title: Adherence and its measurement in phase 2/3 microbicide trials.
abstract: Adherence optimization and measurement have emerged as critically challenging issues for clinical trials of topical microbicides. Although microbicide trials have routinely collected adherence data, their utilization in trial design, implementation, and interpretation has been inconsistent. Drawing on data-driven presentations from several focused meetings, this paper synthesizes lessons from past microbicide trials and provides recommendations for future trials of microbicide and other HIV prevention technologies. First, it describes four purposes for adherence data collection, with particular attention to intention-to-treat versus adherence-adjusted analyses for determining effectiveness. Second, the microbicide field's experiences with adherence measures and data collection modes are discussed, including the strengths and weaknesses of various options and approaches for improving measurement. Then, several approaches to optimizing trial participants' adherence are presented. The paper concludes with a set of recommendations for immediate use or further research.
authors.affiliation: Behavioral and Biomedical Research Department, Health and Development Sciences, Family Health International, Durham, NC 27319, USA. btolley@fhi.org
authors.forename: Elizabeth E
authors.initials: EE
authors.lastname: Tolley
authors.forename: Polly F
authors.initials: PF
authors.lastname: Harrison
authors.forename: Els
authors.initials: E
authors.lastname: Goetghebeur
authors.forename: Kathleen
authors.initials: K
authors.lastname: Morrow
authors.forename: Robert
authors.initials: R
authors.lastname: Pool
authors.forename: Doug
authors.initials: D
authors.lastname: Taylor
authors.forename: Stephanie N
authors.initials: SN
authors.lastname: Tillman
authors.forename: Ariane
authors.initials: A
authors.lastname: van der Straten
mesh_terms: D000891:Anti-Infective Agents, Local / Q000008:administration & dosage*; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D015658:HIV Infections / Q000188:drug therapy* / Q000517:prevention & control*; D006801:Humans; D010349:Patient Compliance; D013089:Spermatocidal Agents / Q000008:administration & dosage
chemical_list: D000891:Anti-Infective Agents, Local; D013089:Spermatocidal Agents