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Review
. 2013 Mar;10(1):89-102.
doi: 10.1007/s11904-012-0141-9.

Methodological lessons from clinical trials and the future of microbicide research

Ariane van der Straten  1 , Elizabeth T Montgomery, Miriam Hartmann, Alexandra Minnis
Affiliations
Review

Methodological lessons from clinical trials and the future of microbicide research

Ariane van der Straten et al. Curr HIV/AIDS Rep. 2013 Mar.

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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