Frailty in People Living With HIV Aged 70 Years or More : Screening Feasibility, Prevalence, Risk Factors and Impact on Pejorative Events
试验速览
- 阶段
- 不适用
- 入组人数
- 512
- 试验地点
- 2
- 主要终点
- Proportion of frail patients at baseline
研究概览
简要总结
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
详细描述
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 :
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To assess frequency frailty according to different indexes or scores (Fried, Health deficits Index, HAS score, VACS index)
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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)
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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)
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To evaluate the association between baseline frailty status and early / long-term pejorative events incidence
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Association between baseline evaluation of frailty and pejorative events incidence during the 60 months of follow-up.
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Transition between frail or non frail status during the 60 months of follow-up
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To assess the prevalence of sarcopenia and osteoporosis
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To describe study population including :
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Demographic characteristics
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HIV medical history and antiretroviral therapy
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Comorbidities, polymedication and evaluation of drug-drug interactions
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Mental Health, quality of life, socioeconomic status
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Healthcare use and additional care implementation (nursing, physical therapy, home care services, ...)
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Assessment of Inflammatory and Immunosenescence biomarkers at Baseline
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Anthropologic substudy about HIV and polypathologies management
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Focus on COVID-19 with clinical questionnaire, self-administrated questionnaire, SARS CoV2 serology and biobank (serum library)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 -
排除标准
- •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
结局指标
主要结局
Proportion of frail patients at baseline
时间窗: 12 months
Proportion of patients classified as frail according to Fried at Baseline
次要结局
- Proportion of frail subjects at M12, M24, M36, M48 and M60(60 months)
- Transition between frail and non-frail status during 5 years of follow up(60 months)
- Proportion of frail subjects accoding different frailty scores(60 months)
- Correlation between Baseline frailty status and early pejorative events incidence(12 months)
- Correlation between Baseline frailty status and long terme pejorative events incidence(60 months)