Reducing Sexual HIV Risk among Methamphetamine-Using MSM in San Diego, CA

描述（由申请人提供）：本研究的目标是开发和试点测试一种创新的干预“工具箱”，以减少使用甲基苯丙胺的男性与男性发生性关系（MUMSM）的艾滋病毒相关的性风险行为。我们提出的研究是基于圣地亚哥，加利福尼亚州，在全国被捕者中甲基苯丙胺使用率第三高的城市，甲基苯丙胺占急诊室与毒品有关的提及的50%以上。吸毒者是一个异质性的人群，需要量身定制的干预措施，以满足他们的个人需求，但大多数干预试验只包括MUMSM的子集。我们建议开发和试点测试的干预措施，可以统一实施的MUMSM谁在艾滋病毒血清状态和药物管理途径方面有所不同。我们的具体目标是：1）制定一个六期理论驱动的行为改变活动干预方案，旨在减少HIV阳性和HIV阴性、注射吸毒（IDU）和非IDU MUMSM中HIV相关的性风险行为; 2）确定所有HIV和IDU分层中MUMSM对干预系列的可接受性; 3）确定干预系列减少性风险行为的潜在功效;以及4）使用假设的效应量范围来确定干预的成本效益。为达致这些目标，我们会举办焦点小组讨论会，并在目的人口中进行预测，以发展和改善有关的干预措施。80例MUMSM将入组一项单臂初步研究，其中将在基线和干预后2个月使用音频计算机辅助自我访谈（ACASI）收集的数据对参与者的行为变化进行比较。我们的招募策略将利用圣地亚哥拉美裔和非洲裔美国人MUMSM的种族多样性人口，以及我们招募MUMSM的能力，这些MUMSM是最近从正在进行的急性和早期HIV感染研究中获得的HIV血清转化者。据我们所知，这将是有史以来第一个针对MUMSM异质性的性风险降低干预研究。如果这项初步研究显示出有希望的结果，它将为提出III期疗效试验提供基础。如果证明具有成本效益，这种干预措施可以填补一个关键的空白，提供急需的选择，以减少使用甲基苯丙胺的男男性行为者之间的性传播艾滋病毒的风险。

DESCRIPTION (provided by applicant): The goal of this study is to develop and pilot test an innovative intervention "toolbox" to reduce HIV- associated sexual risk behaviors among methamphetamine using men who have sex with men (MUMSM). Our proposed study is based in San Diego, CA, the city with the third highest rates of methamphetamine use among arrestees in the country, and where methamphetamine accounts for over 50% of drug-related mentions in emergency departments. Drug users are a heterogeneous population requiring interventions tailored to meet their individual needs, yet most intervention trials have included only subsets of MUMSM. We propose to develop and pilot test an intervention that can be uniformly implemented among MUMSM who vary in terms of HIV serostatus and route of drug administration. Our specific aims are to: 1) develop a six-session intervention of theoretically-driven behavior change activities designed to decrease HIV- associated sexual risk behaviors among HIV-positive and HIV-negative, injection drug using (IDU) and non- IDU MUMSM; 2) determine the acceptability of the intervention series among MUMSM in all HIV and IDU strata; 3) determine the potential efficacy of the intervention series to decrease sexual risk behaviors; and 4) determine the cost-effectiveness of the intervention using a hypothetical range of effect sizes. To achieve these aims, focus groups and intervention pre-testing with the target population will be conducted to develop and refine the intervention. Eighty MUMSM will be enrolled in a single arm pilot study in which behavior change will be compared within participants on data collected using audio computer assisted self interviewing (ACASI) conducted at baseline and two months post-intervention. Our recruitment strategy will capitalize upon the ethnically diverse population of Hispanics and African American MUMSM in San Diego, as well as our ability to recruit MUMSM who are recent HIV seroconverters from an ongoing study of acute and early HIV infection. To our knowledge, this will be the first sexual risk reduction intervention ever studied that addresses the heterogeneous nature of MUMSM. If this pilot study shows promising results, it will provide the foundation for proposing a Phase III efficacy trial. If proven cost-effective, this intervention could fill a critical gap by providing much needed options for reducing the risk of sexual HIV transmission among MSM who use methamphetamine.