Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 5:57 AM
Study NCT ID:
NCT07486661
Status:
RECRUITING
Last Update Posted:
2026-03-20
First Post:
2026-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Project for PLWH Aged 65-75: Preventing the Development of Frailty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'general blood test'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-01-14', 'studyFirstSubmitQcDate': '2026-03-18', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Validate the application of the Fried scale in a population of PLWH', 'timeFrame': 'This analyse will be done at the end of the study when all patients will have complete the evaluation at one year.', 'description': 'compared the number of the PLWH with an Fried scale of a score \\>/= 2 and the number of PLWH with frailty assessed by a complete geriatrician estimation'}], 'primaryOutcomes': [{'measure': 'number of PLWH between 65 and 74 years with frailty', 'timeFrame': 'Baseline', 'description': 'Using Fried scale and complete geriatic assesment The Fried scale is a widely recognized assessment tool designed to evaluate frailty in older adults, particularly those aged 65 and above. It helps identify individuals at increased risk of adverse health outcomes, such as falls, hospitalization, disability, and mortality. The assessment is based on five key criteria: unintentional weight loss, exhaustion, low physical activity, slowness, and weakness, with each positive criterion scoring one point.\n\nScores of 0 indicate a robust individual, 1-2 suggest a state of pre-frailty, and ≥3 confirm frailty.'}], 'secondaryOutcomes': [{'measure': 'Number of PLWH with a Fried test detecting frailty', 'timeFrame': 'Baseline', 'description': 'Fried scale'}, {'measure': 'Number of PLWH with Fried scale detecting pre-frailty condition', 'timeFrame': 'Baseline', 'description': 'Fried scale'}, {'measure': 'Results of Fried scale at one year', 'timeFrame': 'one year after the first Fried scale performed at baseline', 'description': 'Fried scale performed one year after the first Fried scale in those with a abnormal Fried scale at baseline ( \\>/=2)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV', 'frailty', 'ageing'], 'conditions': ['Age Group: 65-74', 'HIV']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Rockwood K,Song X,MacKnight C,Bergman H,Hogan DB,McDowell I,Mitnitski A'}, {'pmid': '11253156', 'type': 'BACKGROUND', 'citation': 'Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.'}, {'type': 'BACKGROUND', 'citation': 'Yamada Y,Kobayashi T,Condo A,Sangarlangkarn A,Ko F,Taniguchi Y,Kojima G'}, {'pmid': '34799510', 'type': 'BACKGROUND', 'citation': 'Jones HT, Levett T, Barber TJ. Frailty in people living with HIV: an update. Curr Opin Infect Dis. 2022 Feb 1;35(1):21-30. doi: 10.1097/QCO.0000000000000798.'}, {'pmid': '36250271', 'type': 'BACKGROUND', 'citation': 'Allavena C, Blain H, Abulizi X, Slama L, Katlama C, Delobel P, Rio V, Cagnot C, Raho-Moussa M, Makinson A, Meyer L. Prevalence and risk factors of frailty among adults living with HIV aged 70 years or older. AIDS. 2023 Jan 1;37(1):183-189. doi: 10.1097/QAD.0000000000003403. Epub 2022 Oct 11.'}, {'pmid': '27756678', 'type': 'BACKGROUND', 'citation': 'Wing EJ. HIV and aging. Int J Infect Dis. 2016 Dec;53:61-68. doi: 10.1016/j.ijid.2016.10.004. Epub 2016 Oct 15.'}]}, 'descriptionModule': {'briefSummary': "In ageing populations, the main risk is the development of a syndrome of frailty, characterized by the addition of polymorbidity, polymedication, psychosocial difficulties, cognitive disorders, ... This functional decline is linked to a reduction in the person's functional reserves, and will lead to an increase in health problems, hospitalizations and, ultimately, mortality. People living with HIV (PLWH) over 50 develop the same kind of comorbidities as HIV-uninfected people over 75 years-old.\n\nIn Belgium, the care of PLWH\\< 75 years with frailty syndrome is not reimbursed by healthcare insurance, and geriatric assessment and management is therefore not possible in this age group, despite the very real need.\n\nGoals of this project are:\n\n1. Determine the proportion and characterize the population of PLWH aged 65 and over who screen positive using the Fried scale\n2. Validate the application of the Fried scale in a population of PLWH\n3. Offer a care pathway model to prevent the onset of frailty in people screened as at-risk and who do not benefit from routine screening or care pathway reimbursement.\n\nProjets proposal:\n\n* Systematic screening of all PLWH aged 65-74 at the MIA Center, by the nurse prior to physician consultation, using the Fried scale.\n* Send all PLWH aged 65-74 who screen positive to Geriatric One Day for an ergo-geriatric consultation to confirm the risk of frailty and set up a preventive care pathway\n* After treatment, perform a patient satisfaction questionnaire + a new Fried scale at one year"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all PLWH followed at the MIA center between 65 and 74 years included', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* living with HIV\n* between 65-74 years\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT07486661', 'acronym': 'Frailty', 'briefTitle': 'A Pilot Project for PLWH Aged 65-75: Preventing the Development of Frailty', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Saint Pierre'}, 'officialTitle': 'A Pilot Project for PLWH Aged 65-75: Preventing the Development of Frailty', 'orgStudyIdInfo': {'id': 'B0762025250403'}}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Agnes Libois, MD', 'role': 'CONTACT', 'email': 'maladiesinfectieuses@stpierre-bru.be', 'phone': '+3225354130'}, {'name': 'Agnes Libois, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Saint-Pierre, centre MIA', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Agnes LIBOIS, MD', 'role': 'CONTACT', 'email': 'maladiesinfectieuses@stpierre-bru.be', 'phone': '+3225354130'}, {'name': 'Charlotte Martin, MD, PHD', 'role': 'CONTACT', 'email': 'maladiesinfectieusess@stpierre-bru.be', 'phone': '+3225354130'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Saint Pierre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}