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

描述(由申请人提供)：这项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男性行为(MUMSM)中与艾滋病毒相关的性危险行为。我们建议的研究是在加利福尼亚州的圣地亚哥进行的，这座城市的甲基苯丙胺使用率在全国被捕者中排名第三，在急诊科提到的与毒品有关的案件中，甲基苯丙胺占50%以上。吸毒者是一个异质人群，需要针对其个人需求量身定做的干预措施，但大多数干预试验只包括MUMSM的子集。我们建议开发和试点一种干预措施，可以在MUMSM中统一实施，这些MUMSM根据艾滋病毒血清状况和给药途径的不同而有所不同。我们的具体目标是：1)开发六个阶段的理论驱动的行为改变活动干预，旨在减少HIV阳性和HIV阴性、注射吸毒(IDU)和非IDU MUMSM中与HIV相关的性危险行为；2)确定MUMSM在所有HIV和IDU层面的干预系列的可接受性；3)确定干预系列的潜在有效性，以减少性危险行为；以及4)使用假设的效果大小范围确定干预的成本-效果。为了实现这些目标，将对目标人群进行焦点小组和干预预试，以发展和完善干预措施。80名MUMSM将参加一项单一的ARM试点研究，在该研究中，参与者将根据在基线和干预后两个月进行的音频计算机辅助自我访谈(ACASI)收集的数据来比较行为变化。我们的招募战略将利用圣地亚哥拉美裔和非裔美国人MUMSM的种族多样性，以及我们招募MUMSM的能力，这些MUMSM是正在进行的急性和早期艾滋病毒感染研究中最近的艾滋病毒血清转换者。据我们所知，这将是有史以来第一次针对MUMSM的异质性进行研究的降低性风险干预。如果这项初步研究显示有希望的结果，它将为提出第三阶段疗效试验提供基础。如果证明具有成本效益，这种干预可以通过提供亟需的选择来减少使用甲基苯丙胺的男男性接触者中艾滋病毒的性传播风险，从而填补一个关键的缺口。

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.