Frailty in People Living With HIV Aged 70 Years or More

Frailty in People Living With HIV Aged 70 Years or More : Screening Feasibility, Prevalence, Risk Factors and Impact on Pejorative Events

The ANRS EP66 SEPTAVIH Study aims to screen feasibility of evaluating frailty in people living with HIV aged 70 or older, to estimate its prevalence, to analyse associated risk factors and to evaluate the impact of frailty on pejorative events.

SEPTAVIH is a French, multicentre, prospective, observational study which will include 500 HIV-infected participants

Study Overview

• Status: Active, not recruiting
• Conditions: HIV Infections
• Intervention / Treatment: Other: Simplified Geriatric Evaluation; Other: Sampling

Detailed Description

The primary objective is to assess the prevalence of frailty at baseline in People living with HIV (PLWH) aged 70 years and older, using the Fried index.

The main secondary objectives of this study are :

• To assess frequency frailty according to different indexes or scores (Fried, Health deficits Index, HAS score, VACS index)
• To evaluate the association between frailty and specific HIV-related characteristics (for example known duration of HIV infection), or non-specific factors (such as non- HIV-related diseases or living conditions)
• To evaluate theproportion of subjects with a pejorative event at 60 months of follow-up (recurrent or serious falls, emergency department visit, unscheduled hospitalization, institutionalization, loss of one point on the IADL scale or death)
• To evaluate the association between baseline frailty status and early / long-term pejorative events incidence
• Association between baseline evaluation of frailty and pejorative events incidence during the 60 months of follow-up.
• Transition between frail or non frail status during the 60 months of follow-up
• To assess the prevalence of sarcopenia and osteoporosis

• To describe study population including :

  • Demographic characteristics
  • HIV medical history and antiretroviral therapy
  • Comorbidities, polymedication and evaluation of drug-drug interactions
  • Mental Health, quality of life, socioeconomic status
  • Healthcare use and additional care implementation (nursing, physical therapy, home care services, …)
• Assessment of Inflammatory and Immunosenescence biomarkers at Baseline
• Anthropologic substudy about HIV and polypathologies management
• Focus on COVID-19 with clinical questionnaire, self-administrated questionnaire, SARS CoV2 serology and biobank (serum library)

• Study Type: Interventional
• Enrollment (Actual): 512
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • Service de Maladies Infectieuses, CHU Hôtel-Dieu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient aged 70 years and older
• HIV-1 infection
• Antiretroviral therapy for at least 12 months
• Free and signed informed consent (article L1122-1-1-1 of the French Public Health Code)
• Person affiliated or benefiting from a social security scheme -

Exclusion Criteria:

• Participation in another research study excluding participation in other studies
• Person under legal protection or deprived of liberty by a judicial or administrative decision
• Isolated HIV-2 infection
• Life expectancy of less than 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: single arm; 500 HIV-1 infected patients, aged 70 years and older	Other: Simplified Geriatric Evaluation; Questionnaires; Self assessment questionnaires; Mobility and balance tests; Other: Sampling; - Blood samples : 35 ml will be collected at baseline, after signature of written informed consent, 7 ml at M12

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of frail patients at baseline	Proportion of patients classified as frail according to Fried at Baseline	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of frail subjects at M12, M24, M36, M48 and M60	Proportion of frail subjects at M12, M24, M36, M48 and M60 according to Fried	60 months
Correlation between Baseline frailty status and early pejorative events incidence	Measure of association between frailty status and the existence of adverse health events (composite criterion defined by the existence of severe or repeated falls, use of emergency services, unscheduled hospitalization, institutionalization, loss of 1 point on the ADL scale, or death in the last 12 months)	12 months
Correlation between Baseline frailty status and long terme pejorative events incidence	Measure of association between frailty status and the existence of adverse health events (composite criterion defined by the existence of severe or repeated falls, use of emergency services, unscheduled hospitalization, institutionalization, loss of an ADL score, or death over the entire follow-up period to 60 months)	60 months
Transition between frail and non-frail status during 5 years of follow up	Evolution of the Fragility phenotype with estimation of the number of transitions from fragile to pre-fragile or robust status and the number of transitions from robust and pre-fragile status to fragile status.	60 months
Proportion of frail subjects accoding different frailty scores	Proportion of frail subjects according to different frailty indexes or scores : Fried, Cumulative Health deficits Index, French HAS score, VACS Index	60 months

Collaborators and Investigators

• Sponsor: ANRS, Emerging Infectious Diseases
• Investigators: Principal Investigator: Clotilde ALLAVENA, Infectious Diseases - CHU Nantes- France; Principal Investigator: Laurence MEYER, INSERM CESP - France; Principal Investigator: Hubert BLAIN, Geriatric Department - CHU Montpellier - France; Principal Investigator: Alain MAKINSON, Infectious Diseases - CHU Montpellier- France; Principal Investigator: Laurence SLAMA, Infectious Diseases - Hôtel Dieu Hospital Paris- France

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Actual): June 22, 2021
• Study Completion (Anticipated): June 22, 2024

Study Registration Dates

• First Submitted: May 20, 2019
• First Submitted That Met QC Criteria: May 20, 2019
• First Posted (Actual): May 22, 2019

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 13, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: ANRS EP66 SEPTAVIH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No