<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/NCT04458558</url>
  </required_header>
  <id_info>
    <org_study_id>2.1</org_study_id>
    <nct_id>NCT04458558</nct_id>
  </id_info>
  <brief_title>Improving Access to Abortion in the Republic of Georgia</brief_title>
  <official_title>Improving Access to Abortion in the Republic of Georgia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Center for Information and Counseling on Reproductive Health - Tanadgoma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gynuity Health Projects</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Healthy Life</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Grand Challenges Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Center for Information and Counseling on Reproductive Health - Tanadgoma</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>
      In the Republic of Georgia, the medical abortion regimen involves three in-person visits.&#xD;
      This study aims to pilot and evaluate a simplified medical abortion service delivery model&#xD;
      that will reduce the number of in-person visits to only one visit for diagnosis and&#xD;
      counseling. Medication will be mailed along with two multi-level pregnancy tests to study&#xD;
      participants, who will assess their abortion outcome at home.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective cohort study of patients obtaining medical abortion medications by mail. The&#xD;
      study investigators aim to recruit approximately 120 patients for this study across three&#xD;
      study sites that have extensive experience providing early medical abortion. Five days after&#xD;
      undergoing in-person consultation and necessary exams to assess eligibility for medical&#xD;
      abortion, study team will mail study participants medical abortion pills and two multi-level&#xD;
      urine pregnancy tests. Medical abortion follow-up will occur at the participant's home&#xD;
      approximately two weeks after the initial visit, and the multi-level pregnancy test will be&#xD;
      used to assess abortion outcome. At follow-up, study participants will be asked questions&#xD;
      about the results of the multi-level pregnancy test, and their experience and feedback about&#xD;
      the acceptability of the process. At the conclusion of the study, investigators will&#xD;
      interview providers to better undertand their experience with the simplified medical abortion&#xD;
      service delivery model.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 30, 2020</start_date>
  <completion_date type="Anticipated">April 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2021</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>Prospective Cohort</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants who report satisfactory experience</measure>
    <time_frame>Day 14 following initial medical abortion visit</time_frame>
    <description>Number of participants who report being &quot;satisfied&quot; or &quot;very satisfied&quot; with the simplified medical abortion service delivery model</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of providers who report satisfactory experience</measure>
    <time_frame>End of the study, month 15</time_frame>
    <description>Number of providers who report being &quot;satisfied&quot; or &quot;very satisfied&quot; with the simplified medical abortion service delivery model</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse event</measure>
    <time_frame>Up to 6 weeks after initial medical abortion visit</time_frame>
    <description>Number of participants who had a medical problem that required them to go to the hospital, emergency department or a doctor's office (other than regularly scheduled follow-up visit) since receiving medical abortion pills</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with a complete abortion with medication alone and who do not require additional interventions to complete the procedure</measure>
    <time_frame>Up to 6 weeks after initial medical abortion visit</time_frame>
    <description>Number of participants who report that their abortion is complete as assessed by the multi-level pregnancy test and medical history.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of particpants with adverse event associated with mailing of medical abortion medications</measure>
    <time_frame>Up to 6 weeks after initial medical abortion visit</time_frame>
    <description>Number of participants who had a problem (such as delayed and lost packages) receiving medical abortion medications by mail</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost associated with the simplified medical abortion service delivery model</measure>
    <time_frame>Up to 6 weeks after initial medical abortion visit</time_frame>
    <description>Cost savings associated with participant travel to the clinic and cost of the standard care at the clinic.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants who refuse to receive medical abortion pills by mail</measure>
    <time_frame>End of the study, month 15</time_frame>
    <description>Number of participants who refuse to receive medical abortion pills by mail during the study period</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Abortion Early</condition>
  <condition>Pregnancy Related</condition>
  <arm_group>
    <arm_group_label>Medical abortion patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral mifepristone 200 mg followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mifepristone</intervention_name>
    <description>Participants will receive mifepristone at a preferred address by mail rather than standard care at clinic visit.</description>
    <arm_group_label>Medical abortion patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women seeking medical abortion through 58 days gestation&#xD;
&#xD;
          -  Eligible for medical abortion according to study provider's assessment&#xD;
&#xD;
          -  Able to receive physical mail&#xD;
&#xD;
          -  Have access to a phone&#xD;
&#xD;
          -  Be willing and able to consent to participate in the study&#xD;
&#xD;
          -  Be willing to follow study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not seeking medical abortion&#xD;
&#xD;
          -  Contraindications to medical abortion&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Nino Tsereteli, MA</last_name>
    <phone>+995 599 158 030</phone>
    <email>tsereteli_nino@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lia Mamatsashvili, MD, MPH</last_name>
    <phone>+995 599 930 440</phone>
    <email>l.mamatsashvili@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Batumi Medical Center</name>
      <address>
        <city>Batumi</city>
        <country>Georgia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Temur Gabaidze, MD</last_name>
      <phone>+995 577 442 328</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>David Gagua Clinic</name>
      <address>
        <city>Tbilisi</city>
        <country>Georgia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>George Tsertsvadze, MD</last_name>
      <phone>+995 599 553 047</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinic Elite</name>
      <address>
        <city>Zestap'oni</city>
        <country>Georgia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kote Bochorishvili, MD</last_name>
      <phone>+995 599 516 227</phone>
    </contact>
  </location>
  <location_countries>
    <country>Georgia</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mifepristone</mesh_term>
  </intervention_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/NCT04458558
org study id: 2.1
nct id: NCT04458558
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In the Republic of Georgia, the medical abortion regimen involves three in-person visits.
