Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-01-29 @ 3:11 PM
Study NCT ID:
NCT06703060
Status:
RECRUITING
Last Update Posted:
2025-03-04
First Post:
2024-11-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multi-Level Trauma-Informed Approach to Increase HIV Pre-exposure Prophylaxis Initiation Among Black Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-03', 'studyFirstSubmitDate': '2024-11-07', 'studyFirstSubmitQcDate': '2024-11-22', 'lastUpdatePostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PrEP initiation', 'timeFrame': 'Post baseline up to 6 months', 'description': 'Self-report of oral or injectable PrEP (Cabotegravir). Assessed from date of the most recent prescription.'}], 'secondaryOutcomes': [{'measure': 'PrEP adherence', 'timeFrame': '2-months post-randomization, 4-months post-randomization, and 6-months post-randomization', 'description': "Biological assess of tenofovir (TFV) levels in client's urine"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV Prevention', 'PrEP', 'Women', 'Intimate Partner Violence (IPV)']}, 'descriptionModule': {'briefSummary': 'U.S. epidemiological data indicates that Black women are a high-risk HIV disparity group, yet initiation of novel prevention strategies like pre-exposure prophylaxis (PrEP) among this group is stagnant. Socio-structural challenges like intimate partner violence and gendered racism can constrain PrEP access among Black women, but few implementation studies have mitigated these challenges to improve PrEP initiation. The proposed research aims to implement and assess the effectiveness, implementation, and sustainability of a multilevel intervention to increase PrEP initiation among Black women with and without intimate partner violence in Baltimore.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Cisgender Black women (Black women who were born with female genital and also identify as women)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* self-identified Black cisgender woman;\n* self-reported HIV-negative status, and\n* ≥18 years.\n* reports unprotected vaginal or anal sex in the past 6 months with a male sexual partner,\n* have at least one substantial HIV risk factor in the past 6 months according to the 2021 Centers for Disease Control (CDC) PrEP Eligibility Guidelines (i.e., HIV-positive sexual partner, recent bacterial Sexually Transmitted Disease (STD), 2+ sex partners, history of inconsistent or no condom use, commercial sex work, and residing in high HIV prevalence area or network), and\n* never taken PrEP\n\nExclusion Criteria:\n\n* non-English speaking and\n* currently living with HIV'}, 'identificationModule': {'nctId': 'NCT06703060', 'acronym': 'MATCH', 'briefTitle': 'A Multi-Level Trauma-Informed Approach to Increase HIV Pre-exposure Prophylaxis Initiation Among Black Women', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins Bloomberg School of Public Health'}, 'officialTitle': 'Trauma-Informed HIV Prevention for Black Women in Baltimore', 'orgStudyIdInfo': {'id': 'IRB00018632'}, 'secondaryIdInfos': [{'id': 'R01MD019178', 'link': 'https://reporter.nih.gov/quickSearch/R01MD019178', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group (Peer Navigation)', 'description': 'Participants randomized to this arm will receive 4 weekly group sessions and 4 one-on-one sessions with a peer navigator', 'interventionNames': ['Behavioral: Peer Navigation Group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Participants randomized to this group will receive a single group session', 'interventionNames': ['Behavioral: Peer Navigation Group']}], 'interventions': [{'name': 'Peer Navigation Group', 'type': 'BEHAVIORAL', 'description': 'Participants randomized to the intervention will receive behavioral lifestyle education on topics related to biomedical HIV prevention. This will include 4 group sessions and 4 one-on-one sessions with a peer navigator.', 'armGroupLabels': ['Control Group', 'Intervention Group (Peer Navigation)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Principal Investigator', 'role': 'CONTACT', 'email': 'twillie2@jhu.edu', 'phone': '410-614-2686'}], 'facility': 'Johns Hopkins Bloomberg School of Public Health', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'centralContacts': [{'name': 'Tiara C. Willie, PhD, MA', 'role': 'CONTACT', 'email': 'twillie2@jhu.edu', 'phone': '410-614-2686'}, {'name': 'Project Director, DrPH', 'role': 'CONTACT', 'email': 'jmassie4@jhu.edu'}], 'overallOfficials': [{'name': 'Tiara C. Willie, PhD, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins Bloomberg School of Public Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared due to privacy, confidentiality, and ethical considerations. Protecting personal information is essential to comply with privacy laws (e.g., HIPAA) and the terms of informed consent. Sharing such data could breach confidentiality agreements and potentially expose sensitive information, even if anonymized. Additionally, there are concerns about data security, misuse, and the potential harm to participants, which researchers must carefully consider.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins Bloomberg School of Public Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}