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Adherence and its measurement in phase 2/3 microbicide trials
Elizabeth E Tolley1, Polly F Harrison, Els Goetghebeur
1Behavioral and Biomedical Research Department, Health and Development Sciences, Family Health International, Durham, NC 27319, USA. btolley@fhi.org
AIDS and Behavior
|November 20, 2009
Summary
Optimizing adherence measurement is crucial for clinical trials of topical microbicides and HIV prevention technologies. This paper offers recommendations for improving adherence data collection and utilization in trial design and analysis.
Area of Science:
- Clinical Trials
- HIV Prevention Technologies
- Microbicides
Background:
- Adherence optimization and measurement present significant challenges in clinical trials for topical microbicides.
- Past microbicide trials have inconsistently utilized collected adherence data in trial design, implementation, and interpretation.
Purpose of the Study:
- To synthesize lessons from past microbicide trials regarding adherence data.
- To provide recommendations for future trials of microbicides and other HIV prevention technologies.
- To discuss the purposes of adherence data collection, focusing on intention-to-treat versus adherence-adjusted analyses for effectiveness.
Main Methods:
- Drawing on data-driven presentations from focused meetings.
- Synthesizing lessons from past microbicide trials.
- Discussing experiences with adherence measures and data collection modes.
Main Results:
- Identified four key purposes for adherence data collection in clinical trials.
- Evaluated strengths and weaknesses of various adherence measurement and data collection approaches.
- Presented several approaches for optimizing participant adherence in trials.
Conclusions:
- Inconsistent utilization of adherence data hinders trial effectiveness assessment.
- Improved adherence measurement and data collection are vital for accurate interpretation of trial results.
- Recommendations are provided for immediate implementation and further research in adherence optimization.
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