Methods of the parent study
neurosyphilis, cognitive impairment, traumatic brain injury
ACQUIRED IMMUNE DEFICIENCY SYNDROME, NEUROSYPHILIS, VITAMIN B12 DEFICIENCY
Study participants were recruited from the Nolungile Site C clinic in Khayelitsha and followed up at Groote Schuur Hospital. The inclusion criteria were: ≥ 18 and ≤ 70 years, cognitive impairment defined by the GDS of ≥ 0.5, uninterrupted ART treatment for at least 6 months a plasma HIV RNA < 400 copies/ml. The exclusion criteria were participants taking lithium within 30 days of entering the study, acquired immune deficiency syndrome, history of substance use including benzodiazepines, presence of neurosyphilis, vitamin B12 deficiency, abnormal brain imaging results, and the presence of traumatic brain injury. In the end, the study recruited 66 patients. The participants were randomly assigned to a placebo arm = 34 (31 completed) and a lithium arm = 32 (30 completed). Demographic data and other outcome measures such as the GDS and blood and CSF biomarkers were collected during the first visit and at the end of the clinical trial. The clinical trial received ethical approval from the universities of Cape Town (071/2013) and Stellenbosch (M13/07/027). The registration number of the trial is PACTR201310000635418.