BACKGROUND: The reliability and validity of self-reports of vaginal microbicide use are questionable given the explicit understanding that participants are expected to comply with study protocols. Our objective was to optimize the use of Population Council's previously validated dye stain assay (DSA) and related procedures, and to establish predictive values for the DSAs ability to identify vaginally inserted single-use, low-density polyethylene microbicide applicators filled with hydroxyethylcellulose gel. METHODS: Applicators, inserted by 252 female sex workers enrolled in a microbicide feasibility study in Southern India, served as positive controls for optimization and validation experiments. Before validation, optimal dye concentration and staining time were ascertained. Three validation experiments were conducted to determine sensitivity, specificity, and negative and positive predictive values. RESULTS: The dye concentration of 0.05% (wt/vol) FD&C Blue No. 1 Granular Food Dye (Prime Ingredients, Inc, Saddlebrook, NJ) and staining time of 5 seconds were determined to be optimal and were used for the 3 validation experiments. There were a total of 1848 possible applicator readings across validation experiments; 1703 (92.2%) applicator readings were correct. On average, the DSA performed with 90.6% sensitivity, 93.9% specificity, and had a negative predictive value of 93.8% and a positive predictive value of 91.0%. No statistically significant differences between experiments were noted. CONCLUSIONS: The DSA was optimized and successfully validated for use with single use, low-density polyethylene applicators filled with hydroxyethylcellulose gel. We recommend including the DSA in future microbicide trials involving vaginal gels so as to identify participants who have low adherence to dosing regimens. In doing so, we can develop strategies to improve adherence as well as investigate the association between product use and efficacy.
BACKGROUND: The reliability and validity of self-reports of vaginal microbicide use are questionable given the explicit understanding that participants are expected to comply with study protocols. Our objective was to optimize the use of Population Council's previously validated dye stain assay (DSA) and related procedures, and to establish predictive values for the DSAs ability to identify vaginally inserted single-use, low-density polyethylene microbicide applicators filled with hydroxyethylcellulose gel. METHODS: Applicators, inserted by 252 female sex workers enrolled in a microbicide feasibility study in Southern India, served as positive controls for optimization and validation experiments. Before validation, optimal dye concentration and staining time were ascertained. Three validation experiments were conducted to determine sensitivity, specificity, and negative and positive predictive values. RESULTS: The dye concentration of 0.05% (wt/vol) FD&C Blue No. 1 Granular Food Dye (Prime Ingredients, Inc, Saddlebrook, NJ) and staining time of 5 seconds were determined to be optimal and were used for the 3 validation experiments. There were a total of 1848 possible applicator readings across validation experiments; 1703 (92.2%) applicator readings were correct. On average, the DSA performed with 90.6% sensitivity, 93.9% specificity, and had a negative predictive value of 93.8% and a positive predictive value of 91.0%. No statistically significant differences between experiments were noted. CONCLUSIONS: The DSA was optimized and successfully validated for use with single use, low-density polyethylene applicators filled with hydroxyethylcellulose gel. We recommend including the DSA in future microbicide trials involving vaginal gels so as to identify participants who have low adherence to dosing regimens. In doing so, we can develop strategies to improve adherence as well as investigate the association between product use and efficacy.
Authors: Deborah Tien; Roger L Schnaare; Feirong Kang; Gina Cohl; Timothy J McCormick; Thomas R Moench; Gustavo Doncel; Karen Watson; Robert W Buckheit; Mark G Lewis; Jill Schwartz; Karen Douville; Joseph W Romano Journal: AIDS Res Hum Retroviruses Date: 2005-10 Impact factor: 2.205
Authors: Barbara S Mensch; Paul C Hewett; Sharon Abbott; Johanna Rankin; Sarah Littlefield; Khatija Ahmed; Nazira Cassim; Smruti Patel; Gita Ramjee; Thesla Palanee; Stan Mierzwa; Stephanie Skoler-Karpoff Journal: AIDS Behav Date: 2011-02
Authors: Jill L Schwartz; Christine Mauck; Jaim-Jou Lai; Mitchell D Creinin; Vivian Brache; Susan A Ballagh; Debra H Weiner; Sharon L Hillier; Raina N Fichorova; Marianne Callahan Journal: Contraception Date: 2006-05-02 Impact factor: 3.375
Authors: Andrea R Wallace; Aaron Teitelbaum; Livia Wan; Maria Gloria Mulima; Laura Guichard; Stephanie Skoler; Stephanie Skiler; Hlengiwe Vilakazi; Fridda S Mapula; Jasmine Rossier; Sumen N Govender; Pekka Lahteenmaki; Robin A Maguire; David M Phillips Journal: Contraception Date: 2007-05-11 Impact factor: 3.375
Authors: Ariane van der Straten; Elizabeth T Montgomery; Miriam Hartmann; Alexandra Minnis Journal: Curr HIV/AIDS Rep Date: 2013-03 Impact factor: 5.071
Authors: Sharon A Abbott; Barbara A Friedland; Avina Sarna; Lauren L Katzen; Ulrike Rawiel; Aylur K Srikrishnan; C S Shalini; Waimar Tun; Christine A Kelly; Suniti Solomon; Barbara S Mensch Journal: AIDS Behav Date: 2013-07
Authors: Ariane van der Straten; Elizabeth Montgomery; Diantha Pillay; Helen Cheng; Anushka Naidoo; Zakhele Cele; Kalendri Naidoo; Miriam Hartmann; Jeanna Piper; Gonasagrie Nair Journal: AIDS Behav Date: 2013-02
Authors: Wutyi S Aung; Rahul P Bakshi; Jennifer Breakey; James E Johnson; Craig W Hendrix; Ethel Weld; Edward J Fuchs; Mark A Marzinke Journal: AIDS Behav Date: 2019-01
Authors: Anke Hemmerling; William G Harrison; Joelle Morgan Brown; Barbara Moscicki; Maria Oziemkowska; Elizabeth A Bukusi; Craig R Cohen Journal: Sex Transm Dis Date: 2012-09 Impact factor: 2.830
Authors: Ariane van der Straten; Helen Cheng; Barbara Mensch; Barbara Friedland; Lauren Katzen; Sarah Littlefield; Niall Buckley; Lilia Espinoza; Marla J Keller; Betsy C Herold; Mark H Einstein Journal: Sex Transm Dis Date: 2013-12 Impact factor: 2.830
Authors: Marla J Keller; Niall Buckley; Lauren L Katzen; Jennifer Walsh; Barbara Friedland; Sarah Littlefield; Juan Lin; Xiaonan Xue; Terri Cornelison; Betsy C Herold; Mark H Einstein Journal: Sex Transm Dis Date: 2013-12 Impact factor: 2.830
Authors: Marla J Keller; Colleen A Carpenter; Yungtai Lo; Mark H Einstein; Congzhou Liu; David N Fredricks; Betsy C Herold Journal: PLoS One Date: 2012-10-08 Impact factor: 3.240
Authors: Terry A Jacot; Ashley Nelson; Andrea Thurman; Angela D M Kashuba; David F Archer; Gustavo F Doncel Journal: PLoS One Date: 2014-12-09 Impact factor: 3.240