      This study aims to pilot and evaluate a simplified medical abortion service delivery model
      that will reduce the number of in-person visits to only one visit for diagnosis and
      counseling. Medication will be mailed along with two multi-level pregnancy tests to study
      participants, who will assess their abortion outcome at home.
This prospective cohort study of patients obtaining medical abortion medications by mail. The
      study investigators aim to recruit approximately 120 patients for this study across three
      study sites that have extensive experience providing early medical abortion. Five days after
      undergoing in-person consultation and necessary exams to assess eligibility for medical
      abortion, study team will mail study participants medical abortion pills and two multi-level
      urine pregnancy tests. Medical abortion follow-up will occur at the participant's home
      approximately two weeks after the initial visit, and the multi-level pregnancy test will be
      used to assess abortion outcome. At follow-up, study participants will be asked questions
      about the results of the multi-level pregnancy test, and their experience and feedback about
      the acceptability of the process. At the conclusion of the study, investigators will
      interview providers to better undertand their experience with the simplified medical abortion
      service delivery model.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Prospective Cohort
primary purpose: Health Services Research
masking: None (Open Label)
measure: Number of participants who report satisfactory experience
time frame: Day 14 following initial medical abortion visit
description: Number of participants who report being "satisfied" or "very satisfied" with the simplified medical abortion service delivery model
measure: Number of providers who report satisfactory experience
time frame: End of the study, month 15
description: Number of providers who report being "satisfied" or "very satisfied" with the simplified medical abortion service delivery model
measure: Number of participants with adverse event
time frame: Up to 6 weeks after initial medical abortion visit
description: Number of participants who had a medical problem that required them to go to the hospital, emergency department or a doctor's office (other than regularly scheduled follow-up visit) since receiving medical abortion pills
measure: Number of participants with a complete abortion with medication alone and who do not require additional interventions to complete the procedure
time frame: Up to 6 weeks after initial medical abortion visit
description: Number of participants who report that their abortion is complete as assessed by the multi-level pregnancy test and medical history.
measure: Number of particpants with adverse event associated with mailing of medical abortion medications
time frame: Up to 6 weeks after initial medical abortion visit
description: Number of participants who had a problem (such as delayed and lost packages) receiving medical abortion medications by mail
measure: Cost associated with the simplified medical abortion service delivery model
time frame: Up to 6 weeks after initial medical abortion visit
description: Cost savings associated with participant travel to the clinic and cost of the standard care at the clinic.
measure: Number of participants who refuse to receive medical abortion pills by mail
time frame: End of the study, month 15
description: Number of participants who refuse to receive medical abortion pills by mail during the study period
arm group label: Medical abortion patients
arm group type: Experimental
description: Oral mifepristone 200 mg followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone).
intervention type: Drug
intervention name: Mifepristone
description: Participants will receive mifepristone at a preferred address by mail rather than standard care at clinic visit.
arm group label: Medical abortion patients
criteria: 
gender: Female
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Nino Tsereteli, MA
phone: +995 599 158 030
email: tsereteli_nino@yahoo.com
last name: Lia Mamatsashvili, MD, MPH
phone: +995 599 930 440
email: l.mamatsashvili@gmail.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Georgia
responsible party type: Sponsor
mesh term: Mifepristone
sharing ipd: No