The aim of the study is to explore the prevalence of HAND in people living with hiv.
ID
Source
Brief title
Condition
- Ancillary infectious topics
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Is the prevalence of a positive HAND screening test-outcome with the hiv
dementia scale (less than 14 points is a positive outcome), higher in people
living with hiv, compared to people living with diabetes mellitus tye 2 or
healthy volunteers?
Secondary outcome
Can we identify determinants associated with a positive result on the hiv
dementia scale?
Background summary
HIV can cause various neurocognitive complications, in the literature described
as hiv-associated neurocognitive disorders (HAND). In the beginning of the
aids-epidemic, HAND was an often seen problem, presented as the
aids-dementia-complex. Since the introduction of the combination
Antiretroviral Therapy (cART) the situation has changed, and aids dementia
complex is now seldom seen in treated patients. However, the prevalence of mild
neurocognitive disorders is still present at a high level. There are even
indications that in patients with an undetectable viral load and a good
immunological status, the neurologic damage continues to increase. Because the
possible enormous impact of HAND on the quality of life, adherence and
mortality, it is important to detect/diagnose HAND in an early stage to prevent
further damage and, if possible, to diminish the complains or consequences.
Patients themselves are increasingly worried about neurocognitive problems
leading to more attention for this topic during outpatient visits. In October
2011, the renewed European Aids Clinical Society Guidelines were published in
which routinely screening for HAND is advised. However, this advice is based on
expert opinion and further evidence is urgently needed.
Study objective
The aim of the study is to explore the prevalence of HAND in people living with
hiv.
Study design
A qualitative exploration study with a cross-sectional, observational design.
Study burden and risks
A minimal burden without any risk for the patient.
Heidelberglaan 100
3584 CX Utrecht
Nederland
Heidelberglaan 100
3584 CX Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
Inclusion criteria:
- diagnosis hiv
- 18 years or older
- capable of speaking and reading Dutch
- adequate sight and hearing ability to join the study;Inclusion criteria controlgroup Diabetes mellitus:
- diagnosis DM 2
- 18 years or older
- capable of speaking and reading Dutch
- adequate sight and hearing ability to join the study
- GFR>30;Inclusion criteria controlgroup healthy volunteer:
- 18 years or older
- capable of speaking and reading Dutch
- adequate sight and hearing ability to join the study
Exclusion criteria
Exclusion criteria:
- drugs- and/ or alcohol abuses (in the past two years)
- Diagnosis of depression (current or last year)
- current use of anti-depressive or anti-psychotic medication
- history of learning disabilities, dyslexia or mental retardation
- history of Cardiac Vascular Attack or neuro-syphilis with sustained brain damage
- Vascular diseases (cerebral, cardiac and peripheral)
- (pre)terminal kidney failure, defined as GFR <30
- Pregnancy;Exclusion criteria control group diabetes mellitus:
- drugs- and/ or alcohol abuses (in the past two years)
- Diagnosis of depression (current or last year)
- current use of anti-depressive or anti-psychotic medication
- history of learning disabilities, dyslexia or mental retardation
- history of Cardiac Vascular Attack or neuro-syphilis with sustained brain damage
- Vascular diseases (cerebral, cardiac and peripheral)
- (pre)terminal kidney failure, defined as GFR <30
- symptomatic hypoglycaemia in the past 3 days
- Pregnancy;Exclusion criteria control group of healthy volunteers:
- drugs- and/ or alcohol abuses (in the past two years)
- Diagnosis of depression (current or last year)
- current use of anti-depressive or anti-psychotic medication
- history of learning disabilities, dyslexia or mental retardation
- history of Cardiac Vascular Attack or neuro-syphilis with sustained brain damage
- Vascular diseases (cerebral, cardiac and peripheral)
- (pre)terminal kidney failure, defined as GFR <30
- Pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL38483.041.11 |