Acceptability and Preference for 3-Month Versus 1-Month Vaginal Rings for HIV-1 Risk Reduction Among Participants in a Phase 1 Trial.
Acceptability and Preference for 3-Month Versus 1-Month Vaginal Rings for HIV-1 Risk Reduction Among Participants in a Phase 1 Trial.
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在第1阶段试验中，参与者的3个月与1个月的阴道降低了3个月与1个月阴道环的偏好。
DOI：
10.1089/jwh.2021.0121
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发表时间：
2022-07
影响因子：
3.5
通讯作者：
van der Straten, Ariane
中科院分区：
文献类型：
--
作者：
Roberts, Sarah T.;Hawley, Imogen;Luecke, Ellen;Mensch, Barbara;Wagner, Theresa;Hoesley, Craig;McClure, Tara;Islas, Clara P. Dominguez;Piper, Jeanna M.;Liu, Albert Y.;van der Straten, Ariane
每月一次的dapivirine阴道环提供了部分抗HIV的保护，持续时间较长的环可以减轻用户负担并提高依从性。我们在1期临床试验中检查了3个月与1个月环降低HIV-1风险的可接受性和偏好。在杀微生物剂试验网络-036/国际杀微生物剂伙伴关系047中，49名18-45岁的艾滋病毒阴性参与者被随机分配到两个3个月的环或1个月的环中。在入组、第4周和研究退出（第13周）时收集可接受性评级。在出口处，戒指偏好进行了定量评估，所有参与者和随机选择的子集24名参与者完成了深入的采访。定量和定性研究结果相结合，探讨影响因素的可接受性和偏好。每个环的可接受性最初为中等，并在试验期间增加。在每个时间点（包括基线），3个月环组的评分均低于1个月组。大多数受试者（34/47; 72%）在退出时首选3个月成形环;然而，在以研究中心、教育、人种/种族和成形环使用经验为特征的一些亚组中，这一比例显著较低。定性访谈揭示了对3个月戒指的卫生和安全性的保留，包括月经期间使用的不适，但这些通常被其增加的便利性所抵消。研究退出时，两个环持续时间均高度可接受。虽然大多数参与者更喜欢3个月的环，但在某些亚组中，偏好的划分更大，突出了提供不同持续时间选项的好处。提供额外的支持来解决卫生和安全问题可能会提高3个月阴道环的可接受性。
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. 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. 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. 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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影响因子：
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作者：
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通讯作者：
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in't Hout, J