临床试验/NCT05678660

NCT05678660进行中（未招募）不适用

Study of Neurological Aging Among People Living With HIV (SNAP)

University of Rochester3 个研究点分布在 1 个国家目标入组 298 人开始时间: 2022年7月6日最近更新: 2026年5月29日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: University of Rochester
入组人数: 298
试验地点: 3
主要终点: Frailty assessment - Body mass index-baseline/during enrollment

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A prospective, exposure-control cohort study of older adults living with HIV comparing the neurological status of those who have had HIV infection for a longer period of time (long HIV group) to age, gender, and community-matched comparison group who have had HIV infection for a shorter period of time (short HIV group).

详细描述

There is a substantial body of evidence that individuals with long-standing HIV infection experience accelerated neurological aging and prospective lifespan studies that incorporate neuropsychological and imaging outcomes are needed. Elevated risks of cerebrovascular disease are evident throughout the life course of persons living with HIV. Stroke risks are clearly increased in the first few months after antiretroviral initiation. Autopsy studies of adults with HIV 24-48 years of age showed all have vascular changes, specifically lymphocytic perivascular infiltration, thickening of arterial and arteriolar walls, widened perivascular space, hypertrophy of the vascular muscle layers and perivascular amyloid deposition. Even when excluding individuals with a history of stroke, cerebrovascular disease risk factors are associated with decreased cognitive capacity in persons with HIV. Basal ganglia enhancement on MRI indicative of decreased regional cerebral blood flow and blood brain barrier breakdown is associated with HIV dementia.

HIV-associated neurocognitive disorder is another manifestation of accelerated aging. Using diffusion tensor imaging and data from healthy controls to calculate an "brain age gaps" in individuals with HIV infection, the "brain age gap", is associated with plasma viral load and cognitive function. In an autopsy study comparing HIV+ persons age 36-60 years with age-matched controls, HIV showed increased amyloid beta immunostaining. The accumulation of these proteins may be one possible mechanisms of accelerated aging in HIV. Some have proposed that BBB breakdown secondary to vascular dysfunction may contribute to this deposition. Distal sensory polyneuropathy (DSPN), a common neurological comorbidity in HIV that also increases in frequency with age in HIV negative individuals. Despite extensive diagnostic evaluations, ~40% of people with a DSPN will have no clear underlying cause identified. DSPN is more common and complex in African population with additional underlying etiologies being medication toxicities and nutritional deficiencies.In the RAAZ study, investigators identified a high prevalence of DSPN among HIV infected individuals prior to ART initiation which is associated with low body mass index and food insecurity. More recent neuropathy studies have shown that folate deficiency may play a role in DSPN in Zambia with HIV+ individuals being especially susceptible. Epilepsy incidence shows a bimodal age distribution with the increased incidence of seizures and epilepsy in the elderly attributed to the increase of age-related and aging-related epileptogenic conditions. While the overall prevalence of epilepsy can be expected to increase with advanced age in HIV, identifying risk factors for this among persons for epilepsy among those with controlled systemic disease may offer important insights into the pathophysiology.

HIV-associated accelerated aging of the nervous system is thought to be related to ongoing low grade inflammation in the setting of treated HIV. Poor CNS penetration of some antiretroviral therapies (ARVs) has also been proposed as one problem contributing to neurological morbidity in systemically controlled HIV. ARV neurotoxicity is also important. Multiple studies have highlighted both the short and long term neurotoxicity of efavirenz. Darunavir and ritonavir may increase the risk of aging-related cerebral degeneration. Heneka 2020 proposed that COVID survivors may be at increased risk of neurological disorders due to direct negative effects of SARS-CoV-2, acceleration of pre-existing problems or de novo induction of neurodegenerative process. Poor complex motor performance in persons with HIV is associated with higher inflammatory burden. A recent report from Ghana found stroke admissions and mortality rates have increased since SARS-CoV-2's arrival.

In the SNAP Study, the investigators will utilize the existing consortia of neuro-HIV rural study sites to enroll 150 HIV+ adults >45 years of age stable on ARVs for at least 7 years and an age, gender, and community-matched comparison group of HIV+ adults stable on ARVs for 1-2 years. These individuals will undergo annual assessments for 6 years to evaluate their general and neurological health and the aging process that evolves during the 6 years of assessments.

Understanding whether or not PLWH experience accelerated aging of the nervous system will provide critical insights for health services planning as antiretroviral therapies allow PLWH to live into middle and late years. Identifying risk factors for specific neurologic aging issues will guide clinical care and screening and may inform regarding the pathophysiological mechanisms involved including the possibility that some therapies contribute to the long-term neurotoxicity of the condition.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 45 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•For the short group, stable on ART for 1 year, but no more than 2 years.
•For long group, on ART for 7 or more years

排除标准

•Acute medical illness.
•Decisional impairment precluding informed consent as noted by clinicians providing care to the patient or by the research staff team members.
•Communication impairments-unable to hear or unable to speak.
•Being unable to communicate in English or in the dominant language at the study site (Tonga).

结局指标

主要结局

Frailty assessment - Body mass index-baseline/during enrollment

时间窗: Baseline/during enrollment

Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the Body Mass Index (BMI) in kilograms(kg). With the following interpretation below 18.5 - underweight range. between 18.5 and 24.9 - healthy weight range. between 25 and 29.9 - overweight range. between 30 and 39.9 - obese range.

Frailty assessment - Body mass index- on year 1 of evaluation

时间窗: Year 1 of evaluation

Frailty assessment - Body mass index- on year 4 of evaluation

时间窗: Year 4 of evaluation

Frailty assessment - on year 2 of evaluation

时间窗: Year 2 of evaluation

Frailty assessment - Body mass index- on year 3 of evaluation

时间窗: Year 3 of evaluation

Cognition - Zambian Mini-Mental Status Examination (zMMSE) - During enrollment

时间窗: baseline/during enrollment

The zMMSE is an adaptation of the well-known MMSE which provides single summary score with a maximum of 30 points

Cognition - Zambian Mini-Mental Status Examination (zMMSE) - on Year 1 of evaluation

时间窗: Year 1 evaluation

The zMMSE is an adaptation of the well-known MMSE which provides single summary score with a maximum of 30 points

Cognition - Zambian Mini-Mental Status Examination (zMMSE) - on Year 2 of evaluation

时间窗: Year 2 evaluation

The zMMSE is an adaptation of the well-known MMSE which provides single summary score with a maximum of 30 points

Cognition - International HIV Dementia Scale (I-HDS) - on Year 3 of evaluation

时间窗: Year 3 evaluation

The IHDS assesses registration, recall, motor speed and psychomotor speed and provides a single summary score of a maximum of 12 points

Cognition - International HIV Dementia Scale (I-HDS)- on Year 4 of evaluation

时间窗: Year 4 evaluations

The IHDS assesses registration, recall, motor speed and psychomotor speed and provides a single summary score of a maximum of 12 points

Cognition - International HIV Dementia Scale (I-HDS) - on Year 5 of evaluation

时间窗: Year 5 evaluation

The IHDS assesses registration, recall, motor speed and psychomotor speed and provides a single summary score of a maximum of 12 points

Cognition - International HIV Dementia Scale (I-HDS)- on Year 6 of evaluation

时间窗: Year 6 evaluation

The IHDS assesses registration, recall, motor speed and psychomotor speed and provides a single summary score of a maximum of 12 points

Mental Health - The Alcohol Use Disorders Identification Test (AUDIT) -Baseline/during enrollment

时间窗: Baseline/during enrollment

The Alcohol Use Disorders Identification Test (AUDIT) is an alcohol screening instrument for patient self reporting. This 10-item alcohol screen helps identify persons who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence). A score of 1 to 7 =low-risk consumption; 8 to 14 suggest harmful alcohol consumption, and ≥15 moderate-severe alcohol use disorder with a total score of 40.

Mental Health - The Alcohol Use Disorders Identification Test (AUDIT) - on Year 1 of enrollment

时间窗: Year 1 evaluation

Mental Health - The Alcohol Use Disorders Identification Test (AUDIT)- on year 2 of evaluation

时间窗: Year 2 evaluation

Mental Health - The Alcohol Use Disorders Identification Test (AUDIT) - on year 3 of evaluation

时间窗: Year 3 evaluation

Mental Health - Center for Epidemiologic Studies Depression Scale (CES-D)- on year 4 of evaluation

时间窗: Year 4 evaluation

is a 7-item screen with a total score for the seven items ranging from 0 to 21. In most populations, 0-4: minimal anxiety / 5-9: mild anxiety / 10-14: moderate anxiety/ 15-21: severe anxiety.

