Document Detail

Adherence and its measurement in phase 2/3 microbicide trials.
MedLine Citation:
PMID:  19924525     Owner:  NLM     Status:  MEDLINE    
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.
Elizabeth E Tolley; Polly F Harrison; Els Goetghebeur; Kathleen Morrow; Robert Pool; Doug Taylor; Stephanie N Tillman; Ariane van der Straten
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Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  AIDS and behavior     Volume:  14     ISSN:  1573-3254     ISO Abbreviation:  AIDS Behav     Publication Date:  2010 Oct 
Date Detail:
Created Date:  2010-09-24     Completed Date:  2010-12-20     Revised Date:  2013-05-31    
Medline Journal Info:
Nlm Unique ID:  9712133     Medline TA:  AIDS Behav     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1124-36     Citation Subset:  IM    
Behavioral and Biomedical Research Department, Health and Development Sciences, Family Health International, Durham, NC 27319, USA.
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MeSH Terms
Anti-Infective Agents, Local / administration & dosage*
Clinical Trials, Phase II as Topic
Clinical Trials, Phase III as Topic
HIV Infections / drug therapy*,  prevention & control*
Patient Compliance*
Spermatocidal Agents / administration & dosage
Reg. No./Substance:
0/Anti-Infective Agents, Local; 0/Spermatocidal Agents

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