Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-02-17 @ 6:23 PM
Study NCT ID:
NCT05858034
Status:
RECRUITING
Last Update Posted:
2025-09-30
First Post:
2023-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identifying Challenges to Healthy Aging in Persons With Human Immunodeficiency Virus (HIV) Age 50 and Older
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Persons with HIV age ≥50 years followed in the Atrium Health Wake Forest Baptist Health Infectious Diseases Specialty Clinic (AHWFB IDSC), The study will take place at in the outpatient clinics of Atrium Health Wake Forest Baptist Health IDSC in Winston-Salem, NC, High Point Medical Center in High Point, NC, and Lexington Memorial Hospital (Lexington, NC).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-26', 'studyFirstSubmitDate': '2023-04-26', 'studyFirstSubmitQcDate': '2023-05-12', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'electronic frailty index human immunodeficiency virus (eFI-HIV) scores', 'timeFrame': 'Baseline', 'description': 'categorized as fit (eFI ≤0.10), pre-frail (0.10 \\< eFI≤0.21), and frail (eFI \\> 0.21) - the greater the score, the increased frailty'}, {'measure': 'Comprehensive geriatric screening (CGS) - Short Physical Performance Battery', 'timeFrame': 'Week 12', 'description': 'Short performance battery score (0-12) - The SPPB total score ranges from 0 (worst performance) to 12 points (best performance) and categorically evaluates performance in the tests using three or four classes of scores: three classes: 0-6 points (poor performance), 7-9 points (moderate performance), and 10-12 points (good performance)'}, {'measure': 'Comprehensive geriatric screening (CGS) - Pepper Assessment Tool for Disability (PAT-D) Scores', 'timeFrame': 'Week 12', 'description': 'self-reported mobility, basic and instrumental activities of daily living - Responses are made on a five-point Likert scale ranging from 1 ("usually did with no difficulty") to 5 ("unable to do") or a box can be checked that reads "usually did not do for other reasons".'}, {'measure': 'Comprehensive geriatric screening (CGS) - brief cognitive screen (Mini-Cog) Scores', 'timeFrame': 'Week 12', 'description': '(Total Possible Score: 0-5) - A total score of 0, 1, or 2 indicates higher likelihood of clinically important cognitive impairment. A total score of 3, 4, or 5 indicates lower likelihood of dementia but does not rule out some degree of cognitive impairment.'}, {'measure': 'depression Patient Health Questionnaire (PHQ-9) Scores', 'timeFrame': 'Week 12', 'description': 'Scores less than 5 almost always signified the absence of a depressive disorder; scores of 5 to 9 predominantly represented patients with either no depression or subthreshold (i.e., other) depression; scores of 10 to 14 represented a spectrum of patients; and scores of 15 or greater usually indicated major depression.'}, {'measure': 'anxiety questionnaire - General Anxiety Disorder-7 (GAD-7) Scores', 'timeFrame': 'Week 12', 'description': 'Scoring GAD-7 Anxiety Severity. This is calculated by assigning scores - GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety.'}, {'measure': 'fatigue/exhaustion survey scores', 'timeFrame': 'Week 12', 'description': 'The fatigue/exhaustion questions will be administered using a paper survey'}], 'primaryOutcomes': [{'measure': 'Physical Performance scores', 'timeFrame': 'Week 12', 'description': 'Change in physical performance battery scores - Minimum score 0 - Maximum score 12 - Higher scores indicate better lower extremity function'}], 'secondaryOutcomes': [{'measure': 'Quality of Life - 12-Item Short Form Health Survey (SF-12) Scores', 'timeFrame': 'Week 12', 'description': 'Change in quality of life as measured by SF-12 - Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning'}, {'measure': 'Percentage of Adherence with Plan', 'timeFrame': 'Week 12', 'description': 'Reported adherence to activity and nutrition plan'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['human immunodeficiency virus', 'frailty', 'biomarkers of aging'], 'conditions': ['HIV', 'Aging']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to identify and characterize frailty and pre-frailty in persons age 50 and older living with human immunodeficiency virus (HIV) followed by the Atrium Health Wake Forest Baptist Infectious Diseases Specialty Clinics (IDSC).', 'detailedDescription': 'The study will implement electronic medical record-based screening for frailty (eFI), further