NCT03958786

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 512 (actual)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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)

Conditions

• HIV Infections

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-05-15
• Primary completion: 2021-06-22
• Completion: 2024-06-22
• First posted: 2019-05-22
• Last updated: 2022-05-17

Locations

1 site across 1 country: France