Men Who Have Sex With Men (MSM) Neurocog 1&2 Study
Condition: HIV Related Neurocognitive Impairment
Study type: Observational

Summary: 
      The treatment of HIV and the tests performed for HIV care have changed over the last 20 years
      but improvement of management of HIV-infected subjects is still warranted. The investigators
      would like to collect and analyse clinical information obtained from subjects who are between
      18 and 50 years of age. The investigators will look at routine clinic information such as
      blood pressure, recent blood test results and clinical history. The investigators will then
      assess cognitive (brain) function by talking and/or written tests. These tests will include
      tests for memory, depression and anxiety.

      All of those who are identified as having problems with their brain function in this way will
      be offered onward referral for further assessment as appropriate. Those taking part will be
      offered a follow up visit at 24-48 weeks after the first assessment to see if there are any
      changes. This will allow us to understand how brain problems develop, get worse, or get
      better over time. No genetic research will be done. Depression is a mental health condition
      that can be characterized by negative feelings, a generally low mood, or problems with eating
      and sleeping normally. Anxiety is also a mental health condition where a person can feel
      general anxiousness or fear of specific situations, or, in more serious cases, can have panic
      attacks. Impaired brain function is a condition of the nervous system or brain where the
      brain does not function as well as it normally should, and can include symptoms such as
      forgetfulness, doing everyday tasks more slowly or becoming disorientated to the time of day
      or the place one is in.

      For this study, the investigators will also collect data from medical records, including (and
      if known)social and educational-related data, HIV infection-related data (e.g. date of
      diagnosis, blood test results), relevant medical history (e.g. previous psychiatric
      conditions) and medication used (e.g. date started, the drugs used).

      The information the investigators will get from this study will be used to inform healthcare
      providers (doctor, nurse, health advisor, psychologist) on whether it is necessary to
      routinely assess HIV infected patients for the presence of anxiety/depression and impaired
      brain function. The investigators will also get information on whether the treatments used
      for HIV infection make a difference to how commonly these conditions occur in patients.
    

Detailed description: 
      The aim of this project is to examine neurocognitive functioning in HIV infected men who have
      sex with men (MSMs). We have limited our study to this group in order to better study other
      shared risk factors (hepatitis coinfection, recreational drug use). Given ongoing work in an
      older cohort our aim is to study neurocognitive impairment in younger subjects (18-49 years).
      There are two parts to this study. The first is a cross sectional pilot (MSM Neurocog-1)
      looking at neurocognitive function in HIV infected and HIV uninfected MSMs. The second plan
      is for a prospective 48 week cohort study 24-48 week study (MSM Neurocog-2) following
      neurocognitive function in HIV infected subjects and a group of HIV uninfected controls over
      time.

      The shift in HIV care to that of a chronic, manageable condition has transferred focus to
      long-term morbidities and drug toxicities. One such area in which there is renewed interest
      is the prevalence and relevance of neurocognitive impairment, as well as the significance of
      compartmentalised virus in the CSF as compared to blood. Controlled, comparative data are
      lacking - many of the cross-sectional studies to date have not controlled for important
      confounders such as recreational and injecting drug use, current or prior co-infections or
      co-morbidities. Where this has happened, researchers generally use general population
      controls that may differ markedly from HIV-infected individuals in terms of lifestyle and
      demographic factors. In addition the paucity of longitudinal data means it is unclear whether
      an individual with normal neurocognitive function pre-ART will develop impairment later or if
      subjects with evidence of impairment can expect improvement or normalisation over time; these
      issues are highly important for clinical management and patient counselling. There is no
      consensus on which surrogate markers, if any, are important in terms of diagnosing,
      monitoring and/or predicting neurocognitive impairment. Studies measuring correlation between
      neurocognitive performance and neuronal markers of inflammation have been conflicting.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HIV infected and uninfected MSM 18-50 years old
      
Keywords: HIV; Neurocognitive