HIV-associated Neurocognitive DisordersBRAINNCT06466642
B.R.A.I.N in People Living With HIV Study
A study testing Combined Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) and BrainHQ© in people with HIV-associated Neurocognitive Disorders, run by University of Cape Town at 3 sites in South Africa.
Trial summary
People living with HIV (PLWH) often have memory and thinking problems, which can range from mild to severe. These problems, which are called neurocognitive impairment (NCI), can appear even when PLWH are taking medicine to manage their HIV. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV-associated Neurocognitive Disorders
- What is being tested?
- Combined Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) and BrainHQ©
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 3 sitesSouth Africa
- Study dates
- 16 Jan 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 30 and 50 years;
- ≥ 8 years of schooling;
- Fluent Xhosa speaking;
- HIV-positive;
- on Antiretroviral therapy (ART);
- ability to sign informed consent;
- willing to attend: (a) two NP testing sessions, (b) a minimum of 10 hours (twenty 30-minute sessions) of R-CR sessions, and (c) 10 CogSMART sessions over a period of five weeks; and
- meeting the criteria for NCI (as described further in document).
Who cannot join
- Participants with significant neuro-medical comorbidities (e.g., schizophrenia, epilepsy, bipolar disorder, multiple sclerosis, intellectual disability) necessitate exclusion. These comorbidities will be assessed for during screening.
- Other conditions (e.g., legally blind or deaf, currently undergoing radiation or chemotherapy, a history of brain trauma with a loss of consciousness greater than 30 minutes) that could impact cognitive functioning, testing or consistent study participation over 7 weeks necessitate exclusion; again, this information is conferred in the screen.
Trial locations and contacts
3 sites in 1 country.
South Africa3 sites, 2 recruiting
- Recruiting
Michael Mapongwana Community Health Clinic
Cape Town, Western Cape, 8000
Khanyisa Jacobs, 021 361 3353, khanyisa.jacobs@westerncape.gov.za
- Completed
TB HIV Care
Cape Town, Western Cape, 8000
- Recruiting
Nolungile Community Clinic
Cape Town, Western Cape, 800
Nothemba Mbomvu, 021 829 0004, Nothemba.mbomvu@westerncape.gov.za
About this study
Official title: Building Resources to Achieve Improvement in Neurocognition (B.R.A.I.N) in People Living With HIV
People living with HIV (PLWH) often have memory and thinking problems, which can range from mild to severe. These problems, which are called neurocognitive impairment (NCI), can appear even when PLWH are taking medicine to manage their HIV.
PLWH who are experiencing NCI can have difficulties managing everyday activities. For instance, they might not remember to take their medicine on time, they might struggle to manage their money properly, and they might even be at a higher risk of passing HIV on to other. Ultimately, PLWH who are experiencing NCI might not enjoy life as much as others do.
Read more
Currently, there are no specific medicines designed to treat NCI in PLWH. There are, however, some useful memory and thinking strategies that can help improve cognitive abilities. These strategies are called cognitive remediation (CR).
In South Africa, there are many PLWH. Unfortunately, the country does not have clear plans for identifying and managing NCI in PLWH. It's difficult to use CR in South Africa because of cultural differences between where the strategies were developed and the patients who might need to use it, limited healthcare resources, and HIV clinics not having enough information about NCI.
There are, however, some promising ways to deal with these issues. For example, it can be helpful to involve regular counselors and to use simple tests on mobile phones to find people who need assistance. With some effort and creativity, investigators can improve the situation and help PLWH lead better lives.
The proposed study is a unique opportunity to find new ways to help PLWH and others with brain-related diseases who might be experiencing NCI. Investigators want to explore ways to use cognitive exercises to improve thinking abilities. This study will be the first of its kind because investigators will adapt these exercises to fit the cultures and languages of South Africa, where many people are affected by HIV and NCI.
By doing this research, investigators hope to make important progress in addressing NCI in HIV and similar conditions. Investigators will learn how to make these cognitive exercises work best in South Africa's public clinics, and this knowledge can help people with NCI live better lives. Our goal is to improve healthcare not only in South Africa but also in other parts of the world that might be facing similar challenges with improving the lives of PLWH.
