Trypan blue staining to determine vaginal exposure in two types of plastic vaginal applicators containing two different microbicide formulations.
Dye staining of applicators has been shown to be a reliable and objective method to test vaginal insertion in clinical microbicide trials, but different plastics, dyes, and product formulations may impact the accuracy of this method. Reportedly used applicators returned from 3 clinical trials were stained with 1% trypan blue. In a phase 1 study (VivaGel), using gel-filled HTI polypropylene applicators, 1271 (97%) of applicators stained positive. In a phase 1 and a phase 2a study (LACTIN-V) using linear low-density polyethylene applicators to deliver a dry powder formulation, 57 (95%) and 135 (86%) tested positive, respectively. Dye staining of vaginal applicators is an objective low-cost measure suitable for low-resource settings.
Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California at San Francisco, San Francisco, CA 94105, USA. ahemmerling@globalhealth.ucsf.edu
Anke
A
Hemmerling
William G
WG
Harrison
Joelle Morgan
JM
Brown
Barbara
B
Moscicki
Maria
M
Oziemkowska
Elizabeth A
EA
Bukusi
Craig R
CR
Cohen
D000163:Acquired Immunodeficiency Syndrome / Q000517:prevention & control*; D000282:Administration, Intravaginal; D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage*; D004396:Coloring Agents / Q000494:pharmacology*; D016503:Drug Delivery Systems / Q000295:instrumentation*; D005260:Female; D006801:Humans; D020959:Polyethylene; D011126:Polypropylenes; D013194:Staining and Labeling; D013499:Surface Properties; D014343:Trypan Blue / Q000494:pharmacology*; D014621:Vagina / Q000737:chemistry; D016903:Drug Monitoring
D000890:Anti-Infective Agents; D004396:Coloring Agents; D011126:Polypropylenes; D020959:Polyethylene; D014343:Trypan Blue