The Prevalence of Neurocognitive Disorder in a Primary Care-based HIV Cohort Compared to a HIV-negative Control Cohort - (CNS HAND)
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|ClinicalTrials.gov Identifier: NCT01434563|
Recruitment Status : Completed
First Posted : September 15, 2011
Last Update Posted : October 24, 2012
Holdsworth House Medical Practice
Information provided by (Responsible Party):
Dr. Mark Bloch, Holdsworth House Medical Practice
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.
|Condition or disease|
|HIV-1-Associated Cognitive Motor Complex|
|Study Type :||Observational|
|Actual Enrollment :||326 participants|
|Official Title:||The CNS HAND Study: The Prevalence of Neurocognitive Disorder in a Primary Care-based HIV Cohort Compared to a HIV-negative Control Cohort|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
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)
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.
Primary Outcome Measures :
- 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. [ Time Frame: 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.
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