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/NCT05968183</url>
    </required_header>
    <id_info>
      <org_study_id>CHSD_0026_MATER</org_study_id>
      <secondary_id>2022-A01844-39</secondary_id>
      <nct_id>NCT05968183</nct_id>
    </id_info>
    <brief_title>The Value of HPV Testing for Cervical Cancer Screening in Women Living With HIV (PAPILLO-VIH)</brief_title>
    <acronym>PAPILLO-VIH</acronym>
    <official_title>The Value of HPV Testing for Cervical Cancer Screening in Women Living With HIV</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier de Saint-Denis</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Hospitalier de Saint-Denis</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 main objective of this study is to evaluate the interest of a screening strategy based on&#xD;
        the HPV test in patients living with HIV, compared to the cell smear alone in the same&#xD;
        population.&#xD;
  &#xD;
        The Secondary objective of this study is to verify if the use of HPV testing could allow for&#xD;
        a longer follow-up of these patients in case of negativity, and thus allow for a&#xD;
        standardization of clinicians' practices.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Since 2019, a new screening strategy has been implemented and is based on high-risk, HPV&#xD;
        tests, which, when negative, allow for spaced monitoring in the general population after age&#xD;
        30 (every 5 years instead of every 3 years.)&#xD;
  &#xD;
        These tests therefore allow for earlier detection of patients at risk but also for longer&#xD;
        follow-up when they are negative.&#xD;
  &#xD;
        To our knowledge, there is currently no evaluation of HPV testing as part of routine&#xD;
        screening in patients living with HIV.&#xD;
  &#xD;
        The recommendations for this population are based on the use of the cervico-vaginal smear&#xD;
        with cytological analysis. The smear should be taken every year and surveillance may be&#xD;
        repeated every 3 years. If there are 3 consecutive smears without abnormalities and a&#xD;
        controlled viral load with CD4 counts &gt; 500 mm3. In practice, many patients do not meet these&#xD;
        criteria and must, therefore, undergo annual screening; the increase in the number of smears&#xD;
        also leads to an increase in the number of second-line examinations such as colposcopy.&#xD;
  &#xD;
        Since there is no recommendation for HPV testing in this population, the use of dual&#xD;
        detection (cytology and HPV testing) is left to the discretion of the clinician.&#xD;
  &#xD;
        By mutual agreement with the clinicians of the maternity department of the Saint-Denis&#xD;
        Hospital (CHSD), this double detection was introduced in 2021, using the same sample (single&#xD;
        swab for both analyses: cytology and HPV test).&#xD;
  &#xD;
        Therefore, it seems interesting to verify the possibility of a screening strategy based on&#xD;
        HPV testing in patients living with HIV, by correlating the results of HPV testing and cell&#xD;
        smears in the population of patients living with HIV.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 1, 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>Demographic characteristics</measure>
      <time_frame>Day 1</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>HIV history</measure>
      <time_frame>Day 1</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>medical history</measure>
      <time_frame>Day 1</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>comorbidities</measure>
      <time_frame>Day 1</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>clinical examination data</measure>
      <time_frame>Day 1</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Results of HPV Cytology</measure>
      <time_frame>Day 1</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Results of cell smear</measure>
      <time_frame>Day 1</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Results of additional examinations prescribed</measure>
      <time_frame>Day 1</time_frame>
      <description>Results of any additional examinations prescribed</description>
    </secondary_outcome>
    <enrollment type="Anticipated">200</enrollment>
    <condition>HIV Seropositivity</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Cohort of patients who have been living with HIV seen in maternity consultations&#xD;
  &#xD;
          over 1 year at our institution.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women living with HIV&#xD;
  &#xD;
            -  Age 25-65 years&#xD;
  &#xD;
            -  Managed in the CHSD maternity ward: consultation or hospitalization&#xD;
  &#xD;
            -  Having signed a consent form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age ≤ 24 years, or ≥ 66 years&#xD;
  &#xD;
            -  Women who are not HIV positive&#xD;
  &#xD;
            -  Patients under legal protection (guardianship, curatorship)&#xD;
  &#xD;
            -  Patients deprived of liberty&#xD;
  &#xD;
            -  Patients not affiliated to a social security system&#xD;
  &#xD;
            -  Refusal to participate in the research&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
    </eligibility>
    <location>
      <facility>
        <name>Centre Hospitalier de Saint-Denis</name>
