Validation of CD4+ T-cell and viral load data from the HIV-Brazil Cohort Study using secondary system data

Abstract

Background: The HIV-Brazil Cohort Study (HIV-BCS) is a research primarily based on data collection from medical records of people living with HIV/AIDS in Brazil. The aim of this study was to present the validating design and results for the laboratory biomarkers viral load and CD4+ T-cell count from the HIV-Brazil Cohort Study. Methods: A total of 8007 patients who were started cART from 2003 to 2013 were considered eligible for this study. Total follow-up time was 32,397 years. The median duration of follow-up was 3.51 years (interquartile range - IQR 1.63-6.13 years; maximum 11.51 years). We used secondary data from the Brazilian Laboratory Tests Control System (SISCEL). Incidence of lab testing rates per 100 person years (100 py) were used to compare the number of laboratory tests carried out among cohort sites considering different databases for CD4+ T-cell counts and HIV viral load assessments. Descriptive statistics including 95% confidence interval, Pearson correlation coefficient, Bland-Altman agreement analysis and kappa coefficient agreement were applied for analysis. Results: A total of 80,302 CD4+ T-cell counts and 79,997 HIV viral load assessments were observed in HIV-BCS versus 94,083 CD4+ T-cell counts and 84,810 viral loads from the Brazilian Laboratory Tests Control System. The general CD4+ T-cell HIV-BCS testing rate was 247 per 100 py versus 290 per 100 py and the viral load HIV-BCS testing rate was 246 per 100 py versus 261 per 100 py. The general correlation observed for the lowest quantitative CD4+ T-cell count before cART was 0.970 (p < 0.001) and for the log of the highest viral load before cART was 0.971 (p < 0.001). The general agreement coefficient for categorized CD4+ T-cell count was 0.932 (p < 0.001) and for viral load was 0.996 (p < 0.001). Conclusions: The current study confirms that biomarkers CD4+ T-cell count and viral load from the HIV-BCS have a high correlation and agreement with data from SISCEL, rendering both databases reliable and useful for epidemiological studies on HIV care in Brazil.