MA-ASAP at Independent Abortion Clinics: A Demonstration Project

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

Detailed Description
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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.

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

Conditions
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Abortion Early

Intervention / Treatment
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* Other: Screening for Eligibility


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Asynchronous Screening<br>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<br>* Asynchronous Screening for MA Eligibility<br>|

What is the study measuring?
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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 |