Abstract
We evaluated the adherence and acceptability of a vaginal ring containing dapivirine, maraviroc, or both drugs for 28 days during a Phase I placebo-controlled trial in 48 HIV-negative sexually abstinent U.S. women aged 18–40. Adherence was assessed weekly by clinical interview and computer-assisted self-interviewing; acceptability assessment occurred at the last product-use visit. Study retention was 98 % (47/48); 94 % (45/48) reported being fully adherent with ring use during the 28-day period. Two participants experienced the ring partially coming out. Analysis was blinded and behavioral data were combined across study groups. Most women reported being very comfortable having the ring in their vagina; 44 % preferred continuous use, whereas 51 % had no preference compared to episodic use. Although a range of minor ring concerns were expressed, few were actually experienced. High adherence to and acceptability of this vaginal ring in this Phase I trial contributes to its promise as a sustained mechanism for multidrug vaginal microbicide delivery.
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Notes
The link to the vaginal ring use instructions sheet provided to participants is http://www.mtnstopshiv.org/sites/default/files/attachments/Section%209%20-Study%20Product%20Considerations%20-%20Version%201.0%2002Sept11.pdf (Section. 9.1).
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Acknowledgements
We would like to acknowledge the women who participated in this study and to extend special thanks to the clinical research sites’ teams in Pittsburgh, PA, Birmingham, AL, and Boston, MA. The full MTN-013/IPM 026 study team can be viewed at http://www.mtnstopshiv.org/studies/2241. The study was designed and implemented by the Microbicide Trials Network (MTN). The MTN is funded by the National Institute of Allergy and Infectious Diseases (UM1AI068633, UM1AI068615, UM1AI106707), with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The International Partnership for Microbicides (IPM), IND sponsor, supplied the products used in this study [Dapivirine vaginal ring (VR), maraviroc VR, maraviroc/dapivirine VR, placebo VR].
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On behalf of the MTN-013/IPM 026 Protocol Team for the Microbicide Trials Network.
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van der Straten, A., Panther, L., Laborde, N. et al. Adherence and Acceptability of a Multidrug Vaginal Ring for HIV Prevention in a Phase I Study in the United States. AIDS Behav 20, 2644–2653 (2016). https://doi.org/10.1007/s10461-016-1299-8
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DOI: https://doi.org/10.1007/s10461-016-1299-8