<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/NCT03229603</url>
  </required_header>
  <id_info>
    <org_study_id>TMHPO1763</org_study_id>
    <nct_id>NCT03229603</nct_id>
  </id_info>
  <brief_title>A Pilot Study on HPV and Cervical Cancer Screening in Mumbai</brief_title>
  <acronym>HPV</acronym>
  <official_title>A Pilot Study on HPV and Cervical Cancer Screening in Mumbai</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tata Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Arizona</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tata Memorial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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 Study goals are to test feasibility and acceptability of point of care HPV testing with&#xD;
      227 women already accessing an existing cancer screening program in Mumbai, India. Describe&#xD;
      HPV infection types in women screened. Compare if the quality of HPV clinician-collected and&#xD;
      self-collected samples are equally efficient to detect HPV and cervical cancer precursor&#xD;
      lesions. Compare the agreement between HPV GeneXpert and HPV HC2 test on the&#xD;
      clinician-collected sample&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this pilot study, Investigators will assess the feasibility and acceptability of point of&#xD;
      care HPV testing in an existing SVA program. There is no control group since neither the&#xD;
      efficacy nor effectiveness is to be tested. In the pilot study the screen positive women will&#xD;
      be referred to the Tata Memorial Hospital for further diagnostic work-up to restrict the&#xD;
      programme logistics. While in the main study, Colposcopy and Cryotherapy will be conducted at&#xD;
      the community level. The evaluation framework will be based on a robust D&amp;I model called&#xD;
      REAIM.&#xD;
&#xD;
      i.TMH staff will hold health camps to mobilize women to attend. Providers already trained in&#xD;
      the TMH outreach program will identify women eligible for screening. After obtaining the&#xD;
      consent, the medical social worker will collect baseline data and record the results of the&#xD;
      GeneXpert HPV testing on self sample and health care provider collected sample.&#xD;
&#xD;
      Data Collection:&#xD;
&#xD;
      ii. Quantitative data: Data will be collected in-person by the Medical Social worker.&#xD;
      De-identified data will be uploaded to Own Cloud, a file-sharing program in the University of&#xD;
      Arizona, College of Nursing.&#xD;
&#xD;
      ii. Qualitative data: There will be a discussion on cultural appropriateness and possible&#xD;
      adjustments to the procedures based on the healthcare providers' experiences with a small&#xD;
      subset of the 227 women already screened. Between one to two focus groups will be conducted&#xD;
      by the study investigators with assistance from local staff with a subset of women,&#xD;
      separately to qualitatively assess acceptability of HPV testing using GeneXpert.&#xD;
&#xD;
      The focus group discussions with women participants will be audio-recorded and transcribed&#xD;
      verbatim. The moderator will be guided by a semi-structured set of questions to facilitate&#xD;
      discussion, and will specifically probe to elicit distinctive/ unusual behaviors or symptoms&#xD;
      related to the program, screening and HPV testing.&#xD;
&#xD;
      In keeping with standards for objective evaluation, Dr. Menon or Kue will conduct a focus&#xD;
      group discussion with Medical Social workers at the end of the study period for program&#xD;
      evaluation (i.e., acceptability, potential changes in delivery, etc.). Discussions will be&#xD;
      recorded by a note-taker, not previously associated with the study.&#xD;
&#xD;
      Given the small numbers, a think-aloud group, in a question and answer format with a&#xD;
      note-taker to record the main points will be simply conducted with the providers. Both the&#xD;
      facilitator and note-taker will not be among TMH staff as this may introduce bias to the&#xD;
      conversation.&#xD;
&#xD;
      iii: Training of TMH staff to use GeneXpert: Personnel from the India office of Cepheid will&#xD;
      train providers on how to use GeneXpert using standardized training protocols. The quality of&#xD;
      the self- collected sample will be compared to the quality of the provider collected sample&#xD;
      (by running two separate GeneXpert tests on each sample) to establish the feasibility of&#xD;
      self-sampling.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">April 2018</start_date>
  <completion_date type="Anticipated">May 2018</completion_date>
  <primary_completion_date type="Anticipated">April 2018</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The feasibility of HPV testing as a single visit approach will be summarized using the appropriate descriptive statistics.</measure>
    <time_frame>3 months</time_frame>
    <description>This will be predominantly for counts and percentages for categorical variables (e.g., number of women screened, number of women with incomplete self-collected specimens). In addition to the numbers of participants, the notes from the providers' debriefing regarding culturally appropriateness of HPV testing will be considered.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall agreement between clinician-collected versus self-collected samples will be compared using pairwise t tests</measure>
    <time_frame>3 months</time_frame>
    <description>For all pairwise comparisons, the agreement will be estimated with the kappa statistic and corresponding 95% confidence intervals. McNemar's test shall be used to detect significant differences in the discordant results (p&lt;0.05), indicating systematic differences by assay or sample type in the detection of HPV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The focus group data will be analyzed using constant comparative data analysis to identify thematic components and sub-themes.</measure>
    <time_frame>3 months</time_frame>