Read the detailed description
Neurocognitive Impairment (NCI) is a condition where HIV infection affects the brain, leading to problems with memory, thinking, and other cognitive functions. It is a common issue among people living with HIV, even those who are receiving antiretroviral therapy (ART) to control the virus. The exact reasons why NCI occurs in HIV are not fully understood, but it is likely influenced by several factors, including direct HIV-related processes in the central nervous system and other contributing elements like stress.
NCI can range from mild cognitive deficits to more severe impairments that impact daily functioning and quality of life. People experiencing NCI may find it challenging to remember things, concentrate, make decisions, and perform tasks they once managed easily. This condition can also affect their adherence to HIV treatment, which is crucial for managing the infection effectively.
In South Africa, where HIV prevalence is high, NCI poses a significant concern. Despite its prevalence, there are no established protocols for the routine screening and management of NCI in HIV clinics. This lack of systematic approach hinders early identification and appropriate intervention for affected individuals.
The consequences of NCI in HIV are not just medical; they extend to functional and public health aspects as well. For instance, impaired cognitive abilities can hinder a person's ability to adhere to their medication schedule, leading to treatment challenges and potential disease progression. Additionally, NCI can hinder daily activities and job performance, affecting overall productivity and livelihood. Furthermore, those with cognitive impairments may be at a higher risk of transmitting HIV to others, as they might struggle with understanding and adhering to preventive measures.
Currently, there are no specific pharmacological treatments available to directly address NCI in HIV. However, cognitive remediation (CR) strategies have shown promise in managing and improving cognitive abilities in this population. CR involves structured activities and exercises designed to enhance memory, attention, problem-solving, and other cognitive functions. While more research is needed, CR holds potential for improving the quality of life for individuals living with HIV and NCI.
Implementing CR interventions in South Africa faces several challenges. The country's cultural diversity calls for approaches that are sensitive and adaptable to different communities. Moreover, limited healthcare resources and the lack of awareness and guidelines for NCI in HIV clinics add further complexity to the situation.
One promising approach involves task-shifting strategies, which involve the participation of lay counselors in the delivery of CR interventions. This can help address resource constraints while potentially reaching more affected individuals. Additionally, utilizing mobile health screening tests can aid in identifying people with NCI, especially in remote or underserved areas.
The proposed study provides a unique opportunity to establish an entirely new therapeutic approach on the African continent for treating neurocognitive impairment (NCI) in people living with HIV (PWH) and patients with other brain-involved diseases. Additionally, it aims to explore barriers to the utility and future implementation of cognitive remediation (CR) in public clinics.
This study will be the first of its kind in several ways: (1) It will culturally and linguistically adapt a CR program specifically for HIV-associated NCI in a low- and middle-income setting with high rates of HIV and NCI; (2) It will assess the usability and acceptability of the CR intervention by both key stakeholders, such as the Department of Health, and PWH in South Africa; (3) It will combine evidence-based restorative and compensatory cognitive remediation strategies and evaluate which components are most acceptable and feasible to implement in the South African context.
By undertaking this groundbreaking research, investigators aim to make significant strides in addressing NCI in HIV and potentially extend the benefits to other brain-involved conditions. The study's outcomes will provide valuable insights into the implementation of CR in the country's public clinics and pave the way for more effective and culturally appropriate interventions for improving cognitive function in those affected by HIV-associated NCI and other related diseases. Through this collaborative effort, investigators hope to improve the lives of individuals living with NCI and contribute to the advancement of healthcare in South Africa and beyond.
- Conditions
- HIV-associated Neurocognitive Disorders
- Being tested
- Combined Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) and BrainHQ©
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) and BrainHQ©Behavioural
The intervention combines Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) and BrainHQ. This integrated program helps individuals with cognitive impairment improve daily activities and achieve work, social, and daily living goals. CogSMART uses compensatory techniques to enhance prospective memory (remembering to do things), attention, learning/memory, and executive functioning (problem-solving, planning, organization, and cognitive flexibility). BrainHQ complements CogSMART with stimulating, game-like modules focusing on memory, attention, and executive functions. Together, they provide a comprehensive therapeutic tool to support cognitive impairment treatments and can also be used as a brain-training tool to prevent memory loss and maintain cognitive abilities.
