterial Sexually Transmitted Infections (STIs):
             Neisseria gonorrhoeae, Chlamydia trachomatis and Syphilis, globally and by anatomical
             site and HIV status.
  
        Methodology This is a national, non-interventional, cross-sectional, monocentric study among
        TG people (man to woman, and woman to man)
  
        Estimated enrolment 200 participants
  
        Outcomes Primary outcome:
  
        The prevalence of HPV infections among TG people. Prevalence is defined as the percentage of
        subjects with HPV infection among TG people included, regardless the site where infection was
        detected.
  
        Secondary outcomes:
  
          1. The prevalence of HPV infections in each anatomical site (genital, anal and ENT) and by
             HIV status.
  
          2. The prevalence of hrHPV infections in each anatomical site (genital, anal and ENT),
             globally and according to HIV status.
  
          3. The prevalence of lrHPV infections in each anatomical site (genital, anal and ENT),
             globally and by HIV status.
  
          4. The types of hrHPV and lrHPV in each anatomical site (genital, anal).
  
          5. The prevalence of dysplastic lesions (low grade and high grade) by HIV status.
  
          6. The prevalence of bacterial STIs: Neisseria gonorrhoeae, Chlamydia trachomatis and
             Syphilis, globally, by anatomical site and HIV status.
  
        Eligibility Inclusion criteria
  
          -  Age ≥ 18 years
  
          -  To belong to transgender population : i.e. people who doesn't identify to the gender
             assigned at birth
  
          -  To be affiliated to a social security system or be beneficiary of the Aide Médicale
             d'Etat (AME)
  
        Non-inclusion criteria
  
          -  To have ever been vaccinated against HPV
  
          -  Research participation refusal
  
          -  People under guardianship or curatorship, or deprived of liberty by administrative or
             judiciary measure
  
        Statistical methods Individuals' characteristics will be described for all included subjects.
        Continuous variables will be described using mean, standard deviation, median, interquartiles
        values, minimal and maximal values. Qualitative variables will be described using numbers and
        percentages by modality. Prevalences will be described by proportion and their confidence
        interval will be calculated under binomial law. All statistical tests will be performed using
        5% as significance level. Prevalence of high risk HPV infection in each anatomical site and
        the concordance of HPV types by anatomical site will be determined using Fleiss Kappa test.
  observational model: Cohort
  time perspective: Prospective
  measure: Prevalence of HPV infection in transgender population
  time frame: 12 months
  description: The prevalence of HPV infections is defined as the percentage of subjects with HPV infection among transgender people included, regardless the site of infection.
  measure: Prevalence of HPV infections at the genital, anal and ENT level and according to HIV status
  time frame: 12 months
  description: We will estimate the prevalence of HPV infections in each anatomical site (genital, anal and ENT) and according to HIV status.
  measure: Prevalence of hrHPV infections at the genital, anal and ENT levels, globally and according to HIV status
  time frame: 12 months
  description: We will estimate the prevalence of hrHPV infections in each anatomical site (genital, anal and ENT), globally and according to HIV status.
  measure: Prevalence of lrHPV infections at the genital, anal and ENT level globally and by HIV status
  time frame: 12 months
  description: We will estimate the prevalence of lrHPV infections in each anatomical site (genital, anal and ENT), globally and by HIV status.
  measure: Types of hrHPV and lrHPV detected at the genital, anal and ENT level
  time frame: 12 months
  description: We will describe the types of hrHPV and lrHPV detected at the genital, anal and ENT level
  measure: Prevalence of dysplastic lesions (low grade and high grade) by HIV status
  time frame: 12 months
  description: We will estimate the prevalence of dysplastic lesions (low grade and high grade) by HIV status.
  measure: Prevalence of bacterial sexually transmitted infections: Neisseria gonorrhoeae, Chlamydia trachomatis and Syphilis, globally and by anatomical site and HIV status
  time frame: 12 months
  description: We will estimate the prevalence of bacterial sexually transmitted infections: Neisseria gonorrhoeae, Chlamydia trachomatis and Syphilis, globally, by anatomical site and HIV status.
  arm group label: Transgender population
  description: Cohort of transgender people (man to woman and woman to man)
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jade GHOSN, MD PhD
  role: Principal Investigator
  affiliation: Assistance Publique - Hôpitaux de Paris
  last name: Jade GHOSN, MD PhD
  phone: (+33) 1 40 25 78 03
  email: jade.ghosn@aphp.fr
  responsible party type: Sponsor
  mesh term: Infections
  mesh term: Communicable Diseases
  mesh term: Acquired Immunodeficiency Syndrome
  mesh term: HIV Infections
  mesh term: Sexually Transmitted Diseases
  mesh term: Papillomavirus Infections