<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/NCT03808064</url>
  </required_header>
  <id_info>
    <org_study_id>ADS18</org_study_id>
    <nct_id>NCT03808064</nct_id>
  </id_info>
  <brief_title>Community-based Intervention for Cervical Cancer Screening Uptake in Nepal</brief_title>
  <acronym>COBIN-C</acronym>
  <official_title>Community-based Intervention for Cervical Cancer Screening Uptake in a Semi-urban Area of Pokhara Metropolitan, Nepal: A Cluster Randomized Controlled Trial (COBIN-C)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aarhus</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>
      This study aims to evaluate the effect of a Female Community Health Volunteer (FCHV) led&#xD;
      community-based educational intervention through home visits increasing cervical cancer&#xD;
      screening uptake.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cervical cancer is the major cause of cancer deaths among women in Nepal. Screening is one of&#xD;
      the most effective tools for early diagnosis, prevention, and treatment. However, skilled&#xD;
      health professionals and tools available for cervical cancer screening are limited in low and&#xD;
      middle-income countries (LMICs) including Nepal. The World Health Organization (WHO) and&#xD;
      Alliance for Cervical Cancer Prevention (ACCP) recommends that countries, areas, or&#xD;
      institutions seeking to initiate or strengthen cervical cancer screening programs should&#xD;
      consider introducing or expanding Visual Inspection with Acetic acid (VIA) until more&#xD;
      appropriate and affordable HPV-based tests become available. 'National Guideline for Cervical&#xD;
      Cancer Screening and Prevention in Nepal, 2010' includes VIA as a screening method for&#xD;
      cervical cancer. Current studies reveal Nepalese women's participation in cervical cancer&#xD;
      screening is low. Thus, there is a need for appropriate, cost-effective and sustainable&#xD;
      interventions to increase VIA screening uptake at the primary health care level across Nepal.&#xD;
&#xD;
      The primary objective of this study is to evaluate the effect of a Female Community Health&#xD;
      Volunteer (FCHV) led community-based educational intervention through home visits increasing&#xD;
      cervical cancer screening uptake. The primary outcome of the study is to increase the&#xD;
      cervical cancer-screening uptake in the intervention group. This will be the first&#xD;
      community-based cluster-randomized trial designed to mobilize FCHVs for increasing cervical&#xD;
      cancer screening uptake in Nepal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 17, 2019</start_date>
  <completion_date type="Actual">December 26, 2020</completion_date>
  <primary_completion_date type="Actual">December 26, 2020</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The increase in the number of participants attending cervical cancer screening after education intervention</measure>
    <time_frame>One year</time_frame>
    <description>The effect of Female Community Health Volunteers led community based educational intervention through home visits for increasing cervical cancer screening uptake will be evaluated by comparing the baseline with follow up study.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">690</enrollment>
  <condition>Cervical Cancer Screening</condition>
  <arm_group>
    <arm_group_label>Intervention arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After randomization, the FCHVs in the intervention arm will receive training, health education materials and a recording register. After receiving training, they will educate women of their respective ward on cervical cancer screening and prevention through home visits and maintain records in their service register.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>There won't be any intervention in the control arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>FCHV home visit</intervention_name>
    <description>Behavioral: FCHV visit Female Community Health Volunteer will visit selected households 3 times a year for providing health promotion messages Other Name: FCHV Home Visit</description>
    <arm_group_label>Intervention arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All women of age group 30-60 years who were recruited in the COBIN Wave I survey&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are not able to give consent&#xD;
&#xD;
          -  Severely ill,&#xD;
&#xD;
          -  Pregnant or less than 6 weeks after delivery,&#xD;
&#xD;
          -  Who is already diagnosed with cervical pre-cancer and cancer&#xD;
&#xD;
          -  With a history of total hysterectomy&#xD;
&#xD;
          -  Who are reluctant to participate in the study or unable to complete the interview&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aamod D Shrestha, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Public Health, Aarhus University, Aarhus, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nepal Development Society</name>
      <address>
        <city>Pokhara</city>
        <state>Gandaki</state>
        <zip>33700</zip>
        <country>Nepal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Nepal</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>December 2, 2021</last_update_submitted>
  <last_update_submitted_qc>December 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Aarhus</investigator_affiliation>
    <investigator_full_name>Aamod Dhoj Shrestha</investigator_full_name>
    <investigator_title>PhD Fellow</investigator_title>
  </responsible_party>
  <keyword>Cervical cancer screening</keyword>
  <keyword>Community health worker</keyword>
  <keyword>Community-based</keyword>
  <keyword>Female community health volunteers</keyword>
  <keyword>Non-communicable diseases</keyword>
  <keyword>Randomized controlled trial</keyword>
  <keyword>Nepal</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/NCT03808064
org study id: ADS18
nct id: NCT03808064
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to evaluate the effect of a Female Community Health Volunteer (FCHV) led
      community-based educational intervention through home visits increasing cervical cancer
      screening uptake.
Cervical cancer is the major cause of cancer deaths among women in Nepal. Screening is one of
      the most effective tools for early diagnosis, prevention, and treatment. However, skilled
      health professionals and tools available for cervical cancer screening are limited in low and
      middle-income countries (LMICs) including Nepal. The World Health Organization (WHO) and
      Alliance for Cervical Cancer Prevention (ACCP) recommends that countries, areas, or
      institutions seeking to initiate or strengthen cervical cancer screening programs should
      consider introducing or expanding Visual Inspection with Acetic acid (VIA) until more
      appropriate and affordable HPV-based tests become available. 'National Guideline for Cervical
      Cancer Screening and Prevention in Nepal, 2010' includes VIA as a screening method for
      cervical cancer. Current studies reveal Nepalese women's participation in cervical cancer
      screening is low. Thus, there is a need for appropriate, cost-effective and sustainable
      interventions to increase VIA screening uptake at the primary health care level across Nepal.

      The primary objective of this study is to evaluate the effect of a Female Community Health
      Volunteer (FCHV) led community-based educational intervention through home visits increasing
      cervical cancer screening uptake. The primary outcome of the study is to increase the
      cervical cancer-screening uptake in the intervention group. This will be the first
      community-based cluster-randomized trial designed to mobilize FCHVs for increasing cervical
      cancer screening uptake in Nepal.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: The increase in the number of participants attending cervical cancer screening after education intervention
time frame: One year
description: The effect of Female Community Health Volunteers led community based educational intervention through home visits for increasing cervical cancer screening uptake will be evaluated by comparing the baseline with follow up study.
arm group label: Intervention arm
arm group type: Experimental
description: After randomization, the FCHVs in the intervention arm will receive training, health education materials and a recording register. After receiving training, they will educate women of their respective ward on cervical cancer screening and prevention through home visits and maintain records in their service register.
arm group label: Control arm
arm group type: No Intervention
description: There won't be any intervention in the control arm.
intervention type: Behavioral
intervention name: FCHV home visit
description: Behavioral: FCHV visit Female Community Health Volunteer will visit selected households 3 times a year for providing health promotion messages Other Name: FCHV Home Visit
arm group label: Intervention arm
criteria: 
gender: Female
gender based: Yes
minimum age: 30 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Aamod D Shrestha, MPH
role: Principal Investigator
affiliation: Department of Public Health, Aarhus University, Aarhus, Denmark
facility: 
country: Nepal
responsible party type: Principal Investigator
investigator affiliation: University of Aarhus
investigator full name: Aamod Dhoj Shrestha
investigator title: PhD Fellow
mesh term: Uterine Cervical Neoplasms
sharing ipd: No