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Completed

NCT Number: NCT04432792

The California Home Abortion by Telehealth (CHAT) 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.

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Key information

Conditions

Abortion Early

Age range

13 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Advancing New Standards in Reproductive Health (ANSIRH)

San Francisco, California, 94612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Questionnaire

Other

Study survey participants will be administered 3 online surveys.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • California Latinas for Reproductive Justice
  • UCGHI Center for Gender and Health Justice Center of Expertise

Registry information

Acronym: CHAT

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 16, 2020
Registry last updated
Feb 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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