<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/NCT04401670</url>
  </required_header>
  <id_info>
    <org_study_id>2016-6070</org_study_id>
    <secondary_id>3P30CA013330</secondary_id>
    <nct_id>NCT04401670</nct_id>
  </id_info>
  <brief_title>Cervical Cancer Screening in Cameroon</brief_title>
  <official_title>Cervical Cancer Screening Strategies in Women Living With HIV and HIV Uninfected Women in Cameroon</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Albert Einstein College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Albert Einstein College of Medicine</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>
      Human immunodeficiency virus-infected (HIV[+]) women have a several-fold increased risk of&#xD;
      invasive cervical cancer (ICC) as well as increased risk of cervical pre-cancer. In low- and&#xD;
      middle-income countries (LMICs), ICC is the 1st or 2nd most common cause of cancer and&#xD;
      cancer-related death in women. Rates of ICC and ICC-related mortality are particularly high&#xD;
      in Sub-Saharan Africa, which also has the highest rates of HIV infection in the world.&#xD;
      Although prophylactic HPV vaccines may be the optimal cervical cancer prevention strategy,&#xD;
      2-3 generations of at-risk HIV[+] and HIV[-] women are already highly exposed to human&#xD;
      papillomavirus (HPV) and would not benefit from (and will not be immunized with) HPV vaccine.&#xD;
      Thus cervical cancer screening is needed for the foreseeable future. However, Pap testing is&#xD;
      expensive and requires a complex clinical and lab infrastructure that does not generally&#xD;
      exist in LMICs; strategies based on high-risk HPV (hrHPV) testing or visual inspection after&#xD;
      acetic acid (VIA) are promising but are either too non-specific, leading to over-referral for&#xD;
      colposcopy or over-treatment, or are too insensitive, respectively. Thus, inexpensive, easily&#xD;
      implemented, and effective cervical cancer screening methods are greatly needed in&#xD;
      Sub-Saharan Africa, especially for HIV[+] women. This cervical cancer screening study of&#xD;
      1,200 women (800 HIV[+] and 400 HIV[-] women), aged 25-59 years, living in Cameroon, utilized&#xD;
      our existing research site. The investigators evaluated screening tests (hrHPV testing, VIA&#xD;
      and Pap), traditional triage tests (HPV16/18/45 detection, VIA, Pap), and promising new&#xD;
      biomarkers for triage (Ki-C67, TOP2a, CDKN2A, and HPV viral load) of screen-positive women.&#xD;
      All screen positives underwent rigorous disease ascertainment to obtain unbiased estimates of&#xD;
      sensitivity, specificity, and positive and negative predictive value. The goal of this study&#xD;
      was to establish the foundation and capacity for future studies designed to reduce the burden&#xD;
      of HPV-associated cancers in the Cameroon population. It will inform Cameroon and other&#xD;
      countries with high HIV burdens on the best strategies for cervical cancer screening in their&#xD;
      HIV[+] and HIV[-] women.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 25, 2017</start_date>
  <completion_date type="Actual">May 1, 2020</completion_date>
  <primary_completion_date type="Actual">August 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The US pathologist was masked to the original cytologic interpretation but unmasked to being hrHPV positive to reduce influence of how the slides were read.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Triage Testing of HIV[+] and HIV[-] Women for Detection of CIN2+ and CIN3+</measure>
    <time_frame>0 days</time_frame>
    <description>To evaluate and compare the clinical performance of high-risk human papillomavirus (hrHPV) DNA testing using provider-collected specimens (Provider/hrHPV) and self-collected specimens (Self/hrHPV), visual inspection after acetic acid (VIA), and liquid-based cytology (LBC) for detection of cervical intraepithelial neoplasia (CIN) grade 2 or more severe diagnoses (CIN2+) and grade 3 or more severe diagnoses (CIN3+) in HIV[+] and HIV[-] women.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Triage Testing of HPV-Positive Women for the Detection of CIN2+ and CIN3+</measure>
    <time_frame>0 days</time_frame>
    <description>To compare the clinical performance of VIA, detection of the most carcinogenic hrHPV genotypes HPV16, 18, or/and 45, and biomarkers Ki-67, p16INK4a, and TOP2A mRNA, HPV viral load, and LBC as triage strategies for hrHPV-positive women for detection of CIN2+ and CIN3+.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Age-Specific Prevalence of Screen Positives in Limbé</measure>
    <time_frame>0 days</time_frame>
    <description>To measure the age-group specific prevalence of hrHPV DNA, LBC, and VIA positivity, and CIN2+ and CIN3+ in HIV[+] and HIV[-] women living in Limbé, Cameroon.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Qualitative interviews to assess acceptability and feasibility of self-collection from women</measure>
    <time_frame>0 days</time_frame>
