Application of a composite measure of product adherence, protocol compliance, and semen exposure to a phase III microbicide HIV prevention trial

Abstract Background Strict adherence to antiretroviral-based microbicide use is important for effective HIV prevention. We previously developed a composite measure of product adherence, protocol compliance, and semen exposure determining vaginal tenofovir (TFV) 1% gel applicators through biomarkers residual drug analyses. In this study, we tested the ability in vaginally used TFV from Phase III prevention clinical trial. Methods Used FACTS 001 study were swabbed detection bacterial markers (vaginal insertion), DNA (semen exposure), (product use). Results Of 1,098 evaluable placebo applicators, 80% had detectable insertion 52% biomarkers. Ninety-nine percent inserted as measured by liquid chromatography with tandem mass spectroscopy (LC–MS/MS). Residual levels also successfully detected using Fourier Transform Infrared (FTIR)-based spectroscopy. Conclusions Vaginal on applicators. these was LC–MS/MS FTIR-based spectroscopy, which has potential be more convenient quicker method detecting use. With continual improvements, assess not only but other topical microbicides or products.