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

October 22, 2012 updated by: Dr. Mark Bloch, Holdsworth House Medical Practice

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
326

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients attending Holdsworth House Medical Practice, Sydney, Australia

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
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.
Time Frame: 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Holdsworth House Medical Practice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 15, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 24, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CNS HAND Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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