Topical Microbicide Acceptability

无保护的接受性肛交是导致HIV感染的首要性危险行为。虽然避孕套可以防止病毒传播，但大量未感染的男女在与艾滋病毒阳性男子或血清状况不明的男子发生肛交时并不坚持使用避孕套-这可能是出于自愿，也可能是由于他们无法控制的原因。对他们来说，直肠杀微生物剂可能是一种保护替代品。 直肠杀微生物剂不仅需要对艾滋病毒有效，而且同样重要的是，需要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”。“这项研究将评估直肠杀微生物剂在男男性行为者（MSM）和女性中的可接受性。对于男男性接触者，我们将进行一项使用杀微生物剂安慰剂的实际试验，即一种惰性的、没有安全性问题的产品，与“真实的”杀微生物剂无法区分。对于女性，我们将进行深入的可接受性访谈，但没有实际的试验。 针对接受性肛交（RAI）的HIV阴性男性，这些男性使用安全套不一致或根本不使用安全套，本研究的主要目的是（1）通过直肠凝胶体积递增试验确定RAI期间使用的最大可接受凝胶体积;（2）通过配方偏好试验确定哪种直肠杀微生物剂递送载体（凝胶或栓剂）优选用于RAI;和（3）通过定性和定量评估， 定量研究方法，是否有不同的态度和意图使用直肠杀微生物剂凝胶剂而不是栓剂;以及态度和意图是否从产品试验前到后发生变化。 本研究的重点是HIV阴性的女性，她们与男性发生肛交时不经常使用安全套或根本不使用安全套，本研究的次要目的是（I）通过定性深入访谈，引出与肛交相关的心理、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、使用意图和偏好。 本研究将由纽约州立精神病学研究所和哥伦比亚大学（位于纽约纽约市）的H IV临床和行为研究中心以及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.