Background: Depression is associated with worse outcomes in persons living with HIV/AIDS and has a prevalence more than three times as high as in the general population. Despite this, there are few randomized studies of antidepressants in HIV-infected Africans. Methods: We enrolled 460 HIV-infected Africans with cryptococcal meningitis into a randomized clinical trial of adjunctive sertraline vs placebo (2015-2017). We screened for clinical depression using the Center for Epidemiologic Studies Depression Scale (CES-D) at one and three months after meningitis diagnosis and initiation of treatment. We evaluated the relationship between sertraline and depression, as well as associations with persistent depression, at three months. Results: At one- and three-months post meningitis diagnosis, 62% (108/174) and 44% (74/169) of all subjects had depression (CES>15), respectively. At three months, sertraline-treated subjects were non-significantly more likely to be depressed than placebo-treated subjects (64% vs 37%, p=0.09) but were significantly less likely to have severe depression (CES>26) (OR 0.335; 95%CI, 0.130-0.865). Of those with depression at one month, sertraline-treated subjects were less likely than placebo-treated subjects to be depressed at three months (p=0.05). Sertraline was the only factor we found significant in predicting persistent depression at three months among those who had depression at one month. Conclusions: Depression is highly prevalent in HIV-infected persons who have survived cryptococcal meningitis. We found that sertraline is associated with a modest reduction in depression in those with depression at baseline and a significant reduction in severe depression.

1=male , 2=female 1=on ART, 2=not on ART 1=GCS < 15, 2=GCS = 15 GCS= Glascow Coma Scale ART=Antiretroviral Therapy CSF= Cerebral Spinal Fluid LP= Lumbar Punctures CESD= Center for Epidemiological Studies Depression Scale The underscore than numbers is a time. _000 means baseline. CSF WBCs are <5 or 5+ Sterile14= sterile CSF culture at 14 weeks Sterile18= sterile CSF culture at 18 weeks CESD4 means CESD numeric score at 4 weeks post diagnosis with Cryptococcal Meningitis CESD12 is CESD score at 12 weeks vnum= visit number

Using DataFax SAS was used to combine CRFs into a unified dataset