Understanding Viral Suppression for Newly Diagnosed HIV+ Men to Inform Implementation of TasP and U=U

了解新诊断的 HIV 男性的病毒抑制，为 TasP 和 U=U 的实施提供信息

• 批准号: 10361553
• 负责人: H. Jonathon Rendina
• 金额: $ 111.59万
• 依托单位: WHITMAN-WALKER INSTITUTE, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-03-24 至 2026-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10361553
• 关键词: AIDS prevention; Address; Adherence; Advocacy; American; Back; Behavioral; Biological; Bisexual; Blood; Caring; Centers for Disease Control and Prevention (U.S.); Clinical; Clinical Trials; Complement; Consensus; Continuity of Patient Care; Couples; Data Reporting; Diagnosis; Drops; Early Intervention; Empirical Research; Enrollment; Epidemic; Epidemiology; Event; Financial compensation; Focus Groups; Future; Gays; General Population; Goals; Guidelines; HIV; HIV Infections; HIV Seronegativity; HIV Seropositivity; HIV diagnosis; Health; Health Personnel; Home; Individual; Infection; Intervention; Interview; Lead; Link; Location; Methods; Modeling; Monitor; Morbidity - disease rate; Movement; National Institute of Allergy and Infectious Disease; National Institute of Child Health and Human Development; National Institute of Mental Health; Nature; Newly Diagnosed; Outcome; Patient Self-Report; Pattern; Persons; Phase; Population; Provider; Public Health; Qualitative Methods; Research; Resistance; Risk; Risk Factors; Safety; Sampling; Sex Behavior; Spottings; Study models; Surveys; Time; TimeLine; Translating; Treatment Efficacy; United States National Institutes of Health; Viral; Viral Load result; antiretroviral therapy; base; care providers; cohort; critical period; design; efficacy validation; high risk; implementation barriers; improved; improved outcome; indexing; insight; men; men who have sex with men; men' s group; minority stress; mortality; psychosocial; recruit; resilience; routine practice; scale up; sexual HIV transmission; sexual minority health; sexual minority men; social; success; surveillance data; theories; therapy adherence; therapy development; transmission process; treatment as prevention; uptake; virtual

Project Summary Gay and bisexual men and other sexual minority men (SMM) in the U.S. are burdened by a high and disproportionate rate of HIV infection. Improving outcomes of the HIV Care Continuum through to maintaining viral load (VL) suppression is associated with a significant reduction in the sexual transmission of HIV and significantly better long-term health outcomes. However, little research provides insight into the preventable structural, psychosocial, and behavioral factors that influence durable VL suppression during early infection that can be used in developing effective early intervention strategies. Moreover, the successful implementation of TasP and U=U messaging is a necessary component of the strategy to end the HIV epidemic, but rigorous research is needed to address real-world implementation issues, including safety concerns and perceived barriers among key stakeholder populations. We aim to address these issues with two studies grounded in the Social Ecological Model (SEM) to simultaneously examine both VL suppression and implementation barriers surrounding U=U from multiple levels of influence. Specifically, Aim 1 of the study is to examine time to initial VL suppression and patterns in VL rebound to better understand the dynamic nature of VL suppression and use the SEM along with an intersectional minority stress framework to longitudinally investigate structural, psychosocial, and behavioral factors associated with VL suppression among SMM to better understand risk and resilience. Next, Aim 2 is to examine how adherence and perceived VL status are associated with objective VL status and whether concordance between perceived and actual VL suppression influences sexual risk compensation as captured by event-level sexual behaviors and STI infections. Finally, Aim 3 is designed to understand ongoing barriers to implementing U=U from the perspectives of the three populations critical to its successful implementation among SMM—namely, SMM living with HIV, HIV-negative SMM, and HIV care providers. To do so, Study 1 (Aims 1 and 2) will leverage two LITE cohorts to recruit 250 SMM newly diagnosed with HIV during the course of the studies—we will follow these men for two years immediately following diagnosis, collecting home-based dried blood spot for VL on a monthly basis to examine the dynamic nature of VL suppression. In addition to VL and self-reported data, the study will include objective indicators of adherence and care engagement as well as qualitative interviews. The goal of Study 1 will be to identify risk and resilience factors that influence VL suppression and can be used to guide future intervention development (Aim 1) while simultaneously addressing understudied safety concerns of implementing U=U with regard to unintended risks (Aim 2). In Study 2 (Aim 3), we will use focus groups conducted three times over five years to inform implementation of U=U messaging. Achieving the aims of the proposed study will provide key insights that will be critical for translating to or adapting interventions to enhance their potency and durability and improve the health of SMM living with HIV and curb new infections.

项目摘要 在美国，同性恋和双性恋男性以及其他性少数男性（SMM）负担着高， 艾滋病毒感染率过高。通过维持艾滋病毒持续护理， 病毒载量（VL）抑制与HIV性传播的显著减少有关， 更好的长期健康结果。然而，很少有研究能够深入了解可预防的 影响早期感染期间VL持久抑制的结构、社会心理和行为因素 这可以用来制定有效的早期干预策略。此外，成功实施 TasP和U=U信息传递是结束艾滋病毒流行战略的必要组成部分，但严格 需要进行研究，以解决现实世界的实施问题，包括安全问题和感知问题。 关键利益攸关方群体之间的障碍。我们的目标是解决这些问题的两个研究接地在 社会生态模型（SEM），同时检查VL抑制和实施障碍 从多个层次的影响包围U=U。具体来说，研究的目标1是检查初始化的时间 VL抑制和VL反弹的模式，以更好地了解VL抑制的动态性质， 利用扫描电镜沿着与交叉少应力框架纵向研究结构， 与SMM中VL抑制相关的心理社会和行为因素，以更好地了解风险 和韧性。接下来，目标2是检查依从性和感知的VL状态如何与 客观VL状态以及感知和实际VL抑制之间的一致性是否影响性 风险补偿，如事件层面的性行为和性传播感染。最后，目标3旨在 从三个关键人群的角度理解实施U=U的持续障碍， 在SMM-即艾滋病毒感染者SMM、艾滋病毒阴性SMM和艾滋病毒护理中成功实施 提供商为此，研究1（目标1和2）将利用两个LITE队列招募250名新的SMM 在研究过程中被诊断为艾滋病毒感染者--我们将立即对这些人进行为期两年的跟踪调查 诊断后，每月采集家庭干血斑进行VL动态检查， VL抑制的性质。除了VL和自我报告的数据外，该研究还将包括以下客观指标： 坚持和护理参与以及定性访谈。研究1的目标是识别风险 和影响VL抑制的弹性因素，可用于指导未来的干预发展 (Aim 1）同时解决关于实施U=U的未充分研究的安全性问题， 非预期风险（目标2）。在研究2（目标3）中，我们将在五年内进行三次焦点小组讨论， 通知U=U消息传递实现。实现拟议研究的目标将提供关键的见解 这对于转化为或调整干预措施以提高其效力和持久性至关重要， 改善艾滋病毒感染者的健康，遏制新的感染。