Mental Health - Center for Epidemiologic Studies Depression Scale (CES-D)- on year 5 of evaluation

时间窗: Year 5 evaluation

is a 7-item screen with a total score for the seven items ranging from 0 to 21. In most populations, 0-4: minimal anxiety / 5-9: mild anxiety / 10-14: moderate anxiety/ 15-21: severe anxiety.

Mental Health - Center for Epidemiologic Studies Depression Scale (CES-D)- on year 6 of evaluation

时间窗: Year 6 evaluation

is a 7-item screen with a total score for the seven items ranging from 0 to 21. In most populations, 0-4: minimal anxiety / 5-9: mild anxiety / 10-14: moderate anxiety/ 15-21: severe anxiety.

Mental Health - The Generalized Anxiety Disorders Screen (GAD-7)- baseline/during enrollment

时间窗: Baseline/during enrollment

General Anxiety Disorder-7 (GAD-7). GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. The higher the score, the more severe the anxiety.

Mental Health - The Generalized Anxiety Disorders Screen (GAD-7)- on year 1 of evaluation

时间窗: Year 1 evaluation

Mental Health - The Generalized Anxiety Disorders Screen (GAD-7)- on year 2 of evaluation

时间窗: Year 2 evaluation

Mental Health - The Generalized Anxiety Disorders Screen (GAD-7)- on year 3 of evaluation

时间窗: Year 3 evaluation

Mental Health - The Generalized Anxiety Disorders Screen (GAD-7)- on year 4 of evaluation

时间窗: Year 4 evaluation

Mental Health - The Generalized Anxiety Disorders Screen (GAD-7)- on year 5 of evaluation

时间窗: Year 5 evaluation

Mental Health - The Generalized Anxiety Disorders Screen (GAD-7)- on year 6 of evaluation

时间窗: Year 6 evaluation

Mental Health - An adaptation of the Harvard Trauma Questionnaire (HTQ)-baseline/during enrolment

时间窗: Baseline/during enrollment

Includes 10 traumatic events yielding a score of 0-10 and then 40 follow-up questions regarding post traumatic symptoms that will be delivered only to individuals scoring at least 1 on the initial 10 questions. The post traumatic symptom score will range is from 0-120.

Mental Health - An adaptation of the Harvard Trauma Questionnaire (HTQ)- on year 1 of enrolment

时间窗: Year 1 evaluation

Mental Health - An adaptation of the Harvard Trauma Questionnaire (HTQ)- on year 1 of evaluation

时间窗: Year 2 evaluation

Mental Health - An adaptation of the Harvard Trauma Questionnaire (HTQ)- on year 3 of evaluation

时间窗: Year 3 evaluation

Mental Health - An adaptation of the Harvard Trauma Questionnaire (HTQ)- on year 4 of evaluation

时间窗: Year 4 evaluation

Mental Health - An adaptation of the Harvard Trauma Questionnaire (HTQ)- on year 5 of evaluation

时间窗: Year 5 evaluation

Mental Health - An adaptation of the Harvard Trauma Questionnaire (HTQ) - on year 6 of evaluation

时间窗: Year 6 evaluation

Frailty assessment - Body weight - baseline/during enrollment

时间窗: Baseline/during enrollment

Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the following measurement: Body weight in kilograms (kg).

Frailty assessment - Body weight - on year 1 of evaluation.

时间窗: Year 1 evaluation

Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the following measurements: Body Weight in kilograms (kg)

Frailty assessment - Body weight- on year 2 of evaluation

时间窗: Year 2 evaluation

Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the following measurements: Body Weight in kilograms (kg)

Frailty assessment - Body weight - on year 3 of evaluation

时间窗: Year 3 evaluation

Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the following measurements: Body Weight, Body Fat, Body Muscle, and the Body Mass Index (BMI).

Frailty assessment - Body weight on year 4 of evaluation

时间窗: Year 4 evaluation

Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the following measurements: Body Weight in kilograms(kg)

Frailty assessment - Body weight - on year 5

时间窗: Year 5 evaluation

Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the following measurements: Body Weight, Body Fat, Body Muscle, and the Body Mass Index (BMI).