characterize frailty using comprehensive geriatric screening, and offer a customized activity and nutrition plan to a subset of participants. Participation in phlebotomy for research biomarkers of aging is optional. The study also seeks to validate the electronic medical record embedded electronic frailty index (eFI) for the prediction of adverse outcomes in aging persons with HIV, characterize the symptoms of pre-frailty and frailty in persons followed in the IDSC, and assess the acceptability and efficacy of a customized activity and nutrition intervention targeting frailty. The study will also correlate research biomarkers of aging with aging symptoms in a subset of participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Person living with human immunodeficiency virus (HIV)\n* Age ≥50 years\n* Followed by the Atrium Health Wake Forest Baptist Infectious Diseases Specialty Clinic (IDSC)\n* Eligible for Ryan White Program\n* Able to provide informed consent\n* Pre-frail or frail by electronic frailty index (eFI)\n\nExclusion Criteria:\n\n* Age \\<50 years (study designed to characterize frailty in aging persons with HIV)\n* Unable to complete the required assessments or questionnaires'}, 'identificationModule': {'nctId': 'NCT05858034', 'briefTitle': 'Identifying Challenges to Healthy Aging in Persons With Human Immunodeficiency Virus (HIV) Age 50 and Older', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Identifying Challenges to Healthy Aging in Persons With HIV Age 50 and Older', 'orgStudyIdInfo': {'id': 'IRB00095309'}, 'secondaryIdInfos': [{'id': '3P30AG021332-20', 'link': 'https://reporter.nih.gov/quickSearch/3P30AG021332-20', 'type': 'NIH'}, {'id': '6 H97HA46081-01-01', 'type': 'OTHER_GRANT', 'domain': 'Health Resources and Services Administration'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Activity Intervention', 'description': 'Customized selection of exercise and other community and online activity options to improve activity.', 'interventionNames': ['Other: Customized activity plan']}, {'type': 'OTHER', 'label': 'Nutrition Intervention', 'description': 'Development of a customized nutrition plan to address nutritional needs.', 'interventionNames': ['Other: Customized nutrition plan']}], 'interventions': [{'name': 'Customized activity plan', 'type': 'OTHER', 'description': 'Clients with identified challenges to successful aging (pre-frail or frail on screening) will be invited to develop an individualized activity plan to increase mobility, strength, and stamina. Plans will combine activities to improve strength (resistance training), balance (balance exercises), and stamina, and establish weekly goals. Resistance bands and pedometers will be provided. Progress will be measured by self-reported adherence to the activity plan at week 2, 4, 8, 12 and 24 (assessed by telephone at weeks 2, 4, 8 and in person at week 12 and 24). Depression questionnaire (PHQ-9), fatigue screen, exhaustion questions, and SF-12, a measure of health-related quality of life, will be administered at baseline, week 12 and 24.', 'armGroupLabels': ['Activity Intervention']}, {'name': 'Customized nutrition plan', 'type': 'OTHER', 'description': 'Participants with nutritional needs will have the option of meeting with a nutritionist to develop a personalized nutritional plan with a goal of improving diet quality and optimizing caloric intake. Progress will be measured as above.', 'armGroupLabels': ['Nutrition Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yoland Belin', 'role': 'CONTACT', 'email': 'ybelin@wakehealth.edu', 'phone': '336-716-7079'}, {'name': 'Caryn G Morse, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Atrium Health Wake Forest Baptist', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'centralContacts': [{'name': 'Yolanda Belin', 'role': 'CONTACT', 'email': 'ybelin@wakehealth.edu', 'phone': '(336) 716-7079'}, {'name': 'Rica Abbott', 'role': 'CONTACT', 'email': 'rabbott@wakehealth.edu', 'phone': '(336) 716-7079'}], 'overallOfficials': [{'name': 'Caryn G Morse, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': '12 months after completion of the study.', 'ipdSharing': 'YES', 'description': 'Deidentified participant data', 'accessCriteria': 'Principal investigator permission and Institutional Review Board (IRB) review required.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Health Resources and Services Administration (HRSA)', 'class': 'FED'}, {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}