Status:
COMPLETED
Neurodevelopmental Assessment of Children in Uganda and Malawi Using a Software Package
Lead Sponsor:
Michigan State University
Collaborating Sponsors:
University of Michigan
Johns Hopkins University
Conditions:
BPG Intervention
Control
Eligibility:
All Genders
5-12 years
Phase:
NA
Brief Summary
The investigators will use Brain Power Games as a neurocognitive "stress test" or medical "challenge" test, in order to evaluate or improve brain/behavior functional integrity in HIV-affected children...
Detailed Description
We randomize equal numbers of each of three exposure groups of children (perinatally HIV infected, perinatally HIV-exposed but not infected, and unexposed/uninfected children) to one of two interventi...
Eligibility Criteria
Inclusion
- HEU and HUU children at least 5 yrs of age and older from the PROMISE ND study (Uganda and Malawi)
- HIV+ children from P1104s (Uganda and Malawi)
- HUU children age-matched from PROMISE ND and P1104s study cohorts (Uganda and Malawi)
Exclusion
- Medical history of serious birth complications
- Severe malnutrition
- Bacterial meningitis
- Encephalitis
- Cerebral malaria
- Other known brain injury or disorder requiring hospitalization
- Seizures or other neurological disabilities
Key Trial Info
Start Date :
March 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2024
Estimated Enrollment :
599 Patients enrolled
Trial Details
Trial ID
NCT03878147
Start Date
March 30 2020
End Date
December 23 2024
Last Update
April 20 2025
Active Locations (2)
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1
Johns Hopkins Research Project
Blantyre, Malawi
2
Makerere University Johns Hopkins University Research Collaboration
Kampala, Uganda