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Preferred product attributes of a multipurpose vaginal ring: Findings from a phase 1 trial

INTRODUCTION: Most women face multiple and co-occurring risks from unwanted pregnancy, human immunodeficiency virus (HIV) and other sexually transmitted infections (STIs) at some point during their lifetime. While a range of contraceptive methods exist and options for HIV prevention are increasing,...

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Autores principales: Tolley, Elizabeth E., Hanif, Homaira, Thurman, Andrea, Brache, Vivian, Doncel, Gustavo F.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10097978/
https://www.ncbi.nlm.nih.gov/pubmed/37064825
http://dx.doi.org/10.3389/frph.2023.1148134
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author Tolley, Elizabeth E.
Hanif, Homaira
Thurman, Andrea
Brache, Vivian
Doncel, Gustavo F.
author_facet Tolley, Elizabeth E.
Hanif, Homaira
Thurman, Andrea
Brache, Vivian
Doncel, Gustavo F.
author_sort Tolley, Elizabeth E.
collection PubMed
description INTRODUCTION: Most women face multiple and co-occurring risks from unwanted pregnancy, human immunodeficiency virus (HIV) and other sexually transmitted infections (STIs) at some point during their lifetime. While a range of contraceptive methods exist and options for HIV prevention are increasing, to date, only male and female condoms provide multipurpose protection from both pregnancy and disease. METHODS: From September 2017 to December 2018, 60 women from the United States and the Dominican Republic, randomized 1:1 to continuous or interrupted use and 4:1 to active vs. placebo ring, participated in a Phase I trial to assess the safety and tolerability of a three-month multipurpose intravaginal ring (IVR) containing the antiviral tenofovir and the contraceptive levonorgestrel. This study examines survey responses from all participants and qualitative data from a subset of 17 women to assess acceptability of and preferences for IVR characteristics. RESULTS: Overall, women liked the concept of a multipurpose IVR and found it easy to insert and remove. Initial concerns about the size or thickness of the ring generally disappeared with use experience. Women weighed trade-offs between the ease of continuous use for a longer duration against concerns about hygiene and discoloration of the ring when left in place during menses. Whether randomized to continuous or interrupted use, most women found ring attributes (size, thickness, flexibility) very acceptable. They provided recommendations via survey and qualitative interviews for ring modifications that would further increase acceptability. Insights into women's use experiences also suggest the need for clear counseling messages and introduction strategies that can facilitate women's choice and use of prevention methods. DISCUSSION: Study findings suggest that a multipurpose IVR would make a valuable contribution to women's sexual and reproductive health options, and that both continuous and interrupted use strategies may be preferred.
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spelling pubmed-100979782023-04-14 Preferred product attributes of a multipurpose vaginal ring: Findings from a phase 1 trial Tolley, Elizabeth E. Hanif, Homaira Thurman, Andrea Brache, Vivian Doncel, Gustavo F. Front Reprod Health Reproductive Health INTRODUCTION: Most women face multiple and co-occurring risks from unwanted pregnancy, human immunodeficiency virus (HIV) and other sexually transmitted infections (STIs) at some point during their lifetime. While a range of contraceptive methods exist and options for HIV prevention are increasing, to date, only male and female condoms provide multipurpose protection from both pregnancy and disease. METHODS: From September 2017 to December 2018, 60 women from the United States and the Dominican Republic, randomized 1:1 to continuous or interrupted use and 4:1 to active vs. placebo ring, participated in a Phase I trial to assess the safety and tolerability of a three-month multipurpose intravaginal ring (IVR) containing the antiviral tenofovir and the contraceptive levonorgestrel. This study examines survey responses from all participants and qualitative data from a subset of 17 women to assess acceptability of and preferences for IVR characteristics. RESULTS: Overall, women liked the concept of a multipurpose IVR and found it easy to insert and remove. Initial concerns about the size or thickness of the ring generally disappeared with use experience. Women weighed trade-offs between the ease of continuous use for a longer duration against concerns about hygiene and discoloration of the ring when left in place during menses. Whether randomized to continuous or interrupted use, most women found ring attributes (size, thickness, flexibility) very acceptable. They provided recommendations via survey and qualitative interviews for ring modifications that would further increase acceptability. Insights into women's use experiences also suggest the need for clear counseling messages and introduction strategies that can facilitate women's choice and use of prevention methods. DISCUSSION: Study findings suggest that a multipurpose IVR would make a valuable contribution to women's sexual and reproductive health options, and that both continuous and interrupted use strategies may be preferred. Frontiers Media S.A. 2023-03-30 /pmc/articles/PMC10097978/ /pubmed/37064825 http://dx.doi.org/10.3389/frph.2023.1148134 Text en © 2023 Tolley, Hanif, Thurman, Brache and Doncel. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY) (https://creativecommons.org/licenses/by/4.0/) . The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Reproductive Health
Tolley, Elizabeth E.
Hanif, Homaira
Thurman, Andrea
Brache, Vivian
Doncel, Gustavo F.
Preferred product attributes of a multipurpose vaginal ring: Findings from a phase 1 trial
title Preferred product attributes of a multipurpose vaginal ring: Findings from a phase 1 trial
title_full Preferred product attributes of a multipurpose vaginal ring: Findings from a phase 1 trial
title_fullStr Preferred product attributes of a multipurpose vaginal ring: Findings from a phase 1 trial
title_full_unstemmed Preferred product attributes of a multipurpose vaginal ring: Findings from a phase 1 trial
title_short Preferred product attributes of a multipurpose vaginal ring: Findings from a phase 1 trial
title_sort preferred product attributes of a multipurpose vaginal ring: findings from a phase 1 trial
topic Reproductive Health
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10097978/
https://www.ncbi.nlm.nih.gov/pubmed/37064825
http://dx.doi.org/10.3389/frph.2023.1148134
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