Qualitative exploration of intrinsic and extrinsic factors that influence acceptability of semisoft vaginal suppositories.
Qualitative exploration of intrinsic and extrinsic factors that influence acceptability of semisoft vaginal suppositories.
复制标题
DOI：
10.1186/s12905-018-0657-2
复制
发表时间：
2018-10-20
期刊：
影响因子：
--
通讯作者：
Hayes JE
中科院分区：
文献类型：
--
作者：
Zaveri T;Powell KA;Guthrie KM;Bakke AJ;Ziegler GR;Hayes JE
阴道杀微生物剂是预防艾滋病毒和其他性传播感染传播的一种很有希望的手段，因为它使妇女能够在认为自己有危险时开始预防性使用。然而，在临床试验中，杀菌剂显示出好坏参半的结果，一致的发现是，有效性随着使用者的坚持而有很大的不同。基于黏着性是由影响可接受性的产品特性驱动的假设，我们使用软凝胶技术在固体和液体之间的中间结构空间中开发阴道给药系统，以克服当前剂型的潜在缺点。在这里，我们使用焦点小组和调查来确定女性对用于预防艾滋病毒和性传播感染的半软阴道栓剂的初始反应（即接受和愿意尝试），并特别关注阴道栓剂的感知和偏好如何受到产品特性（如大小，形状和硬度）的影响。通过焦点小组，我们确定了与半软栓剂原型可接受性相关的内在和外在因素。尝试的意愿取决于诸如预期功能、预期泄漏、性行为类型、推荐使用频率、性伴侣类型和感知风险等因素。在体外处理时，栓剂的形状、大小和硬度传达了关于想象的插入和处理的便利性、感知的有效性、产品在体内的预期意识和舒适度的信息。这些印象部分是基于先前使用阴道产品的经验。感觉属性似乎在女性偏好和愿意尝试半软栓剂方面发挥了重要作用。在临床前开发过程中使用这些方法应该有助于有效地优化最终产品，既具有生物学有效性，又受到女性的青睐，以提高依从性和有效性。
Vaginal microbicides are a promising means to prevent the transmission of HIV and other sexually transmitted infections, by empowering women to initiate use prophylactically when they perceive themselves to be at risk. However, in clinical trials, microbicides have shown mixed results, with the consistent finding that effectiveness varies substantially as a function of user adherence. Based on the assumption that adherence is driven, at least in part, by product properties that influence acceptability, we used softgel technology to develop vaginal drug delivery systems in the intermediate texture space between solids and liquids to overcome potential shortcomings of current dosage forms. Here, we used focus groups and surveys to determine women’s initial reactions (i.e., acceptance and willingness-to-try) for semisoft vaginal suppositories intended for HIV and STI prevention, with a specific focus on how perception of and preferences for vaginal suppositories may be influenced by product characteristics such as size, shape, and firmness. Via focus groups, we identified intrinsic and extrinsic factors relevant to acceptability of semisoft suppository prototypes. Willingness-to-try depended on factors like intended functionality, anticipated leakage, type of sex, recommended frequency of use, type of sexual partner, and perceived risk. When handled ex vivo, shape, size, and firmness of suppositories communicated information about ease of imagined insertion and handling, perceived effectiveness, anticipated awareness and comfort of the product in the body. These impressions were partly based on prior experience with vaginal products. Sensory attributes appear to play a substantial role in women’s preferences and willingness to try the semisoft suppositories. Using these methods during preclinical development should help efficiently optimize a final product that is both biologically efficacious and preferred by women, toward a goal of enhancing adherence and effectiveness.
登录
查看更多内容
影响因子：
3.7
作者：
Coupland JN;Hayes JE
通讯作者：
Hayes JE
影响因子：
2
作者：
Duby, Zoe;Mensch, Barbara;van der Straten, Ariane
通讯作者：
van der Straten, Ariane
DOI：
10.1126/science.1193748
发表时间：
2010-09-03
期刊：
Science (New York, N.Y.)
影响因子：
--
作者：
Abdool Karim Q;Abdool Karim SS;Frohlich JA;Grobler AC;Baxter C;Mansoor LE;Kharsany AB;Sibeko S;Mlisana KP;Omar Z;Gengiah TN;Maarschalk S;Arulappan N;Mlotshwa M;Morris L;Taylor D;CAPRISA 004 Trial Group
通讯作者：
CAPRISA 004 Trial Group
DOI：
10.1080/13691058.2011.630099
发表时间：
2012
期刊：
Culture, health & sexuality
影响因子：
--
作者：
Giguere R;Carballo-Diéguez A;Ventuneac A;Mabragaña M;Dolezal C;Chen BA;Kahn JA;Zimet GD;McGowan I
通讯作者：
McGowan I
影响因子：
4.4
作者：
Carballo-Dieguez, Alex;Giguere, Rebecca;Dolezal, Curtis;Chen, Beatrice A.;Kahn, Jessica;Zimet, Greg;Mabragana, Marina;Leu, Cheng-Shiun;McGowan, Ian
通讯作者：
McGowan, Ian