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

NCT06466642 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2024-08-23

No results posted yet for this study

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.

Conditions

  • HIV-associated Neurocognitive Disorders

Interventions

BEHAVIORAL

Combined Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) and BrainHQ©

The intervention combines Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) and BrainHQ. This integrated program helps individuals with cognitive impairment improve daily activities and achieve work, social, and daily living goals. CogSMART uses compensatory techniques to enhance prospective memory (remembering to do things), attention, learning/memory, and executive functioning (problem-solving, planning, organization, and cognitive flexibility). BrainHQ complements CogSMART with stimulating, game-like modules focusing on memory, attention, and executive functions. Together, they provide a comprehensive therapeutic tool to support cognitive impairment treatments and can also be used as a brain-training tool to prevent memory loss and maintain cognitive abilities.

Sponsors & Collaborators

  • University of Cape Town

    lead OTHER

Principal Investigators

  • Hetta Gouse, PhD · University of Cape Town

  • John Joska, PhD · University of Cape Town

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-16
Primary Completion
2024-08-30
Completion
2024-12-31

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06466642 on ClinicalTrials.gov