    <description>To identify micro- and meso-level factors from an exploratory qualitative analysis using data obtained through focus group discussions and in-depth interviews to evaluate acceptability and feasibility of self-sampling for hrHPV testing among HIV[+] and HIV[-] women living in Limbé, Cameroon. This approach was used to better understand and describe women's knowledge, attitudes, and practices regarding cancers in general, cervical cancer, HPV infection, screening as well as behavioral and structural facilitators and barriers to cervical cancer prevention. Additional information was obtained to assess and compare perceptions and preferences for self-versus health provider-collected biological specimens to understand women's preferences given peculiar contextual factors that facilitate or inhibit access to cervical cancer screening for women at risk.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">873</enrollment>
  <condition>Cervical Cancer</condition>
  <condition>HIV/AIDS</condition>
  <arm_group>
    <arm_group_label>Triage with different options</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Self-Collection: hrHPV and Biomarkers Testing (among hrHPV+)&#xD;
ThinPrep Specimen: Liquid-Based Cytology (LBC), hrHPV Testing, and Biomarker Testing (among hrHPV+)&#xD;
Visual Inspection after Acetic Acid (VIA)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HPV screening and triage tests</intervention_name>
    <description>The participants underwent a pelvic exam to have a provider-collected sample placed in PreservCyt [Hologic, Inc., Bedford, MA, USA] and a visual inspection by acetic acid (VIA) by a nurse.</description>
    <arm_group_label>Triage with different options</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HPV self-sampling</intervention_name>
    <description>The participant was escorted by the nurse to a private room and given instructions on how to self-collect their sample using &quot;Just for Me&quot; sampler [Preventive Oncology International, Cleveland, OH, USA].</description>
    <arm_group_label>Triage with different options</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women living in Limbe town and neighborhood&#xD;
&#xD;
          -  Confirmed to be HIV[+] or HIV[-]&#xD;
&#xD;
          -  Have never undergone cervical cancer screening, with no history of ICC&#xD;
&#xD;
          -  Willing and able to competently understand and provide written, informed paper-based&#xD;
             consent&#xD;
&#xD;
          -  Women who are having a menstrual period will be deferred for 2 weeks from&#xD;
             participating in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Women with signs of abnormalities&#xD;
&#xD;
          -  Non-menstrual bleeding suggestive of ICC&#xD;
&#xD;
          -  Without a cervix because they have undergone hysterectomy&#xD;
&#xD;
          -  Based on the judgment of the clinicians not sufficiently healthy to participate in a&#xD;
             research study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>56 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philip E Castle</last_name>
    <role>Principal Investigator</role>
    <affiliation>Albert Einstein College of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Adebola Adedimeji</last_name>
    <role>Principal Investigator</role>
    <affiliation>Albert Einstein College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Limbé Regional Hospital</name>
      <address>
        <city>Limbé</city>
        <country>Cameroon</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Cameroon</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>May 22, 2020</last_update_submitted>
  <last_update_submitted_qc>May 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Albert Einstein College of Medicine</investigator_affiliation>
    <investigator_full_name>Adebola Adedimeji</investigator_full_name>
    <investigator_title>Research Associate Professor</investigator_title>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>HPV screening</keyword>
  <keyword>cervical cancer</keyword>
  <keyword>self sampling</keyword>
  <keyword>human papillomavirus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04401670
org study id: 2016-6070
secondary id: 3P30CA013330
nct id: NCT04401670
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Human immunodeficiency virus-infected (HIV[+]) women have a several-fold increased risk of
      invasive cervical cancer (ICC) as well as increased risk of cervical pre-cancer. In low- and
      middle-income countries (LMICs), ICC is the 1st or 2nd most common cause of cancer and
      cancer-related death in women. Rates of ICC and ICC-related mortality are particularly high
      in Sub-Saharan Africa, which also has the highest rates of HIV infection in the world.
      Although prophylactic HPV vaccines may be the optimal cervical cancer prevention strategy,
      2-3 generations of at-risk HIV[+] and HIV[-] women are already highly exposed to human
      papillomavirus (HPV) and would not benefit from (and will not be immunized with) HPV vaccine.
