<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/NCT02237326</url>
  </required_header>
  <id_info>
    <org_study_id>SSC 1825</org_study_id>
    <secondary_id>10-00197</secondary_id>
    <nct_id>NCT02237326</nct_id>
  </id_info>
  <brief_title>Visual Inspection With Acetic Acid Compared to Lugol's Iodine in HIV-infected Women</brief_title>
  <acronym>SAVE</acronym>
  <official_title>Safety and Validity Evaluation for Cervical Cancer Screening and Treatment Techniques Among HIV-infected Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kenya Medical Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The clinical trial is part of a larger study to evaluate the safety and efficacy of screening&#xD;
      techniques for cervical cancer among HIV-infected women. The investigators randomized women&#xD;
      to undergo screening with Visual Inspection with Acetic Acid (VIA) or Visual Inspection with&#xD;
      Lugol's Iodine (VILI), along with a colposcopy. All outcome and treatment decisions were&#xD;
      based on the colposcopy exam done at the study visit. The investigators then compared&#xD;
      outcomes between the two groups to assess the test characteristics of both VIA and VILI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cervical cancer and HIV are intersecting epidemics that both disproportionately affect&#xD;
      low-income women; the impact of the socioeconomic disparity and biologic synergy of these two&#xD;
      diseases is seen dramatically in Kenya, where cervical cancer is the most common cancer&#xD;
      killer. HIV-infected women are at increased risk for the development of cervical precancer&#xD;
      and cancer, develop more aggressive lesions and are affected at younger ages. Although&#xD;
      screening for and treatment of precancer has reduced the incidence of cervical cancer to&#xD;
      close to zero in resource-rich countries, strategies are costly and not available in most&#xD;
      resource-limited countries. Novel testing and treatment methods that can be carried out in&#xD;
      low-resource settings are urgently needed to prevent cervical cancer in these settings,&#xD;
      especially among HIV-infected women. Using a cross-sectional study design, the investigators&#xD;
      tested two potentially low-cost and effective cervical cancer screening methods: visual&#xD;
      inspection with acetic acid (VIA) and protein biomarkers expressed in the presence of&#xD;
      cervical dysplasia, neither of which have been well-studied in HIV-infected women.&#xD;
      Investigators also randomized a small subset of women to undergo VIA compared to Visual&#xD;
      Inspection with Lugol's Iodine (VILI) to compare the test characteristics of these two&#xD;
      screening exams. In addition, remarkably little is known about the potential impact of the&#xD;
      presence, diagnosis and treatment of human papillomavirus-related dysplasia on HIV genital&#xD;
      shedding, a major risk factor for HIV transmission. To explore the impact of the presence,&#xD;
      diagnosis and treatment of human papillomavirus-related cervical dysplasia on HIV-1 in&#xD;
      genital secretions, investigators compared the levels of HIV-1 RNA found in the&#xD;
      cervicovaginal secretions of women with no evidence of cervical dysplasia to levels in women&#xD;
      with high-grade cervical dysplasia. They also compared the levels of HIV-1 RNA prior to and&#xD;
      after cervical biopsy as well as up to 14 weeks after standard treatment for cervical&#xD;
      dysplasia using loop electrosurgical excision procedure (LEEP). Results from this study will&#xD;
      inform the prioritization and design of safe, effective and low-cost cervical cancer&#xD;
      screening and prevention programs for HIV-infected&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Test Positivity Rate</measure>
    <time_frame>eight months</time_frame>
    <description>Investigators compared the test positivity between VIA and VILI.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensitivity</measure>
    <time_frame>12 Months</time_frame>
    <description>Investigators compared the sensitivity of VIA and VILI for the outcome of cervical intraepithelial neoplasia 2 or greater.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Specificity</measure>
    <time_frame>12 months</time_frame>
    <description>Investigators compared the specificity of VIA and VILI for the outcome of cervical intraepithelial neoplasia 2 or greater</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">654</enrollment>
  <condition>Cervical Intraepithelial Neoplasia</condition>
  <condition>Cervical Cancer</condition>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>Visual Inspection with Lugol's Iodine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants underwent colposcopic exam, followed by Visual Inspection with Lugol's Iodine (VILI) by a second, blinded clinician (the order of exams was reversed to eliminate potential interference with exam results due to iodine staining). Biopsy was done after the VILI.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Visual Inspection with Acetic Acid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants underwent Visual Inspection with Acetic Acid followed by colposcopy by a second clinician who was blinded to the screening test result.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Visual Inspection with Acetic Acid</intervention_name>
    <description>Visual Inspection with Acetic Acid is the application of acetic acid to a cervix, followed by examination with a light source. It is not a new drug or device, and has been used in resource-limited settings for several decades. The purpose of this trial is to compare the two screening techniques, which had not been done previously.</description>
    <arm_group_label>Visual Inspection with Acetic Acid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Visual Inspection with Lugol's Iodine</intervention_name>
    <description>Visual Inspection with Lugol's Iodine is the application of lugol's iodine to a woman's cervix, followed by examination with a light source with the goal of detecting precancerous lesions. Like Visual Inspection with Acetic Acid, it is not a new drug or device.</description>
    <arm_group_label>Visual Inspection with Lugol's Iodine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  23-59&#xD;
&#xD;
          -  Intact cervix/uterus&#xD;
&#xD;
          -  no evidence of infection&#xD;
&#xD;
          -  ability to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>23 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Family AIDS Care and Education Services</name>
      <address>
        <city>Kisumu</city>
        <state>Nyanza</state>
        <zip>04100</zip>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kenya</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>September 9, 2014</last_update_submitted>
  <last_update_submitted_qc>September 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Visual Inspection with Acetic Acid</keyword>
  <keyword>Visual Inspection with Lugol's Iodine</keyword>
  <keyword>Cervical Intraepithelial neoplasia</keyword>
  <keyword>Cervical Cancer Screening</keyword>
  <keyword>HIV infected women</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Uterine Cervical Dysplasia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetic Acid</mesh_term>
    <mesh_term>Retinol acetate</mesh_term>
    <mesh_term>Lugol's solution</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02237326
org study id: SSC 1825
secondary id: 10-00197
nct id: NCT02237326
lead sponsor: 
collaborator: 
has dmc: No
The clinical trial is part of a larger study to evaluate the safety and efficacy of screening
      techniques for cervical cancer among HIV-infected women. The investigators randomized women
      to undergo screening with Visual Inspection with Acetic Acid (VIA) or Visual Inspection with
      Lugol's Iodine (VILI), along with a colposcopy. All outcome and treatment decisions were
      based on the colposcopy exam done at the study visit. The investigators then compared
      outcomes between the two groups to assess the test characteristics of both VIA and VILI.