    <description>The research team will conduct a content analysis taking the following approach set forth by Huberman and Miles.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The HPV GeneXpert by health care provider and HPV HC2 samples by health care provider will be compared to study the agreement rates.</measure>
    <time_frame>3 months</time_frame>
    <description>For all pairwise comparisons, the agreement will be estimated with the kappa statistic and corresponding 95% confidence intervals. McNemar's test shall be used to detect significant differences in the discordant results (p&lt;0.05), indicating systematic differences by assay or sample type in the detection of HPV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Documentation of six different genotypes/ genotype families of HPV from cervical tissue samples, which will inform the development of HPV vaccinations specific to the strains of HPV in India.</measure>
    <time_frame>3 months</time_frame>
    <description>The prevalence and distribution of HPV genotypes in Indian women with cervical cancer and the trends in HPV infections will be summarized using the appropriate descriptive statistics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Probe for perceptions about self-collection of vaginal samples to describe acceptability of this process.</measure>
    <time_frame>3 months</time_frame>
    <description>Mainly descriptive statistics in percentage, numbers and description</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fit a predictive model of HPV infection(s).</measure>
    <time_frame>3 months</time_frame>
    <description>This will be predicted by sexual behavior, sociodemographic and clinical characteristics of the women screened, controlling for the two screening sites. A positive intra-class correlation (ICC) is expected among participants at the same screening site due to commonalities in selection, exposure, mutual interaction, or a combination of those factors. We will fit Linear Mixed Models (LMMs) and Generalized Linear Mixed Models (GLMMs) to account for various levels of correlation among participants (also known as a &quot;mixed-model ANCOVA&quot; (Brown, 2009). We will fit these models using SAS PROC MIXED and GLIMMIX, Version 9.3.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">227</enrollment>
  <condition>HPV Infection</condition>
  <arm_group>
    <arm_group_label>Cluster of 3000 women</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Cluster will be selected from an existing cervical, breast, and oral cancer screening program in Mumbai, India and its surrounding semi-urban and rural areas.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cluster of 3000 women</intervention_name>
    <description>An evaluation of the feasibility, reach, adoption and implementation of a cervical cancer screening program where we diagnose HPV using the GeneXpert point of care testing kit prior to VIA and cryotherapy.</description>
    <arm_group_label>Cluster of 3000 women</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females aged 30 to 55 years (the age when screening for HPV and cervical cancer is&#xD;
             recommended) who participate in the TMH cancer screening outreach program.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women with a known diagnosis of cancer, any other terminal diagnosis, or who are&#xD;
             pregnant&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gauravi A Mishra, M.D PSM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tata Memorial Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gauravi A Mishra, M.D PSM</last_name>
    <phone>+912224177000</phone>
    <phone_ext>4634</phone_ext>
    <email>gauravi2005@yahoo.co.in</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sharmila A Pimple, M.D PSM</last_name>
    <phone>+912224177000</phone>
    <phone_ext>4631</phone_ext>
    <email>drsharmilapatil@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Tata Memorial Hospital</name>
      <address>
        <city>Mumbai</city>
        <state>Mharashtra</state>
        <zip>400012</zip>
        <country>India</country>
      </address>
    </facility>
    <contact>
      <last_name>Gauravi A Mishra, M.D PSM</last_name>
      <phone>+912224177000</phone>
      <phone_ext>4634</phone_ext>
      <email>gauravi2005@yahoo.co.in</email>
    </contact>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>April 18, 2017</study_first_submitted>
  <study_first_submitted_qc>July 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>December 21, 2017</last_update_submitted>
  <last_update_submitted_qc>December 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tata Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Gauravi Ashish Mishra</investigator_full_name>
    <investigator_title>Professor and Physician</investigator_title>
  </responsible_party>
  <keyword>HPV infection and Cervical cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Papillomavirus Infections</mesh_term>
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03229603
org study id: TMHPO1763
nct id: NCT03229603
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The Study goals are to test feasibility and acceptability of point of care HPV testing with
      227 women already accessing an existing cancer screening program in Mumbai, India. Describe
      HPV infection types in women screened. Compare if the quality of HPV clinician-collected and
      self-collected samples are equally efficient to detect HPV and cervical cancer precursor
      lesions. Compare the agreement between HPV GeneXpert and HPV HC2 test on the
      clinician-collected sample
In this pilot study, Investigators will assess the feasibility and acceptability of point of
      care HPV testing in an existing SVA program. There is no control group since neither the
      efficacy nor effectiveness is to be tested. In the pilot study the screen positive women will
      be referred to the Tata Memorial Hospital for further diagnostic work-up to restrict the
      programme logistics. While in the main study, Colposcopy and Cryotherapy will be conducted at
      the community level. The evaluation framework will be based on a robust D&I model called
      REAIM.

