Adherence and its measurement in phase 2/3 microbicide trials.
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.
Tolley
Elizabeth E
EE
Behavioral and Biomedical Research Department, Health and Development Sciences, Family Health International, Durham, NC 27319, USA. btolley@fhi.org
Harrison
Polly F
PF
Goetghebeur
Els
E
Morrow
Kathleen
K
Pool
Robert
R
Taylor
Doug
D
Tillman
Stephanie N
SN
van der Straten
Ariane
A
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
D000891:Anti-Infective Agents, Local; D013089:Spermatocidal Agents