Clinical trial NCT06466642: B.R.A.I.N in People Living With HIV Study
Official title: Building Resources to Achieve Improvement in Neurocognition (B.R.A.I.N) in People Living With HIV
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV-associated Neurocognitive Disorders
Lead sponsor: University of Cape Town
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 43
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Neuropsychological assessment: Learning and Memory (1)
timeFrame: 10 weeks
measure: Neuropsychological assessment: Learning and Memory (2)
timeFrame: 10 weeks
measure: Neuropsychological assessment: Learning and Memory (3)
timeFrame: 10 weeks
measure: Neuropsychological assessment: Processing Speed (1)
timeFrame: 10 weeks
measure: Neuropsychological assessment: Processing Speed (2)
timeFrame: 10 weeks
measure: Neuropsychological assessment: Processing Speed (3)
timeFrame: 10 weeks
measure: Neuropsychological assessment: Processing Speed (4)
timeFrame: 10 weeks
measure: Neuropsychological assessment: Executive Functioning (1)
timeFrame: 10 weeks
measure: Neuropsychological assessment: Executive Functioning (2)
timeFrame: 10 weeks
measure: Neuropsychological assessment: Executive Functioning (3)
timeFrame: 10 weeks
measure: Neuropsychological assessment: Executive Functioning (4)
timeFrame: 10 weeks
Secondary outcomes:
measure: HIV outcomes: ART Adherence (Dried Blood Spot Analysis) (1)
timeFrame: 5 weeks
measure: HIV outcomes: Systemic Inflammation (Dried Blood Spot Analysis) (2)
timeFrame: 5 weeks
measure: HIV outcomes: Self-Reported ART Adherence (3)
timeFrame: 5 weeks
Other outcomes:
measure: Other Study Measures: Mood Disorders (1)
timeFrame: 5 weeks
measure: Other Study Measures: Mood Disorders (2)
timeFrame: 5 weeks
measure: Other Study Measures: Post-Traumatic Stress
timeFrame: 5 weeks
measure: Other Study Measures: Physical Functioning
timeFrame: 5 weeks
measure: Other Study Measures: Disease-Specific Quality of Life
timeFrame: 5 weeks
measure: Other Study Measures: Adherence
timeFrame: 5 weeks
measure: Other Study Measures: Communication skills
timeFrame: 5 weeks
measure: Other Study Measures: Anxiety
timeFrame: 5 weeks
measure: Other Study Measures: Neurobehavioral Symptom
timeFrame: 5 weeks
measure: Other Study Measures: Quality of Life
timeFrame: 5 weeks
measure: Other Study Measures: Psychological Distress
timeFrame: 5 weeks
measure: Other Measures: Cognitive Skills: Applied Cognition General Concerns Scale (1)
timeFrame: 5 weeks
measure: Other Measures: Cognitive Skills: Applied Cognition Executive Functions Total Scale (2)
timeFrame: 5 weeks
measure: Other Measures: Cognitive Skills: Cognitive Problems and Strategies Assessment Strategies Total Scale (3)
timeFrame: 5 weeks
measure: Other Measures: Cognitive Skills: Patient's Assessment of Own Functioning High Frequency Total Scale (4)
timeFrame: 5 weeks
measure: Other Measures: Cognitive Skills: Patient's Assessment of Own Functioning Memory Total Scale (5)
timeFrame: 5 weeks
measure: Other Study Measures: Exit Interviews
timeFrame: 10 weeks
measure: Other Study Measures: Focus Group Discussion
timeFrame: 10 weeks
Locations:
city: Cape Town
country: South Africa
facility: Michael Mapongwana Community Health Clinic
state: Western Cape
city: Cape Town
country: South Africa
facility: TB HIV Care
state: Western Cape
city: Cape Town
country: South Africa
facility: Nolungile Community Clinic
state: Western Cape
Study officials:
affiliation: University of Cape Town
name: Hetta Gouse, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cape Town
name: John Joska, PhD
role: PRINCIPAL_INVESTIGATOR
References: