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Acceptability and Preference for 3-Month Versus 1-Month Vaginal Rings for HIV-1 Risk Reduction Among Participants in a Phase 1 Trial
BACKGROUND: The monthly dapivirine vaginal ring provides partial protection against HIV, and a longer duration ring may reduce user burden and improve adherence. We examined acceptability and preference for 3-month versus 1-month rings for HIV-1 risk reduction in a phase 1 clinical trial. MATERIALS...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Mary Ann Liebert, Inc., publishers
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9299526/ https://www.ncbi.nlm.nih.gov/pubmed/34665672 http://dx.doi.org/10.1089/jwh.2021.0121 |
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author | Roberts, Sarah T. Hawley, Imogen Luecke, Ellen Mensch, Barbara Wagner, Theresa Hoesley, Craig McClure, Tara Dominguez Islas, Clara P. Piper, Jeanna M. Liu, Albert Y. van der Straten, Ariane |
author_facet | Roberts, Sarah T. Hawley, Imogen Luecke, Ellen Mensch, Barbara Wagner, Theresa Hoesley, Craig McClure, Tara Dominguez Islas, Clara P. Piper, Jeanna M. Liu, Albert Y. van der Straten, Ariane |
author_sort | Roberts, Sarah T. |
collection | PubMed |
description | BACKGROUND: The monthly dapivirine vaginal ring provides partial protection against HIV, and a longer duration ring may reduce user burden and improve adherence. We examined acceptability and preference for 3-month versus 1-month rings for HIV-1 risk reduction in a phase 1 clinical trial. MATERIALS AND METHODS: In Microbicide Trials Network-036/International Partnership for Microbicides 047, 49 HIV-negative participants aged 18–45 were randomized to one of two 3-month rings or the 1-month ring. Acceptability ratings were collected at enrollment, week 4, and study exit (week 13). At exit, ring preference was assessed quantitatively among all participants and a randomly selected subset of 24 participants completed in-depth interviews. Quantitative and qualitative findings were integrated to explore factors influencing acceptability and preference. RESULTS: Acceptability of each ring was initially moderate and increased during the trial. Ratings were lower in the 3-month ring arms than the 1-month arm at each time point, including baseline. Most participants (34/47; 72%) preferred a 3-month ring at exit; however, this proportion was significantly lower within some subgroups characterized by site, education, race/ethnicity, and experiences with ring use. Qualitative interviews revealed reservations about hygiene and safety of the 3-month ring, including discomfort with use during menses, but these were usually outweighed by its increased convenience. CONCLUSIONS: Both ring durations were highly acceptable at study exit. Although most participants preferred a 3-month ring, preference was more divided in certain subgroups, highlighting the benefit of offering different duration options. Providing additional support to address concerns about hygiene and safety may improve acceptability of a 3-month vaginal ring. |
format | Online Article Text |
id | pubmed-9299526 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Mary Ann Liebert, Inc., publishers |
record_format | MEDLINE/PubMed |
spelling | pubmed-92995262022-08-01 Acceptability and Preference for 3-Month Versus 1-Month Vaginal Rings for HIV-1 Risk Reduction Among Participants in a Phase 1 Trial Roberts, Sarah T. Hawley, Imogen Luecke, Ellen Mensch, Barbara Wagner, Theresa Hoesley, Craig McClure, Tara Dominguez Islas, Clara P. Piper, Jeanna M. Liu, Albert Y. van der Straten, Ariane J Womens Health (Larchmt) Original Articles BACKGROUND: The monthly dapivirine vaginal ring provides partial protection against HIV, and a longer duration ring may reduce user burden and improve adherence. We examined acceptability and preference for 3-month versus 1-month rings for HIV-1 risk reduction in a phase 1 clinical trial. MATERIALS AND METHODS: In Microbicide Trials Network-036/International Partnership for Microbicides 047, 49 HIV-negative participants aged 18–45 were randomized to one of two 3-month rings or the 1-month ring. Acceptability ratings were collected at enrollment, week 4, and study exit (week 13). At exit, ring preference was assessed quantitatively among all participants and a randomly selected subset of 24 participants completed in-depth interviews. Quantitative and qualitative findings were integrated to explore factors influencing acceptability and preference. RESULTS: Acceptability of each ring was initially moderate and increased during the trial. Ratings were lower in the 3-month ring arms than the 1-month arm at each time point, including baseline. Most participants (34/47; 72%) preferred a 3-month ring at exit; however, this proportion was significantly lower within some subgroups characterized by site, education, race/ethnicity, and experiences with ring use. Qualitative interviews revealed reservations about hygiene and safety of the 3-month ring, including discomfort with use during menses, but these were usually outweighed by its increased convenience. CONCLUSIONS: Both ring durations were highly acceptable at study exit. Although most participants preferred a 3-month ring, preference was more divided in certain subgroups, highlighting the benefit of offering different duration options. Providing additional support to address concerns about hygiene and safety may improve acceptability of a 3-month vaginal ring. Mary Ann Liebert, Inc., publishers 2022-07-01 2022-07-12 /pmc/articles/PMC9299526/ /pubmed/34665672 http://dx.doi.org/10.1089/jwh.2021.0121 Text en © Sarah T. Roberts et al. 2022; Published by Mary Ann Liebert, Inc. https://creativecommons.org/licenses/by-nc/4.0/This Open Access article is distributed under the terms of the Creative Commons Attribution Noncommercial License [CC-BY-NC] (http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) ) which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are cited |
spellingShingle | Original Articles Roberts, Sarah T. Hawley, Imogen Luecke, Ellen Mensch, Barbara Wagner, Theresa Hoesley, Craig McClure, Tara Dominguez Islas, Clara P. Piper, Jeanna M. Liu, Albert Y. van der Straten, Ariane Acceptability and Preference for 3-Month Versus 1-Month Vaginal Rings for HIV-1 Risk Reduction Among Participants in a Phase 1 Trial |
title | Acceptability and Preference for 3-Month Versus 1-Month Vaginal Rings for HIV-1 Risk Reduction Among Participants in a Phase 1 Trial |
title_full | Acceptability and Preference for 3-Month Versus 1-Month Vaginal Rings for HIV-1 Risk Reduction Among Participants in a Phase 1 Trial |
title_fullStr | Acceptability and Preference for 3-Month Versus 1-Month Vaginal Rings for HIV-1 Risk Reduction Among Participants in a Phase 1 Trial |
title_full_unstemmed | Acceptability and Preference for 3-Month Versus 1-Month Vaginal Rings for HIV-1 Risk Reduction Among Participants in a Phase 1 Trial |
title_short | Acceptability and Preference for 3-Month Versus 1-Month Vaginal Rings for HIV-1 Risk Reduction Among Participants in a Phase 1 Trial |
title_sort | acceptability and preference for 3-month versus 1-month vaginal rings for hiv-1 risk reduction among participants in a phase 1 trial |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9299526/ https://www.ncbi.nlm.nih.gov/pubmed/34665672 http://dx.doi.org/10.1089/jwh.2021.0121 |
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