Clinical parameters essential to methodology and interpretation of mucosal responses

Research aimed at putting an end to the HIV pandemic is dynamic given the marked advances in understanding of pathogenesis since its origin. Attention has shifted from systemic management of disease to a focus on the most common site of acquisition, the female genital tract. Research on the female genital tract of humans requires consideration of a number of specific clinical parameters. If such parameters are not considered when enrolling subjects into studies, it could lead to faulty data ascertainment. This article reviews important clinical characteristics to consider when conducting studies of the human female genital tract in regard to mucosal immunity and HIV disease. Important topics to consider include the method and source of sample collection, the individual patient characteristics, and in the case of recruitment of HIV-infected women, HIV disease characteristics.