      Thus cervical cancer screening is needed for the foreseeable future. However, Pap testing is
      expensive and requires a complex clinical and lab infrastructure that does not generally
      exist in LMICs; strategies based on high-risk HPV (hrHPV) testing or visual inspection after
      acetic acid (VIA) are promising but are either too non-specific, leading to over-referral for
      colposcopy or over-treatment, or are too insensitive, respectively. Thus, inexpensive, easily
      implemented, and effective cervical cancer screening methods are greatly needed in
      Sub-Saharan Africa, especially for HIV[+] women. This cervical cancer screening study of
      1,200 women (800 HIV[+] and 400 HIV[-] women), aged 25-59 years, living in Cameroon, utilized
      our existing research site. The investigators evaluated screening tests (hrHPV testing, VIA
      and Pap), traditional triage tests (HPV16/18/45 detection, VIA, Pap), and promising new
      biomarkers for triage (Ki-C67, TOP2a, CDKN2A, and HPV viral load) of screen-positive women.
      All screen positives underwent rigorous disease ascertainment to obtain unbiased estimates of
      sensitivity, specificity, and positive and negative predictive value. The goal of this study
      was to establish the foundation and capacity for future studies designed to reduce the burden
      of HPV-associated cancers in the Cameroon population. It will inform Cameroon and other
      countries with high HIV burdens on the best strategies for cervical cancer screening in their
      HIV[+] and HIV[-] women.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
masking description: The US pathologist was masked to the original cytologic interpretation but unmasked to being hrHPV positive to reduce influence of how the slides were read.
measure: Triage Testing of HIV[+] and HIV[-] Women for Detection of CIN2+ and CIN3+
time frame: 0 days
description: To evaluate and compare the clinical performance of high-risk human papillomavirus (hrHPV) DNA testing using provider-collected specimens (Provider/hrHPV) and self-collected specimens (Self/hrHPV), visual inspection after acetic acid (VIA), and liquid-based cytology (LBC) for detection of cervical intraepithelial neoplasia (CIN) grade 2 or more severe diagnoses (CIN2+) and grade 3 or more severe diagnoses (CIN3+) in HIV[+] and HIV[-] women.
measure: Triage Testing of HPV-Positive Women for the Detection of CIN2+ and CIN3+
time frame: 0 days
description: To compare the clinical performance of VIA, detection of the most carcinogenic hrHPV genotypes HPV16, 18, or/and 45, and biomarkers Ki-67, p16INK4a, and TOP2A mRNA, HPV viral load, and LBC as triage strategies for hrHPV-positive women for detection of CIN2+ and CIN3+.
measure: Age-Specific Prevalence of Screen Positives in Limbé
time frame: 0 days
description: To measure the age-group specific prevalence of hrHPV DNA, LBC, and VIA positivity, and CIN2+ and CIN3+ in HIV[+] and HIV[-] women living in Limbé, Cameroon.
measure: Qualitative interviews to assess acceptability and feasibility of self-collection from women
time frame: 0 days
description: To identify micro- and meso-level factors from an exploratory qualitative analysis using data obtained through focus group discussions and in-depth interviews to evaluate acceptability and feasibility of self-sampling for hrHPV testing among HIV[+] and HIV[-] women living in Limbé, Cameroon. This approach was used to better understand and describe women's knowledge, attitudes, and practices regarding cancers in general, cervical cancer, HPV infection, screening as well as behavioral and structural facilitators and barriers to cervical cancer prevention. Additional information was obtained to assess and compare perceptions and preferences for self-versus health provider-collected biological specimens to understand women's preferences given peculiar contextual factors that facilitate or inhibit access to cervical cancer screening for women at risk.
arm group label: Triage with different options
arm group type: Other
description: Self-Collection: hrHPV and Biomarkers Testing (among hrHPV+)
ThinPrep Specimen: Liquid-Based Cytology (LBC), hrHPV Testing, and Biomarker Testing (among hrHPV+)
Visual Inspection after Acetic Acid (VIA)
intervention type: Other
intervention name: HPV screening and triage tests
description: The participants underwent a pelvic exam to have a provider-collected sample placed in PreservCyt [Hologic, Inc., Bedford, MA, USA] and a visual inspection by acetic acid (VIA) by a nurse.
arm group label: Triage with different options
intervention type: Behavioral
intervention name: HPV self-sampling
description: The participant was escorted by the nurse to a private room and given instructions on how to self-collect their sample using "Just for Me" sampler [Preventive Oncology International, Cleveland, OH, USA].
arm group label: Triage with different options
criteria: 
gender: Female
gender based: Yes
minimum age: 25 Years
maximum age: 56 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Philip E Castle
role: Principal Investigator
affiliation: Albert Einstein College of Medicine
last name: Adebola Adedimeji
role: Principal Investigator
affiliation: Albert Einstein College of Medicine
facility: 
country: Cameroon
responsible party type: Principal Investigator
investigator affiliation: Albert Einstein College of Medicine
investigator full name: Adebola Adedimeji
investigator title: Research Associate Professor
mesh term: Uterine Cervical Neoplasms
sharing ipd: No