<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/NCT04432792</url>
  </required_header>
  <id_info>
    <org_study_id>20-32951</org_study_id>
    <nct_id>NCT04432792</nct_id>
  </id_info>
  <brief_title>The California Home Abortion by Telehealth (CHAT) Study</brief_title>
  <acronym>CHAT</acronym>
  <official_title>The California Home Abortion by Telehealth (CHAT) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>California Latinas for Reproductive Justice</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>UCGHI Center for Gender and Health Justice Center of Expertise</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to assess efficacy and safety outcomes of a telehealth model of abortion&#xD;
      care. The study will compare efficacy of this model to usual in-clinic care based on&#xD;
      published rates. It will also investigate participant acceptability and feasibility of this&#xD;
      model of care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are 2 components to the study:&#xD;
&#xD;
        1. A clinical records review on all patients&#xD;
&#xD;
        2. A survey study on a subset of patients who agree to participate.&#xD;
&#xD;
      Clinical Records Review: We will examine medical chart data on all patients from partnered&#xD;
      telehealth providers to analyze efficacy and safety outcomes for medication abortion. These&#xD;
      medical chart data will include medical/pregnancy history and abortion outcome and&#xD;
      de-identified apart from date of birth, zip code, and dates of service.&#xD;
&#xD;
      Survey Study: Following completion of the telehealth provider's standard medical screening,&#xD;
      all patients eligible to receive care through the telehealth provider will be directed to a&#xD;
      page providing detailed information about the CHAT Evaluation Study and given the option to&#xD;
      participate. Participation in the study involves completing our online questionnaires only.&#xD;
      Being in the research study will not affect their care or treatment plan. Declining to&#xD;
      participate in our research study will not affect their care.&#xD;
&#xD;
      If interested, the patient will provide electronic consent and complete a baseline survey to&#xD;
      report socio-demographic characteristics, pregnancy history, and reasons for interest in&#xD;
      telehealth medication abortion services. An online follow-up survey will be administered 3-7&#xD;
      days after receiving mifepristone and then once again 4 weeks after taking mifepristone;&#xD;
      assessments will include self-report of medication administration, adverse events, and&#xD;
      satisfaction.&#xD;
&#xD;
      Among those who complete the study surveys, we will investigate the feasibility, time to&#xD;
      abortion, efficacy, safety, and acceptability of telehealth provision of mifepristone,&#xD;
      measured using a 4-week follow-up though open-ended and closed-ended survey questions.&#xD;
      Individuals who opted not to take the medications will be asked a separate set of follow-up&#xD;
      questions to collect data related to diversion, to better understand potential risks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2021</start_date>
  <completion_date type="Actual">June 30, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The proportion of participants with a successful abortion</measure>
    <time_frame>Documented resolution of pregnancy, for most patients assessed at 7 days</time_frame>
    <description>The proportion of participants who have a successful abortion defined as complete abortion without continuing pregnancy, need for manual vacuum aspiration or an additional round of treatment to complete the abortion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The proportion of participants reporting satisfaction with telehealth for abortion</measure>
    <time_frame>Documented satisfaction measured at approximately 4 weeks follow up</time_frame>
    <description>The proportion of participants reporting being satisfied or very satisfied with telehealth for abortion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The proportion of participants reporting they would use the telehealth option again if needed</measure>
    <time_frame>Documented at approximately 4 weeks follow up</time_frame>
    <description>The proportion of participants reporting they would use the telehealth option again if needed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The total percentage of participants who carried out the study tasks as directed.</measure>
    <time_frame>Documented at the 7 day follow up survey</time_frame>
    <description>The total percentage of participants who carried out the study tasks as directed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The total percentage of participants who experienced a major adverse event</measure>
    <time_frame>Assessed at the 7 day and 4 week follow up surveys or any unscheduled contacts from participants</time_frame>
    <description>Major adverse events, either reported by the patient or documented through clinical records. Major adverse events will be defined as any abortion requiring blood transfusion, surgery, or hospitalization</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">6020</enrollment>
  <condition>Abortion Early</condition>
  <arm_group>
    <arm_group_label>Clinical Records Review</arm_group_label>
    <description>We will receive clinical chart data from the telehealth providers on 3,000 patients (which could include the survey study participants, but we will not know their identities) which will include date of birth, zip code, and dates of service - but will otherwise be de-identified.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study Survey Participants</arm_group_label>
    <description>We aim to enroll at least 3,000 participants to complete the study surveys.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>Study survey participants will be administered 3 online surveys.</description>
    <arm_group_label>Study Survey Participants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study will aim to reach a diverse sample of medication abortion patients across the&#xD;
        country in states where care is provided including California, New York, and Washington,&#xD;
        thus far. In California alone, an estimated 50% of all abortions are medication abortions&#xD;
        resulting in &gt;66,000 medication abortions per year. California accounts for 20% of the&#xD;
        nation's medication abortions.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Current patient of a participating telehealth platform for medication abortion&#xD;
             (includes ages 13-64 years)&#xD;
&#xD;
          2. Able to read and write in English or Spanish&#xD;
&#xD;
          3. Willing to participate in enrollment survey and two follow-up surveys&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Not a current patient of a participating telehealth platform for medication abortion&#xD;
&#xD;
          2. Unable to read or write in English or Spanish&#xD;
&#xD;
          3. Unwilling to participate in study surveys&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Any pregnant person seeking medication abortion regardless of gender identity.</gender_description>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ushma Upadhyay, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Advancing New Standards in Reproductive Health (ANSIRH)</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>February 1, 2023</last_update_submitted>
  <last_update_submitted_qc>February 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Telemedicine</keyword>
  <keyword>Telehealth</keyword>
  <keyword>Telephone</keyword>
  <keyword>Remote</keyword>
  <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/NCT04432792
org study id: 20-32951
nct id: NCT04432792
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
This study aims to assess efficacy and safety outcomes of a telehealth model of abortion
      care. The study will compare efficacy of this model to usual in-clinic care based on
      published rates. It will also investigate participant acceptability and feasibility of this
      model of care.
There are 2 components to the study:

