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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Determining the feasibility of utilizing the microbicide applicator compliance assay for use in clinical trials
Contraception, Volume 76, No. 1, Year 2007
Notification
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Description
Introduction: Participant's adherence to use of study product is a major concern in microbicide clinical trials, which can impact on proving product efficacy. In a previously described assay, single-use microbicide applicators exposed to the vagina were tested by spraying the applicator with trypan blue dye, resulting in vaginal mucus staining on inserted applicators. As subjects in our Phase 3 trials return applicators only at quarterly visits, often mixing inserted and not-inserted applicators together in the same bag, cross-contamination could confound results. In addition, trypan blue is carcinogenic and thus potentially hazardous to technicians spraying daily. Methods: Applicators that were exposed to the vagina were placed in the same bag as unexposed applicators and shaken daily for up to 4 months. Validation was carried out in three clinical sites in South Africa. Results: Trypan blue was replaced with FD&C Blue #1 granular food dye. Cross-contamination did not occur, nor did the length of time affect reaction to dye. In South Africa, the assay was validated with an accuracy of over 95%. Conclusion: Applicator assay modifications render the test safe and suitable for use in clinical trials. © 2007 Elsevier Inc. All rights reserved.
Authors & Co-Authors
Wallace, Andrea R.
United States, New York
The Population Council, Inc.
Teitelbaum, Aaron
United States, New York
The Population Council, Inc.
Wan, Livia
United States, New York
Nyu Grossman School of Medicine
Mulima, Maria Gloria
United States, New York
Nyu Grossman School of Medicine
Guichard, Laura
United States, New York
The Population Council, Inc.
Skiler, Stephanie
United States, New York
The Population Council, Inc.
Vilakazi, Hlengiwe
South Africa, Tygerberg
South African Medical Research Council
Mapula, Fridda S.
South Africa, Pretoria
Setshaba Research Centre
Rossier, Jasmine
South Africa, Cape Town
University of Cape Town
Govender, Sumen N.
South Africa, Johannesburg
Population Council, Johannesburg
Lähteenmäki, Pekka L.A.
South Africa, Johannesburg
Population Council, Johannesburg
Maguire, Robin A.
United States, New York
The Population Council, Inc.
Phillips, David M.
United States, New York
The Population Council, Inc.
Statistics
Citations: 52
Authors: 13
Affiliations: 6
Identifiers
Doi:
10.1016/j.contraception.2006.10.012
ISSN:
00107824
Research Areas
Food Security
Study Locations
South Africa