Abortion EarlyCHATNCT04432792
The California Home Abortion by Telehealth (CHAT) Study
An observational study of Abortion Early, run by University of California, San Francisco at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion Early
- What is being tested?
- Questionnaire
- How many people
- 6,020 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study will aim to reach a diverse sample of medication abortion patients across the country in states where care is provided including California, New York, and Washington, thus far. In California alone, an estimated 50% of all abortions are medication abortions resulting in >66,000 medication abortions per year. California accounts for 20% of the nation's medication abortions.
Who may be able to join
- Current patient of a participating telehealth platform for medication abortion (includes ages 13-64 years)
- Able to read and write in English or Spanish
- Willing to participate in enrollment survey and two follow-up surveys
Who cannot join
- Not a current patient of a participating telehealth platform for medication abortion
- Unable to read or write in English or Spanish
- Unwilling to participate in study surveys
Trial locations and contacts
1 site in 1 country.
United States1 site
Advancing New Standards in Reproductive Health (ANSIRH)
San Francisco, California, 94612
About this study
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.
Read the detailed description
There are 2 components to the study:
- A clinical records review on all patients
- 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.
- Conditions
- Abortion Early
- Being tested
- Questionnaire
- Keywords
- Telemedicine, Telehealth, Telephone, Remote
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Study survey participants will be administered 3 online surveys.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Records Review | 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. | |
| Study Survey Participants | We aim to enroll at least 3,000 participants to complete the study surveys. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants with a successful abortion
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.
Measured: Documented resolution of pregnancy, for most patients assessed at 7 days
The proportion of participants reporting satisfaction with telehealth for abortion
The proportion of participants reporting being satisfied or very satisfied with telehealth for abortion.
Measured: Documented satisfaction measured at approximately 4 weeks follow up
The proportion of participants reporting they would use the telehealth option again if needed
The proportion of participants reporting they would use the telehealth option again if needed
Measured: Documented at approximately 4 weeks follow up
The total percentage of participants who carried out the study tasks as directed.
The total percentage of participants who carried out the study tasks as directed.
Measured: Documented at the 7 day follow up survey
Secondary outcomes (1)
The total percentage of participants who experienced a major adverse event
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
Measured: Assessed at the 7 day and 4 week follow up surveys or any unscheduled contacts from participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 May 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Abortion EarlyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,020 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- California Latinas for Reproductive Justice, UCGHI Center for Gender and Health Justice Center of Expertise
- Responsible party
- Sponsor
- Investigators
- Ushma Upadhyay, PhD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432792
- Sponsor's protocol ID
- 20-32951
- Acronym
- CHAT
- Status last verified
- Feb 2023
- First submitted
- 11 Jun 2020
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Phillips KK, Koenig LR, Peters L, Ko J, Antonia Biggs M, Upadhyay UD. Reasons for using telehealth medication abortion: adolescents and young adults compared with adults. Contraception. 2026 Sep 30:111741. doi: 10.1016/j.contraception.2026.111741. Online ahead of print.
PubMed 42815876Upadhyay UD, Koenig LR, Meckstroth K, Ko J, Valladares ES, Biggs MA. Effectiveness and safety of telehealth medication abortion in the USA. Nat Med. 2024 Apr;30(4):1191-1198. doi: 10.1038/s41591-024-02834-w. Epub 2024 Feb 15.
PubMed 38361123
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The California Home Abortion by Telehealth (CHAT) Study
- ClinicalTrials.gov ID
- NCT04432792
- Acronym / sponsor ID
- CHAT / 20-32951
- Conditions
- Abortion Early
- Keywords
- Telemedicine, Telehealth, Telephone, Remote
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,020 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- California Latinas for Reproductive Justice, UCGHI Center for Gender and Health Justice Center of Expertise
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There are 2 components to the study:
- A clinical records review on all patients
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical Records Review | – | –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. |
| Study Survey Participants | – | Other: QuestionnaireWe aim to enroll at least 3,000 participants to complete the study surveys. |
Who may qualify
- Ages
- 13 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will aim to reach a diverse sample of medication abortion patients across the country in states where care is provided including California, New York, and Washington, thus far. In California alone, an estimated 50% of all abortions are medication abortions resulting in >66,000 medication abortions per year. California accounts for 20% of the nation's medication abortions.
Key inclusion criteria (3 listed)
- Current patient of a participating telehealth platform for medication abortion (includes ages 13-64 years)
- Able to read and write in English or Spanish
- Willing to participate in enrollment survey and two follow-up surveys
Key exclusion criteria (3 listed)
- Not a current patient of a participating telehealth platform for medication abortion
- Unable to read or write in English or Spanish
- Unwilling to participate in study surveys
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireStudy survey participants will be administered 3 online surveys. | Other | Study Survey Participants |
Primary outcome
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.
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.
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
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Derived from this study: PubMed 42815876Phillips KK, Koenig LR, Peters L, Ko J, Antonia Biggs M, Upadhyay UD. Reasons for using telehealth medication abortion: adolescents and young adults compared with adults. Contraception. 2026 Sep 30:111741. doi: 10.1016/j.contraception.2026.111741. Online ahead of print.
- Derived from this study: PubMed 38361123Upadhyay UD, Koenig LR, Meckstroth K, Ko J, Valladares ES, Biggs MA. Effectiveness and safety of telehealth medication abortion in the USA. Nat Med. 2024 Apr;30(4):1191-1198. doi: 10.1038/s41591-024-02834-w. Epub 2024 Feb 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ushma Upadhyay, PhD, MPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abortion Early, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants with a successful abortion (time frame: Documented resolution of pregnancy, for most patients assessed at 7 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04432792, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.