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.
Sponsor:
Information provided by (Responsible Party):
Dr. Mark Bloch, Holdsworth House Medical Practice
ClinicalTrials.gov Identifier:
NCT01434563
First received: September 14, 2011
Last updated: October 22, 2012
Last verified: October 2012

September 14, 2011
October 22, 2012
October 2011
October 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01434563 on ClinicalTrials.gov Archive Site
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The Prevalence of Neurocognitive Disorder in a Primary Care-based HIV Cohort Compared to a HIV-negative Control Cohort -
The CNS HAND Study: The Prevalence of Neurocognitive Disorder in a Primary Care-based HIV Cohort Compared to a HIV-negative Control Cohort

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients attending Holdsworth House Medical Practice, Sydney, Australia

HIV-1-Associated Cognitive Motor Complex
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  • HIV positive
    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
    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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
326
October 2012
October 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT01434563
CNS HAND Study
No
Dr. Mark Bloch, Holdsworth House Medical Practice
Holdsworth House Medical Practice
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Holdsworth House Medical Practice
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP