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

NCT01434563 | Completed

• 1 other identifier: CNS HAND Study
• Study Type: observational
• Target: 326
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

HIV-1-Associated Cognitive Motor Complex

Keywords

HIV; neurocognitive disorder; primary care; HIV negative; HAND; CNS

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients attending Holdsworth House Medical Practice, Sydney, Australia

You may qualify if:

• Documented HIV infection
• Able to participate in study procedures

You may not qualify if:

• 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
• Negative HIV-1 test within 12 months of study entry
• 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.

Sponsors & Collaborators

• Holdsworth House Medical Practice: lead

MeSH Terms

Conditions

AIDS Dementia Complex; Neurocognitive Disorders

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 14, 2011
• First Posted: September 15, 2011
• Study Start: October 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 24, 2012

Record last verified: 2012-10