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:
Holdsworth House Medical Practice
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
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Purpose
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 |
|---|
|
HIV-1-Associated Cognitive Motor Complex |
| Study Type: | Observational |
| 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:
Further study details as provided by 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 ] [ 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.
| Enrollment: | 326 |
| Study Start Date: | October 2011 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients attending Holdsworth House Medical Practice, Sydney, Australia
Criteria
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.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Dr. Mark Bloch, Doctor, Holdsworth House Medical Practice |
| ClinicalTrials.gov Identifier: | NCT01434563 History of Changes |
| Other Study ID Numbers: | CNS HAND Study |
| Study First Received: | September 14, 2011 |
| Last Updated: | October 22, 2012 |
| Health Authority: | Australia: National Health and Medical Research Council |
Keywords provided by Holdsworth House Medical Practice:
|
HIV neurocognitive disorder primary care |
HIV negative HAND CNS |
Additional relevant MeSH terms:
|
AIDS Dementia Complex HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Immunologic Deficiency Syndromes Immune System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on March 05, 2013
