Mobile health platform for providing real-time follow-up after home-based HIV self-testing for high-risk men who have sex with men

项目总结/摘要 在美国，艾滋病毒对男男性行为者（MSM）的影响不成比例， 继续增加，特别是在非洲裔美国人（AA）和西班牙裔/拉丁裔（H/L）男男性接触者中。过去的研究 据估计，这些新感染中高达50%来自大约20%的男男性行为者， 不知道他们的地位。扩大艾滋病毒检测可以降低发病率， 通过促进早期诊断和治疗来扩大规模。AA中的艾滋病毒检测率特别低 和H/L男男性接触者，鼓励检测的创新方法可能有助于解决这些男性的高发病率。 以家庭为基础的艾滋病毒自我检测（HBST）为增加MSM人数提供了相当大的希望， 通过克服基于诊所的测试的关键障碍，如不便和 保密问题。HBST也可能特别适合AA和H/L MSM，因为这种耻辱感和 对医疗服务的不信任导致了低检测率。然而，尽管它有希望，许多人担心， HBST没有充分连接用户与关键的测试后资源，如验证性测试， 这些限制可能会导致与护理的延迟联系。现有的， FDA批准的HBST试剂盒提供免费的24小时服务热线，为寻求这些服务的人提供这些服务， 很少有用户这样做，这种"被动"的方法可能会错过与MSM进一步接触的关键机会。 预防服务。为了应对这些挑战，我们开发了一个移动的健康平台（"eTEST"）， 物联网（IoT）技术，用于监控HBST用户何时真实的打开测试，使我们能够 在他们这样做之后，通过电话提供及时的、"积极的"后续咨询和转介。在试点研究中，我们 表明定期通过邮件提供HBST可以提高高危人群中任何/重复HIV检测的比率， MSM与基于诊所的检测提醒进行比较。此外，那些接受后续电话咨询的人 HBST后更有可能接受降低风险咨询，向医疗服务提供者咨询 鉴于这些有希望的结果，拟议的研究将进行全面的动力 在有大量AA和H/L MSM人群和HIV高发病率的地区进行这种方法的有效性试验： 杰克逊，MS，洛杉矶，CA和波士顿，MA。过去一年未进行HIV检测的高危MSM 将从面向MSM的"勾搭"移动的应用程序中招募，并分配接受（1）HBST后， 测试电话咨询/转诊（"eTEST"条件），（2）"标准" HBST，无主动随访，或（3） 提醒在当地诊所进行艾滋病毒检测（"控制"条件），在整个过程中每隔三个月进行一次 12个月我们将探讨eTEST系统对关键结果的影响，包括艾滋病毒检测率， 与标准HBST或诊所相比，接受额外的艾滋病毒预防服务和PrEP启动- 仅基于测试提醒。我们亦会探讨电子考试系统在多个范畴的成本效益 与仅依赖传统的基于诊所的测试相比，

Project Summary/Abstract HIV disproportionately affects men who have sex with men (MSM) in the United States, and new infections continue to increase particularly among African American (AA) and Hispanic/Latino (H/L) MSM. Past studies estimate that up to 50% of these new infections originate from the approximately 20% of MSM who are unaware of their status. Expanded HIV testing can produce reductions in incidence when implemented on a broad scale by facilitating earlier diagnosis and treatment. Rates of HIV testing are particularly low among AA and H/L MSM, and innovative approaches to encourage testing may help address high incidence in these men. Home-based, self-testing (HBST) for HIV offers considerable promise for increasing the number of MSM who are aware of their status by overcoming key barriers to clinic-based testing, such as inconvenience and confidentiality concerns. HBST may also be particularly well-suited for AA and H/L MSM, given that stigma and mistrust of medical care contribute to low testing rates. Despite its promise, however, many are concerned that HBST does not sufficiently connect users with critical post-testing resources, such as confirmatory testing and care among those who test positive, and that these limitations may result in delayed linkage to care. Existing, FDA-approved HBST kits provide a free, 24-hour helpline that offers these services to those who seek it, but few users do, and this “passive” approach may miss critical opportunities to engage with MSM for further prevention services. To address these challenges, we developed a mobile health platform (“eTEST”) that uses internet-of-things (IoT) technologies to monitor when HBST users open their tests in real time, allowing us to provide timely, “active” follow-up counseling and referral over the phone after they do so. In a pilot study, we show that providing HBST by mail at regular intervals boosted rates of any/repeat HIV testing among high-risk MSM compared with clinic-based testing reminders. Moreover, those who received follow-up phone counseling after HBST were more likely to receive risk reduction counseling, to consult with a medical provider about PrEP, and to initiate PrEP. Given these promising results, the proposed research will conduct a fully-powered efficacy trial of this approach in areas with large populations of AA and H/L MSM and high HIV incidence: Jackson, MS, Los Angeles, CA, and Boston, MA. High-risk MSM who have not tested for HIV in the last year will be recruited from MSM-oriented “hook-up” mobile apps, and assigned to receive either (1) HBST with post- test phone counseling/referral (“eTEST” condition), (2) “standard” HBST without active follow-up, or (3) reminders to get tested for HIV at a local clinic (“control” condition) at three month intervals over the course of 12 months. We will explore the impact of the eTEST system on key outcomes, including rates of HIV testing, receipt of additional HIV prevention services, and PrEP initiation, compared with standard HBST or clinic- based testing reminders alone. We will also explore the cost effectiveness of the eTEST system under various scenarios compared with relying on traditional, clinic-based testing alone.