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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...

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Autores principales: Woodsong, Cynthia, MacQueen, Kathleen, Amico, K Rivet, Friedland, Barbara, Gafos, Mitzy, Mansoor, Leila, Tolley, Elizabeth, McCormack, Sheena
Formato: Online Artículo Texto
Lenguaje:English
Publicado: International AIDS Society 2013
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.
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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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