Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The California Home Abortion by Telehealth (CHAT) Study (CHAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04432792
Recruitment Status : Not yet recruiting
First Posted : June 16, 2020
Last Update Posted : June 16, 2020
Sponsor:
Collaborators:
California Latinas for Reproductive Justice
UCGHI Women's Health, Gender, and Empowerment Center of Expertise
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
This study aims to assess efficacy and safety outcomes of a model of abortion care implemented in response to the COVID-19 pandemic. The study involves telehealth for counseling and information, to maintain social distancing, but requires participants to pick up their medications in the clinic in keeping with the Food and Drug Administration's (FDA's) Risk Evaluation and Mitigation Strategy (REMS) requirements. 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.

Condition or disease Intervention/treatment Phase
Abortion Early Other: Telehealth Consultation Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Participants will complete an online medical screening form and watch videos about the study. Within 24 hours, the study clinician will conduct a face-to-face video-chat with the participant, review their medical history, and ensure they understand the study requirements, risks and benefits and provide additional information and counseling. The participant will then be directed to pick up their medication abortion pills from a study clinic. The participant will have 3 follow-up online check-ins or surveys: the first follow-up will be 3 days after the package is received, the second follow-up will be 7 days after the participant takes mifepristone, and third and final follow-up will be 4 weeks after the mifepristone.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The California Home Abortion by Telehealth (CHAT) Study
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Arm Intervention/treatment
Experimental: Telehealth Arm
Participants will receive information and counseling via video chat.
Other: Telehealth Consultation
Participants will complete an online medical screening form and watch videos about the study. Within 24 hours, the study clinician will conduct a face-to-face video-chat with the participant, review their medical history, and ensure they understand the study requirements, risks and benefits and provide additional information and counseling. The participant will then be directed to pick up their medication abortion pills from a study clinic. The participant will have 3 follow-up online check-ins or surveys: the first follow-up will be 3 days after the package is received, the second follow-up will be 7 days after the participant takes mifepristone, and third and final follow-up will be 4 weeks after the mifepristone.
Other Name: Telemedicine




Primary Outcome Measures :
  1. The proportion of participants with a successful abortion [ Time Frame: Documented resolution of pregnancy, for most patients assessed at 7 days ]
    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.

  2. The proportion of participants reporting satisfaction with telehealth for abortion [ Time Frame: Documented satisfaction measured at approximately 4 weeks follow up ]
    The proportion of participants reporting being satisfied or very satisfied with telehealth for abortion.

  3. The proportion of participants reporting they would use the telehealth option again if needed [ Time Frame: Documented at approximately 4 weeks follow up ]
    The proportion of participants reporting they would use the telehealth option again if needed

  4. The total percentage of participants who carried out the study tasks as directed. [ Time Frame: Documented at the 7 day follow up survey ]
    The total percentage of participants who carried out the study tasks as directed.


Secondary Outcome Measures :
  1. 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 ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Any pregnant person seeking medication abortion regardless of gender identity.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Able to read and write in English or Spanish
  2. Currently pregnant (self-confirmed through pregnancy test result and/or ultrasound)
  3. At least 18 years old
  4. Clear and confident in the decision to obtain abortion care
  5. Seeking a medication abortion
  6. Have a history of regular menstrual cycles (between 24-38 days)
  7. Be certain of the date of their last normal menstrual period within 1 or 2 days (or have had an ultrasound demonstrating gestational age <70 days)
  8. Have a date of last menstrual period that is <56 days at enrollment (despite the label indicating eligibility up to 70 days LMP) (or have had an ultrasound demonstrating gestational age <70 days)
  9. Meet inclusion criteria based on the mifepristone label
  10. Willing and able to visit one of the participating clinic sites

Exclusion Criteria:

  1. Not pregnant
  2. Under 18 years old
  3. Not interested in medication abortion
  4. Not able to visit one of the designated pick-up clinic sites
  5. Unsure about abortion decision
  6. Contraindications to mifepristone or misoprostol
  7. Have a date of last menstrual period that is >56 days at enrollment (unless they have an ultrasound demonstrating gestational age <70 days)
  8. Significant risk factors for ectopic pregnancy (in the absence of an ultrasound confirming an intrauterine pregnancy)
  9. Signs or symptoms suggestive of ectopic pregnancy (in the absence of an ultrasound confirming an intrauterine pregnancy)
  10. Presence of a condition or abnormality that in the opinion of the clinician Investigator would compromise the safety of the patient.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04432792


Contacts
Layout table for location contacts
Contact: Ushma Upadhyay, PhD, MPH (510) 986-8990 ushma.upadhyay@ucsf.edu

Locations
Layout table for location information
United States, California
Mt. Zion Women's Options Center
San Francisco, California, United States, 94143
Contact: Karen Meckstroth, MD       karen.meckstroth@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
California Latinas for Reproductive Justice
UCGHI Women's Health, Gender, and Empowerment Center of Expertise
Investigators
Layout table for investigator information
Principal Investigator: Ushma Upadhyay, PhD, MPH University of California, San Francisco
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04432792    
Other Study ID Numbers: 19-29437
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of California, San Francisco:
Telemedicine
Telehealth
Telephone
Remote