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Methodological Lessons from Clinical Trials and the Future of Microbicide Research

  • The Science of Prevention (S Kalichman, Section Editor)
  • Published:
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Abstract

Interpretation of microbicide trial results has been compromised by challenges to accurate measurement of product adherence and sexual risk behaviors. This article provides an evaluation of the methods used to measure adherence and other sensitive behaviors relevant to assessment of product safety and effectiveness in recently completed trials of vaginal and rectal microbicides. We review the strengths and limitations of existing and novel behavioral measurement strategies and provide recommendations for future trial design with the goal of facilitating the development and identification of safe and effective microbicides for HIV prevention.

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Notes

  1. Microbicide Trials Network statements on decision to discontinue use of oral Tenofovir tablets and Tenofovir gel in VOICE, a major HIV prevention study in women. http://www.mtnstopshiv.org/node/3909: Microbicide Trials Network; 2011. Note that the oral Truvada and placebo arms continued and were completed on schedule in August 2012 (http://www.mtnstopshiv.org/studies/70).

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Acknowledgments

The authors would like to thank the International Partnership for Microbicides (IPM) and Drs. Sue Napierala Mavedzenge and Christine Mauck for their review of an earlier version of the manuscript. Support for preparation of this manuscript was provided in part by a Professional Development Award from RTI International, for Ariane van der Straten. Alexandra Minnis’s contributions to the manuscript were supported by the Eunice Kennedy Shriver National Institutes of Child Health and Human Development at the National Institutes of Health (K01 HD047434). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of RTI or of the NIH. Drs. van der Straten, Minnis and Montgomery are members of the Behavioral Research Working Group of the Microbicide Trial Network. Dr. van der Straten is Co-Investigator on the VOICE and ASPIRE trials and Dr. Minnis on the MTN-001 trial. Dr. van der Straten conceived the idea and led the writing of this manuscript. All authors wrote at least 1 section of the manuscript and contributed to editing and modifying the content of the manuscript as a whole.

Disclosure

A. van der Straten: none; E. T. Montgomery: none; M. Hartmann: none; A. Minnus: conference travel and accommodations from Microbicides Trial Network.

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Authors and Affiliations

  1. Women’s Global Health Imperative, RTI International, 114 Sansome Street, Suite 500, San Francisco, CA, 94104, USA

    Ariane van der Straten, Elizabeth T. Montgomery, Miriam Hartmann & Alexandra Minnis

  2. Center for AIDS Prevention Studies, Department of Medicine, University of California San Francisco, San Francisco, USA

    Ariane van der Straten

  3. School of Public Health, University of California Berkeley, Berkeley, USA

    Alexandra Minnis

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  1. Ariane van der Straten
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  4. Alexandra Minnis
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Correspondence to Ariane van der Straten.

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van der Straten, A., Montgomery, E.T., Hartmann, M. et al. Methodological Lessons from Clinical Trials and the Future of Microbicide Research. Curr HIV/AIDS Rep 10, 89–102 (2013). https://doi.org/10.1007/s11904-012-0141-9

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