      i.TMH staff will hold health camps to mobilize women to attend. Providers already trained in
      the TMH outreach program will identify women eligible for screening. After obtaining the
      consent, the medical social worker will collect baseline data and record the results of the
      GeneXpert HPV testing on self sample and health care provider collected sample.

      Data Collection:

      ii. Quantitative data: Data will be collected in-person by the Medical Social worker.
      De-identified data will be uploaded to Own Cloud, a file-sharing program in the University of
      Arizona, College of Nursing.

      ii. Qualitative data: There will be a discussion on cultural appropriateness and possible
      adjustments to the procedures based on the healthcare providers' experiences with a small
      subset of the 227 women already screened. Between one to two focus groups will be conducted
      by the study investigators with assistance from local staff with a subset of women,
      separately to qualitatively assess acceptability of HPV testing using GeneXpert.

      The focus group discussions with women participants will be audio-recorded and transcribed
      verbatim. The moderator will be guided by a semi-structured set of questions to facilitate
      discussion, and will specifically probe to elicit distinctive/ unusual behaviors or symptoms
      related to the program, screening and HPV testing.

      In keeping with standards for objective evaluation, Dr. Menon or Kue will conduct a focus
      group discussion with Medical Social workers at the end of the study period for program
      evaluation (i.e., acceptability, potential changes in delivery, etc.). Discussions will be
      recorded by a note-taker, not previously associated with the study.

      Given the small numbers, a think-aloud group, in a question and answer format with a
      note-taker to record the main points will be simply conducted with the providers. Both the
      facilitator and note-taker will not be among TMH staff as this may introduce bias to the
      conversation.

      iii: Training of TMH staff to use GeneXpert: Personnel from the India office of Cepheid will
      train providers on how to use GeneXpert using standardized training protocols. The quality of
      the self- collected sample will be compared to the quality of the provider collected sample
      (by running two separate GeneXpert tests on each sample) to establish the feasibility of
      self-sampling.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: The feasibility of HPV testing as a single visit approach will be summarized using the appropriate descriptive statistics.
time frame: 3 months
description: This will be predominantly for counts and percentages for categorical variables (e.g., number of women screened, number of women with incomplete self-collected specimens). In addition to the numbers of participants, the notes from the providers' debriefing regarding culturally appropriateness of HPV testing will be considered.
measure: Overall agreement between clinician-collected versus self-collected samples will be compared using pairwise t tests
time frame: 3 months
description: For all pairwise comparisons, the agreement will be estimated with the kappa statistic and corresponding 95% confidence intervals. McNemar's test shall be used to detect significant differences in the discordant results (p<0.05), indicating systematic differences by assay or sample type in the detection of HPV.
measure: The focus group data will be analyzed using constant comparative data analysis to identify thematic components and sub-themes.
time frame: 3 months
description: The research team will conduct a content analysis taking the following approach set forth by Huberman and Miles.
measure: The HPV GeneXpert by health care provider and HPV HC2 samples by health care provider will be compared to study the agreement rates.
time frame: 3 months
description: For all pairwise comparisons, the agreement will be estimated with the kappa statistic and corresponding 95% confidence intervals. McNemar's test shall be used to detect significant differences in the discordant results (p<0.05), indicating systematic differences by assay or sample type in the detection of HPV.
measure: Documentation of six different genotypes/ genotype families of HPV from cervical tissue samples, which will inform the development of HPV vaccinations specific to the strains of HPV in India.
time frame: 3 months
description: The prevalence and distribution of HPV genotypes in Indian women with cervical cancer and the trends in HPV infections will be summarized using the appropriate descriptive statistics.
measure: Probe for perceptions about self-collection of vaginal samples to describe acceptability of this process.
time frame: 3 months
description: Mainly descriptive statistics in percentage, numbers and description
measure: Fit a predictive model of HPV infection(s).
time frame: 3 months
description: This will be predicted by sexual behavior, sociodemographic and clinical characteristics of the women screened, controlling for the two screening sites. A positive intra-class correlation (ICC) is expected among participants at the same screening site due to commonalities in selection, exposure, mutual interaction, or a combination of those factors. We will fit Linear Mixed Models (LMMs) and Generalized Linear Mixed Models (GLMMs) to account for various levels of correlation among participants (also known as a "mixed-model ANCOVA" (Brown, 2009). We will fit these models using SAS PROC MIXED and GLIMMIX, Version 9.3.
arm group label: Cluster of 3000 women
arm group type: Other
description: Cluster will be selected from an existing cervical, breast, and oral cancer screening program in Mumbai, India and its surrounding semi-urban and rural areas.
intervention type: Other
intervention name: Cluster of 3000 women
description: An evaluation of the feasibility, reach, adoption and implementation of a cervical cancer screening program where we diagnose HPV using the GeneXpert point of care testing kit prior to VIA and cryotherapy.
arm group label: Cluster of 3000 women
criteria: 
gender: Female
minimum age: 30 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gauravi A Mishra, M.D PSM
role: Principal Investigator
affiliation: Tata Memorial Hospital
last name: Gauravi A Mishra, M.D PSM
phone: +912224177000
phone ext: 4634
email: gauravi2005@yahoo.co.in
last name: Sharmila A Pimple, M.D PSM
phone: +912224177000
phone ext: 4631
email: drsharmilapatil@yahoo.com
facility: 
contact: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Tata Memorial Hospital
investigator full name: Gauravi Ashish Mishra
investigator title: Professor and Physician
mesh term: Papillomavirus Infections
mesh term: Uterine Cervical Neoplasms
sharing ipd: Undecided