
Adherence and its measurement in phase 2/3 microbicide trials
- Author
- Elizabeth E Tolley, Polly F Harrison, Els Goetghebeur (UGent) , Kathleen Morrow, Robert Pool, Doug Taylor, Stephanie N Tillman and Ariane van der Straten
- Organization
- 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.
- Keywords
- DIAPHRAGM, Clinical trials, BIOMARKERS, HIV prevention, TRANSMISSION, RECOMMENDATIONS, GEL, BEHAVIOR, PREVENTION, ENHANCING ADHERENCE, VAGINAL MICROBICIDES, Adherence, RANDOMIZED CONTROLLED-TRIAL, Microbicides
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Citation
Please use this url to cite or link to this publication: http://hdl.handle.net/1854/LU-1250140
- MLA
- Tolley, Elizabeth E., et al. “Adherence and Its Measurement in Phase 2/3 Microbicide Trials.” AIDS AND BEHAVIOR, vol. 14, no. 5, 2010, pp. 1124–36, doi:10.1007/s10461-009-9635-x.
- APA
- Tolley, E. E., Harrison, P. F., Goetghebeur, E., Morrow, K., Pool, R., Taylor, D., … van der Straten, A. (2010). Adherence and its measurement in phase 2/3 microbicide trials. AIDS AND BEHAVIOR, 14(5), 1124–1136. https://doi.org/10.1007/s10461-009-9635-x
- Chicago author-date
- Tolley, Elizabeth E, Polly F Harrison, Els Goetghebeur, Kathleen Morrow, Robert Pool, Doug Taylor, Stephanie N Tillman, and Ariane van der Straten. 2010. “Adherence and Its Measurement in Phase 2/3 Microbicide Trials.” AIDS AND BEHAVIOR 14 (5): 1124–36. https://doi.org/10.1007/s10461-009-9635-x.
- Chicago author-date (all authors)
- Tolley, Elizabeth E, Polly F Harrison, Els Goetghebeur, Kathleen Morrow, Robert Pool, Doug Taylor, Stephanie N Tillman, and Ariane van der Straten. 2010. “Adherence and Its Measurement in Phase 2/3 Microbicide Trials.” AIDS AND BEHAVIOR 14 (5): 1124–1136. doi:10.1007/s10461-009-9635-x.
- Vancouver
- 1.Tolley EE, Harrison PF, Goetghebeur E, Morrow K, Pool R, Taylor D, et al. Adherence and its measurement in phase 2/3 microbicide trials. AIDS AND BEHAVIOR. 2010;14(5):1124–36.
- IEEE
- [1]E. E. Tolley et al., “Adherence and its measurement in phase 2/3 microbicide trials,” AIDS AND BEHAVIOR, vol. 14, no. 5, pp. 1124–1136, 2010.
@article{1250140, 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.}}, author = {{Tolley, Elizabeth E and Harrison, Polly F and Goetghebeur, Els and Morrow, Kathleen and Pool, Robert and Taylor, Doug and Tillman, Stephanie N and van der Straten, Ariane}}, issn = {{1090-7165}}, journal = {{AIDS AND BEHAVIOR}}, keywords = {{DIAPHRAGM,Clinical trials,BIOMARKERS,HIV prevention,TRANSMISSION,RECOMMENDATIONS,GEL,BEHAVIOR,PREVENTION,ENHANCING ADHERENCE,VAGINAL MICROBICIDES,Adherence,RANDOMIZED CONTROLLED-TRIAL,Microbicides}}, language = {{eng}}, number = {{5}}, pages = {{1124--1136}}, title = {{Adherence and its measurement in phase 2/3 microbicide trials}}, url = {{http://doi.org/10.1007/s10461-009-9635-x}}, volume = {{14}}, year = {{2010}}, }
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