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Microbicide clinical trial adherence: insights for introduction.

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dc.contributor.authorWoodsong, Cynthia.
dc.contributor.authorMacQueen, Kathleen M.
dc.contributor.authorAmico, Kathy Rivet.
dc.contributor.authorFriedland, Barbara A.
dc.contributor.authorGafos, Mitzy.
dc.contributor.authorMansoor, Leila Essop.
dc.contributor.authorTolley, Elizabeth E.
dc.contributor.authorMcCormack, Sheena.
dc.date.accessioned2013-11-13T13:28:04Z
dc.date.available2013-11-13T13:28:04Z
dc.date.created2012
dc.date.issued2012
dc.description.abstractAfter two decades of microbicide clinical trials it remains uncertain if vaginally- delivered products will be clearly shown to reduce the risk of HIV infection in women and girls. Furthermore, a microbicide product with demonstrated clinical efficacy must be used correctly and consistently if it is to prevent infection. Information on adherence that can be gleaned from microbicide trials is relevant for future microbicide safety and efficacy trials, pre-licensure implementation trials, Phase IV post-marketing research, and microbicide introduction and delivery. Drawing primarily from data and experience that has emerged from the large-scale microbicide efficacy trials completed to-date, the paper identifies six broad areas of adherence lessons learned: (1) Adherence measurement in clinical trials, (2) Comprehension of use instructions/Instructions for use, (3) Unknown efficacy and its effect on adherence/Messages regarding effectiveness, (4) Partner influence on use, (5) Retention and continuation and (6) Generalizability of trial participants’ adherence behavior. Each is discussed, with examples provided from microbicide trials. For each of these adherence topics, recommendations are provided for using trial findings to prepare for future microbicide safety and efficacy trials, Phase IV post-marketing research, and microbicide introduction and delivery programs.en
dc.identifier.citationWoodsong, C., et al. 2013. Microbicide clinical trial adherence: insights for introduction. Journal of the International AIDS Society 16:18505.en
dc.identifier.issn1758-2652
dc.identifier.urihttp://dx.doi.org/10.7448/IAS.16.1.18505en
dc.identifier.urihttp://hdl.handle.net/10413/9991
dc.language.isoenen
dc.publisherBioMed Central.en
dc.subjectClinical trials--Research.en
dc.subjectHIV infections--Prevention.en
dc.subject.otherVaginal microbicides.en
dc.subject.otherClinical trial adherence.en
dc.titleMicrobicide clinical trial adherence: insights for introduction.en
dc.typePeer reviewed journal articleen

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