HYPOTHESIS AND STUDY OBJECTIVES
Hypothesis: Data from this study will aid in the interpretation of neurocognitive data from other studies collecting neurocognitive data in these settings. No hypothesis is being tested
Primary Objective: To collect comparative neuropsychological data in healthy controls to aid in the interpretation of neuropsychological tests in resource-limited settings.
Secondary Objectives: To describe the distribution of neuropsychological scores in neurologically healthy HIV-seronegative individuals in resource-limited settings. And to estimate practice/learning effects associated with repeated neuropsychological assessment in resource-limited settings.
SITES PARTICIPATING IN THE A5271 STUDY:
- Rio de Janeiro, Brazil (12101)
- Chennai, India (11701)
- Pune, India (11601)
- Blantyre, Malawi (30301)
- Lilongwe, Malawi (12001)
- Lima, Peru (11301 and 11302, enrolling as one site)
- Johannesburg, South Africa (11101)
- Durban, South Africa (11201)
- Chiang Mai, Thailand (11501)
- Harare, Zimbabwe (30313)
DESIGN: A two-step prospective, observational, multinational study to collect comparative neurocognitive data for application to other studies. Neurologically healthy HIV-seronegative individuals from resource-limited settings will be enrolled. Participants will have a baseline neuropsychological assessment performed, and a subset of participants will have a second visit in 6 months.
DURATION: One day for the 1600 participants who do not enter Step 2; 6 months for 800 Step 2 participants.
SAMPLE SIZE: 2400 men and women ≥ 18 years of age.
POPULATION: All participants will be determined as neurologically healthy HIV-seronegative individuals on the basis of a detailed medical history.
STRATIFICATION: Eighty (80) strata will be utilized, defined by site (10 levels), sex (2 levels), age (2 levels), and years of education (2 levels). Each of 10 sites will enroll 30 participants in each of eight strata as defined below:
- Male, age <35 years, <10 years of education
- Male, age <35 years, ≥ 10 years of education
- Male, age ≥35 years, <10 years of education
- Male, age ≥35 years, ≥ 10 years of education
- Female, age <35 years, <10 years of education
- Female, age <35 years, ≥ 10 years of education
- Female, age ≥35 years, <10 years of education
- Female, age ≥35 years, ≥ 10 years of education
STEP 1: At Step 1, study participants will be offered the option of a single 6-month follow-up visit.
STEP 2: Participants who have elected to complete a follow-up visit (800 total participants comprising 10 from each stratum) will be registered to Step 2 and return for a second/final study visit in 6 months.