Evaluation of 3 approaches for assessing adherence to vaginal gel application in clinical trials. Accurate measurement of adherence to product use is an ongoing challenge in microbicide trials. We compared adherence estimates using 2 applicator tests (a dye stain assay [DSA] and an ultraviolet light assay [UVA]), the Wisebag (an applicator container that electronically tracks container openings), and self-reported adherence (ability, frequency, and percent missed doses). Healthy, HIV-negative, nonpregnant US women aged 23 to 45 years received a Wisebag and 32 applicators filled with placebo gel were instructed to insert 1 applicator daily for 30 days, returned the Wisebag and all applicators, and completed an exit interview. Emptied applicators were tested by UVA and then DSA, and scored by 2 blinded readers. Positive and negative controls were randomly included in applicator batches.
GlobalResearch at UCSF presents the broad scope of health research that is being conducted by UCSF researchers worldwide