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

Holdsworth House Medical Practice

Status: Completed

Conditions: HIV-1-Associated Cognitive Motor Complex

Study type: Observational

Funder types: Other

Identifiers

NCT01434563

CNS HAND Study

Details and patient eligibility

About

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.

Enrollment: 326 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

326 participants in 2 patient groups

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)

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.