MA-ASAP at Independent Abortion Clinics: A Demonstration Project

Medication Abortion With Autonomous Self-Assessment Project at Independent Abortion Clinics: A Demonstration Project

In this study, the investigators propose to conduct a parallel study to MA-ASAP (ClinicalTrials.gov Identifier: NCT05278780) at an independent clinic.

Study Overview

• Status: Recruiting
• Conditions: Abortion Early
• Intervention / Treatment: Other: Screening for Eligibility

Detailed Description

In this study, the investigators propose to conduct a parallel study to the MA-ASAP pilot study (ClinicalTrials.gov Identifier: NCT05278780) at one or more independent abortion clinics. This new study will be similar in structure to pilot study, except that all completed screening questionnaires will be sent to the study site rather than only those deemed eligible according a computer algorithm. The investigators expect that this change will better serve the needs of both clinics and patients, and it will also allow us to assess whether the algorithm is overly restrictive, i.e., whether it is excluding patients who are in fact eligible for MA. The primary goal of the study is to collect data on feasibility of the approach and safety. Secondarily, the investigators aim to assess the ability of a defined set of responses to the screening questionnaire to predict the clinician's decision about whether a clinical consultation is needed.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth Raymond, MD; Phone Number: (212) 448-1230; Email: eraymond@gynuity.org

Study Locations

• United States
  • Montana
    • Whitefish, Montana, United States, 59937
      • Recruiting
      • All Families Healthcare
      • Contact: Helen Weems, MSN; Phone Number: 406-730-8682; Email: helen@allfamilieshealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Can speak and read English
• Has an address in a state where the study clinicians are licensed to practice medicine and where the service is legal
• Is old enough to consent to abortion and study participation without parental consent in the study state
• Has reviewed the study website
• Has had a positive pregnancy test
• Has signed the study informed consent form (ICF), which will be included within the questionnaire
• Is pregnant with a gestational age of ≤77 days from last menstrual period
• Desires MA
• Has no symptoms of or risk factors for ectopic pregnancy
• Has no medical contraindications to MA, specifically:

Hemorrhagic disorder or concurrent anticoagulant therapy Chronic adrenal failure Concurrent long-term systemic corticosteroid therapy Inherited porphyria Allergy to mifepristone or misoprostol, or other prostaglandin

• Is not asked by the site to have a synchronous consultation with clinician OR facility-based tests such as ultrasound, laboratory tests, examination, etc.
• Is comfortable obtaining the abortion pills without a pre-treatment ultrasound and without speaking by phone or video with the abortion provider.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Asynchronous Screening; Participants will be screened for medication abortion eligibility using written or online materials and questionnaires, without a synchronous conversation between the prescribing clinician and the patient.	Other: Screening for Eligibility; Asynchronous Screening for MA Eligibility

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of participant questions	The proportion of participants who have questions after completing the questionnaire and the types of questions that are asked.	6 months
Proportion of participants that are followed through the study	The numbers and proportions of people who complete the questionnaire once initiated, are reached by study staff after submitting a completed questionnaire, and are ultimately followed through the study.	6 months
Incidence of reported problems by site staff	Problems with the study process as reported by site staff	6 months
Study site satisfaction (self-reported)	Interest on the part of study sites to continue to utilize this approach to MA provision after the study ends.	6 months
Incidence of Treatment-Emergent Adverse Events	Proportion of treated participants with SAE related to the study	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of computer algorithm to determine MA eligibility	We will estimate the predictive value of this algorithm for selecting participants who were deemed eligible for MA or ultimately did receive treatment without a synchronous consultation or facility-based tests	6 months

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Collaborators: All Families Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2023
• Primary Completion (Anticipated): June 15, 2023
• Study Completion (Anticipated): June 15, 2023

Study Registration Dates

• First Submitted: March 1, 2023
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No