Use of Novel Mobile Technology to Screen Sexual Partners for HIV and STIs

 描述(申请人提供)：男男性行为者(MSM)和变性人女性(TGW)中艾滋病毒和性传播疾病的发病率不断上升，突显了减少感染的新方法的必要性--特别是在不经常使用避孕套的个人中。我们之前对经常从事高危性行为的男男性行为者使用快速艾滋病毒自我检测(ST)的研究表明，这些男性愿意与伴侣使用ST，避免在伴侣检测艾滋病毒呈阳性的情况下发生性行为，并且随着时间的推移，他们的高危性行为往往会减少。这项拟议的研究通过探索一种新设备mChip加密狗的使用来扩展这一研究路线。这种设备由哥伦比亚大学工程学院开发，使用智能手机技术分析一滴血液，并检测其艾滋病毒和梅毒抗体。MChip加密狗为ST、艾滋病毒和梅毒以及可能的其他性传播感染测试带来了更高的精确度，并可以利用智能手机技术提供更清晰的用户说明、有关艾滋病毒/性传播感染的现有信息、远程监测艾滋病毒/性传播感染的使用情况，以及将新诊断的个人与护理联系起来。在这项拟议的定量和定性研究中，我们将再次关注未感染艾滋病毒的MSM和TGW，他们有多个性伴，他们知道如何预防艾滋病毒感染，但仍从事高危性行为。具体目的是：1)评估MSM和TGW使用mChip加密狗测试性伴侣的可接受性；2)优化智能手机应用程序和mChip加密狗以供家庭使用；以及3)评估性伴侣使用mChip加密狗的可行性，包括：a)与性伴侣使用mChip加密狗的频率超过3个月；b)与使用或不使用mChip加密狗有关的因素；c)未经筛查的伴侣与使用mChip加密狗筛查HIV或STI阴性的伴侣使用避孕套；以及d)与超过3个月的性行为变化相关的因素。这项研究分为两个阶段。在第1A阶段，60名参与者将在一次考察访问中接受定量、定性和技能演示评估(使用面试者面前的mChip加密狗)。第一阶段的调查结果将为第一阶段B提供信息，该阶段的重点是为家庭用户修改智能手机应用程序和mChip加密狗，以及对第二阶段评估的修订。在第2A阶段，80名新参与者将接受基线量化和技能示范评估，以筛选出50名参与者，这些参与者将被邀请参加为期3个月的第2B阶段研究。这50名参与者将被提供一个mChip加密狗，并可以选择使用它来筛查性伴侣。3个月后，参与者将接受一次关于与合作伙伴使用(或不使用)mChip加密狗的经历的定量和定性访谈。这项研究将利用mChip加密狗开发的关键时刻，系统地吸引其预期用户，就如何优化其在高危人群中的可用性和接受性向工程团队提供反馈。这项研究还将使我们能够评估进行更大规模和更长时间的试验以开发和测试基于mChip的减少伤害干预措施的可行性。

 DESCRIPTION (provided by applicant): Increasing incidence of HIV and STIs among men who have sex with men (MSM) and transgender women (TGW) highlight the need for novel approaches to reducing infections-especially among individuals who do not use condoms consistently. Our prior studies on the use of rapid HIV self-testing (ST) by MSM who regularly engage in high-risk sexual behavior, show that these men are willing to use ST with partners, avoid intercourse in situations where partners test HIV-positive, and, over time tend to reduce their high-risk sexual behavior. This proposed study expands this line of research by exploring the use of a new device, the mChip dongle. Developed at the Columbia University School of Engineering, this device uses smartphone technology to analyze a drop of blood and test it for HIV and syphilis antibodies. The mChip dongle brings more precision to ST, tests for HIV and syphilis and potentially other STIs, and can capitalize on smartphone technology to provide clearer user instructions, on-hand information about HIV/STI, remote monitoring of the its use, and linkage of newly diagnosed individuals to care. For this proposed quantitative and qualitative study, we will again focus on HIV-uninfected MSM and TGW with multiple sexual partners who know how to prevent HIV infection, yet engage in high-risk sexual behavior. The Specific Aims are to: 1) Assess acceptability among MSM and TGW of using the mChip dongle to test sexual partners; 2) Optimize the smartphone app and mChip dongle for home use; and 3) Assess the feasibility of using the mChip dongle to test sexual partners, including: a) frequency of use of the mChip dongle with sexual partners over 3 months; b) factors associated with mChip dongle use or non-use; c) condom use with partners who were not screened vs. partners screened HIV or STI- negative with the mChip dongle; and d) factors associated with changes in sexual risk behavior over 3 months. The study consists of two phases. In Phase 1A, 60 participants will undergo a quantitative, qualitative, and skill-demonstration assessment (using the mChip dongle in front of the interviewer) in a single study visit. Phase 1A findings wil inform Phase 1B, which focuses on revising the smartphone app and mChip dongle for home users, as well as revisions to the Phase 2 assessment. In Phase 2A, 80 new participants will undergo a baseline quantitative and skill-demonstration assessment in order to screen for 50 participants who will be invited into the Phase 2B 3-month study. These 50 participants will be provided with an mChip dongle and given the choice to use it to screen sexual partners. After 3 months participants will undergo a quantitative and qualitative interview about experiences using (or not using) the mChip dongle with partners. This study will capitalize on a critical juncture in the development of the mChip dongle by systematically engaging its intended users in offering feedback to the engineering team on how to optimize its usability and acceptability among high-risk populations. This study will also allow us to assess the feasibility of conducting a larger and longer trial to develop and test an mChip-based harm-reduction intervention.