Actively Recruiting

Phase Not Applicable
Age: 30Years - 50Years
All Genders
Healthy Volunteers
NCT06466642

B.R.A.I.N in People Living With HIV Study

Led by University of Cape Town · Updated on 2024-08-23

43

Participants Needed

3

Research Sites

102 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

B.R.A.I.N in People Living With HIV Study

Who Can Participate

Age: 30Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged between 30 and 50 years
  • At least 8 years of schooling completed
  • Fluent in Xhosa
  • HIV-positive
  • Currently on antiretroviral therapy (ART)
  • Able to provide informed consent
  • Willing to attend two neuropsychological testing sessions
  • Willing to complete a minimum of 10 hours (twenty 30-minute sessions) of cognitive remediation sessions
  • Willing to complete 10 CogSMART sessions over five weeks
  • Meets criteria for neurocognitive impairment (NCI) as specified in the study
Not Eligible

You will not qualify if you...

  • Diagnosis of significant neuro-medical conditions such as schizophrenia, epilepsy, bipolar disorder, multiple sclerosis, or intellectual disability
  • Conditions affecting cognitive function or ability to participate, including legal blindness or deafness
  • Currently receiving radiation or chemotherapy treatment
  • History of brain trauma causing loss of consciousness greater than 30 minutes

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Michael Mapongwana Community Health Clinic

Cape Town, Western Cape, South Africa, 8000

Actively Recruiting

2

TB HIV Care

Cape Town, Western Cape, South Africa, 8000

Completed

3

Nolungile Community Clinic

Cape Town, Western Cape, South Africa, 800

Actively Recruiting

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Research Team

H

Hetta Gouse, PhD

CONTACT

K

Kevin GF Thomas, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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