B.R.A.I.N in People Living With HIV Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-50
SponsorUniversity of Cape Town
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged between 30 and 50 years;
≥ 8 years of schooling;
Fluent Xhosa speaking;
HIV-positive;
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Combined Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) and BrainHQ©
BehavioralThe 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.
Treatment groups
43 Participants
are divided into 2 treatment groupsGroup A: Combined CogSMART and BrainHQ intervention groupExperimental treatment 1 intervention
Group B: Attention-matched Combined CogSMART and BrainHQ Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Neuropsychological assessment: Learning and Memory (1)
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.
Time frame
10 weeks2
Neuropsychological assessment: Learning and Memory (2)
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.
Time frame
10 weeks3
Neuropsychological assessment: Learning and Memory (3)
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.
Time frame
10 weeks4
Neuropsychological assessment: Processing Speed (1)
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.
Time frame
10 weeksSecondary outcomes
1
HIV outcomes: ART Adherence (Dried Blood Spot Analysis) (1)
* Assessment Used: Measurement of Tenofovir Diphosphate Levels * Units of Measure: Concentration (ng/mL) * Minimum: 10 ng/mL * Maximum: 2000 ng/mL * Description: Dried blood spots will be collected and analyzed to measure tenofovir diphosphate levels as a marker of ART adherence. Higher concentrations of tenofovir diphosphate indicate better adherence to antiretroviral therapy.
Time frame
5 weeks2
HIV outcomes: Systemic Inflammation (Dried Blood Spot Analysis) (2)
* Assessment Used: Measurement of Interleukin-6 Levels * Units of Measure: Concentration (pg/mL) * Minimum: 0.5 pg/mL * Maximum: 500 pg/mL * Description: Dried blood spots will be analyzed to measure interleukin-6, a pro-inflammatory cytokine linked to neurocognitive impairment. Higher concentrations of interleukin-6 indicate greater levels of systemic inflammation.
Time frame
5 weeks3
HIV outcomes: Self-Reported ART Adherence (3)
* Assessment Used: Three-item Self-Report Medication Adherence Scale * Units of Measure: Adherence score (0-3) * Minimum: 0 * Maximum: 3 * Description: Participants will self-report their ART adherence using a three-item scale, providing a subjective measure of adherence. Higher scores indicate better self-reported adherence to antiretroviral therapy.
Time frame
5 weeksOther outcomes
1
Other Study Measures: Mood Disorders (1)
Center for Epidemiologic Studies Depression Scale: Measures symptoms of depression. Scores; minimum 0, maximum 60. Higher scores indicate greater severity.
Time frame
5 weeks2
Other Study Measures: Mood Disorders (2)
Patient Health Questionnaire-2: Measures frequency of depressed mood and anhedonia over the past 5 weeks. Scores; minimum 0, maximum 6. Higher scores indicate greater severity.
Time frame
5 weeks3
Other Study Measures: Post-Traumatic Stress
Primary Care Post Traumatic Stress Disorder Screen: Measures symptoms of post-traumatic stress disorder. Scores; minimum 0, maximum 6. Higher scores indicate greater severity.
Time frame
5 weeks4
Other Study Measures: Physical Functioning
World Health Organization Disability Assessment Schedule: Measures general health and disability. Scores; minimum 0, maximum 100. Higher scores indicate greater disability.
Time frame
5 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov