Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-27 @ 11:00 PM
Study NCT ID:
NCT05947266
Status:
RECRUITING
Last Update Posted:
2025-05-04
First Post:
2023-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intervening With Haitian Immigrants in the U.S. to Improve HIV Outcomes
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': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective, quasi-experimental, single arm study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-30', 'studyFirstSubmitDate': '2023-06-26', 'studyFirstSubmitQcDate': '2023-07-07', 'lastUpdatePostDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Care of Engagement Index Score', 'timeFrame': 'Baseline, post-intervention (week 12 to 14 post baseline), 6-month post-baseline follow up', 'description': 'Change in Engagement in Care score over time, including comfort and communication with provider'}, {'measure': 'Viral suppression', 'timeFrame': 'Baseline, 6-month post-baseline follow up', 'description': 'Change in HIV load measurement toward a target of less than 200 copies/ml'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Viral suppression'], 'conditions': ['HIV Infection Primary']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to test a culturally tailored engagement and retention intervention for Haitian Immigrants Living With HIV (HILWH). The main questions it aims to answer are:\n\n* Does this intervention result in measurable engagement and retention in care?\n* Does this intervention result in measurable viral suppression within 6 months?\n\nParticipants will\n\n* participate in a pilot health intervention entailing 4 individual meetings, approximately once monthly over a six-month period and completing research questionnaires at enrollment, post-intervention and at 6 months post-enrollment.\n* Six participants who have completed the pilot intervention and agree to take part, will participate in the photovoice portion of the study. This activity will consist of 6 additional meetings where participants will be taught about using photographs to illustrate their experience participating in the study and take and display photographs.', 'detailedDescription': 'Research design: The proposed study will test a culturally tailored engagement and retention intervention for Haitian immigrants living with HIV (HILWH). This is sequential mixed-methods formative pilot research that is designed to examine engagement and retention in care, and viral suppression (VS) for HILWH and adapt a promising intervention that will result in viral suppression between baseline and a 6 month follow-up assessment. The pilot will be conducted as a prospective, quasi-experimental single arm with a sample of newly diagnosed or nonvirally suppressed HIWLH adults drawn from 2 Federally Qualified Health Centers (FQHC) sites in Miami.\n\nProcedures to be used:\n\nAIM 1 mixed methods (quantitative and qualitative) data collection on barriers and facilitators to viral suppression among HILWH. Quantitative questionnaires will be completed by health care service providers and HILWH who will also participate in a Focus group. A sample of HILWH will participate in individual in-depth interviews.\n\nAIM 2 consists of a pilot health intervention entailing completing research questionnaires at enrollment, post-intervention and at 6 months post-enrollment. In addition, participants will have 4 individual meetings, approximately once monthly over a six month period.\n\nAIM 3 Photovoice participants will be 6 participants who have completed the pilot intervention (AIM 2) and agree to participate in the photovoice portion of the study. This activity will consist of 6 additional meetings where participants will be taught about using photographs to illustrate their experience participating in the study and taking photographs. This activity is expected to take approximately 8 additional hours over 2 and a half months. For these six participants, the total amount of time will be approximately 20 hours over 8 and 1/2 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Seropositive for HIV\n2. Either a recent HIV diagnosis (within the last 2 months) or non-virally suppressed.\n3. Migrated to the US from Haiti\n\nExclusion Criteria:\n\n1\\. Virally suppressed'}, 'identificationModule': {'nctId': 'NCT05947266', 'briefTitle': 'Intervening With Haitian Immigrants in the U.S. to Improve HIV Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Florida International University'}, 'officialTitle': 'Intervening With Haitian Immigrants in the U.S. to Improve HIV Outcomes', 'orgStudyIdInfo': {'id': 'NIMH34133481'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Haitian immigrant iENGAGE (H-iENGAGE) intervention', 'description': '1. Enrollment;\n2. Baseline assessment;\n3. Upon baseline completion, scheduling of H-iENGAGE sessions 1 through 4\n4. Following Session 4, conduct Process evaluation;\n5. Post-intervention assessment;\n6. Six-month follow up assessment\\*\n\n \\*Six participants will complete AIM 3: Identify multi-level implementation factors contributing to intervention outcomes, using photovoice in mixed methods.\n7. End of study participation', 'interventionNames': ['Behavioral: an adaptation of the iENGAGE']}], 'interventions': [{'name': 'an adaptation of the iENGAGE', 'type': 'BEHAVIORAL', 'otherNames': ['Haitian immigrant iENGAGE (H-iENGAGE)'], 'description': 'Haitian immigrant iENGAGE (H-iENGAGE) is an adaptation of the iENGAGE intervention culturally adapted for Haitian immigrants with HIV that will be tested in a quasi-experimental pilot for preliminary efficacy among recently diagnosed or nonvirally suppressed adults across two Federally Qualified Health Centers (FQHCs) in Miami.', 'armGroupLabels': ['Haitian immigrant iENGAGE (H-iENGAGE) intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33137', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'MICHELE JEAN-GILLES, PhD', 'role': 'CONTACT', 'email': 'gillesm@fiu.edu', 'phone': '561-536-4186'}], 'facility': 'Care Resource, Inc.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'centralContacts': [{'name': 'MICHELE JEAN-GILLES, PHD', 'role': 'CONTACT', 'email': 'gillesm@fiu.edu', 'phone': '561-536-4186'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}