| Study group | Role | What they receive |
|---|---|---|
| Combined CogSMART and BrainHQ intervention group | Experimental | Intervention: The experimental condition in this trial is a combination of CogSMART and BrainHQ. This integrated intervention helps individuals with cognitive impairment improve daily activities and achieve goals. CogSMART, a compensatory cognitive remediation (C-CR) program, employs techniques to enhance prospective memory, attention, learning/memory, and executive functioning. BrainHQ, a restorative cognitive remediation (R-CR) program, provides game-like modules targeting memory, attention, and executive functions. Together, they offer a comprehensive approach, combining C-CR with R-CR to reduce impairment and enhance problem-solving skills. Receives: Behavioral: Combined Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) and BrainHQ© |
| Attention-matched Combined CogSMART and BrainHQ Control group | No intervention | This control-matched approach to the CogSMART group, currently utilized in Dr. Twamley's studies, has been well received by participants, with no significant increase in dropout rates. Additionally, control participants will receive the BrainHQ component, involving Internet Navigation Training previously employed by Dr. Vance consisting of 20 sessions lasting 30 minutes each aimed to provide no therapeutic benefit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological assessment: Learning and Memory (1)
Hopkins Verbal Learning Test Total Recall: Measures verbal learning and memory. Scores range from 0 to 30, with higher scores indicating better memory retention. Task done over 20 minutes.
Measured: 10 weeks
Neuropsychological assessment: Learning and Memory (2)
Hopkins Verbal Learning Test Delayed Recall: Assesses delayed verbal recall. Scores range from 0 to 12, reflecting the ability to retain information. Task done over 20 minutes.
Measured: 10 weeks
Neuropsychological assessment: Learning and Memory (3)
Wechsler Adult Intelligence Scale-III Digit Span Total: Evaluates auditory attention and working memory. Scores range from 0 to 16, with higher scores indicating better performance in recalling sequences of digits.
Measured: 10 weeks
Neuropsychological assessment: Processing Speed (1)
Wechsler Adult Intelligence Scale-III Symbol Search Total: Assesses processing speed and attention. Scores range from 0 to 60, with higher scores indicating better performance in quickly identifying matching symbols. This task is done in 120 seconds.
Measured: 10 weeks
Neuropsychological assessment: Processing Speed (2)
Wechsler Adult Intelligence Scale-III Coding Total: Evaluates processing speed, attention, and visual-motor coordination. Scores range from 3 to 70, with higher scores indicating faster completion of the coding task.
Measured: 10 weeks
Neuropsychological assessment: Processing Speed (3)
Trail Making Test Part A Time: Evaluates processing speed, visual attention, and task-switching ability. Scores range from 0 to 158 seconds, with lower times indicating better performance in processing speed, visual attention and task-switching ability, as they reflect faster task completion without errors
Measured: 10 weeks
Neuropsychological assessment: Processing Speed (4)
Trail Making Test Part A Time (Extended): This extended version of the Trail Making Test Part A measures processing speed, with scores ranging from 0 to 300 seconds. Lower times indicate better performance, as they reflect quicker task completion without errors.
Measured: 10 weeks
Neuropsychological assessment: Executive Functioning (1)
Semantic Fluency Animals Correct: Assesses language and executive function over 60 seconds. Scores range from 0 to 22, with higher scores indicating greater fluency.
Measured: 10 weeks
Neuropsychological assessment: Executive Functioning (2)
Semantic Fluency Fruit/Vegetable Correct: Evaluates semantic fluency for fruits and vegetables over 60 seconds. Scores can range from 0 to 22, reflecting the participant's ability to generate words within this category.
Measured: 10 weeks
Neuropsychological assessment: Executive Functioning (3)
Grooved Pegboard Test Dominant Hand Time: This test evaluates fine motor skills and coordination in the dominant hand. Scores range from 0 to 160 seconds, with lower times indicating better manual dexterity and motor coordination.
Measured: 10 weeks
Neuropsychological assessment: Executive Functioning (4)
Grooved Pegboard Test Non-Dominant Hand Time: Assesses fine motor skills and coordination for the non-dominant hand. Scores range from 60 to 300 seconds, with lower times indicating better manual dexterity and motor coordination.
