The Prevalence of Neurocognitive Disorder in a Primary Care-based HIV Cohort Compared to a HIV-negative Control Cohort - (CNS HAND)
This study has been completed.
Holdsworth House Medical Practice
First Posted: September 15, 2011
Last Update Posted: October 24, 2012
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.
|HIV-1-Associated Cognitive Motor Complex|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Dr. Mark Bloch, Holdsworth House Medical Practice:
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.
|Study Start Date:||October 2011|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
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.
Contacts and Locations
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