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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

326 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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HIV-1-Associated Cognitive Motor Complex

Keywords

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HIV neurocognitive disorder primary care HIV negative HAND CNS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Documented HIV infection
* Able to participate in study procedures

* Negative HIV-1 test within 12 months of study entry

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

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Dr. Mark Bloch

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Countries

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Australia

Other Identifiers

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CNS HAND Study

Identifier Type: -

Identifier Source: org_study_id