B.R.A.I.N in People Living With HIV Study
NCT Number: NCT06466642
Acronym: BRAIN
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: HIV-associated Neurocognitive Disorders
Interventions: BEHAVIORAL: Combined Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) and BrainHQ©
Sponsor: University of Cape Town
Sex: ALL
Age: ADULT
Enrollment: 43
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-01-16
Completion Date: 2024-12-31
Locations: Michael Mapongwana Community Health Clinic, Cape Town, Western Cape, 8000, South Africa|TB HIV Care, Cape Town, Western Cape, 8000, South Africa|Nolungile Community Clinic, Cape Town, Western Cape, 800, South Africa

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.

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.

Primary Outcome Measures: 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., 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., 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., 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., 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., 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, 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., 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., 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., 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., 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., 10 weeks
Secondary Outcome Measures: 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., 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., 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., 5 weeks
Other Outcome Measures: Other Study Measures: Mood Disorders (1), Center for Epidemiologic Studies Depression Scale: Measures symptoms of depression. Scores; minimum 0, maximum 60. Higher scores indicate greater severity., 5 weeks|Other Study Measures: Mood Disorders (2), Patient Health Questionnaire-2: Measures frequency of depressed mood and anhedonia over the past 5 weeks. Scores; minimum 0, maximum 6. Higher scores indicate greater severity., 5 weeks|Other Study Measures: Post-Traumatic Stress, Primary Care Post Traumatic Stress Disorder Screen: Measures symptoms of post-traumatic stress disorder. Scores; minimum 0, maximum 6. Higher scores indicate greater severity., 5 weeks|Other Study Measures: Physical Functioning, World Health Organization Disability Assessment Schedule: Measures general health and disability. Scores; minimum 0, maximum 100. Higher scores indicate greater disability., 5 weeks|Other Study Measures: Disease-Specific Quality of Life, Ability to Perform Social Roles and Activities: Measures ability to perform social roles and activities. Scores; minimum 0, maximum 100. Higher scores indicate better social functioning., 5 weeks|Other Study Measures: Adherence, Adherence Questionnaire: Measures adherence to treatment or prescribed interventions. Scores; minimum 0, maximum 100. Higher scores indicate better adherence., 5 weeks|Other Study Measures: Communication skills, World Health Organization Disability Assessment Schedule: Measures communication difficulties. Scores; minimum 0, maximum 100. Higher scores indicate more disability., 5 weeks|Other Study Measures: Anxiety, Generalized Anxiety Disorder Scale: Measures severity of generalized anxiety disorder. Scores; minimum 0, maximum 21. Higher scores indicate more severe anxiety., 5 weeks|Other Study Measures: Neurobehavioral Symptom, Neurobehavioral Symptom Inventory: Measures severity of neurobehavioral symptoms such as headache, dizziness, and irritability. Scores; minimum 0, maximum 88. Higher scores indicate more severe symptoms., 5 weeks|Other Study Measures: Quality of Life, Patient-Reported Outcomes Measurement Information System T-score: Measures general health and well-being. Higher scores indicate better quality of life., 5 weeks|Other Study Measures: Psychological Distress, Stress and Anxiety Symptom Scale - Bothered: Measures level of psychological distress and how bothered the individual feels, scores; minimum 0, maximum 100. Higher scores indicate more distress., 5 weeks|Other Measures: Cognitive Skills: Applied Cognition General Concerns Scale (1), Measures general concerns about cognitive functioning, including memory, attention, and executive function. Scores: maximum 0, minimum 36. Scores indicate the level of concern an individual has about their cognitive abilities, with higher scores suggesting more concerns., 5 weeks|Other Measures: Cognitive Skills: Applied Cognition Executive Functions Total Scale (2), Measures executive functions, including planning, problem-solving, and cognitive flexibility. Scores minimum 0, maximum 40. Scores indicate the degree of impairment in executive functions, with higher scores indicating more severe impairment., 5 weeks|Other Measures: Cognitive Skills: Cognitive Problems and Strategies Assessment Strategies Total Scale (3), The Cognitive Problems and Strategies Assessment Total Scale evaluates memory-related cognitive issues and the effectiveness of coping strategies. It measures the severity of memory problems and how frequently individuals use cognitive strategies to manage them, scoring; a minimum of 0, and a maximum of 90. Higher scores indicate more severe cognitive issues and more frequent use of coping strategies., 5 weeks|Other Measures: Cognitive Skills: Patient's Assessment of Own Functioning High Frequency Total Scale (4), Measures high-frequency cognitive functioning, including attention, memory, and executive function. Scores; minimum 0, maximum 55. Scores indicate the level of impairment in high-frequency cognitive tasks, with higher scores suggesting more impairment., 5 weeks|Other Measures: Cognitive Skills: Patient's Assessment of Own Functioning Memory Total Scale (5), Measures memory-related cognitive functioning, including recall and recognition. Scores; minimum 0, maximum 60. Scores indicate the level of impairment in memory-related cognitive tasks, with higher scores indicating more severe impairment in memory function., 5 weeks|Other Study Measures: Exit Interviews, The assessment used is a structured exit interview questionnaire, to explore participants' subjective experiences and perceived benefits of the intervention. The units of measure will be qualitative themes and sub-themes identified from participant responses. A thematic analysis will be conducted to identify common themes., 10 weeks|Other Study Measures: Focus Group Discussion, The assessment will utilize a structured focus group discussion guide to explore the collective views and experiences of the participants regarding the intervention. The units of measure will be qualitative themes and sub-themes identified from the group discussion. Thematic analysis will be conducted to identify common themes., 10 weeks