Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-17 @ 6:43 PM
Study NCT ID:
NCT03830567
Status:
COMPLETED
Last Update Posted:
2024-04-04
First Post:
2019-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacists Expand Access to Reproductive heaLthcare
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 471}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-02', 'studyFirstSubmitDate': '2019-02-02', 'studyFirstSubmitQcDate': '2019-02-02', 'lastUpdatePostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Contraceptive continuation rates', 'timeFrame': '12 months', 'description': 'Percentage of contraceptive continuation assessed through survey at 12 months among women who present for contraception in pharmacies.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hormonal Contraception', 'Birth Control', 'Pharmacists'], 'conditions': ['Contraception']}, 'descriptionModule': {'briefSummary': 'Prospective cohort study of women presenting to initiate hormonal contraception, prescribed by a clinician or pharmacist. Women will be followed for one year to assess contraceptive continuation and unintended pregnancy rates, as well as measures of safety and acceptability.', 'detailedDescription': "Direct prescription of hormonal contraception (HC) by pharmacists, without a doctor's visit or medical prescription, is a strategy to improve access to contraception and reduce unintended pregnancy. Oregon is the first state in the nation to implement legislation, as of January 1, 2016, expanding the scope of pharmacists to prescribe short-acting HCs. House Bill (HB) 2879 allows pharmacists to directly prescribe HC including the patch and pill, without a medical prescription. Women over 18 years of age can either initiate or continue HCs with a pharmacist, and women under 18 can continue a prescription.\n\nThis prospective cohort study of women presenting to initiate hormonal contraception, prescribed by a clinician or pharmacist, aims to determine contraceptive continuation and incident pregnancy rates between women receiving hormonal contraception from a pharmacist versus other prescriber. Women will be followed for one year to assess contraceptive continuation and unintended pregnancy rates."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '51 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women presenting to initiate hormonal contraception at a study pharmacy.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women presenting to initiate hormonal contraception at a study pharmacy\n\nExclusion Criteria:\n\n* Pregnancy\n* Contraindications to hormonal contraception\n* Under 18 years of age\n* Unable or unwilling to consent'}, 'identificationModule': {'nctId': 'NCT03830567', 'acronym': 'PEARL', 'briefTitle': 'Pharmacists Expand Access to Reproductive heaLthcare', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Pharmacists Expand Access to Reproductive Healthcare: Reducing Unintended Pregnancy Through Pharmacist Prescription of Contraception', 'orgStudyIdInfo': {'id': 'OHSU IRB 16158'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pharmacist prescription', 'interventionNames': ['Other: Pharmacist prescription']}, {'label': 'Clinician prescription', 'interventionNames': ['Other: Clinician prescription']}], 'interventions': [{'name': 'Pharmacist prescription', 'type': 'OTHER', 'description': 'Pharmacist prescribed hormonal contraception (initiation or continuation).', 'armGroupLabels': ['Pharmacist prescription']}, {'name': 'Clinician prescription', 'type': 'OTHER', 'description': 'Clinician prescribed hormonal contraception (initiation or continuation).', 'armGroupLabels': ['Clinician prescription']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Maria I Rodriguez, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Laura and John Arnold Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Maria Rodriguez, MD, MPH', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}