Implementation of a rapid diagnostic assay package for Cryptococcosis, Histoplasmosis and Tuberculosis in People Living with HIV in Paraguay

Abstract Background Opportunistic infections (OIs) are common causes of mortality among people living with HIV (PLHIV). We determined prevalence and 30-day mortality due to histoplasmosis, cryptococcosis, and TB in PLHIV with advanced HIV disease (AHD). Methods PLHIV 18 years and older, not receiving ART with advanced HIV were enrolled and followed for 30 days. Detection of Histoplasma Ag (HisAg) in urine was done by enzyme immunoassay (EIA), Cryptococcus antigen (CrAg) was detected in serum and cerebrospinal fluid (CSF) specimens by lateral flow assay (LFA), and lipoarabinomannan (LAM) detection in urine was by LFA (TB LAM) and in sputum by GeneXpert for diagnosis of Mycobacterium infections. Results From August 2021 to June 2022, 491 PLHIV were enrolled; 482 (98%) had a CD4 result, and 381 patients (79%) were classified with AHD according to CD4 cell count (< 200 CD4/mm 3 ). Frequency of an OI was 38% (n = 145/381). Antigen test positivity rate was 16% (72/467) for TB-LAM, 9% (43/464) for HisAg, and 11% (51/484) for CrAg. Twenty-one of 34 (62%) patients receiving CSF CrAg tests were positive, confirming meningitis. Significant differences in 30-day mortality were observed in patients with an OI (16%) vs no OI (7%) ( p = 0.002). Mortality was highest in patients with histoplasmosis (25%), co-infection (22%), cryptococcosis (18% overall; 19% for cryptococcal meningitis), and TB (10%). Conclusions TB and fungal (OIs), including co-infection, were common in PLHIV in Paraguay and had high associated mortality. Laboratories and health facilities need access to CD4 testing and rapid diagnostic assays.