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/NCT06042556</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00014317</org_study_id>
      <nct_id>NCT06042556</nct_id>
    </id_info>
    <brief_title>IUD Self-Removal: Evaluating an Online Guide for Self-removal in Clinical and Non-clinical Settings</brief_title>
    <official_title>A Randomized Trial Evaluating the Effectiveness of a Previously Developed Online IUD Self-removal Guide Versus Basic Information Sheet in Clinical and Non-clinical Settings</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Washington</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Washington</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>
        Investigators previously developed a guide to help people with IUD self-removal. In this&#xD;
        randomized study, the goal is to see if this guide makes it easier for IUD-users to remove&#xD;
        their own IUDs.&#xD;
  &#xD;
        The main question the study aims to answer is:&#xD;
  &#xD;
        -Does use of the previously developed IUD self-removal guide increase rates of self removal?&#xD;
  &#xD;
        Participants will:&#xD;
  &#xD;
          -  Complete a pre-study survey&#xD;
  &#xD;
          -  Be randomized to self-removal with use of the guide or no additional resource&#xD;
  &#xD;
          -  Self-select participation at home or in clinic&#xD;
  &#xD;
          -  Attempt IUD self-removal either at home or in clinic&#xD;
  &#xD;
          -  Complete a post-study survey.&#xD;
  &#xD;
        Investigators will compare rates of successful self-removal between those randomized to the&#xD;
        guide to those randomized to no additional resource to see if increases success.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 3, 2021</start_date>
    <completion_date type="Actual">February 16, 2023</completion_date>
    <primary_completion_date type="Actual">February 16, 2023</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>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Comparison of successful IUD self-removal rates</measure>
      <time_frame>The post study survey will be completed within 48 hours of study participation. Participants schedule their participation on average 1-3 months from study enrollment but up to 1 year (the duration of the study being open).</time_frame>
      <description>Successful self-removal will be reported by participants on the post-study survey and documented with an uploaded photo of the removed IUD on a study ruler sheet. Rates of successful self-removal will be compared between those randomized to the guide versus no additional resource.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">116</enrollment>
    <condition>IUD</condition>
    <condition>Contraception</condition>
    <arm_group>
      <arm_group_label>Guide</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Randomized to use of our IUD self-removal guide</description>
    </arm_group>
    <arm_group>
      <arm_group_label>No guide</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Randomized to use of no additional resource</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>IUD self-removal guide</intervention_name>
      <description>We previously developed an online guide for IUD self-removal through an iterative process including advice from key expert informants, focus groups, interviews, and a pilot clinical study. It includes an online animation, step-by-step guide, troubleshooting tips, and information about pregnancy and contraception.</description>
      <arm_group_label>Guide</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Ages 14 and older&#xD;
  &#xD;
            -  IUD in place and desiring removal&#xD;
  &#xD;
            -  Interest in attempting self-removal&#xD;
  &#xD;
            -  English speaking&#xD;
  &#xD;
            -  Working cell-phone with camera.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Not meeting above inclusion criteria, no other specific exclusion criteria&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>14 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kelsey Petrie, MD, MPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Washington</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Cedar River Clinics</name>
        <address>
          <city>Renton</city>
          <state>Washington</state>
          <zip>98057</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Washington</investigator_affiliation>
      <investigator_full_name>Kelsey Petrie</investigator_full_name>
      <investigator_title>Clinical Instructor</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06042556
  org study id: STUDY00014317
  nct id: NCT06042556
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Investigators previously developed a guide to help people with IUD self-removal. In this
        randomized study, the goal is to see if this guide makes it easier for IUD-users to remove
        their own IUDs.
  
        The main question the study aims to answer is:
  
        -Does use of the previously developed IUD self-removal guide increase rates of self removal?
  
        Participants will:
  
          -  Complete a pre-study survey
  
          -  Be randomized to self-removal with use of the guide or no additional resource
  
          -  Self-select participation at home or in clinic
  
          -  Attempt IUD self-removal either at home or in clinic
  
          -  Complete a post-study survey.
  
        Investigators will compare rates of successful self-removal between those randomized to the
        guide to those randomized to no additional resource to see if increases success.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Comparison of successful IUD self-removal rates
  time frame: The post study survey will be completed within 48 hours of study participation. Participants schedule their participation on average 1-3 months from study enrollment but up to 1 year (the duration of the study being open).
  description: Successful self-removal will be reported by participants on the post-study survey and documented with an uploaded photo of the removed IUD on a study ruler sheet. Rates of successful self-removal will be compared between those randomized to the guide versus no additional resource.
  arm group label: Guide
  arm group type: Experimental
  description: Randomized to use of our IUD self-removal guide
  arm group label: No guide
  arm group type: No Intervention
  description: Randomized to use of no additional resource
  intervention type: Other
  intervention name: IUD self-removal guide
  description: We previously developed an online guide for IUD self-removal through an iterative process including advice from key expert informants, focus groups, interviews, and a pilot clinical study. It includes an online animation, step-by-step guide, troubleshooting tips, and information about pregnancy and contraception.
  arm group label: Guide
  criteria: 
  gender: Female
  minimum age: 14 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Kelsey Petrie, MD, MPH
  role: Principal Investigator
  affiliation: University of Washington
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Washington
  investigator full name: Kelsey Petrie
  investigator title: Clinical Instructor
  sharing ipd: No