Neurodevelopmental Assessment of Children in Uganda and Malawi Using a Software Package

Last updated: March 29, 2025
Sponsor: Michigan State University
Overall Status: Completed

Phase

N/A

Condition

Hiv Infections

Treatment

Cognitive Games Training

Clinical Study ID

NCT03878147
2191
R01HD098027
  • Ages 5-12
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 andMalawi)

Exclusion

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

Study Design

Total Participants: 599
Treatment Group(s): 1
Primary Treatment: Cognitive Games Training
Phase:
Study Start date:
March 30, 2020
Estimated Completion Date:
December 23, 2024

Study 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.

Connect with a study center

  • Johns Hopkins Research Project

    Blantyre,
    Malawi

    Site Not Available

  • Makerere University Johns Hopkins University Research Collaboration

    Kampala,
    Uganda

    Site Not Available

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