<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/NCT02231619</url>
  </required_header>
  <id_info>
    <org_study_id>677/2013</org_study_id>
    <nct_id>NCT02231619</nct_id>
  </id_info>
  <brief_title>Use of Low Sensitivity Pregnancy Test for Self-assessment of Medical Abortion</brief_title>
  <acronym>m-Assist+</acronym>
  <official_title>The Feasibility of Replacing In-person Follow-up for Early Medical Abortion With a Low Sensitivity Pregnancy Test, Symptom Checklist and Text Messages in the South African Public Sector Setting.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Cape Town</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Cape Town</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to design a self-assessment package that could be the preferred&#xD;
      option to a follow-up visit at the clinic by the majority of women having early medical&#xD;
      abortion.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Accurate self-assessment of medical abortion using a low sensitivity pregnancy test</measure>
    <time_frame>12 months</time_frame>
    <description>Participants will be randomized to 2 groups. Women in Group A will conduct a baseline low sensitivity urine pregnancy test (LSUPT) on their own urine specimen at their clinic visit with help from the fieldworker. Group B will receive a standardized set of verbal instructions on how to do the test. Both groups will do a LSUPT at home on Day 12.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">525</enrollment>
  <condition>Completion of Medical Abortion</condition>
  <arm_group>
    <arm_group_label>Demonstration of LSUPT at baseline</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group conduct a LSUPT on their own urine sample at baseline with assistance from a fieldworker.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Baseline verbal instruction of LSUPT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Verbal instruction on how to do LSUPT at baseline</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Baseline verbal instruction on LSUPT</intervention_name>
    <arm_group_label>Baseline verbal instruction of LSUPT</arm_group_label>
    <other_name>Low sensitivity urine pregnancy test</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Already be signed up to do a medical abortion at this clinic&#xD;
&#xD;
          2. Be willing to come to all clinic appointments and be accessible by phone for 2 weeks&#xD;
             after sign up for the study&#xD;
&#xD;
          3. Own a cellphone to which will be sent medical abortion-related information and&#xD;
             messaging.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Be doing a medical abortion due to failed natural miscarriage 2. Not have a working&#xD;
        cellphone&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nolungile Youth Clinic, Khayelitsha</name>
      <address>
        <city>Cape Town</city>
        <state>Western Province</state>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>South Africa</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>August 31, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>November 6, 2015</last_update_submitted>
  <last_update_submitted_qc>November 6, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 9, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Cape Town</investigator_affiliation>
    <investigator_full_name>Deborah Constant</investigator_full_name>
    <investigator_title>Ms</investigator_title>
  </responsible_party>
  <keyword>feasibility</keyword>
  <keyword>self assessment</keyword>
  <keyword>medical abortion</keyword>
  <keyword>low sensitivity urine pregnancy test</keyword>
  <keyword>South Africa</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_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/NCT02231619
org study id: 677/2013
nct id: NCT02231619
lead sponsor: 
collaborator: 
has dmc: No
The purpose of the study is to design a self-assessment package that could be the preferred
      option to a follow-up visit at the clinic by the majority of women having early medical
      abortion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Accurate self-assessment of medical abortion using a low sensitivity pregnancy test
time frame: 12 months
description: Participants will be randomized to 2 groups. Women in Group A will conduct a baseline low sensitivity urine pregnancy test (LSUPT) on their own urine specimen at their clinic visit with help from the fieldworker. Group B will receive a standardized set of verbal instructions on how to do the test. Both groups will do a LSUPT at home on Day 12.
arm group label: Demonstration of LSUPT at baseline
arm group type: No Intervention
description: This group conduct a LSUPT on their own urine sample at baseline with assistance from a fieldworker.
arm group label: Baseline verbal instruction of LSUPT
arm group type: Active Comparator
description: Verbal instruction on how to do LSUPT at baseline
intervention type: Behavioral
intervention name: Baseline verbal instruction on LSUPT
arm group label: Baseline verbal instruction of LSUPT
other name: Low sensitivity urine pregnancy test
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: South Africa
responsible party type: Principal Investigator
investigator affiliation: University of Cape Town
investigator full name: Deborah Constant
investigator title: Ms
mesh term: Hypersensitivity