title: Methodological lessons from clinical trials and the future of microbicide research.
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.
authors.affiliation: Women's Global Health Imperative, RTI International, 114 Sansome Street, Suite 500, San Francisco, CA 94104, USA. ariane@rti.org
authors.forename: Ariane
authors.initials: A
authors.lastname: van der Straten
authors.forename: Elizabeth T
authors.initials: ET
authors.lastname: Montgomery
authors.forename: Miriam
authors.initials: M
authors.lastname: Hartmann
authors.forename: Alexandra
authors.initials: A
authors.lastname: Minnis
mesh_terms: D000282:Administration, Intravaginal; D000890:Anti-Infective Agents / Q000008:administration & dosage*; D002986:Clinical Trials as Topic / Q000379:methods*; D005260:Female; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D016903:Drug Monitoring
chemical_list: D000890:Anti-Infective Agents