Open AccessTrypan Blue Staining to Determine Vaginal Exposure in Two Types of Plastic Vaginal Applicators Containing Two Different Microbicide Formulations
Author(s) -
Anke Hemmerling,
W. G. Harrison,
Joelle Brown,
Barbara Moscicki,
Maria Oziemkowska,
Elizabeth A. Bukusi,
Craig R. Cohen
Publication year - 2012
Publication title -
sexually transmitted diseases
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.507
H-Index - 105
eISSN - 1537-4521
pISSN - 0148-5717
DOI - 10.1097/olq.0b013e3182641f08
Subject(s) - microbicide , medicine , staining , trypan blue , intravaginal administration , vaginal microbicide , vagina , microbicides for sexually transmitted diseases , surgery , population , human immunodeficiency virus (hiv) , pathology , virology , cell , health services , genetics , environmental health , biology
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.