The CNS HAND Study: The Prevalence of Neurocognitive Disorder in a Primary Care-based HIV Cohort Compared to a HIV-negative Control Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 326
- 主要终点
- The primary outcome measure is percentage of patients with abnormal (-1.5 SD in 2 domains) CogState battery in HIV positive patients vs HIV negative patients.
研究概览
简要总结
To determine the prevalence of HIV associated Neurological Disorder (HAND) in a population of HIV positive patients within a primary care setting compared with the HIV negative population. The investigators aim is to assess the use of optimal screening methods to assess HAND. For this the investigators will be comparing the performance of a group of persons who are HIV positive and a group of persons who are HIV negative to test their memory and concentration abilities over-time.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Documented HIV infection
- •Able to participate in study procedures
- •HIV positive
排除标准
- •Inability to comprehend or read English (as established by the English proficiency questionnaire)
- •Drug or alcohol intoxicated (as determined by the investigator)
- •Lack of information in medical records to determine the HAND predictive algorithm (current CD4 count, past CNS HIV-related disease, and duration of HIV therapy)
- •Life expectancy <6 months
- •Inability to attend the clinic for required study follow up visits
- •HIV-negative Inclusion Criteria:
- •Negative HIV-1 test within 12 months of study entry
- •HIV-negative Exclusion Criteria:
- •Life time traumatic brain injury leading to loss of consciousness of at least 30 minutes.
- •Inability to comprehend or read English (as established by the English proficiency questionnaire).
- •Inability to attend the clinic for required study follow up visits.
- •History of chronic neurological illness.
- •Unstable psychiatric conditions such as bipolar disorder or depression.
- •Individuals with psychiatric disorder on the psychotic axis.
- •Active or past (within the last 6 months) severe alcohol or substance abuse sufficient, in the investigator's judgement, to prevent completion of tests or Inability to attend for the planned required study follow up visits.
结局指标
主要结局
The primary outcome measure is percentage of patients with abnormal (-1.5 SD in 2 domains) CogState battery in HIV positive patients vs HIV negative patients.
时间窗: 12 months
The primary outcome measure is percentage of patients with abnormal (-1.5 SD in 2 domains) CogState battery in HIV positive patients vs HIV negative patients.
次要结局
未报告次要终点
研究者
Dr. Mark Bloch
Doctor
Holdsworth House Medical Practice