Ignite Creation Date:
2024-07-17 @ 10:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466642
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-05-22
Brief Title:
BRAIN in People Living With HIV Study
Sponsor:
University of Cape Town
Organization:
University of Cape Town
Study Overview
Official Title:
Building Resources to Achieve Improvement in Neurocognition BRAIN in People Living With HIV
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BRAIN
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 Its 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 Africas 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
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 Its 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 Africas 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 persons 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 countrys 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 studys outcomes will provide valuable insights into the implementation of CR in the countrys 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
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 persons 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 countrys 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 studys outcomes will provide valuable insights into the implementation of CR in the countrys 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None