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/NCT05983679</url>
    </required_header>
    <id_info>
      <org_study_id>PREMINF</org_study_id>
      <nct_id>NCT05983679</nct_id>
    </id_info>
    <brief_title>Prevalence of Sexually Transmitted Infections (STIs) and Coinfections in the General Population</brief_title>
    <acronym>PREMINF</acronym>
    <official_title>Prevalence of Sexually Transmitted Infections (STIs) and Co-infections in the General Population</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>CerbaXpert</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>CerbaXpert</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>
        Prevalence of Sexually Transmitted Infections (STIs) and co-infections in the general&#xD;
        population&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 4, 2023</start_date>
    <completion_date type="Anticipated">September 4, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 4, 2025</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>3 Years</target_duration>
    <primary_outcome>
      <measure>The prevalence of each STI will be assessed by the participant's positive or negative status for each pathogen, determined by the following screening tests:</measure>
      <time_frame>3 years</time_frame>
      <description>HIV testing is based on finding antibodies to HIV-1 and HIV-2 and P24 antigen of the virus;&#xD;
  Hepatitis B screening is based on HBsAg (hepatitis B surface antigen) research;&#xD;
  Herpes screening is based on testing for antibodies to Herpes Simplex virus (HSV-1 and HSV-2);&#xD;
  Papilloma virus screening is based on the HPV-HR test from a smear on the cervix;&#xD;
  Chlamydia screening is based on a nucleic acid amplification (NAAT) test;&#xD;
  Gonorrhea screening is based on the identification of the bacteria on a urine sample or secretions from the vagina or cervix;&#xD;
  Screening for trichomoniasis is based on a molecular diagnosis that involves identifying the parasite's DNA from a genital or urinary sample;&#xD;
  The detection of syphilis is based on antibody research.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">9000</enrollment>
    <condition>HIV Infections</condition>
    <arm_group>
      <arm_group_label>Adults</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Blood sample</intervention_name>
      <description>Blood sample</description>
      <arm_group_label>Adults</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          A cohort of 9,000 participants meeting all the inclusion criteria will be recruited. A&#xD;
          participant identification list will be created and maintained at clinical investigation&#xD;
          sites, linking the participant's personal data to the code assigned in the research. The&#xD;
          identification list of participants will be kept on the research site in paper or digital&#xD;
          format classified in the investigator binder.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subject, male or female, 18 years of age or older&#xD;
  &#xD;
            -  Subject capable of understanding the purpose of the research having given their free&#xD;
               and informed written consent&#xD;
  &#xD;
            -  Subject presenting to the laboratory for a biological examination&#xD;
  &#xD;
            -  Affiliated subject or beneficiary of a social security scheme&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          - Protected subject: adult under guardianship, curatorship or other legal protection,&#xD;
          deprived of liberty by judicial or administrative decision&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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>Sexually Transmitted Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05983679
  org study id: PREMINF
  nct id: NCT05983679
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Prevalence of Sexually Transmitted Infections (STIs) and co-infections in the general
        population
  observational model: Cohort
  time perspective: Prospective
  measure: The prevalence of each STI will be assessed by the participant's positive or negative status for each pathogen, determined by the following screening tests:
  time frame: 3 years
  description: HIV testing is based on finding antibodies to HIV-1 and HIV-2 and P24 antigen of the virus;
  Hepatitis B screening is based on HBsAg (hepatitis B surface antigen) research;
  Herpes screening is based on testing for antibodies to Herpes Simplex virus (HSV-1 and HSV-2);
  Papilloma virus screening is based on the HPV-HR test from a smear on the cervix;
  Chlamydia screening is based on a nucleic acid amplification (NAAT) test;
  Gonorrhea screening is based on the identification of the bacteria on a urine sample or secretions from the vagina or cervix;
  Screening for trichomoniasis is based on a molecular diagnosis that involves identifying the parasite's DNA from a genital or urinary sample;
  The detection of syphilis is based on antibody research.
  arm group label: Adults
  intervention type: Diagnostic Test
  intervention name: Blood sample
  description: Blood sample
  arm group label: Adults
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Infections
  mesh term: Communicable Diseases
  mesh term: Sexually Transmitted Diseases
  sharing ipd: No