Performance of Clinical Algorithms for HIV-1 Diagnosis and Antiretroviral Initiation Among HIV-1-Exposed Children Aged Less Than 18 Months in Kenya

Department of Paediatrics, Kenyatta National Hospital, Hospital Road, Box 29720, Nairobi 00202, Kenya. .
JAIDS Journal of Acquired Immune Deficiency Syndromes (Impact Factor: 4.56). 03/2009; 50(5):492-8. DOI: 10.1097/QAI.0b013e318198a8a4
Source: PubMed


Ninety percent of HIV-1-infected children live in sub-Saharan Africa. In the absence of diagnosis and antiretroviral therapy, approximately 50% die before 2 years.
We evaluated sensitivity and specificity of clinical algorithms for diagnosis of HIV-1 infection and antiretroviral therapy initiation among HIV-1-exposed children aged less than 18 months. Children were identified with routine HIV-1 testing and assessed using 3 sets of criteria: (1) Integrated Management of Childhood Illnesses (IMCI), (2) World Health Organization Presumptive Diagnosis (WHO-PD) for HIV-1 infection, and (3) CD4 T-lymphocyte cell subsets. HIV-1 infection status was determined using DNA polymerase chain reaction testing.
A total of 1418 children (median age 5.4 months) were screened for HIV-1 antibodies, of whom 144 (10.2%) were seropositive. Of these, 134 (93%) underwent HIV-1 DNA testing and 80 (60%) were found to be HIV-1 infected. Compared with HIV-1 DNA testing, sensitivity and specificity of the IMCI criteria were 19% and 96% and for WHO-PD criteria 43% and 88%, respectively. Inclusion of severe immune deficiency determined by CD4% improved sensitivity of IMCI and WHO-PD criteria to 74% and 84%, respectively; however, specificity declined to 43% and 41%, respectively.
Diagnosis of HIV-1 infection among exposed children less than 18 months in a high-prevalence resource-limited setting remains a challenge, and current recommended algorithms have low sensitivity. This underscores the need for rapid scale-up of viral assays for early infant diagnosis.

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    • "The median age of infants starting ART in 2010 was 5.6 months which is well above the median age of <2 months in the immediate arm of the CHER Study. There are a number of barriers to early ART initiation including lack of access to HIV-DNA PCR testing for diagnosis [24], [47], [48], [49], poor integration of antenatal, PMTCT, maternal and child health (MCH) and HIV services with poor infant HIV testing even among those whose mothers enrolled in PMTCT care [50], lack of expertise, experience and confidence with initiating and maintaining infants on ART and poor availability of drugs in suitable formulations for infants [4], [51]. Strategies to improve ART access for infants such as integration of PMTCT, MCH and HIV services and provider initiated testing at vaccination and other health visits [45], [52], [53], [54] need to be developed and expanded. "
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    • "This finding highlights the fact that the diagnosis of HIV in infants cannot efficiently rely on clinical manifestations. Although clinical and immunologic criteria can be used for presumptive diagnosis of HIV infection for the purpose of ART initiation [31], they have low sensitivity and specificity [32, 33] and clinical manifestations of HIV infection can be difficult to distinguish from those of other prevalent conditions in uninfected children such as malnutrition and tuberculosis [32]. "
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    • "More sophisticated molecular biologic tests such as those using polymerase chain reaction (PCR) technology are needed to distinguish HIV infected from HIV exposed but uninfected children during the first 1-2 years of life [7-9]. Clinical and immunologic criteria can be used for presumptive diagnosis of HIV infection for the purpose of starting ART [10], but these have low sensitivity and specificity [11,12] and symptoms of HIV infection can be difficult to distinguish from those of other prevalent conditions in uninfected children such as malnutrition and tuberculosis. "
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