Measured: 10 weeks
Secondary outcomes (3)
HIV outcomes: ART Adherence (Dried Blood Spot Analysis) (1)
- Assessment Used: Measurement of Tenofovir Diphosphate Levels
- Units of Measure: Concentration (ng/mL)
- Minimum: 10 ng/mL
- Maximum: 2000 ng/mL
- Description: Dried blood spots will be collected and analyzed to measure tenofovir diphosphate levels as a marker of ART adherence. Higher concentrations of tenofovir diphosphate indicate better adherence to antiretroviral therapy.
Measured: 5 weeks
HIV outcomes: Systemic Inflammation (Dried Blood Spot Analysis) (2)
- Assessment Used: Measurement of Interleukin-6 Levels
- Units of Measure: Concentration (pg/mL)
- Minimum: 0.5 pg/mL
- Maximum: 500 pg/mL
- Description: Dried blood spots will be analyzed to measure interleukin-6, a pro-inflammatory cytokine linked to neurocognitive impairment. Higher concentrations of interleukin-6 indicate greater levels of systemic inflammation.
Measured: 5 weeks
HIV outcomes: Self-Reported ART Adherence (3)
- Assessment Used: Three-item Self-Report Medication Adherence Scale
- Units of Measure: Adherence score (0-3)
- Minimum: 0
- Maximum: 3
- Description: Participants will self-report their ART adherence using a three-item scale, providing a subjective measure of adherence. Higher scores indicate better self-reported adherence to antiretroviral therapy.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start16 Jan 2023
- Primary completion30 Aug 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV-associated Neurocognitive DisordersStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Recruited participants will first be screened for eligibility and required to provide informed consent. After the baseline assessment, participants will be randomized into one of two study arms: an active experimental group receiving CR (CogSMART and BrainHQ©) or an attention-matched control group. Measures, both subjective and objective, will evaluate participants' cognition, behavior, and functional abilities. Exit focus groups will gather participant feedback. The study aims to inform a larger RCT to enhance cognitive functioning and well-being among PWH in South Africa.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KevinThomas, University of Cape Town
- Investigators
- Hetta Gouse, PhD, Principal investigator, University of Cape TownJohn Joska, PhD, Principal investigator, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466642
- Sponsor's protocol ID
- 045-2022
- Acronym
- BRAIN
- Status last verified
- Aug 2024
- First submitted
- 22 May 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mohamad N, Thomas KGF, Chernotsky R, Robbins RN, Twamley EW, Vance DE, Nyembezi N, Nhlabatsi-Khumalo Z, Gouse H. Development of cognitive remediation interventions for people living with HIV in South Africa: participant experiences of adapted CogSMART and BrainHQ(c) programs. Front Neurol. 2026 Apr 29;17:1741135. doi: 10.3389/fneur.2026.1741135. eCollection 2026.
PubMed 42136814Gouse H, Nhlabatsi-Khumalo Z, Chernotsky R, Twamley EW, Vance D, Henry M, Robbins R, Thomas KGF. Changes in cognitive performance following combined CogSMART-SA and BrainHQ interventions: a pilot study. BMC Neurol. 2026 Mar 21;26(1):311. doi: 10.1186/s12883-026-04778-9.
PubMed 41864902
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Resources to Achieve Improvement in Neurocognition (B.R.A.I.N) in People Living With HIV
- ClinicalTrials.gov ID
- NCT06466642
- Acronym / sponsor ID
- BRAIN / 045-2022
- Conditions
- HIV-associated Neurocognitive Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 20 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People living with HIV (PLWH) often have memory and thinking problems, which can range from mild to severe. These problems, which are called neurocognitive impairment (NCI), can appear even when PLWH are taking medicine to manage their HIV.
PLWH who are experiencing NCI can have difficulties managing everyday activities. For instance, they might not remember to take their medicine on time, they might struggle to manage their money properly, and they might even be at a higher risk of passing HIV on to other. Ultimately, PLWH who are experiencing NCI might not enjoy life as much as others do.
Currently, there are no specific medicines designed to treat NCI in PLWH. There are, however, some useful memory and thinking strategies that can help improve cognitive abilities. These strategies are called cognitive remediation (CR).
