Microbicide Safety and Acceptability in Young Men

说明(申请人提供)：杀菌剂是一种产品，可以涂在阴道或直肠的内层，试图降低与无保护措施的性行为有关的艾滋病毒感染风险。阴道杀菌剂的安全性和有效性在有感染风险的妇女中得到了广泛的研究，但很少有研究关注直肠使用杀菌剂的安全性和可接受性。人们认为，一旦开发出一种阴道杀菌剂，它将同时用于阴道和直肠性交。因此，重要的是我们要观察这些产品在进行直肠性交的人中的安全性和可接受性。在美国，感染艾滋病毒的最脆弱群体之一是年轻男性，特别是年轻的黑人和拉丁裔男性。我们的研究将在18-30岁的HIV阴性男性中进行，他们的种族差异很大，他们报告说，他们使用避孕套进行了不一致的直肠性交，或者根本不使用。我们的最终目标是测试这些高度脆弱的人群是否可以安全地使用杀微生物剂候选VivaGel“以及与VivaGel无异的安慰剂的使用模式是否表明该产品将在现实生活环境中正确和一致地使用”。我们的研究将分两个阶段进行，在这两个阶段中，首先将使用安慰剂凝胶在现实生活的性行为中或之前使用专门设计的直肠分娩装置来研究可接受性和依从性。随后，将在那些对凝胶使用依从性最高的男性中研究VivaGel的安全性(定义为在E80%的发作期间使用研究产品)。这一安全阶段将包括单剂凝胶，然后每天使用凝胶一周。在这两个阶段的每个阶段开始时，我们将按照个性化认知风险降低咨询方案为所有参与者提供避孕套使用咨询，这是一种预防艾滋病毒和性传播感染的风险降低咨询方法，在随机对照试验中显示出有效性。所有参与者都将接受临床、实验室和行为评估的密切监测。将使用定量和定性研究方法，以及自我报告、生物标记物和产品叙述相结合的方法。这项研究将由宾夕法尼亚州匹兹堡的匹兹堡大学和纽约的艾滋病毒临床和行为研究中心(哥伦比亚大学和纽约精神病学研究所)进行。将有三个临床试验地点：宾夕法尼亚州匹兹堡的匹兹堡大学；马萨诸塞州波士顿的芬威社区卫生中心；以及宾夕法尼亚州圣胡安的波多黎各大学临床试验单位。这项创新研究将有助于开发一种安全有效的杀微生物剂来预防艾滋病毒感染。公共卫生相关性：男男性接触者(MSM)，特别是黑人和拉丁裔MSM，是美国人口中感染艾滋病毒的最高风险群体之一。杀微生物剂凝胶是一种可以涂在直肠或阴道内壁上的产品，可以预防或至少显著降低与不安全性行为有关的艾滋病毒感染风险。这项研究试图确定这一高度脆弱的人群是否可以安全地使用杀微生物剂凝胶(VivaGel)，以及安慰剂的使用模式是否表明该产品将在现实生活环境中正确和一致地使用。

DESCRIPTION (provided by applicant): Microbicides are products that can be applied to the lining of the vagina or rectum to try and reduce the risk of HIV infection associated with unprotected sexual intercourse. The safety and effectiveness of vaginal microbicides have been studied widely in women at risk of infection but there are very few studies looking at the safety and acceptability of microbicides when used rectally. It is thought that once a vaginal microbicide is developed, it will be used for both vaginal and rectal intercourse. It is therefore important that we look at the safety and acceptability of these products in people who practice rectal sex. In the US, one of the most vulnerable groups for getting HIV infection are young men, especially young Black and Latino men. Our study will be conducted with an ethnically diverse sample of HIV-negative men, 18-30 year-olds, who report engaging in receptive rectal intercourse using condoms inconsistently or not at all. Our ultimate goal is to test whether this highly vulnerable population could safely use the microbicide candidate VivaGel" and whether patterns of use of a placebo indistinguishable from VivaGel" suggest that the product would be correctly and consistently used in real life circumstances. Our study will be conducted in two stages in which acceptability and adherence will be studied first using a placebo gel applied with a specifically designed rectal delivery device in, or prior to, real-life sexual encounters. Subsequently, the safety of VivaGel" will be studied among those men who show the highest adherence to gel use (defined as using the study product during e80% episodes). This safety phase will consist of a single dose of gel followed by one week of daily dosing with the gel. At the beginning of each of these two stages, we will provide all participants condom-use counseling following the Personalized Cognitive Risk-Reduction Counseling protocol, a risk-reduction counseling method to prevent HIV and STIs that showed efficacy in a randomly controlled trial. All of the participants will be closely monitored with clinical, laboratory, and behavioral assessments. Quantitative and qualitative research methods will be used, as well as combination of self-reports, biomarkers, and product recounts. The study will be undertaken by University of Pittsburgh in Pittsburgh, PA., and the HIV Center for Clinical and Behavioral Studies (Columbia University and NYS Psychiatric Institute) in NY, NY. There will be three clinical trial sites: the University of Pittsburgh in Pittsburgh, PA; the Fenway Community Health in Boston, MA; and the University of Puerto Rico Clinical Trial Unit in San Juan, PR. This innovative study will contribute to the development of a safe and effective microbicide for the prevention of HIV infection. PUBLIC HEALTH RELEVANCE: Young men who have sex with men (MSM), especially Black and Latino MSM, represent one of the highest risk groups for HIV infection in the US population. Microbicide gels are products that can be applied to the lining of the rectum or vagina to prevent, or at least significantly reduce, the risk of HIV infection associated with unsafe sex. This study seeks to establish whether this highly vulnerable population could safely use a microbicide gel (VivaGel") and whether patterns of use of a placebo, indistinguishable from VivaGel", suggest that the product would be correctly and consistently used in real life circumstances.