Cognitive therapy for people living with HIV and memory issues

Building Resources to Achieve Improvement in Neurocognition (B.R.A.I.N) in People Living With HIV

This study is testing if a special brain training program can help people living with HIV who have memory problems think better and improve their daily lives.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 43 (estimated)
• Ages: 30 Years to 50 Years
• Sex: All
• Sponsor: University of Cape Town (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 3 sites (Cape Town, Western Cape and 2 other locations)
• Trial ID: NCT06466642 on ClinicalTrials.gov

What this trial studies

This study focuses on individuals living with HIV who experience neurocognitive impairment (NCI), which affects their memory and thinking abilities. It aims to implement cognitive remediation strategies, specifically Combined Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) and BrainHQ©, to improve cognitive functions in these patients. Participants will undergo a series of cognitive training sessions over five weeks to assess the effectiveness of these interventions in enhancing their daily functioning and quality of life. The study is particularly relevant in South Africa, where there is a high prevalence of HIV and a lack of established protocols for managing NCI.

Who should consider this trial

Good fit: Ideal candidates for this study are HIV-positive individuals aged 30 to 50 who are fluent in Xhosa and currently on antiretroviral therapy.

Not a fit: Patients with significant neuro-medical comorbidities or other conditions that could affect cognitive functioning will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide effective cognitive strategies to improve the quality of life for people living with HIV who suffer from memory and thinking problems.

How similar studies have performed: While cognitive remediation strategies have been explored in other contexts, this specific approach for managing NCI in HIV-positive individuals is relatively novel.

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.

Where this trial is running

Cape Town, Western Cape and 2 other locations

• Michael Mapongwana Community Health Clinic — Cape Town, Western Cape, South Africa (Recruiting)
• TB HIV Care — Cape Town, Western Cape, South Africa (Completed)
• Nolungile Community Clinic — Cape Town, Western Cape, South Africa (Recruiting)

Study contacts

• Principal investigator: Hetta Gouse, PhD — University of Cape Town
• Study coordinator: Hetta Gouse, PhD

Conditions HIV-associated Neurocognitive Disorders