In South Africa, there are many PLWH. Unfortunately, the country does not have clear plans for identifying and managing NCI in PLWH. It's difficult to use CR in South Africa because of cultural differences between where the strategies were developed and the patients who might need to use it, limited healthcare resources, and HIV clinics not having enough information about NCI.
There are, however, some promising ways to deal with these issues. For example, it can be helpful to involve regular counselors and to use simple tests on mobile phones to find people who need assistance. With some effort and creativity, investigators can improve the situation and help PLWH lead better lives.
The proposed study is a unique opportunity to find new ways to help PLWH and others with brain-related diseases who might be experiencing NCI. Investigators want to explore ways to use cognitive exercises to improve thinking abilities. This study will be the first of its kind because investigators will adapt these exercises to fit the cultures and languages of South Africa, where many people are affected by HIV and NCI.
By doing this research, investigators hope to make important progress in addressing NCI in HIV and similar conditions. Investigators will learn how to make these cognitive exercises work best in South Africa's public clinics, and this knowledge can help people with NCI live better lives. Our goal is to improve healthcare not only in South Africa but also in other parts of the world that might be facing similar challenges with improving the lives of PLWH.
Detailed description
Neurocognitive Impairment (NCI) is a condition where HIV infection affects the brain, leading to problems with memory, thinking, and other cognitive functions. It is a common issue among people living with HIV, even those who are receiving antiretroviral therapy (ART) to control the virus. The exact reasons why NCI occurs in HIV are not fully understood, but it is likely influenced by several factors, including direct HIV-related processes in the central nervous system and other contributing elements like stress.
NCI can range from mild cognitive deficits to more severe impairments that impact daily functioning and quality of life. People experiencing NCI may find it challenging to remember things, concentrate, make decisions, and perform tasks they once managed easily. This condition can also affect their adherence to HIV treatment, which is crucial for managing the infection effectively.
In South Africa, where HIV prevalence is high, NCI poses a significant concern. Despite its prevalence, there are no established protocols for the routine screening and management of NCI in HIV clinics. This lack of systematic approach hinders early identification and appropriate intervention for affected individuals.
The consequences of NCI in HIV are not just medical; they extend to functional and public health aspects as well. For instance, impaired cognitive abilities can hinder a person's ability to adhere to their medication schedule, leading to treatment challenges and potential disease progression. Additionally, NCI can hinder daily activities and job performance, affecting overall productivity and livelihood. Furthermore, those with cognitive impairments may be at a higher risk of transmitting HIV to others, as they might struggle with understanding and adhering to preventive measures.
Currently, there are no specific pharmacological treatments available to directly address NCI in HIV. However, cognitive remediation (CR) strategies have shown promise in managing and improving cognitive abilities in this population. CR involves structured activities and exercises designed to enhance memory, attention, problem-solving, and other cognitive functions. While more research is needed, CR holds potential for improving the quality of life for individuals living with HIV and NCI.
Implementing CR interventions in South Africa faces several challenges. The country's cultural diversity calls for approaches that are sensitive and adaptable to different communities. Moreover, limited healthcare resources and the lack of awareness and guidelines for NCI in HIV clinics add further complexity to the situation.
One promising approach involves task-shifting strategies, which involve the participation of lay counselors in the delivery of CR interventions. This can help address resource constraints while potentially reaching more affected individuals. Additionally, utilizing mobile health screening tests can aid in identifying people with NCI, especially in remote or underserved areas.
The proposed study provides a unique opportunity to establish an entirely new therapeutic approach on the African continent for treating neurocognitive impairment (NCI) in people living with HIV (PWH) and patients with other brain-involved diseases. Additionally, it aims to explore barriers to the utility and future implementation of cognitive remediation (CR) in public clinics.
This study will be the first of its kind in several ways: (1) It will culturally and linguistically adapt a CR program specifically for HIV-associated NCI in a low- and middle-income setting with high rates of HIV and NCI; (2) It will assess the usability and acceptability of the CR intervention by both key stakeholders, such as the Department of Health, and PWH in South Africa; (3) It will combine evidence-based restorative and compensatory cognitive remediation strategies and evaluate which components are most acceptable and feasible to implement in the South African context.
By undertaking this groundbreaking research, investigators aim to make significant strides in addressing NCI in HIV and potentially extend the benefits to other brain-involved conditions. The study's outcomes will provide valuable insights into the implementation of CR in the country's public clinics and pave the way for more effective and culturally appropriate interventions for improving cognitive function in those affected by HIV-associated NCI and other related diseases. Through this collaborative effort, investigators hope to improve the lives of individuals living with NCI and contribute to the advancement of healthcare in South Africa and beyond.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Recruited participants will first be screened for eligibility and required to provide informed consent. After the baseline assessment, participants will be randomized into one of two study arms: an active experimental group receiving CR (CogSMART and BrainHQ©) or an attention-matched control group. Measures, both subjective and objective, will evaluate participants' cognition, behavior, and functional abilities. Exit focus groups will gather participant feedback. The study aims to inform a larger RCT to enhance cognitive functioning and well-being among PWH in South Africa.
| Arm | Type | Receives |
|---|---|---|
| Combined CogSMART and BrainHQ intervention group | Experimental | Behavioral: Combined Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) and BrainHQ©Intervention: The experimental condition in this trial is a combination of CogSMART and BrainHQ. This integrated intervention helps individuals with cognitive impairment improve daily activities and achieve goals. CogSMART, a compensatory cognitive remediation (C-CR) program, employs techniques to enhance prospective memory, attention, learning/memory, and executive functioning. BrainHQ, a restorative cognitive remediation (R-CR) program, provides game-like modules targeting memory, attention, and executive functions. Together, they offer a comprehensive approach, combining C-CR with R-CR to reduce impairment and enhance problem-solving skills. |
| Attention-matched Combined CogSMART and BrainHQ Control group | No intervention | –This control-matched approach to the CogSMART group, currently utilized in Dr. Twamley's studies, has been well received by participants, with no significant increase in dropout rates. Additionally, control participants will receive the BrainHQ component, involving Internet Navigation Training previously employed by Dr. Vance consisting of 20 sessions lasting 30 minutes each aimed to provide no therapeutic benefit. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Aged between 30 and 50 years;
- ≥ 8 years of schooling;
- Fluent Xhosa speaking;
- HIV-positive;
- on Antiretroviral therapy (ART);
Key exclusion criteria (2 listed)
- Participants with significant neuro-medical comorbidities (e.g., schizophrenia, epilepsy, bipolar disorder, multiple sclerosis, intellectual disability) necessitate exclusion. These comorbidities will be assessed for during screening.
- Other conditions (e.g., legally blind or deaf, currently undergoing radiation or chemotherapy, a history of brain trauma with a loss of consciousness greater than 30 minutes) that could impact cognitive functioning, testing or consistent study participation over 7 weeks necessitate exclusion; again, this information is conferred in the screen.
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 |
|---|---|---|
| Combined Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) and BrainHQ©The intervention combines Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) and BrainHQ. This integrated program helps individuals with cognitive impairment improve daily activities and achieve work, social, and daily living goals. CogSMART uses compensatory techniques to enhance prospective memory (remembering to do things), attention, learning/memory, and executive functioning (problem-solving, planning, organization, and cognitive flexibility). BrainHQ complements CogSMART with stimulating, game-like modules focusing on memory, attention, and executive functions. Together, they provide a comprehensive therapeutic tool to support cognitive impairment treatments and can also be used as a brain-training tool to prevent memory loss and maintain cognitive abilities. | Behavioural | Combined CogSMART and BrainHQ intervention group |
Primary outcome
Neuropsychological assessment: Learning and Memory (1)
Time frame: 10 weeks
Hopkins Verbal Learning Test Total Recall: Measures verbal learning and memory. Scores range from 0 to 30, with higher scores indicating better memory retention. Task done over 20 minutes.
Neuropsychological assessment: Learning and Memory (2)
Time frame: 10 weeks
Hopkins Verbal Learning Test Delayed Recall: Assesses delayed verbal recall. Scores range from 0 to 12, reflecting the ability to retain information. Task done over 20 minutes.
Neuropsychological assessment: Learning and Memory (3)
Time frame: 10 weeks
Wechsler Adult Intelligence Scale-III Digit Span Total: Evaluates auditory attention and working memory. Scores range from 0 to 16, with higher scores indicating better performance in recalling sequences of digits.
