Clinical trial NCT03878147: Neurodevelopmental Assessment of Children in Uganda and Malawi Using a Software Package
Official title: Culture-Specific Neurodevelopmental Assessment of HIV-affected Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: BPG Intervention
Control
Keywords: cognitive games, attention, memory, learning, reasoning, planning, HIV, African, children
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: Johns Hopkins University
name: MU-JHU CARE
name: Kamuzu University of Health Sciences
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-03-18
Enrollment: 599
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The subject population for this proposal will consist of 600 children roughly equally divided between males and females and between HIV exposed uninfected and HIV unexposed and uninfected. These are Ugandan and Malawian children 5-12 years of age at study initiation who live in Uganda or Malawi.
Primary purpose: DIAGNOSTIC

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. This dual use of BPG is a key innovative feature. Each of the 5 core BPG games lasts 10 minutes and trains fine motor, monitoring/attention, visual/auditory working memory, spatial navigational learning.

The investigator's central hypothesis is that the BPG performance gains will be improved compared to waitlist control for children in Uganda and Malawi.

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 intervention arms. They are randomized to either the Brain Powered Games (BPG) intervention arm of 12 sessions of hour-long training (twice a day for several days weekly at the study clinic), or to the "wait-listed" arm of no BPG training sessions.

Separate analyses by country (Uganda and Malawi) are planned. HIV exposure status is used for balancing of randomization.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Kaufman Assessment Battery for Children 2nd Edition (KABC-II) Mental Processing Index (MPI)
timeFrame: Month 2, month 6
Secondary outcomes:
measure: Test of Variables of Attention (TOVA) Attention Deficit Hyperactivity Disorder (ADHD) Index
timeFrame: Month 2, month 6
measure: Cognitive State (CogState) Correct Moves Per Second
timeFrame: Month 2, month 6
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: Johns Hopkins Research Project
city: Kampala
country: Uganda
facility: Makerere University Johns Hopkins University Research Collaboration
Study officials:
References: