The Prevalence of Neurocognitive Disorder in a Primary Care-based HIV Cohort Compared to a HIV-negative Control Cohort -

Study Overview
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Brief Summary
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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.

Official Title
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The CNS HAND Study: The Prevalence of Neurocognitive Disorder in a Primary Care-based HIV Cohort Compared to a HIV-negative Control Cohort

Conditions
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HIV-1-Associated Cognitive Motor Complex

Participation Criteria
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Eligibility Criteria
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HIV positive Inclusion Criteria: Documented HIV infection Able to participate in study procedures HIV positive Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV positive<br>Subjects must have documented HIV, be english speaking, with life expectancy greater than 6 months, and must have adequate information available in their medical record to apply HAND predictive algorithm (HIV-associated neurological disease) | |
| HIV negative<br>Must have documented negative HIV test within 12 months of study entry, have no traumatic brain injury or history of chronic neurological illness/psychiatric conditions (such as bipolar or depression),be english speaking and have no history of drug or alcohol abuse. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, neurocognitive disorder, primary care, HIV negative, HAND, CNS