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

Culture-Specific Neurodevelopmental Assessment of HIV-affected Children

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.

Study Overview

• Status: Completed
• Conditions: Control; BPG Intervention
• Intervention / Treatment: Behavioral: Cognitive Games Training

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.

• Study Type: Interventional
• Enrollment (Actual): 599
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malawi
  • Blantyre, Malawi
    • Johns Hopkins Research Project
• Uganda
  • Kampala, Uganda
    • Makerere University Johns Hopkins University Research Collaboration

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BPG, Uganda; Children in Uganda randomized to BPG	Behavioral: Cognitive Games Training; Brain Powered Games (BPG) uses games for neurocognitive assessment and training, using images and sounds more familiar to African children. As a computerized cognitive rehabilitation training (CCRT) program designed for Sub-Saharan African school-age children, it can help children infected affected directly or indirectly by HIV. BPG consists of 5 core games evaluating different cognitive abilities (learning, memory, language, attention). Each game includes a visual tutorial, several adjustable settings on the administrative side (Admin), and records game play data for research purposes. Village Builder (VB) is a pro-social reasoning/planning world building strategy type game intended to evaluate frontal lobe executive functions in a culture-friendly and enjoyable game manner. It consists of many of the village artistic components as used in BPG but orchestrated into a village setting where children must gather resources and protect them in order to expand the capacity of the village.; Other Names: Brain Powered Games; Village Builder
No Intervention: Waitlist control, Uganda; Children in Uganda randomized to waitlist control
Experimental: BPG, Malawi; Children in Malawi randomized to BPG	Behavioral: Cognitive Games Training; Brain Powered Games (BPG) uses games for neurocognitive assessment and training, using images and sounds more familiar to African children. As a computerized cognitive rehabilitation training (CCRT) program designed for Sub-Saharan African school-age children, it can help children infected affected directly or indirectly by HIV. BPG consists of 5 core games evaluating different cognitive abilities (learning, memory, language, attention). Each game includes a visual tutorial, several adjustable settings on the administrative side (Admin), and records game play data for research purposes. Village Builder (VB) is a pro-social reasoning/planning world building strategy type game intended to evaluate frontal lobe executive functions in a culture-friendly and enjoyable game manner. It consists of many of the village artistic components as used in BPG but orchestrated into a village setting where children must gather resources and protect them in order to expand the capacity of the village.; Other Names: Brain Powered Games; Village Builder
No Intervention: Waitlist control, Malawi; Children in Malawi randomized to waitlist control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kaufman Assessment Battery for Children 2nd Edition (KABC-II) Mental Processing Index (MPI)	The KABC mental processing index (MPI) is a summary score across domains. The normative mean 100 and standard deviation 15 are based on American norms. Range is 43 to 160. Higher score reflects better outcome.	Month 2, month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test of Variables of Attention (TOVA) Attention Deficit Hyperactivity Disorder (ADHD) Index	TOVA is a computerized visual continuous performance test used in to screen, diagnose and monitor children and adults at risk for ADHD. TOVA consists of the rapid (tachistoscopic) presentation of a large geometric square on the computer screen with a smaller dark box either in the upper position (signal) or lower position (non-signal). The child is asked to press a switch in response to the signal (measuring vigilance attention), but to withhold responding to the non-signal (measuring impulsivity). The potential range of the TOVA ADHD index is from -10 to 10, higher score is better.	Month 2, month 6
Cognitive State (CogState) Correct Moves Per Second	CogState presents a 30-minute session that includes playing cards in a game-like manner to assess memory, attention, discrimination learning, and executive function that is non-language dependent. The number of correct moves per second during maze learning reflects executive functioning/planning. The range is from 0 to 5. Higher number reflects better outcome.	Month 2, month 6

Collaborators and Investigators

• Sponsor: Michigan State University
• Collaborators: Johns Hopkins University; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of Michigan; Kamuzu University of Health Sciences; MU-JHU CARE

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2020
• Primary Completion (Actual): February 29, 2024
• Study Completion (Actual): December 23, 2024

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (Actual): March 18, 2019

Study Record Updates

• Last Update Posted (Actual): April 20, 2025
• Last Update Submitted That Met QC Criteria: March 29, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: cognitive games, attention, memory, learning, reasoning, planning, HIV, African, children
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Urogenital Diseases; Genital Diseases; HIV Infections
• Other Study ID Numbers: 2191; R01HD098027 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual-level data will be made available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No