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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...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Mary Ann Liebert, Inc., publishers 2022
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.
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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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