Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-27 @ 9:28 PM
Study NCT ID:
NCT04943861
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-05
First Post:
2021-06-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Immunodeficiency Virus (HIV) Food Insecurities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011236', 'term': 'Prediabetic State'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C081645', 'term': 'Secure resin cement'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2021-06-22', 'studyFirstSubmitQcDate': '2021-06-22', 'lastUpdatePostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores', 'timeFrame': 'Baseline', 'description': 'Healthy Range: 1.0 (0.5-1.4) - Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance'}, {'measure': 'Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores', 'timeFrame': 'Month 12', 'description': 'Healthy Range: 1.0 (0.5-1.4) - Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance'}, {'measure': 'Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores', 'timeFrame': 'Month 24', 'description': 'Healthy Range: 1.0 (0.5-1.4) - Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance'}, {'measure': 'Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores', 'timeFrame': 'Month 36', 'description': 'Healthy Range: 1.0 (0.5-1.4) - Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Food Insecurity'], 'conditions': ['Food Insecurities', 'Cardiometabolic Comorbidities', 'HIV', 'PreDiabetes', 'Type 2 Diabetes Mellitus (T2DM)']}, 'referencesModule': {'references': [{'pmid': '36510319', 'type': 'DERIVED', 'citation': 'Tanner AE, Palakshappa D, Morse CG, Mann-Jackson L, Alonzo J, Garcia M, Wright E, Dharod A, Isom S, Sucaldito AD, Aviles LR, Rhodes SD. Exploring the consequences of food insecurity and harnessing the power of peer navigation and mHealth to reduce food insecurity and cardiometabolic comorbidities among persons with HIV: protocol for development and implementation trial of weCare/Secure. Trials. 2022 Dec 12;23(1):998. doi: 10.1186/s13063-022-06924-3.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to better understand how FI (food insecurities) contributes to the development of cardiometabolic comorbidities among PWH (People with HIV) and to test a novel bilingual FI intervention designed to reduce these comorbidities among food insecure PWH. The PI and staff will conduct this study in partnership with the Wake Forest Infectious Diseases Specialty Clinic, one of the largest Ryan White-funded clinics in North Carolina, which serves more than 2,000 PWH annually from a predominantly rural catchment area that includes South Central Appalachia. This area has high rates of both FI and HIV.', 'detailedDescription': 'The proposed study the team has created a conceptually integrated, mixed methods study that includes\n\n* Longitudinal data collection to explore the difference in the prevalence and incidence of cardiometabolic comorbidities between food secure and insecure PWH\n* Implementation and evaluation of the weCare/Secure intervention designed to improve insulin sensitivity among food insecure PWH with prediabetes or Type 2 diabetes (T2DM)\n* Semi-structured individual in-depth interviews to understand the effect of the intervention on FI and insulin sensitivity among participants in an randomized controlled trial (RCT) trial\n* Broad dissemination of study findings to inform both research and clinical practice'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* participant must be a patient of the Wake Forest Infectious Diseases Specialty Clinic\n* be living with HIV\n* ≥18 years of age\n* provide informed consent\n\nExclusion Criteria:\n\n* unable to speak English or Spanish\n* have cognitive impairment that would prevent participation'}, 'identificationModule': {'nctId': 'NCT04943861', 'briefTitle': 'Human Immunodeficiency Virus (HIV) Food Insecurities', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Exploring the Consequences of Food Insecurity and Harnessing the Power of Peer Navigation and mHealth to Reduce Food Insecurity and Cardiometabolic Comorbidities Among Persons With HIV', 'orgStudyIdInfo': {'id': 'IRB00075503'}, 'secondaryIdInfos': [{'id': 'R01NR020307', 'link': 'https://reporter.nih.gov/quickSearch/R01NR020307', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'weCare/Secure', 'description': 'The weCare intervention is based on the social cognitive and empowerment theories and social support and is currently designed to reduce missed HIV care appointments and increase viral suppression among PWH who are newly diagnosed or out of care through the use of peer navigation and mHealth', 'interventionNames': ['Behavioral: weCare/Secure']}, {'type': 'OTHER', 'label': 'Usual Care', 'description': 'There is no peer navigation within usual care.', 'interventionNames': ['Other: Usual Care']}], 'interventions': [{'name': 'weCare/Secure', 'type': 'BEHAVIORAL', 'description': 'The weCare intervention is based on the social cognitive and empowerment theories and social support and is currently designed to reduce missed HIV care appointments and increase viral suppression among PWH who are newly diagnosed or out of care through the use of peer navigation and mHealth', 'armGroupLabels': ['weCare/Secure']}, {'name': 'Usual Care', 'type': 'OTHER', 'description': 'There is no peer navigation within usual care.', 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Scott D Rhodes, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest Health Sciences'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Last 6 months of Year 5', 'ipdSharing': 'YES', 'description': 'Sharing data generated from this study is an essential part of our proposed activities. This study will generate both quantitative and qualitative data', 'accessCriteria': 'De-identified data and associated documentation (including codebooks) will be available from the Principal Investigators under a data-sharing agreement with users that provides for a commitment to:\n\n(1) using the data for research purposes; (2) securing the data using appropriate computer technology; and (3) to destroying or returning the data after analyses are completed'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of North Carolina, Greensboro', 'class': 'OTHER'}, {'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}