Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-30 @ 3:48 PM
Study NCT ID:
NCT05781061
Status:
COMPLETED
Last Update Posted:
2025-01-27
First Post:
2023-03-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MA-ASAP at Independent Abortion Clinics: A Demonstration Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008403', 'term': 'Mass Screening'}, {'id': 'D004608', 'term': 'Eligibility Determination'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006306', 'term': 'Health Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D015980', 'term': 'Public Health Practice'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-24', 'studyFirstSubmitDate': '2023-03-01', 'studyFirstSubmitQcDate': '2023-03-21', 'lastUpdatePostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of participant questions', 'timeFrame': '6 months', 'description': 'The proportion of participants who have questions after completing the questionnaire and the types of questions that are asked.'}, {'measure': 'Proportion of participants that are followed through the study', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Incidence of reported problems by site staff', 'timeFrame': '6 months', 'description': 'Problems with the study process as reported by site staff'}, {'measure': 'Study site satisfaction (self-reported)', 'timeFrame': '6 months', 'description': 'Interest on the part of study sites to continue to utilize this approach to MA provision after the study ends.'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': '6 months', 'description': 'Proportion of treated participants with SAE related to the study'}], 'secondaryOutcomes': [{'measure': 'Efficacy of computer algorithm to determine MA eligibility', 'timeFrame': '6 months', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Abortion Early']}, 'descriptionModule': {'briefSummary': 'In this study, the investigators propose to conduct a parallel study to MA-ASAP (ClinicalTrials.gov Identifier: NCT05278780) at an independent clinic.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Can speak and read English\n* Has an address in a state where the study clinicians are licensed to practice medicine and where the service is legal\n* Is old enough to consent to abortion and study participation without parental consent in the study state\n* Has reviewed the study website\n* Has had a positive pregnancy test\n* Has signed the study informed consent form (ICF), which will be included within the questionnaire\n* Is pregnant with a gestational age of ≤77 days from last menstrual period\n* Desires MA\n* Has no symptoms of or risk factors for ectopic pregnancy\n* Has no medical contraindications to MA, specifically:\n\nHemorrhagic disorder or concurrent anticoagulant therapy Chronic adrenal failure Concurrent long-term systemic corticosteroid therapy Inherited porphyria Allergy to mifepristone or misoprostol, or other prostaglandin\n\n* Is not asked by the site to have a synchronous consultation with clinician OR facility-based tests such as ultrasound, laboratory tests, examination, etc.\n* Is comfortable obtaining the abortion pills without a pre-treatment ultrasound and without speaking by phone or video with the abortion provider.'}, 'identificationModule': {'nctId': 'NCT05781061', 'briefTitle': 'MA-ASAP at Independent Abortion Clinics: A Demonstration Project', 'organization': {'class': 'OTHER', 'fullName': 'Gynuity Health Projects'}, 'officialTitle': 'Medication Abortion With Autonomous Self-Assessment Project at Independent Abortion Clinics: A Demonstration Project', 'orgStudyIdInfo': {'id': '1059'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Asynchronous Screening', 'description': '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.', 'interventionNames': ['Other: Screening for Eligibility']}], 'interventions': [{'name': 'Screening for Eligibility', 'type': 'OTHER', 'description': 'Asynchronous Screening for MA Eligibility', 'armGroupLabels': ['Asynchronous Screening']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59937', 'city': 'Whitefish', 'state': 'Montana', 'country': 'United States', 'facility': 'All Families Healthcare', 'geoPoint': {'lat': 48.41108, 'lon': -114.33763}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynuity Health Projects', 'class': 'OTHER'}, 'collaborators': [{'name': 'All Families Healthcare', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}