MA-ASAP at Independent Abortion Clinics: A Demonstration Project

NCT05781061 | Completed

• 1 other identifier: 1059
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Abortion Early

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Efficacy of computer algorithm to determine MA eligibility

  6 months

Study Arms (1)

Asynchronous Screening

EXPERIMENTAL

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

Interventions

Screening for Eligibility OTHER

Asynchronous Screening for MA Eligibility

Asynchronous Screening

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Gynuity Health Projects: lead
• All Families Healthcare: collaborator

Study Sites (1)

All Families Healthcare

Whitefish, Montana, 59937, United States

Location

MeSH Terms

Interventions

Mass Screening; Eligibility Determination

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice; Organization and Administration; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 23, 2023
• Study Start: February 16, 2023
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: January 27, 2025

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)