        <address>
          <city>Saint-Denis</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Claire FIEVRE</last_name>
        <phone>01 42 35 68 97</phone>
        <email>claire.fievre@ch-stdenis.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <reference>
      <citation>Laara E, Day NE, Hakama M. Trends in mortality from cervical cancer in the Nordic countries: association with organised screening programmes. Lancet. 1987 May 30;1(8544):1247-9. doi: 10.1016/s0140-6736(87)92695-x.</citation>
      <PMID>2884378</PMID>
    </reference>
    <reference>
      <citation>Koliopoulos G, Nyaga VN, Santesso N, Bryant A, Martin-Hirsch PP, Mustafa RA, Schunemann H, Paraskevaidis E, Arbyn M. Cytology versus HPV testing for cervical cancer screening in the general population. Cochrane Database Syst Rev. 2017 Aug 10;8(8):CD008587. doi: 10.1002/14651858.CD008587.pub2.</citation>
      <PMID>28796882</PMID>
    </reference>
    <reference>
      <citation>Srisomboon S, Tantipalakorn C, Muangmool T, Srisomboon J. Risk of High-Grade Cervical Lesions in Atypical Squamous Cells of Undetermined Significance (ASC-US) Cytology: Comparison between HIV-Infected and HIV-Negative Women. Asian Pac J Cancer Prev. 2021 Feb 1;22(2):547-551. doi: 10.31557/APJCP.2021.22.2.547.</citation>
      <PMID>33639672</PMID>
    </reference>
    <reference>
      <citation>Denslow SA, Rositch AF, Firnhaber C, Ting J, Smith JS. Incidence and progression of cervical lesions in women with HIV: a systematic global review. Int J STD AIDS. 2014 Mar;25(3):163-77. doi: 10.1177/0956462413491735. Epub 2013 Aug 29.</citation>
      <PMID>24216030</PMID>
    </reference>
    <reference>
      <citation>Liu G, Sharma M, Tan N, Barnabas RV. HIV-positive women have higher risk of human papilloma virus infection, precancerous lesions, and cervical cancer. AIDS. 2018 Mar 27;32(6):795-808. doi: 10.1097/QAD.0000000000001765.</citation>
      <PMID>29369827</PMID>
    </reference>
    <reference>
      <citation>Sakdadech N, Muangmool T, Srisomboon J. HIV-Infected Women with Low-Grade Squamous Intraepithelial Lesion on Cervical Cytology Have Higher Risk of Underlying High-Grade Cervical Intraepithelial Neoplasia. Int J Environ Res Public Health. 2021 Sep 28;18(19):10211. doi: 10.3390/ijerph181910211.</citation>
      <PMID>34639509</PMID>
    </reference>
    <reference>
      <citation>Nappi L, Carriero C, Bettocchi S, Herrero J, Vimercati A, Putignano G. Cervical squamous intraepithelial lesions of low-grade in HIV-infected women: recurrence, persistence, and progression, in treated and untreated women. Eur J Obstet Gynecol Reprod Biol. 2005 Aug 1;121(2):226-32. doi: 10.1016/j.ejogrb.2004.12.003. Epub 2005 Jan 18.</citation>
      <PMID>16054967</PMID>
    </reference>
    <reference>
      <citation>Gupta K, Philipose CS, Rai S, Ramapuram J, Kaur G, Kini H, Gv C, Adiga D. A Study of Pap Smears in HIV-Positive and HIV-Negative Women from a Tertiary Care Center in South India. Acta Cytol. 2019;63(1):50-55. doi: 10.1159/000496211. Epub 2019 Feb 5.</citation>
      <PMID>30721904</PMID>
    </reference>
    <reference>
      <citation>Hawes SE, Critchlow CW, Sow PS, Toure P, N'Doye I, Diop A, Kuypers JM, Kasse AA, Kiviat NB. Incident high-grade squamous intraepithelial lesions in Senegalese women with and without human immunodeficiency virus type 1 (HIV-1) and HIV-2. J Natl Cancer Inst. 2006 Jan 18;98(2):100-9. doi: 10.1093/jnci/djj010.</citation>
      <PMID>16418512</PMID>
    </reference>
    <reference>
      <citation>Keller MJ, Burk RD, Xie X, Anastos K, Massad LS, Minkoff H, Xue X, D'Souza G, Watts DH, Levine AM, Castle PE, Colie C, Palefsky JM, Strickler HD. Risk of cervical precancer and cancer among HIV-infected women with normal cervical cytology and no evidence of oncogenic HPV infection. JAMA. 2012 Jul 25;308(4):362-9. doi: 10.1001/jama.2012.5664.</citation>
      <PMID>22820789</PMID>
    </reference>
    <reference>
      <citation>Clifford GM, Goncalves MA, Franceschi S; HPV and HIV Study Group. Human papillomavirus types among women infected with HIV: a meta-analysis. AIDS. 2006 Nov 28;20(18):2337-44. doi: 10.1097/01.aids.0000253361.63578.14.</citation>
      <PMID>17117020</PMID>
    </reference>
    <reference>
      <citation>Harris TG, Burk RD, Palefsky JM, Massad LS, Bang JY, Anastos K, Minkoff H, Hall CB, Bacon MC, Levine AM, Watts DH, Silverberg MJ, Xue X, Melnick SL, Strickler HD. Incidence of cervical squamous intraepithelial lesions associated with HIV serostatus, CD4 cell counts, and human papillomavirus test results. JAMA. 2005 Mar 23;293(12):1471-6. doi: 10.1001/jama.293.12.1471.</citation>
      <PMID>15784870</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 4, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>HPV test</keyword>
    <keyword>cervical cancer</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>HIV Seropositivity</mesh_term>
      <mesh_term>Uterine Cervical Neoplasms</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/NCT05968183
  org study id: CHSD_0026_MATER
  secondary id: 2022-A01844-39
  nct id: NCT05968183
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The main objective of this study is to evaluate the interest of a screening strategy based on
        the HPV test in patients living with HIV, compared to the cell smear alone in the same
        population.
  