Neuropsychological assessment: Processing Speed (1)
Time frame: 10 weeks
Wechsler Adult Intelligence Scale-III Symbol Search Total: Assesses processing speed and attention. Scores range from 0 to 60, with higher scores indicating better performance in quickly identifying matching symbols. This task is done in 120 seconds.
Neuropsychological assessment: Processing Speed (2)
Time frame: 10 weeks
Wechsler Adult Intelligence Scale-III Coding Total: Evaluates processing speed, attention, and visual-motor coordination. Scores range from 3 to 70, with higher scores indicating faster completion of the coding task.
Neuropsychological assessment: Processing Speed (3)
Time frame: 10 weeks
Trail Making Test Part A Time: Evaluates processing speed, visual attention, and task-switching ability. Scores range from 0 to 158 seconds, with lower times indicating better performance in processing speed, visual attention and task-switching ability, as they reflect faster task completion without errors
Neuropsychological assessment: Processing Speed (4)
Time frame: 10 weeks
Trail Making Test Part A Time (Extended): This extended version of the Trail Making Test Part A measures processing speed, with scores ranging from 0 to 300 seconds. Lower times indicate better performance, as they reflect quicker task completion without errors.
Neuropsychological assessment: Executive Functioning (1)
Time frame: 10 weeks
Semantic Fluency Animals Correct: Assesses language and executive function over 60 seconds. Scores range from 0 to 22, with higher scores indicating greater fluency.
Neuropsychological assessment: Executive Functioning (2)
Time frame: 10 weeks
Semantic Fluency Fruit/Vegetable Correct: Evaluates semantic fluency for fruits and vegetables over 60 seconds. Scores can range from 0 to 22, reflecting the participant's ability to generate words within this category.
Neuropsychological assessment: Executive Functioning (3)
Time frame: 10 weeks
Grooved Pegboard Test Dominant Hand Time: This test evaluates fine motor skills and coordination in the dominant hand. Scores range from 0 to 160 seconds, with lower times indicating better manual dexterity and motor coordination.
Neuropsychological assessment: Executive Functioning (4)
Time frame: 10 weeks
Grooved Pegboard Test Non-Dominant Hand Time: Assesses fine motor skills and coordination for the non-dominant hand. Scores range from 60 to 300 seconds, with lower times indicating better manual dexterity and motor coordination.
3 secondary outcomes
HIV outcomes: ART Adherence (Dried Blood Spot Analysis) (1)
Time frame: 5 weeks
HIV outcomes: Systemic Inflammation (Dried Blood Spot Analysis) (2)
Time frame: 5 weeks
HIV outcomes: Self-Reported ART Adherence (3)
Time frame: 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Derived from this study: PubMed 42136814Mohamad N, Thomas KGF, Chernotsky R, Robbins RN, Twamley EW, Vance DE, Nyembezi N, Nhlabatsi-Khumalo Z, Gouse H. Development of cognitive remediation interventions for people living with HIV in South Africa: participant experiences of adapted CogSMART and BrainHQ(c) programs. Front Neurol. 2026 Apr 29;17:1741135. doi: 10.3389/fneur.2026.1741135. eCollection 2026.
- Derived from this study: PubMed 41864902Gouse H, Nhlabatsi-Khumalo Z, Chernotsky R, Twamley EW, Vance D, Henry M, Robbins R, Thomas KGF. Changes in cognitive performance following combined CogSMART-SA and BrainHQ interventions: a pilot study. BMC Neurol. 2026 Mar 21;26(1):311. doi: 10.1186/s12883-026-04778-9.
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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.
Hetta Gouse, PhD principal investigator
University of Cape Town
John Joska, PhD principal investigator
University of Cape Town
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) and BrainHQ© in people with HIV-associated Neurocognitive Disorders, run by University of Cape Town at 3 sites in South Africa.
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 8 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Africa. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hetta Gouse, PhD (+642102064321, hetta.gouse@uct.ac.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological assessment: Learning and Memory (1) (time frame: 10 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06466642, which also lists 2 linked publications.
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 23 Aug 2024.