An integrated intervention using a pill ingestible sensor system to trigger actions on multifaceted social and behavioral determinants of health among PLWH

摘要 不可检测等于不可传播（U=U）减少了艾滋病毒的耻辱感，增强了艾滋病毒感染者（PLWH）的权能， 已经成为终结艾滋病流行的一个支柱。病毒抑制消除性传播艾滋病毒的风险 艾滋病毒传播强调了坚持抗逆转录病毒治疗的重要性。战略以提高 依从性通常没有实时干预，而是专注于服药提醒， 针对与贫困人口相关的不利的社会和行为健康决定因素的干预措施 坚持和参与护理。SBDOH的复杂多因素途径，如粮食不安全， 不稳定的住房和物质使用障碍，导致了在实现最佳依从性方面的不公平， 持续的病毒抑制洛杉矶县是艾滋病毒感染和传播的热点地区， 据报道，病毒抑制率约为60%，远低于到2030年结束艾滋病毒流行的95%目标。 我们的团队在提高依从性的测量和干预措施方面有着广泛的研究记录 我们使用了过去二十年中开发的基于新技术的ART依从性测量， 包括尖端的可摄取传感器（IS）技术，以获得非推断的实时依从性 通过Proteus®数字健康反馈（PDHF）系统进行监测。尽管我们最近报道了它的有效性， 在一些出版物中，PDHF系统由于没有纳入SBDOH而受到限制。多年来， 艾滋病诊所的重点是由护士、社会工作者和病例管理者组成的多学科小组， 解决SBDOH;然而，干预的时间往往是在这些问题发生后的几周到几个月。 鉴定这项研究将开发和测试一种综合干预，结合信息系统技术和不良反应， SBDOH警报，以最大限度地提高依从性和病毒抑制。使用实时IS监控，我们的集成 干预将能够立即触发诊所现有的多学科团队来解决SBDOH 一旦观察到预定义的不良依从性模式，就会出现问题。一组110名成年患者 或处于次优依从性的高风险者将从洛杉矶县安全网艾滋病诊所招募， 一个地理艾滋病毒热点，处理许多不利的SBDOH问题。受试者将被随机分配至 干预或常规护理。综合干预措施将持续20周，然后是10周， 评估可持续性。主要终点包括综合干预的可接受性、频率和 SBDOH干预措施的及时性，SBDOH在艾滋病毒治疗方面的挑战程度，以及坚持抗逆转录病毒疗法。 次要终点包括病毒载量、自我报告定义的高危性行为和性行为检测。 传播感染。总体目标是评价（一）综合干预措施的可接受性， SBDOH干预的频率和及时性，以及SBDOH在艾滋病毒治疗方面的挑战程度;（ii） 监测、促进和改善抗逆转录病毒治疗依从性的综合干预措施的有效性;以及（iii） 综合干预措施对改善病毒学结果和减少高危性活动的有效性。 1

ABSTRACT Undetectable equals Untransmittable (U=U) reduces HIV stigma, empowers people living with HIV (PLWH), and has become a pillar in the goal of ending the HIV epidemic. Viral suppression eliminating risk of sexual HIV transmission emphasizes the importance of adherence to antiretroviral therapy (ART). Strategies to enhance adherence have typically not intervened in real-time and have focused on pill-taking reminders without interventions that address adverse social and behavioral determinants of health (SBDOH) associated with poor adherence and engagement in care. The complex multifactorial pathways of SBDOH, such as food insecurity, unstable housing, and substance use disorders, have led to inequities in achieving optimal adherence and sustained viral suppression. Los Angeles (LA) County, a hot spot for HIV infection and transmission, has been reported to have viral suppression rates of ~60%, well below the 95% target of Ending HIV Epidemic by 2030. Our team has an extensive track record of research on measurement of and interventions to enhance adherence to ART. We have used novel technology-based adherence measures of ART developed in the past two decades, including the cutting-edge ingestible sensor (IS) technology to obtain non-inferred, real-time adherence monitoring by Proteus® Digital Health Feedback (PDHF) system. Despite its validation reported in our recent publications, the PDHF system has been limited by the lack of incorporation of SBDOH. For many years, a major focus in HIV clinics has been to have multidisciplinary teams of nurses, social workers, and case managers to address SBDOH; however, timing of interventions are often weeks to months after such problems have been identified. This study will develop and test an integrated intervention that combines IS technology and adverse SBDOH alerts to maximize adherence and viral suppression. Using real-time IS monitoring, our integrated intervention will be able to immediately trigger the existing multidisciplinary team at clinic to address SBDOH issues as soon as predefined patterns of poor adherence are observed. A cohort of 110 adult patients who have or are at high risk for sub-optimal adherence will be recruited from a LA County safety net HIV clinic, located in a geographic HIV hotspot, dealing many adverse SBDOH issues. Participants will be randomized into the intervention or usual care. The integrated intervention will run for 20 weeks, followed by a 10-week period to assess sustainability. The primary end points include acceptability of the integrated intervention, frequency and timeliness of SBDOH interventions, level of challenges of SBDOH in HIV treatment, and adherence to ART. The secondary end points include viral load, high-risk sexual activity defined by self-report, and detection of sexually transmitted infections. The overarching goals are to evaluate (i) acceptability of the integrated intervention, frequency and timeliness of SBDOH intervention, and level of challenges of SBDOH in HIV treatment; (ii) the efficacy of the integrated intervention for monitoring, facilitating, and improving adherence to ART; and (iii) the efficacy of the integrated intervention for improving virologic outcome and reducing high-risk sexual activity. 1