        1. A clinical records review on all patients

        2. A survey study on a subset of patients who agree to participate.

      Clinical Records Review: We will examine medical chart data on all patients from partnered
      telehealth providers to analyze efficacy and safety outcomes for medication abortion. These
      medical chart data will include medical/pregnancy history and abortion outcome and
      de-identified apart from date of birth, zip code, and dates of service.

      Survey Study: Following completion of the telehealth provider's standard medical screening,
      all patients eligible to receive care through the telehealth provider will be directed to a
      page providing detailed information about the CHAT Evaluation Study and given the option to
      participate. Participation in the study involves completing our online questionnaires only.
      Being in the research study will not affect their care or treatment plan. Declining to
      participate in our research study will not affect their care.

      If interested, the patient will provide electronic consent and complete a baseline survey to
      report socio-demographic characteristics, pregnancy history, and reasons for interest in
      telehealth medication abortion services. An online follow-up survey will be administered 3-7
      days after receiving mifepristone and then once again 4 weeks after taking mifepristone;
      assessments will include self-report of medication administration, adverse events, and
      satisfaction.

      Among those who complete the study surveys, we will investigate the feasibility, time to
      abortion, efficacy, safety, and acceptability of telehealth provision of mifepristone,
      measured using a 4-week follow-up though open-ended and closed-ended survey questions.
      Individuals who opted not to take the medications will be asked a separate set of follow-up
      questions to collect data related to diversion, to better understand potential risks.
observational model: Cohort
time perspective: Prospective
measure: The proportion of participants with a successful abortion
time frame: Documented resolution of pregnancy, for most patients assessed at 7 days
description: The proportion of participants who have a successful abortion defined as complete abortion without continuing pregnancy, need for manual vacuum aspiration or an additional round of treatment to complete the abortion.
measure: The proportion of participants reporting satisfaction with telehealth for abortion
time frame: Documented satisfaction measured at approximately 4 weeks follow up
description: The proportion of participants reporting being satisfied or very satisfied with telehealth for abortion.
measure: The proportion of participants reporting they would use the telehealth option again if needed
time frame: Documented at approximately 4 weeks follow up
description: The proportion of participants reporting they would use the telehealth option again if needed
measure: The total percentage of participants who carried out the study tasks as directed.
time frame: Documented at the 7 day follow up survey
description: The total percentage of participants who carried out the study tasks as directed.
measure: The total percentage of participants who experienced a major adverse event
time frame: Assessed at the 7 day and 4 week follow up surveys or any unscheduled contacts from participants
description: Major adverse events, either reported by the patient or documented through clinical records. Major adverse events will be defined as any abortion requiring blood transfusion, surgery, or hospitalization
arm group label: Clinical Records Review
description: We will receive clinical chart data from the telehealth providers on 3,000 patients (which could include the survey study participants, but we will not know their identities) which will include date of birth, zip code, and dates of service - but will otherwise be de-identified.
arm group label: Study Survey Participants
description: We aim to enroll at least 3,000 participants to complete the study surveys.
intervention type: Other
intervention name: Questionnaire
description: Study survey participants will be administered 3 online surveys.
arm group label: Study Survey Participants
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Any pregnant person seeking medication abortion regardless of gender identity.
minimum age: 13 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ushma Upadhyay, PhD, MPH
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No