Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-03-01 @ 5:39 PM
Study NCT ID:
NCT02801266
Status:
COMPLETED
Last Update Posted:
2022-11-02
First Post:
2016-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Contraceptive Counseling in the United States
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1418}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-31', 'studyFirstSubmitDate': '2016-06-02', 'studyFirstSubmitQcDate': '2016-06-11', 'lastUpdatePostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Method switching for pill users as assessed by a questionnaire designed for this study asking current method used at posttest to determine if it is no longer the pill using questions designed for this study', 'timeFrame': 'six months to one year from initial clinic visit'}, {'measure': 'Gaps in pregnancy protection (number of weeks not using any birth control during contraceptive method switches as assessed by a questionnaire designed for this study using retrospective recall', 'timeFrame': 'six months to one year from initial clinic visit'}, {'measure': 'Counselor behavior (topics covered during counseling) as assessed by a questionnaire designed for this study asking if counselor did or did not address key topics about method use', 'timeFrame': 'six months to one year from initial clinic visit'}, {'measure': 'Pill users retrospective report of the number of missed pills using a questionnaire designed for this study', 'timeFrame': 'six months to one year from initial clinic visit'}], 'primaryOutcomes': [{'measure': 'Patient satisfaction with counselors as assessed by 5 point Likert rating scales using questionnaire designed for this study at immediate posttest.', 'timeFrame': 'immediately after counseling session'}, {'measure': 'Patient satisfaction with counseling session as assessed by 5 point Likert rating scales using a questionnaire designed for this study at immediate posttest.', 'timeFrame': 'immediately after counseling session'}, {'measure': 'Patient satisfaction with clinic experience overall as assessed by 5 point Likert rating scales using a questionnaire designed for this study at immediate posttest.', 'timeFrame': 'immediately after counseling session'}, {'measure': 'Patient satisfaction with clinic experience overall as assessed by 5 point Likert rating scales using a questionnaire designed for this study at 6 months.', 'timeFrame': '6 months from initial clinic visit'}, {'measure': 'Patient satisfaction with clinic experience overall as assessed by 5 point Likert rating scales using a questionnaire designed for this study at 12 months.', 'timeFrame': 'one year from initial clinic visit'}], 'secondaryOutcomes': [{'measure': 'Type of contraceptive method currently using (including none and dual use) as assessed by a questionnaire designed for this study (e.g., what method of birth control are you currently using).', 'timeFrame': 'six months to one year from initial clinic visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Contraception', 'Reproductive and Sexual Health', 'Counseling', 'Contraceptive Counseling'], 'conditions': ['New Behavioral Protocol', 'Treatment as Usual']}, 'descriptionModule': {'briefSummary': 'This project develops a contraceptive counseling protocol (CCP) grounded in scientific evidence and evaluates the CCP for promoting behaviors conducive to preventing unintended pregnancy among women. The project develops and refines the CCP using focus groups and in-depth interviews with (a) key administrators in the national office of Planned Parenthood (b) key administrators in participating Title X clinics, (c) contraceptive counselors, and (d) clients of the health centers. The CCP uses scientifically grounded principles for guiding effective decision making and provider-client communication. Ten Title X clinics are randomly assigned to one of two conditions (5 clinics per condition): (1) treatment as usual (TAU) or (2) implementation of the CCP. Approximately 150 women are selected for study participation in each clinic, yielding about 1,400 participants (half control and half CCP). Immediately following their counseling session, women complete a computer-administered interview that serves as a fidelity check and permits evaluation of the effects of the CCP on variables associated with counseling satisfaction. All women are re-interviewed by phone 6 months later and 12 months later. The effect of the CCP on method-choice effectiveness, method switching, gaps in protection, and use accuracy are evaluated.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be seeking contraception from clinic on day of recruitment\n\nExclusion Criteria:\n\n* Not seeking contraception from clinic on day of recruitment'}, 'identificationModule': {'nctId': 'NCT02801266', 'acronym': 'ICC', 'briefTitle': 'Improving Contraceptive Counseling in the United States', 'organization': {'class': 'OTHER', 'fullName': 'New York University'}, 'officialTitle': 'Improving Contraceptive Counseling in the United States', 'orgStudyIdInfo': {'id': 'FPRPA006057'}, 'secondaryIdInfos': [{'id': '12-9103', 'type': 'OTHER', 'domain': 'NYU Committee on Activities Involving Human Subjects'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'The intervention arm receives contraceptive counseling from counselors who underwent training on the use of evidence informed birth control counseling.', 'interventionNames': ['Behavioral: Evidence informed birth control counseling']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention', 'description': 'The no intervention arm receives contraceptive counseling from counselors who underwent no additional training beyond what they normally receive.'}], 'interventions': [{'name': 'Evidence informed birth control counseling', 'type': 'BEHAVIORAL', 'otherNames': ['Improving contraceptive counseling in the United States'], 'description': 'Counselors underwent training on the use of 10 best practices for contraceptive counseling.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10001', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University, Silver School of Social Work', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'James J Jaccard, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Planned Parenthood Federation of America', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}