BPG InterventionNCT03878147
Neurodevelopmental Assessment of Children in Uganda and Malawi Using a Software Package
A study testing Cognitive Games Training in people with BPG Intervention and Control, run by Michigan State University at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- BPG Intervention, Control
- What is being tested?
- Cognitive Games Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 599 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 Mar 2020to 23 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Uganda1 site
Makerere University Johns Hopkins University Research Collaboration
Kampala
About this study
Official title: 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.
Read the 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.
- Conditions
- BPG Intervention, Control
- Being tested
- Cognitive Games Training
- Keywords
- cognitive games, attention, memory, learning, reasoning, planning, HIV, African, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Games TrainingBehavioural
Also called Brain Powered Games, Village Builder
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.
| Study group | Role | What they receive |
|---|---|---|
| BPG, Uganda | Experimental | Children in Uganda randomized to BPG Receives: Behavioral: Cognitive Games Training |
| Waitlist control, Uganda | No intervention | Children in Uganda randomized to waitlist control |
| BPG, Malawi | Experimental | Children in Malawi randomized to BPG Receives: Behavioral: Cognitive Games Training |
| Waitlist control, Malawi | No intervention | Children in Malawi randomized to waitlist control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 2, month 6
Secondary outcomes (2)
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.
Measured: 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.
Measured: Month 2, month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start30 Mar 2020
- Primary completion29 Feb 2024
- Study completion23 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BPG InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 599 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, Johns Hopkins University, MU-JHU CARE, Kamuzu University of Health Sciences, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Michael J. Boivin, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878147
- Sponsor's protocol ID
- 2191
- Other IDs
- R01HD098027
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2019
- Last updated
- 20 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual-level data will be made available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culture-Specific Neurodevelopmental Assessment of HIV-affected Children
- ClinicalTrials.gov ID
- NCT03878147
- Acronym / sponsor ID
- 2191
- Conditions
- BPG Intervention, Control
- Keywords
- cognitive games, attention, memory, learning, reasoning, planning, HIV, African, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 599 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- University of Michigan, Johns Hopkins University, MU-JHU CARE, Kamuzu University of Health Sciences, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 23 Dec 2024 (actual)
- First posted
- 18 Mar 2019 (actual)
- Results
- Posted 20 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| BPG, Uganda | Experimental | Behavioral: Cognitive Games TrainingChildren in Uganda randomized to BPG |
| Waitlist control, Uganda | No intervention | –Children in Uganda randomized to waitlist control |
| BPG, Malawi | Experimental | Behavioral: Cognitive Games TrainingChildren in Malawi randomized to BPG |
| Waitlist control, Malawi | No intervention | –Children in Malawi randomized to waitlist control |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- Medical history of serious birth complications
- Severe malnutrition
- Bacterial meningitis
- Encephalitis
- Cerebral malaria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Games TrainingAlso: Brain Powered Games, Village BuilderBrain 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. | Behavioural | BPG, Malawi, BPG, Uganda |
Primary outcome
Kaufman Assessment Battery for Children 2nd Edition (KABC-II) Mental Processing Index (MPI)
Time frame: Month 2, month 6
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.
2 secondary outcomes
Test of Variables of Attention (TOVA) Attention Deficit Hyperactivity Disorder (ADHD) Index
Time frame: Month 2, month 6
Cognitive State (CogState) Correct Moves Per Second
Time frame: Month 2, month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No individual-level data will be made available to other researchers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Games Training in people with BPG Intervention and Control, run by Michigan State University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malawi, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kaufman Assessment Battery for Children 2nd Edition (KABC-II) Mental Processing Index (MPI) (time frame: Month 2, month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.