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Microbicide clinical trial adherence: insights for introduction
After 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...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
International AIDS Society
2013
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3619032/ https://www.ncbi.nlm.nih.gov/pubmed/23561044 http://dx.doi.org/10.7448/IAS.16.1.18505 |
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author | Woodsong, Cynthia MacQueen, Kathleen Amico, K Rivet Friedland, Barbara Gafos, Mitzy Mansoor, Leila Tolley, Elizabeth McCormack, Sheena |
author_facet | Woodsong, Cynthia MacQueen, Kathleen Amico, K Rivet Friedland, Barbara Gafos, Mitzy Mansoor, Leila Tolley, Elizabeth McCormack, Sheena |
author_sort | Woodsong, Cynthia |
collection | PubMed |
description | After 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. |
format | Online Article Text |
id | pubmed-3619032 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2013 |
publisher | International AIDS Society |
record_format | MEDLINE/PubMed |
spelling | pubmed-36190322013-04-08 Microbicide clinical trial adherence: insights for introduction Woodsong, Cynthia MacQueen, Kathleen Amico, K Rivet Friedland, Barbara Gafos, Mitzy Mansoor, Leila Tolley, Elizabeth McCormack, Sheena J Int AIDS Soc Review Article After 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. International AIDS Society 2013-04-08 /pmc/articles/PMC3619032/ /pubmed/23561044 http://dx.doi.org/10.7448/IAS.16.1.18505 Text en © 2013 Woodsong C et al; licensee International AIDS Society http://creativecommons.org/licenses/by/2.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Review Article Woodsong, Cynthia MacQueen, Kathleen Amico, K Rivet Friedland, Barbara Gafos, Mitzy Mansoor, Leila Tolley, Elizabeth McCormack, Sheena Microbicide clinical trial adherence: insights for introduction |
title | Microbicide clinical trial adherence: insights for introduction |
title_full | Microbicide clinical trial adherence: insights for introduction |
title_fullStr | Microbicide clinical trial adherence: insights for introduction |
title_full_unstemmed | Microbicide clinical trial adherence: insights for introduction |
title_short | Microbicide clinical trial adherence: insights for introduction |
title_sort | microbicide clinical trial adherence: insights for introduction |
topic | Review Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3619032/ https://www.ncbi.nlm.nih.gov/pubmed/23561044 http://dx.doi.org/10.7448/IAS.16.1.18505 |
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