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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01434563

Acronym

CNS HAND

Enrollment

326

Registered

2011-09-15

Start date

2011-10-31

Completion date

2012-10-31

Last updated

2012-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1-Associated Cognitive Motor Complex

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
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	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.

Outcome results