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

 描述（由申请人提供）：男男性行为者（MSM）和变性妇女（TGW）中艾滋病毒和性传播感染的发病率不断增加，这突出表明需要采取新的方法来减少感染，特别是在不经常使用避孕套的人群中。我们以前的研究使用快速艾滋病毒自我检测（ST）的男男性接触者经常从事高风险的性行为，表明这些人愿意使用ST与合作伙伴，避免性交的情况下，合作伙伴测试艾滋病毒呈阳性，并随着时间的推移，往往会减少他们的高风险性行为。这项拟议的研究通过探索使用一种新设备mChip加密狗来扩展这一研究领域。该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，并检测其是否含有艾滋病毒和梅毒抗体。mChip加密狗为ST、艾滋病毒和梅毒以及潜在的其他性传播感染测试带来了更高的精度，并可以利用智能手机技术提供更清晰的用户说明、关于艾滋病毒/性传播感染的现有信息、对其使用的远程监控以及新诊断个人与护理的联系。在这项定量和定性研究中，我们将再次关注未感染HIV的MSM和TGW，他们有多个性伴侣，知道如何预防HIV感染，但从事高危性行为。具体目标是：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）评估使用mChip加密狗测试性伴侣的可行性，包括：a）性伴侣在3个月内使用mChip加密狗的频率; B）与mChip加密狗使用或不使用相关的因素; c）未筛查的伴侣与使用mChip加密狗筛查HIV或STI阴性的伴侣使用避孕套;以及d）与3个月内性风险行为变化相关的因素。研究分为两个阶段。在第1A阶段，60名参与者将在一次研究访问中接受定量，定性和技能演示评估（在面试官面前使用mChip加密狗）。第1A阶段的调查结果将为第1B阶段提供信息，第1B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2阶段评估的修改。在2A期，80名新受试者将接受基线定量和技能演示评估，以筛选50名受试者，这些受试者将被邀请参加2B期3个月研究。这50名参与者将获得一个mChip加密狗，并可以选择使用它来筛选性伴侣。3个月后，参与者将接受定量和定性访谈，了解与合作伙伴使用（或不使用）mChip加密狗的体验。 本研究将利用mChip加密狗开发的关键时刻，系统地让其预期用户向工程团队提供关于如何优化其在高风险人群中的可用性和可接受性的反馈。这项研究还将使我们能够评估进行更大规模和更长时间试验的可行性，以开发和测试基于mChip的减少伤害干预措施。

 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.