Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT05844020
Status:
RECRUITING
Last Update Posted:
2025-05-13
First Post:
2023-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Perceptions of Trauma and Violence Informed Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-07', 'studyFirstSubmitDate': '2023-03-14', 'studyFirstSubmitQcDate': '2023-05-03', 'lastUpdatePostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients who received appropriate intimate partner violence screening and trauma/mental health services referral', 'timeFrame': '12 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intimate Partner Violence']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to adapt, implement and evaluate a trauma and violence informed care intervention designed for Black women in middle Tennessee.', 'detailedDescription': "The primary goal is the adaptation, implementation and evaluation of a trauma and violence informed care (TVIC) intervention designed for Black women in middle Tennessee. In this 5-year RCMI project, the investigators propose 3 aims. Aim 1) Engage a stakeholder committee of patients, providers, and experts (COPE) to adapt a TVIC intervention for Black women and their healthcare providers at Meharry. \\[Years 1-2\\]. Aim 2) Implement and prospectively evaluate the adapted TVIC intervention at the healthcare provider-level, measuring changes in Meharry healthcare provider's self-efficacy for TVIC implementation and alignment with TIC knowledge, attitudes, and practices. \\[Years 2-3\\] Aim 3) Implement the adapted TVIC intervention at the patient-level to provide trauma-informed IPV screening, brief interventions, and referrals to treatment (SBIRT), and rigorously evaluate this TVIC intervention's impact on the primary outcome of patient-perceived usefulness of intervention and reported linkage to IPV services, and the secondary outcome of changes at the clinic-level relative to climate and culture, through a non-randomized pragmatic trial design. \\[Year 4-5\\]."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meharry or Matthew Walker Comprehensive Health Center female patients\n* Self-identify as Black\n* Self-identify as intimate partner violence survivors\n* English or Spanish language fluency\n\nExclusion Criteria:\n\n* Not Black female intimate partner violence survivor of Meharry or Matthew Walker Comprehensive Health Center\n* Those without English or Spanish language fluency'}, 'identificationModule': {'nctId': 'NCT05844020', 'briefTitle': 'Perceptions of Trauma and Violence Informed Care', 'organization': {'class': 'OTHER', 'fullName': 'Meharry Medical College'}, 'officialTitle': 'Assessment of Survivor and Provider Perceptions of Trauma and Violence Informed Care Among Black Women', 'orgStudyIdInfo': {'id': '22-05-1198'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TVIC Intervention', 'interventionNames': ['Behavioral: Educational materials']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care'}], 'interventions': [{'name': 'Educational materials', 'type': 'BEHAVIORAL', 'description': 'Trauma-informed intimate partner violence screening, brief interventions, and referrals to treatment by providers', 'armGroupLabels': ['TVIC Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37208', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maureen Sanderson, PhD', 'role': 'CONTACT', 'email': 'msanderson@mmc.edu', 'phone': '6153212977'}], 'facility': 'Meharry Medical College', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'centralContacts': [{'name': 'Maureen Sanderson, PhD', 'role': 'CONTACT', 'email': 'msanderson@mmc.edu', 'phone': '615-321-2977'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meharry Medical College', 'class': 'OTHER'}, 'collaborators': [{'name': 'Matthew Walker Comprehensive Health Center', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}