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NCT03878147Completed

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

Culture-Specific Neurodevelopmental Assessment of HIV-affected Children

Source: ClinicalTrials.gov · Last updated 20 Apr 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
599 (actual)
First submitted
12 Mar 2019
Start date
30 Mar 2020
Primary completion date
29 Feb 2024
Lead sponsor
Michigan State University
NCT number
NCT03878147

What you commit to

  • Study type: Interventional
  • Participants enrolled: 599
  • From 30 Mar 2020 to the primary completion date, 29 Feb 2024
  • 2 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Medical history of serious birth complications
  • Other known brain injury or disorder requiring hospitalization
  • Seizures or other neurological disabilities

Other

  • Severe malnutrition
  • Bacterial meningitis
  • Encephalitis
  • Cerebral malaria

Who the study is looking for

  • 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)

Age in the registry: 5 years to 12 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Johns Hopkins Research Project
Coordinator of this site? Confirm its status
BlantyreMalawiUnknown status
Makerere University Johns Hopkins University Research Collaboration
Coordinator of this site? Confirm its status
KampalaUgandaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.