Information regarding socio-demographic characteristics and general health-related variables, such as history of AIDS-related illnesses and current medications, were collected using a questionnaire administered during the study visit.
An extra-oral examination of the major salivary glands, and oral mucosal examination were performed by both a CTU examiner (non-OHS) and an OHS on each participant. Both examiners recorded their findings including descriptors of lesions with respect to location, color, and character, and a presumptive diagnosis. Examiners were blinded to each other’s findings. Oral disease endpoints explored included PC; EC; AC; HL; herpes labialis; recurrent intra-oral herpes simplex; warts; recurrent aphthous stomatitis; necrotizing gingivitis/periodontitis; necrotizing stomatitis; KS; non-Hodgkin’s lymphoma; squamous cell carcinoma; and salivary gland disease (as defined by presence/absence of parotid enlargement). A 5-minute unstimulated whole saliva (UWS) flow rate was recorded, and collected. A 1-minute oral rinse/throat wash using 10 mL of sterile saline was also collected. Both saliva and throat wash specimens were processed, frozen in aliquots at minus 80°C at the site laboratory, and shipped to the UNC-CH specimen bank unit. Before, the throat wash was processed at the sites, 2.5 mL was extracted and cultured for the presence of Candida. A blood draw was performed at the time of the visit for CD4+ cell count and plasma HIV-1 viral load to be measured. The CD4+ cell count and the HIV-1 viral load assay were performed in a CLIA certified laboratory for US sites, and in a laboratory certified for protocol testing by the DAIDS Immunology Quality Assurance (IQA) Program for the Haiti site. Plasma HIV-1 viral load were performed utilizing the Abbott Realtime HIV-1 Assay.
An extra-oral examination of the major salivary glands, and oral mucosal examination were performed by both a CTU examiner (non-OHS) and an OHS on each participant. Both examiners recorded their findings including descriptors of lesions with respect to location, color, and character, and a presumptive diagnosis. Examiners were blinded to each other’s findings. Oral disease endpoints explored included PC; EC; AC; HL; herpes labialis; recurrent intra-oral herpes simplex; warts; recurrent aphthous stomatitis; necrotizing gingivitis/periodontitis; necrotizing stomatitis; KS; non-Hodgkin’s lymphoma; squamous cell carcinoma; and salivary gland disease (as defined by presence/absence of parotid enlargement). A 5-minute unstimulated whole saliva (UWS) flow rate was recorded, and collected. A 1-minute oral rinse/throat wash using 10 mL of sterile saline was also collected. Both saliva and throat wash specimens were processed, frozen in aliquots at minus 80°C at the site laboratory, and shipped to the UNC-CH specimen bank unit. Before, the throat wash was processed at the sites, 2.5 mL was extracted and cultured for the presence of Candida. A blood draw was performed at the time of the visit for CD4+ cell count and plasma HIV-1 viral load to be measured. The CD4+ cell count and the HIV-1 viral load assay were performed in a CLIA certified laboratory for US sites, and in a laboratory certified for protocol testing by the DAIDS Immunology Quality Assurance (IQA) Program for the Haiti site. Plasma HIV-1 viral load were performed utilizing the Abbott Realtime HIV-1 Assay.
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