Frailty assessment - Body weight - on year 6 of evaluation

时间窗: Year 6 evaluation

Body composition describes percentages of fat, bone, and muscle in the human body. Body composition also represents a more accurate description of weight and provides a better understanding of the overall health of an individual. Measuring body composition is part of the frailty assessment. The smart scale will be used to capture a full body composition analysis, which includes the following measurements: Body Weight in kilograms(kg).

Frailty assessment - Body height- baseline/during enrollment

时间窗: Baseline/during enrollment

Frailty assessment - Body height- on year 1 of evaluation

时间窗: Year 1 of evaluation

Frailty assessment - Body height- on year 2 of evaluation

时间窗: Year 2 of evaluation

Frailty assessment - Body height- on year 3 of evaluation

时间窗: Year 3 of evaluation

Frailty assessment - Body height- on year 4 of evaluation

时间窗: Year 4 of evaluation

Frailty assessment - Body height- on year 5 of evaluation

时间窗: Year 5 of evaluation

Frailty assessment - Body height- on year 6 of evaluation

时间窗: Year 6 of evaluation

Frailty assessment - Body mass index- on year 5 of evaluation

时间窗: Year 5 of evaluation

Frailty assessment - Body mass index- on year 6 of evaluation

时间窗: Year 6 of evaluation

Frailty assessments - Grip strength - on year 1 of evaluation

时间窗: Year 1 evaluation

Grip strength will be assessed by dynamometry against international norms for age and SNAP\_Protocol\_V2.3\_14June22 Page 7 of 12 Version Date: 2.3 14June22 gender and will be classified as weak, normal or strong.

Frailty assessments - Grip strength- on year 3 of evaluation

时间窗: Year 3 evaluation

Frailty assessments - Grip strength- on year 4 of evaluation

时间窗: Year 4 evaluation

Frail assessment - Physical Activity- on year 6 of evaluation

时间窗: Year 6 evaluation

Physical activity will be scored from 0-100 based upon will be determined based upon self-report in response to a list of items of commonly undertaken activities in this population.

Frailty assessments - Grip strength-on year 5 of evaluation

时间窗: Year 5 evaluation

Frail assessment - Physical Activity- baseline/during enrollment

时间窗: Baseline

Physical activity will be scored from 0-100 based upon will be determined based upon self-report in response to a list of items of commonly undertaken activities in this population.

Frail assessment - Physical Activity- on year 1 of evaluation

时间窗: Year 1 evaluation

Physical activity will be scored from 0-100 based upon will be determined based upon self-report in response to a list of items of commonly undertaken activities in this population.

Frail assessment - Physical Activity- on year 2 of evaluation

时间窗: Year 2 evaluation

Physical activity will be scored from 0-100 based upon will be determined based upon self-report in response to a list of items of commonly undertaken activities in this population.

Frail assessment - Physical Activity- on year 3 of evaluation

时间窗: Year 3 evaluation

Physical activity will be scored from 0-100 based upon will be determined based upon self-report in response to a list of items of commonly undertaken activities in this population.

Frail assessment - Physical Activity- on year 4 of evaluation

时间窗: Year 4 evaluation

Physical activity will be scored from 0-100 based upon will be determined based upon self-report in response to a list of items of commonly undertaken activities in this population.

Frail assessment - Physical Activity- on year 5 of evaluation

时间窗: Year 5 evaluation

Physical activity will be scored from 0-100 based upon will be determined based upon self-report in response to a list of items of commonly undertaken activities in this population.

Frail assessment - Time Gait- baseline/during enrollment

时间窗: baseline

Gait speed is based upon a 15-foot times gait. Normative walking speeds are not available in this population, but decline over time (in the same participant) and comparison within the matched pair will be used to determine slowed gait.

Frail assessment - Time Gait- on year 1 of evaluation

时间窗: Year 1 evaluation

Frail assessment - Time Gait- on year 2 of evaluation

时间窗: Year 2 evaluation

Frail assessment - Time Gaiton year 3 of evaluation

时间窗: Year 3 evaluation

Frail assessment - Time Gait- on year 4 of evaluation

时间窗: Year 4 evaluation

Frail assessment - Time Gait- on year 5 of evaluation

时间窗: Year 5 evaluation

Frail assessment - Time Gait- on year 6 of evaluation

时间窗: Year 6 evaluation

Peripheral nerve health - Brief Peripheral Neuropathy (BPNS)- baseline/during enrollment

时间窗: baseline/ during enrollment