ArticleSexually transmitted diseases2011
Validation of a dye stain assay for vaginally inserted hydroxyethylcellulose-filled microbicide applicators.
Article in Sexually transmitted diseases, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
13 citing papers in PubMed, 22 citations in OpenAlex.
- Baseline Predictors of High Adherence to a Coitally Dependent Microbicide Gel Based on an Objective Marker of Use: Findings from the Carraguard Phase 3 Trial.AIDS and behavior · 2016Trial
- An evaluation of methods to improve the reporting of adherence in a placebo gel trial in Andhra Pradesh, India.AIDS and behavior · 2013Trial
- Feasibility, performance, and acceptability of the Wisebag™ for potential monitoring of daily gel applicator use in Durban, South Africa.AIDS and behavior · 2013Trial
- Phase I randomized safety study of twice daily dosing of acidform vaginal gel: candidate antimicrobial contraceptive.PloS one · 2012Trial
- Randomized trial of multi-strainContemporary clinical trials communications · 2025Article
- Vaginal progesterone to prevent preterm delivery among HIV-infected pregnant women in Zambia: A feasibility study.PloS one · 2020Article
- Fecal Coliform Bacterial Detection to Assess Enema Adherence in HIV Prevention Clinical Studies.AIDS and behavior · 2019Article
- Article
- Use of the dye stain assay and ultraviolet light test for assessing vaginal insertion of placebo-filled applicators before and after sex.Sexually transmitted diseases · 2013Article
- Evaluation of 3 approaches for assessing adherence to vaginal gel application in clinical trials.Sexually transmitted diseases · 2013Article
- Methodological lessons from clinical trials and the future of microbicide research.Current HIV/AIDS reports · 2013Review
- Trypan blue staining to determine vaginal exposure in two types of plastic vaginal applicators containing two different microbicide formulations.Sexually transmitted diseases · 2012Article
- Assessment of a Microbicide Candidate among a Diverse Cohort of Urban Southern US Women and their Male Sexual Partners.Journal of AIDS & clinical research · 2012Article
Corrections and comments
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Authors and funding
7 authors at 3 institutions in 2 countries.
Funding
Abstract
backgroundThe 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.
methodsApplicators, 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.
resultsThe 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.
conclusionsThe 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.
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Registered trials
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