Building Resources to Achieve Improvement in Neurocognition (B.R.A.I.N) in People Living With HIV
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 43
- 试验地点
- 6
- 主要终点
- Neuropsychological assessment: Processing Speed (1)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Randomization to study arm. Participants will be randomized into one of two study arms after the baseline assessment: an active experimental group receiving the CR, or an attention-matched control group. Because our sample size (N=43) is smaller than 100, investigators will use block randomization to assign participant numbers equally across each arm. To prevent the executer (the neuropsychology technician) from predicting the next assignment, they will be kept ignorant of the block size. Concealing the allocation sequence from those assigning participants, will prevent selection bias. Allocation numbers will be placed in individually sealed brown envelopes by the project manager prior to study commencement.
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Neuropsychological assessment: Processing Speed (1)
时间窗: 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 (3)
时间窗: 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)
时间窗: 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: Learning and Memory (1)
时间窗: 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 (3)
时间窗: 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: Executive Functioning (1)
时间窗: 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: Learning and Memory (2)
时间窗: 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: Processing Speed (2)
时间窗: 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: Executive Functioning (2)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- HIV outcomes: Self-Reported ART Adherence (3)(5 weeks)
- HIV outcomes: ART Adherence (Dried Blood Spot Analysis) (1)(5 weeks)
- HIV outcomes: Systemic Inflammation (Dried Blood Spot Analysis) (2)(5 weeks)
研究者
KevinThomas
Professor
University of Cape Town