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/NCT05996016</url>
    </required_header>
    <id_info>
      <org_study_id>PekingUMCH-K2675</org_study_id>
      <nct_id>NCT05996016</nct_id>
    </id_info>
    <brief_title>Gut and Vaginal Microbiota Profile Study for HIV Women</brief_title>
    <official_title>A Cohort Study Among HIV Infected Women：Exploring the Regulatory Mechanism of Gut and Vaginal Microbiota in HPV Infection and Cervical Lesion</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking Union Medical College Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking Union Medical College Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Women Living with HIV Infection （WLHIV）are intended to acquire HPV infection which usually&#xD;
        contributes to variable cervical lesions. we hypothesize that vaginal microbiota imbalance&#xD;
        may make WLHIV prone to HPV infection，thereafter results in severe cervical lesion.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Women Living with HIV Infection （WLHIV）are intended to acquire HPV infection which usually&#xD;
        contributes to variable cervical lesions. Besides the HPV co-infection, microbiota study&#xD;
        recently reveals that the changes of vaginal bacteria spectrum might also be related with&#xD;
        cervical disease in WLHIV. However, data on HPV prevalence in WLHIV and its associated&#xD;
        cervical lesion incidence is still limited in China. Moreover, the causal relationship&#xD;
        between vaginal microbiota and cervical lesion in WLHIV is not clear. Here, we hypothesize&#xD;
        that vaginal microbiota imbalance may make WLHIV prone to HPV infection，thereafter results in&#xD;
        severe cervical lesion.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">November 9, 2022</start_date>
    <completion_date type="Anticipated">July 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">November 9, 2024</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>HPV infection incidence</measure>
      <time_frame>0, 6m, 12m, 24m, 36m</time_frame>
      <description>To collect 400 analyzable samples from women with HIV, including HPV screening, fecal and vaginal microflora samples. Cervical HPV screening will be collected as required in standard containers and stored for transport to the central laboratory.the rates of HPV infection.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>cervical lesions</measure>
      <time_frame>0, 6m, 12m, 24m, 36m</time_frame>
      <description>To collect 400 analyzable samples from women with HIV, including vaginal cleanliness assessment and TCT examination. vaginal swab samples will be collected as required in standard containers and stored for transport to the central laboratory.Variable cervical lesions, including CIN I-III and neoplasma.</description>
    </primary_outcome>
    <enrollment type="Anticipated">400</enrollment>
    <condition>HPV</condition>
    <condition>HIV Infections</condition>
    <condition>Vaginal Microbiota</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Women with HIV Infection from 6 HIV care centers across CHINA, including Beijing, Zhejiang,&#xD;
          Guangxi, Yunan, Shanxi and Shandong.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  HIV women （including pregnant）;&#xD;
  &#xD;
            -  sign consent paper&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  virgin or maiden&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>14 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Wei Lyu, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>No. 10Yi，Chaowai Street ，Chaoyang District ，Beijing ，China</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Wei Lyu, MD</last_name>
      <phone>13501385800</phone>
      <phone_ext>010</phone_ext>
      <email>lvweipumch@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Zhang Qing</last_name>
      <phone>13207572893</phone>
      <phone_ext>022</phone_ext>
      <email>zhangqingpumch@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Peking Union Medical College Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100070</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Wei Lyu, MD</last_name>
        <phone>13501385800</phone>
        <phone_ext>010</phone_ext>
        <email>lvweipumch@163.com</email>
      </contact>
      <investigator>
        <last_name>Wei Lyu, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>November 2022</verification_date>
    <study_first_submitted>November 28, 2022</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>HPV</keyword>
    <keyword>Women With HPV infection</keyword>
    <keyword>vaginal microbiota</keyword>
    <keyword>gut microbiota</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infections</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/NCT05996016
  org study id: PekingUMCH-K2675
  nct id: NCT05996016
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Women Living with HIV Infection （WLHIV）are intended to acquire HPV infection which usually
        contributes to variable cervical lesions. we hypothesize that vaginal microbiota imbalance
        may make WLHIV prone to HPV infection，thereafter results in severe cervical lesion.
  Women Living with HIV Infection （WLHIV）are intended to acquire HPV infection which usually
        contributes to variable cervical lesions. Besides the HPV co-infection, microbiota study
        recently reveals that the changes of vaginal bacteria spectrum might also be related with
        cervical disease in WLHIV. However, data on HPV prevalence in WLHIV and its associated
        cervical lesion incidence is still limited in China. Moreover, the causal relationship
        between vaginal microbiota and cervical lesion in WLHIV is not clear. Here, we hypothesize
        that vaginal microbiota imbalance may make WLHIV prone to HPV infection，thereafter results in
        severe cervical lesion.
  observational model: Cohort
  time perspective: Prospective
  measure: HPV infection incidence
  time frame: 0, 6m, 12m, 24m, 36m
  description: To collect 400 analyzable samples from women with HIV, including HPV screening, fecal and vaginal microflora samples. Cervical HPV screening will be collected as required in standard containers and stored for transport to the central laboratory.the rates of HPV infection.
  measure: cervical lesions
  time frame: 0, 6m, 12m, 24m, 36m
  description: To collect 400 analyzable samples from women with HIV, including vaginal cleanliness assessment and TCT examination. vaginal swab samples will be collected as required in standard containers and stored for transport to the central laboratory.Variable cervical lesions, including CIN I-III and neoplasma.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  minimum age: 14 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Wei Lyu, MD
  role: Principal Investigator
  affiliation: No. 10Yi，Chaowai Street ，Chaoyang District ，Beijing ，China
  last name: Wei Lyu, MD
  phone: 13501385800
  phone ext: 010
  email: lvweipumch@163.com
  last name: Zhang Qing
  phone: 13207572893
  phone ext: 022
  email: zhangqingpumch@163.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: China
  responsible party type: Sponsor
  mesh term: Infections
  sharing ipd: No