Abstract
ObjectiveMany studies include oral HIV-related endpoints that may be diagnosed by non-oral-health specialists (non-OHS) like nurses or physicians. Our objective was to assess the accuracy of clinical diagnoses of HIV-related oral lesions made by non-OHS compared to diagnoses made by OHS.MethodsA5254, a cross-sectional study conducted by the Oral HIV/AIDS Research Alliance within the AIDS Clinical Trial Group, enrolled HIV-1-infected adults participants from six clinical trial units (CTU) in the US (San Francisco, New York, Chapel Hill, Cleveland, Atlanta) and Haiti. CTU examiners (non-OHS) received standardized training on how to perform an oral examination and make clinical diagnoses of specific oral disease endpoints. Diagnoses by calibrated non-OHS were compared to those made by calibrated OHS, and sensitivity and specificity computed.ResultsAmong 324 participants, the majority were black (73%), men (66%), and the median CD4+ cell count 138 cells/mm3. The overall frequency of oral mucosal disease diagnosed by OHS was 43% in US sites, and 90% in Haiti. Oral candidiasis (OC) was detected in 153 (47%) by OHS, with erythematous candidiasis (EC) the most common type (39%) followed by pseudomembranous candidiasis (PC; 26%). The highest prevalence of OC (79%) was among participants in Haiti, and among those with CD4+ cell count ≤ 200 cells/mm3 and HIV-1 RNA > 1000 copies/mL (71%). The sensitivity and specificity of OC diagnoses by non-OHS were 90% and 92% (for EC: 81% and 94%; PC: 82% and 95%). Sensitivity and specificity were also high for KS (87% and 94%, respectively), but sensitivity was < 60% for HL and oral warts in all sites combined. The Candida culture confirmation of OC clinical diagnoses (as defined by ≥ 1 colony forming unit per mL of oral/throat rinse) was ≥ 93% for both PC and EC.ConclusionTrained non-OHS showed high accuracy of clinical diagnoses of OC in comparison with OHS, suggesting their usefulness in studies in resource-poor settings, but detection of less common lesions may require OHS.
Highlights
Since the beginning of the AIDS epidemic, much has been learned about human immunodeficiency virus (HIV)-related oral mucosal diseases
A5254, a cross-sectional study conducted by the Oral HIV/AIDS Research Alliance within the AIDS Clinical Trial Group, enrolled HIV-1-infected adults participants from six clinical trial units (CTU) in the US (San Francisco, New York, Chapel Hill, Cleveland, Atlanta) and Haiti
The Oral HIV/AIDS Research Alliance (OHARA) was created in 2006 to partner with the AIDS Clinical Trials Group (ACTG) Network, which plays a major role in defining the standards of care for treatment of HIV infection and related opportunistic infections.[22]
Summary
Since the beginning of the AIDS epidemic, much has been learned about human immunodeficiency virus (HIV)-related oral mucosal diseases. The occurrence of oral candidiasis (OC) and hairy leukoplakia (HL), the most common HIV-related oral diseases, are strongly associated with a low CD4+ cell count [1,2,3,4,5,6,7] and a higher plasma viral load.[6,8] Even though the prevalence of OC, HL, and Kaposi’s sarcoma (KS) has been found to be lower among patients on antiretroviral therapy (ART),[9,10,11,12,13,14,15,16,17,18] oral warts [19,20,21] and salivary gland disease [19] have not decreased. The OHARA infrastructure comprises: the Epidemiologic/Clinical Sciences Research Unit at the University of California San Francisco (UCSF), the Medical Mycology Unit at Case Western Reserve University, and the Virology Research Unit at the University of North Carolina Chapel Hill (UNC-CH)
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