Cervical cancer and HIV are intersecting epidemics that both disproportionately affect
      low-income women; the impact of the socioeconomic disparity and biologic synergy of these two
      diseases is seen dramatically in Kenya, where cervical cancer is the most common cancer
      killer. HIV-infected women are at increased risk for the development of cervical precancer
      and cancer, develop more aggressive lesions and are affected at younger ages. Although
      screening for and treatment of precancer has reduced the incidence of cervical cancer to
      close to zero in resource-rich countries, strategies are costly and not available in most
      resource-limited countries. Novel testing and treatment methods that can be carried out in
      low-resource settings are urgently needed to prevent cervical cancer in these settings,
      especially among HIV-infected women. Using a cross-sectional study design, the investigators
      tested two potentially low-cost and effective cervical cancer screening methods: visual
      inspection with acetic acid (VIA) and protein biomarkers expressed in the presence of
      cervical dysplasia, neither of which have been well-studied in HIV-infected women.
      Investigators also randomized a small subset of women to undergo VIA compared to Visual
      Inspection with Lugol's Iodine (VILI) to compare the test characteristics of these two
      screening exams. In addition, remarkably little is known about the potential impact of the
      presence, diagnosis and treatment of human papillomavirus-related dysplasia on HIV genital
      shedding, a major risk factor for HIV transmission. To explore the impact of the presence,
      diagnosis and treatment of human papillomavirus-related cervical dysplasia on HIV-1 in
      genital secretions, investigators compared the levels of HIV-1 RNA found in the
      cervicovaginal secretions of women with no evidence of cervical dysplasia to levels in women
      with high-grade cervical dysplasia. They also compared the levels of HIV-1 RNA prior to and
      after cervical biopsy as well as up to 14 weeks after standard treatment for cervical
      dysplasia using loop electrosurgical excision procedure (LEEP). Results from this study will
      inform the prioritization and design of safe, effective and low-cost cervical cancer
      screening and prevention programs for HIV-infected
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Care Provider)
measure: Test Positivity Rate
time frame: eight months
description: Investigators compared the test positivity between VIA and VILI.
measure: Sensitivity
time frame: 12 Months
description: Investigators compared the sensitivity of VIA and VILI for the outcome of cervical intraepithelial neoplasia 2 or greater.
measure: Specificity
time frame: 12 months
description: Investigators compared the specificity of VIA and VILI for the outcome of cervical intraepithelial neoplasia 2 or greater
arm group label: Visual Inspection with Lugol's Iodine
arm group type: Active Comparator
description: Participants underwent colposcopic exam, followed by Visual Inspection with Lugol's Iodine (VILI) by a second, blinded clinician (the order of exams was reversed to eliminate potential interference with exam results due to iodine staining). Biopsy was done after the VILI.
arm group label: Visual Inspection with Acetic Acid
arm group type: Active Comparator
description: Participants underwent Visual Inspection with Acetic Acid followed by colposcopy by a second clinician who was blinded to the screening test result.
intervention type: Procedure
intervention name: Visual Inspection with Acetic Acid
description: Visual Inspection with Acetic Acid is the application of acetic acid to a cervix, followed by examination with a light source. It is not a new drug or device, and has been used in resource-limited settings for several decades. The purpose of this trial is to compare the two screening techniques, which had not been done previously.
arm group label: Visual Inspection with Acetic Acid
intervention type: Procedure
intervention name: Visual Inspection with Lugol's Iodine
description: Visual Inspection with Lugol's Iodine is the application of lugol's iodine to a woman's cervix, followed by examination with a light source with the goal of detecting precancerous lesions. Like Visual Inspection with Acetic Acid, it is not a new drug or device.
arm group label: Visual Inspection with Lugol's Iodine
criteria: 
gender: Female
minimum age: 23 Years
maximum age: 59 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Kenya
responsible party type: Sponsor
mesh term: Uterine Cervical Neoplasms
mesh term: Neoplasms
mesh term: Uterine Cervical Dysplasia
mesh term: Acetic Acid
mesh term: Retinol acetate
mesh term: Lugol's solution