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

使用药丸摄入传感器系统进行综合干预，以针对艾滋病毒感染者健康的多方面社会和行为决定因素采取行动

• 批准号: 10820048
• 负责人: ERIC S DAAR
• 金额: $ 102.59万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-24 至 2028-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10820048
• 关键词: Address; Adherence; Adult; Annual Reports; Anti-Retroviral Agents; Area; Behavioral; Caring; Case Manager; Clinic; Complex; County; Detection; Disparity; Dose; Epidemic; Evaluation; Event; Evolution; FDA approved; Failure; Feedback; Frequencies; Geography; Goals; HIV; HIV Infections; HIV diagnosis; Homelessness; Hot Spot; Incentives; Inequity; Information Technology; Intervention; Life; Los Angeles; Measurement; Measures; Monitor; Outcome; Participant; Pathway interactions; Patient Self-Report; Patients; Pattern; Persons; Pharmaceutical Preparations; Plasma; Poverty; Proteus; Publications; RNA; Randomized; Recording of previous events; Reporting; Research; Risk; Running; Sex Behavior; Sexual Partners; Sexually Transmitted Diseases; Social Workers; Specific qualifier value; Substance Use Disorder; Syphilis; System; Team Nursing; Testing; Text Messaging; Time; Update; Validation; Viral; Viral Load result; Woman; age group; aged; antiretroviral therapy; arm; co-infection; cohort; digital health; efficacy evaluation; empowerment; follow-up; food insecurity; health determinants; high risk; high risk sexual behavior; housing instability; improved; innovation; intervention program; longitudinal design; methamphetamine use; multidisciplinary; new technology; patient population; pill; post intervention; primary endpoint; public health relevance; real time monitoring; recruit; response; safety net; secondary endpoint; sensor; sensor technology; sexual HIV transmission; social; social stigma; synergism; therapy development; transmission process; treatment as usual; usual care arm; young man

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

抽象的 不可检测等于不可传播 (U=U) 减少艾滋病毒耻辱感，增强艾滋病毒感染者 (PLWH) 的权能，以及 病毒抑制已成为消除艾滋病毒性传播风险目标的一个支柱。 传播强调坚持抗逆转录病毒治疗（ART）策略的重要性。 依从性通常不会实时干预，而是集中在服药提醒上，而无需 解决与贫困相关的不良健康社会和行为决定因素（SBDOH）的干预措施 SBDOH 的复杂多因素途径，例如粮食不安全、 不稳定的住房和物质使用障碍导致了在实现最佳依从性和 洛杉矶 (LA) 县是艾滋病毒感染和传播的热点地区，病毒持续受到抑制。 据报道，病毒抑制率约为 60%，远低于 2030 年结束艾滋病毒流行 95% 的目标。 我们的团队在提高依从性的测量和干预方面拥有广泛的研究记录 我们使用了过去二十年开发的基于新技术的 ART 依从性措施， 包括尖端的可摄入传感器 (IS) 技术，以获得非推断的实时依从性 尽管我们最近报告了该系统的验证，但仍由 Proteus® 数字健康反馈 (PDHF) 系统进行监控。 出版物显示，多年来，PDHF 系统一直因缺乏 SBDOH 而受到限制。 艾滋病毒诊所的重点是建立由护士、社会工作者和病例管理员组成的多学科团队， 然而，干预的时间通常是在此类问题出现后数周至数月。 这项研究将开发和测试一种将信息系统技术与不良反应相结合的综合干预措施。 SBDOH 警报可最大限度地提高依从性和病毒抑制，我们的集成系统采用实时 IS 监测。 干预措施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 110 名成年患者的依从性不佳的预定模式，就会出现问题。 或处于次优依从性的高风险将从洛杉矶县安全网艾滋病毒诊所招募，该诊所位于 一个地理上的艾滋病毒热点地区，处理许多不利的 SBDOH 问题。参与者将被随机分配到该地区。 综合干预将持续 20 周，随后为期 10 周。 评估可持续性的主要终点包括综合干预的可接受性、频率和效果。 SBDOH 干预措施的及时性、SBDOH 在 HIV 治疗中面临的挑战程度以及 ART 的依从性。 次要终点包括病毒载量、自我报告定义的高风险性活动以及性行为检测 首要目标是评估 (i) 综合干预措施的可接受性， (ii) SBDOH 干预的频率和及时性，以及 SBDOH 在艾滋病毒治疗中面临的挑战程度； 监测、促进和提高 ART 依从性的综合干预措施的有效性；以及 (iii) 综合干预对于改善病毒学结果和减少高危性活动的功效。 1