Frailty in People Living With HIV Aged 70 Years or More

Not Applicable

• Conditions: HIV Infections
• Interventions: Other: Simplified Geriatric Evaluation; Other: Sampling

• Registration Number: NCT03958786
• Lead Sponsor: ANRS, Emerging Infectious Diseases

Brief Summary

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

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 Timeline

• Study Start: 2019-05-15
• Study First Submitted: 2019-05-20
• Study First Submitted QC: 2019-05-20
• Study First Posted: 2019-05-22
• Primary Completion: 2021-06-22
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-13
• Last Update Posted: 2022-05-17
• Study Completion: 2024-06-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 512

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm	Sampling	500 HIV-1 infected patients, aged 70 years and older
single arm	Simplified Geriatric Evaluation	500 HIV-1 infected patients, aged 70 years and older

Primary Outcome Measures

Name	Time	Method
Proportion of frail patients at baseline	12 months	Proportion of patients classified as frail according to Fried at Baseline

Secondary Outcome Measures

Name	Time	Method
Proportion of frail subjects at M12, M24, M36, M48 and M60	60 months	Proportion of frail subjects at M12, M24, M36, M48 and M60 according to Fried
Transition between frail and non-frail status during 5 years of follow up	60 months	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.
Proportion of frail subjects accoding different frailty scores	60 months	Proportion of frail subjects according to different frailty indexes or scores : Fried, Cumulative Health deficits Index, French HAS score, VACS Index
Correlation between Baseline frailty status and early pejorative events incidence	12 months	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)
Correlation between Baseline frailty status and long terme pejorative events incidence	60 months	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)

Trial Locations

Locations (1)

Service de Maladies Infectieuses, CHU Hôtel-Dieu; 🇫🇷 Nantes, France