        The Secondary objective of this study is to verify if the use of HPV testing could allow for
        a longer follow-up of these patients in case of negativity, and thus allow for a
        standardization of clinicians' practices.
  Since 2019, a new screening strategy has been implemented and is based on high-risk, HPV
        tests, which, when negative, allow for spaced monitoring in the general population after age
        30 (every 5 years instead of every 3 years.)
  
        These tests therefore allow for earlier detection of patients at risk but also for longer
        follow-up when they are negative.
  
        To our knowledge, there is currently no evaluation of HPV testing as part of routine
        screening in patients living with HIV.
  
        The recommendations for this population are based on the use of the cervico-vaginal smear
        with cytological analysis. The smear should be taken every year and surveillance may be
        repeated every 3 years. If there are 3 consecutive smears without abnormalities and a
        controlled viral load with CD4 counts > 500 mm3. In practice, many patients do not meet these
        criteria and must, therefore, undergo annual screening; the increase in the number of smears
        also leads to an increase in the number of second-line examinations such as colposcopy.
  
        Since there is no recommendation for HPV testing in this population, the use of dual
        detection (cytology and HPV testing) is left to the discretion of the clinician.
  
        By mutual agreement with the clinicians of the maternity department of the Saint-Denis
        Hospital (CHSD), this double detection was introduced in 2021, using the same sample (single
        swab for both analyses: cytology and HPV test).
  
