None listed
Conditions
Interventions
None listed
Sponsors
National Institute of Allergy and Infectious Diseases NIAID USA
Eligibility
Inclusion criteria
Inclusion criteria: 4.1 Step 1: Inclusion Criteria 4.1.1 Absence of HIV-1 infection, as documented by a negative result of any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit within 30 days of study entry. NOTE: The term ¡§licensed¡¨ refers to a kit that has been certified or licensed by an oversight body within that country and validated internally. 4.1.2 Presented for HIV testing, at any location, within the last 30 days. 4.1.3 Normal developmental history. 4.1.4 Karnofsky performance score ?d 90 within 15 days prior to study entry. 4.1.5 Men and women age ?d 18 years at study entry. 4.1.6 Ability to provide the number of completed years of education. 4.1.7 Ability and willingness of participant to provide informed consent. 4.3 Step 2: Inclusion Criteria 4.3.1 Absence of HIV-1 infection, as documented by a negative result from any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit within 30 days of Step 2 enrollment. NOTE: The term ¡§licensed¡¨ refers to a kit that has been certified or licensed by an oversight body within that country and validated internally. 4.3.2 Completed Step 1 registration, assessments, and evaluations. 4.3.3 Willingness and ability to complete a second visit.
Exclusion criteria
Exclusion criteria: 4.2 Step 1: Exclusion Criteria 4.2.1 Prior antiretroviral therapy. 4.2.2 Current illness that in the opinion of the investigator is likely to have an impact on neurological or neurocognitive functioning. 4.2.3 Current use of medication that in the opinion of the investigator is likely to alter mental status or neurocognitive functioning including, but not limited to, sedative hypnotics, benzodiazepines, opioid analgesics, barbiturates, antipsychotics, or anticholinergics. 4.2.4 History of physical illness or neurological, psychiatric, or developmental disorder that in the opinion of the investigator is likely to have an impact on the participant?s neurocognitive functioning, including, but not limited to, dementia, neurosyphilis, CNS tuberculosis, CNS mass lesions, stroke, epilepsy, head trauma, or transient ischemic attack. 4.2.5 Active drug or alcohol use or dependence that interferes with social interactions, work, or other areas of functioning. 4.2.6 Serious illness requiring systemic treatment and/or hospitalization within 15 days prior to study entry. 4.2.7 Employment at the ACTG research clinic. 4.4 Step 2: Exclusion Criteria 4.4.1 Since Step 1 study visit, physical, neurological, or psychiatric illness, that in the opinion of the investigator is likely to have an impact on the participant?s neurocognitive functioning, including, but not limited to dementia, neurosyphilis, CNS tuberculosis, CNS mass lesions, stroke, epilepsy, head trauma, or transient ischemic attack. 4.4.2 Active drug or alcohol use or dependence that interferes with social interactions, work, or other areas of functioning. 4.4.3 Serious illness requiring systemic treatment and/or hospitalization within 15 days prior to Step 2 entry. 4.4.4 Current use of medication that in the opinion of the investigator is likely to alter mental status or neurocognitive functioning including, but not limited to, sedative hypnotics, benzodiazepines, opioid analgesics, barbiturates, antipsychotics, or anticholinergics. 4.4.5 Employment at the ACTG research clinic.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Responses to neuropsychological tests: Timed Gait Finger Tapping Grooved Pegboard Semantic Verbal Fluency HVTL-R Color Trails 1 (number of seconds to complete) Color Trails 2 (number of seconds to complete) IHDSTimepoint: One day for the 1600 participants who do not enter Step 2; 6 months for 800 Step 2 participants | — |
Secondary
| Measure | Time frame |
|---|---|
| Results of: â?¢ Functional assessment â?¢ Quality of life assessment Timepoint: One day for the 1600 participants who do not enter Step 2; 6 months for 800 Step 2 participants | — |
Countries
Brazil, India, Malawi, Peru, South Africa, Thailand, Zimbabwe
Contacts
Public ContactDr Srikanth Tripathy
National AIDS Research Institute.
Outcome results
None listed