Acceptability of a novel vaginal microbicide during a safety trial among low-risk women
Acceptability of a novel vaginal microbicide during a safety trial among low-risk women
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DOI：
10.2307/2648235
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发表时间：
2000-07-01
期刊：
影响因子：
--
通讯作者：
Mayer, KH
中科院分区：
文献类型：
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作者：
Bentley, ME;Morrow, KM;Mayer, KH
内容：越来越多的人认识到，不能或不愿与性伴侣讨论或使用避孕套的妇女需要女性控制的方法来预防性传播疾病，包括艾滋病毒，这导致人们相当重视阴道杀微生物剂的开发。虽然许多这样的产品正在测试的安全性和有效性，临床试验通常忽略了另一个关键因素，在产品的影响感染率-其可接受性users.Methods：一个第一阶段的杀微生物凝胶的临床试验包括评估产品的可接受性之间的27个低风险的参与者。从结构化访谈，参与者的日常日记和非结构化的出口interviews.Results：参与者报告的产品使用，如瘙痒，燃烧和排尿困难，只有轻微的副作用的可接受性的信息收集;两名妇女发展念珠菌感染，而参与这项研究。没有一个副作用与使用凝胶有决定性的联系。一些妇女指出，产品排出和凌乱是这种方法的缺点，但这种经历因妇女使用凝胶的频率而异。例如，每天使用一次的人中有三分之一的人说，至少在某些时候，它太“湿或滴水”，而每天插入凝胶两次的女性中有三分之二。然而，参与者认为这些“滋扰因素”可能被产品的潜在保护特性所抵消。大多数人报告说，他们会使用该产品，如果它是可用的，并证明有效，如果他们认为他们是在性病infection.Conclusions的风险：这种产品的额外测试是迫切需要的。此外，随着其他产品接近I期试验，可接受性评估应成为临床试验的关键组成部分。
Context: The increasing recognition that women who are unable or unwilling to discuss or use condoms with their sexual partners need female-controlled methods for preventing sexually transmitted diseases (STDs), including HIV, has led to considerable focus on the development of vaginal microbicides. While many such products are being tested for safety and effectiveness, clinical trials generally overlook another key factor in a product's impact on infection rates-its acceptability to users.Methods: A Phase I clinical trial of a microbicidal gel included an assessment of the product's acceptability among 27 low-risk participants. Information on acceptability was gathered from structured interviews, participants' daily diaries and unstructured exit interviews.Results: Participants reported only minor side effects of product use, such as itching, burning and difficulty urinating; two women developed candida infections while participating in the study. None of the side effects could be conclusively linked to use of the gel Some women noted product discharge and messiness as drawbacks of the method, but this experience varied according to how often the women applied the gel. For example, one-third of those who used it once daily said that at least some of the time, it was too "wet or drippy," compared with two-thirds of women who inserted the gel twice a day. However, participants considered these "nuisance factors" that could be outweighed by the potential protective characteristics of the product. The majority reported that they would use the product if it were available and proven efficacious, and if they perceived that they were at risk of STD infection.Conclusions: Additional testing of this product is urgently needed. Furthermore, as other products approach Phase I testing, acceptability assessments should be a key component of clinical trials.