        Therefore, it seems interesting to verify the possibility of a screening strategy based on
        HPV testing in patients living with HIV, by correlating the results of HPV testing and cell
        smears in the population of patients living with HIV.
  observational model: Cohort
  time perspective: Prospective
  measure: Demographic characteristics
  time frame: Day 1
  measure: HIV history
  time frame: Day 1
  measure: medical history
  time frame: Day 1
  measure: comorbidities
  time frame: Day 1
  measure: clinical examination data
  time frame: Day 1
  measure: Results of HPV Cytology
  time frame: Day 1
  measure: Results of cell smear
  time frame: Day 1
  measure: Results of additional examinations prescribed
  time frame: Day 1
  description: Results of any additional examinations prescribed
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 25 Years
  maximum age: 65 Years
  facility: 
  status: Recruiting
  contact: 
  country: France
  citation: Laara E, Day NE, Hakama M. Trends in mortality from cervical cancer in the Nordic countries: association with organised screening programmes. Lancet. 1987 May 30;1(8544):1247-9. doi: 10.1016/s0140-6736(87)92695-x.
  PMID: 2884378
  citation: Koliopoulos G, Nyaga VN, Santesso N, Bryant A, Martin-Hirsch PP, Mustafa RA, Schunemann H, Paraskevaidis E, Arbyn M. Cytology versus HPV testing for cervical cancer screening in the general population. Cochrane Database Syst Rev. 2017 Aug 10;8(8):CD008587. doi: 10.1002/14651858.CD008587.pub2.
  PMID: 28796882
  citation: Srisomboon S, Tantipalakorn C, Muangmool T, Srisomboon J. Risk of High-Grade Cervical Lesions in Atypical Squamous Cells of Undetermined Significance (ASC-US) Cytology: Comparison between HIV-Infected and HIV-Negative Women. Asian Pac J Cancer Prev. 2021 Feb 1;22(2):547-551. doi: 10.31557/APJCP.2021.22.2.547.
  PMID: 33639672
  citation: Denslow SA, Rositch AF, Firnhaber C, Ting J, Smith JS. Incidence and progression of cervical lesions in women with HIV: a systematic global review. Int J STD AIDS. 2014 Mar;25(3):163-77. doi: 10.1177/0956462413491735. Epub 2013 Aug 29.
  PMID: 24216030
  citation: Liu G, Sharma M, Tan N, Barnabas RV. HIV-positive women have higher risk of human papilloma virus infection, precancerous lesions, and cervical cancer. AIDS. 2018 Mar 27;32(6):795-808. doi: 10.1097/QAD.0000000000001765.
  PMID: 29369827
  citation: Sakdadech N, Muangmool T, Srisomboon J. HIV-Infected Women with Low-Grade Squamous Intraepithelial Lesion on Cervical Cytology Have Higher Risk of Underlying High-Grade Cervical Intraepithelial Neoplasia. Int J Environ Res Public Health. 2021 Sep 28;18(19):10211. doi: 10.3390/ijerph181910211.
  PMID: 34639509
  citation: Nappi L, Carriero C, Bettocchi S, Herrero J, Vimercati A, Putignano G. Cervical squamous intraepithelial lesions of low-grade in HIV-infected women: recurrence, persistence, and progression, in treated and untreated women. Eur J Obstet Gynecol Reprod Biol. 2005 Aug 1;121(2):226-32. doi: 10.1016/j.ejogrb.2004.12.003. Epub 2005 Jan 18.
  PMID: 16054967
  citation: Gupta K, Philipose CS, Rai S, Ramapuram J, Kaur G, Kini H, Gv C, Adiga D. A Study of Pap Smears in HIV-Positive and HIV-Negative Women from a Tertiary Care Center in South India. Acta Cytol. 2019;63(1):50-55. doi: 10.1159/000496211. Epub 2019 Feb 5.
  PMID: 30721904
  citation: Hawes SE, Critchlow CW, Sow PS, Toure P, N'Doye I, Diop A, Kuypers JM, Kasse AA, Kiviat NB. Incident high-grade squamous intraepithelial lesions in Senegalese women with and without human immunodeficiency virus type 1 (HIV-1) and HIV-2. J Natl Cancer Inst. 2006 Jan 18;98(2):100-9. doi: 10.1093/jnci/djj010.
  PMID: 16418512
  citation: Keller MJ, Burk RD, Xie X, Anastos K, Massad LS, Minkoff H, Xue X, D'Souza G, Watts DH, Levine AM, Castle PE, Colie C, Palefsky JM, Strickler HD. Risk of cervical precancer and cancer among HIV-infected women with normal cervical cytology and no evidence of oncogenic HPV infection. JAMA. 2012 Jul 25;308(4):362-9. doi: 10.1001/jama.2012.5664.
  PMID: 22820789
  citation: Clifford GM, Goncalves MA, Franceschi S; HPV and HIV Study Group. Human papillomavirus types among women infected with HIV: a meta-analysis. AIDS. 2006 Nov 28;20(18):2337-44. doi: 10.1097/01.aids.0000253361.63578.14.
  PMID: 17117020
  citation: Harris TG, Burk RD, Palefsky JM, Massad LS, Bang JY, Anastos K, Minkoff H, Hall CB, Bacon MC, Levine AM, Watts DH, Silverberg MJ, Xue X, Melnick SL, Strickler HD. Incidence of cervical squamous intraepithelial lesions associated with HIV serostatus, CD4 cell counts, and human papillomavirus test results. JAMA. 2005 Mar 23;293(12):1471-6. doi: 10.1001/jama.293.12.1471.
  PMID: 15784870
  responsible party type: Sponsor
  mesh term: HIV Seropositivity
  mesh term: Uterine Cervical Neoplasms