Microbicide Safety and Acceptability in Young Men

描述（由申请人提供）：杀微生物剂是可以应用于阴道或直肠内壁的产品，以尝试降低与无保护性交相关的艾滋病毒感染风险。阴道杀微生物剂的安全性和有效性已经在有感染风险的女性中进行了广泛的研究，但很少有研究关注直肠使用杀微生物剂的安全性和可接受性。据认为，一旦开发出阴道杀微生物剂，它将用于阴道和直肠性交。因此，重要的是，我们看看这些产品的安全性和可接受性的人谁实践直肠性行为。在美国，最容易感染艾滋病毒的群体之一是年轻男子，特别是年轻的黑人和拉丁美洲男子。我们的研究将在不同种族的HIV阴性男性样本中进行，年龄在18-30岁之间，他们报告不一致或根本不使用避孕套进行接受性直肠性交。我们的最终目标是测试这一高度脆弱的人群是否可以安全地使用杀微生物剂候选人VivaGel”，以及安慰剂的使用模式是否与VivaGel无法区分”，这表明该产品将在真实的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，首先研究可接受性和依从性，在现实生活中的性接触中或之前，使用安慰剂凝胶与专门设计的直肠给药装置一起使用。随后，将在凝胶使用依从性最高的男性（定义为在e80%发作期间使用研究产品）中研究VivaGel的安全性。该安全性阶段将包括凝胶单次给药，随后是一周的凝胶每日给药。在这两个阶段的开始阶段，我们将根据个性化认知风险降低咨询方案为所有参与者提供安全套使用咨询，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。所有参与者将通过临床、实验室和行为评估进行密切监测。将使用定量和定性研究方法，以及自我报告，生物标志物和产品重新叙述的组合。这项研究将由宾夕法尼亚州匹兹堡的匹兹堡大学进行，以及位于纽约州纽约市的HIV临床和行为研究中心（哥伦比亚大学和纽约州精神病研究所）。将有三个临床试验地点：匹兹堡大学匹兹堡，宾夕法尼亚州;芬威社区卫生在波士顿，马萨诸塞州;和波多黎各临床试验单位在圣胡安，PR的大学。这项创新的研究将有助于开发一种安全有效的杀微生物剂，用于预防艾滋病毒感染。公共卫生相关性：男男性行为者（MSM），尤其是黑人和拉丁裔男男性行为者，是美国人口中艾滋病毒感染的高危人群之一。杀微生物剂凝胶是一种可用于直肠或阴道内壁的产品，以预防或至少显着降低与不安全性行为相关的艾滋病毒感染风险。本研究旨在确定这一高度脆弱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（与VivaGel”无法区分）是否表明该产品将在真实的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.