Topical Microbicide Acceptability

无保护的接受性肛交是导致艾滋病毒感染的最高风险性行为。尽管避孕套可以防止病毒传播，但大量与艾滋病毒阳性男性或血清状态不明的男性发生肛交的未受感染的男性和女性并不总是使用安全套--要么是出于选择，要么是因为他们无法控制的原因。对他们来说，直肠杀菌剂可能是一种保护替代方案。 直肠杀菌剂不仅需要对艾滋病毒有效，而且同样重要的是，人们能够并愿意使用的产品。后一个问题通常被称为“可接受性”。这项研究将评估男男性行为者(MSM)和女性的直肠杀微生物剂的可接受性。对于MSM，我们将进行一项实际试验，使用杀微生物剂安慰剂，即一种惰性的、不存在安全问题的产品，但与“真正的”杀微生物剂没有区别。对于女性，我们将进行深入的可接受性访谈，但不会进行实际试验。 这项研究的主要目的是：(1)通过直肠凝胶容量递增试验，确定接受肛交期间可接受的最大凝胶体积；(2)通过配方优选试验，确定哪种直肠杀菌剂(凝胶或栓剂)更适合用于接受肛交；以及(3)通过定性和定量的方法，评估哪种直肠杀微生物剂(凝胶或栓剂)是治疗肛交的首选载体。 定量研究方法，是否对使用直肠杀微生物剂凝胶与使用栓剂有不同的态度和意图；以及态度和意图在产品试验前后是否发生变化。 本研究的次要目标是：(1)通过深入的定性访谈，了解与肛交有关的心理、社会和文化因素；(2)通过定性和定量技术，评估对直肠杀微生物剂凝胶和栓剂的态度、使用意向和偏好。 这项研究将由纽约州立精神病学研究所的H IV临床和行为研究中心、纽约市的哥伦比亚大学和马萨诸塞州波士顿的芬威社区健康中心合作进行。

Unprotected receptive anal intercourse is the top ranking sexual risk behavior leading to HIV infection. Although condoms can prevent viral transmission, large numbers of uninfected men and women who have receptive anal sex with HIV-positive men or men of unknown serostatus do not use condoms consistently -either by choice or due to reasons out of their control. For them, rectal microbicides could be a protection alternative. Rectal microbicides need to be not only efficacious against HIV but, equally important, products that people are able and willing to use. This latter issue is generally referred to as "acceptability." This study will assess rectal microbicide acceptability among men who have sex with men (MSM) and women. With MSM, we will undertake an actual trial iusing a microbicide placebo, that is, a product that is inert and presents no safety concerns yet is undistinguishable from a "real" microbicide. With women, we will conduct in-depth acceptability interviews but no actual trial. Focusing on HIV-negative men who have receptive anal intercourse (RAI) using condoms inconsistently or not at all, the primary aims of this study are to (1) determine, through a rectal gel volume escalation trial, the maximum acceptable volume of gel for use during RAI; (2) determine, through a formulation preference trial, which rectal microbicide delivery vehicle (gel or suppository) is preferred for RAI; and (3) assess, through qualitative and quantitative research methods, whether or not there are different attitudes about and intentions to use rectal microbicide gels as opposed to suppositories; and whether or not attitudes and intentions change from before to after the product trial. Focusing on HIV-negative women who engage in anal sex with men using condoms inconsistently or not at all, the secondary aims of this study are to (I) elicit, through qualitative in-depth interviews, the psychological, social, and cultural factors associated with anal sex and (2) assess, through qualitative and quantitative techniques, attitudes, intention to use, and preferences concerning rectal microbicide gels and suppositories. This study will be conducted by a partnership between the H IV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute and Columbia University, in New York City, New York, and the Fenway Communit Health, in Boston, Massachusetts.