Utility of clinical parameters to identify HIV infection in infants below ten weeks of age in South Africa: a prospective cohort study
1 Children's Infectious Diseases Clinical Research Unit, Department of Paediatrics and Child Health and Centre for Infectious Diseases, Faculty of Health Sciences, Stellenbosch University, Tygerberg, South Africa
2 School of Child and Adolescent Health, University of Cape Town, Cape Town, South Africa
3 Children's Hospital and Regional Medical Centre, Department of Pediatrics, University of Washington, Seattle, WA, USA
4 Infectious Diseases Epidemiology Unit, School of Public Health & Family Medicine, University of Cape Town, Cape Town, South Africa & Department of Epidemiology, Mailman School of Public Health, Columbia University, USA
5 Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases; & MRC/WITS Respiratory and Meningeal Pathogens Research Unit; University of the Witwatersrand, Johannesburg, South Africa
6 Perinatal HIV research Unit, University of the Witwatersrand, Johannesburg, South Africa
7 Medical Research Council, Clinical Trials Unit, London. UK
8 Department of Molecular Medicine and Haematology, University of the Witwatersrand and National Health Laboratory Service, Johannesburg, South Africa
9 Seattle Biomedical Research Institute, 307 Westlake Ave S, Seattle WA 98109 or University of Cape Town Health Sciences Faculty, Anzio Rd Observatory, Cape Town 7925, South Africa
BMC Pediatrics 2011, 11:104 doi:10.1186/1471-2431-11-104Published: 21 November 2011
As HIV-infected infants have high mortality, the World Health Organization now recommends initiating antiretroviral therapy as early as possible in the first year of life. However, in many settings, laboratory diagnosis of HIV in infants is not readily available. We aimed to develop a clinical algorithm for HIV presumptive diagnosis in infants < 10 weeks old using screening data from the Children with HIV Early Antiretroviral therapy (CHER) study in South Africa.
HIV-infected and HIV-uninfected exposed infants < 10 weeks of age were identified through Vertical Transmission Prevention programs. Clinical and laboratory data were systematically recorded, groups were compared using Kruskal-Wallis, analysis of variance (ANOVA), and Fisher's exact tests. Receiver Operating Characteristic (ROC) curves were compiled using combinations of clinical findings.
417 HIV-infected and 125 HIV-exposed, uninfected infants, median age 46 days (IQR 38-55), were included. The median CD4 percentage in HIV-infected infants was 34 (IQR 28-41)%. HIV-infected infants had lower weight-for-age, more lymphadenopathy, oral thrush, and hepatomegaly than exposed uninfected infants (Adjusted Odds Ratio 0.51, 8.8, 5.6 and 23.5 respectively; p < 0.001 for all). Sensitivity of individual signs was low (< 20%) but specificity high (98-100%). If any one of oral thrush, hepatomegaly, splenomegaly, lymphadenopathy, diaper dermatitis, weight < 50th centile are present, sensitivity for HIV infection amongst HIV-exposed infants was 86%. These algorithms performed similarly when used to predict severe immune suppression.
A combination of physical findings is helpful in identifying infants most likely to be HIV-infected. This may inform management algorithms and provide guidance for focused laboratory testing in some settings, and should be further validated in these settings and elsewhere.