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

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

Sponsors

Lead sponsor: Holdsworth House Medical Practice

Source Holdsworth House Medical Practice
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.

Overall Status Completed
Start Date October 2011
Completion Date October 2012
Primary Completion Date October 2012
Study Type Observational
Primary Outcome
Measure Time Frame
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
Enrollment 326
Condition
Eligibility

Sampling method: Non-Probability Sample

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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Verification Date

October 2012

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Holdsworth House Medical Practice

Investigator full name: Dr. Mark Bloch

Investigator title: Doctor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: HIV positive

Description: 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)

Arm group label: HIV negative

Description: 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.

Acronym CNS HAND
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov