Supporting Sustained HIVTreatment Adherence after Initiation (SUSTAIN)

支持开始后持续的 HIV 治疗依从性 (SUSTAIN)

• 批准号: 10321138
• 负责人: Catherine Orrell
• 金额: $ 68.71万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-10 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10321138
• 关键词: Address; Adherence; Behavioral; Caring; Cessation of life; Client; Clinic; Clinical; Communities; Competence; Continuity of Patient Care; Cost Analysis; Data; Data Collection; Detection; Elements; Engineering; Ensure; Epidemic; Evaluation; Evidence based intervention; Future; Goals; HIV; Health; Individual; Intervention; Interview; Measures; Mediator of activation protein; Methods; Modeling; Monitor; Motivation; Outcome; Participant; Patients; Peer Group; Pharmacy facility; Phase; Pilot Projects; Policy Maker; Preparation; Process; Public Health; Quality of Care; Randomized; Records; Research Design; Resources; Sampling; Self Determination; Services; South Africa; Support Groups; Surveys; Techniques; Technology; Testing; Time; Time and Motion Studies; Treatment Failure; Treatment outcome; United States National Institutes of Health; Use Effectiveness; Viral; Virus; antiretroviral therapy; behavioral adherence; care systems; clinical care; clinical practice; compliance behavior; cost; cost effective; cost effectiveness; design; effective intervention; evidence base; falls; follow-up; high risk; improved; innovation; motivational enhancement therapy; multi-component intervention; multiphase optimization strategy; novel; outreach; practical application; primary outcome; programs; recruit; research clinical testing; secondary outcome; success; theories; transmission process; treatment adherence; treatment risk

Project Summary Globally, suboptimal levels of antiretroviral treatment (ART) adherence and retention are major causes of ongoing HIV transmission, treatment failure, illness, and death. To improve ART outcomes, HIV experts agree that clinical care systems must do two key things: (1) Find nonadherence (identify nonadherent people living with HIV (PLWH) as early as possible); and (2) Support good adherence (implement effective interventions to promote better ART retention and adherence). The SUSTAIN study will pursue both objectives by determining the optimal combination of five evidence-based early nonadherence detection and adherence support compo- nents in local clinics in Cape Town, South Africa. Of these five components, three focus on finding non- adherence: (1) immediate outreach to the patient when standard testing shows unsuppressed virus; (2) pharmacy refill monitoring (PRM) and follow-up; and (3) real-time electronic adherence monitoring (EAM). Two components focus on supporting good adherence by strengthening existing patient support in Cape Town: (4) applying enhanced peer group support using motivational interviewing techniques and (5) weekly check-in texts. Each component is feasible, acceptable, and effective for monitoring or supporting adherence in PLWH in Cape Town or a similar low-resource setting. As informed by Self-Determination Theory, each addresses behavioral mediators that can increase motivation and competence and improve ART adherence and retention. To identify the best combination of components, we will utilize an innovative and practical application of Multiphase Optimization STrategy (MOST), an engineering-inspired approach that is uniquely suited to the testing of separate intervention components and their interactions in combinations to “optimize” a potent multi- component intervention. Guided by MOST, we propose three specific aims: (1) employ an efficient fractional factorial design to determine the effects of five intervention elements on HIV viral suppression, as well as secondary outcomes; (2) evaluate intervention components to address implementation, service, and client outcomes according to the Proctor framework; and (3) use the effectiveness, cost, and implementation data from Aims 1 and 2 to model the multi-component intervention optimized for cost-effectiveness and implement- ation success. SUSTAIN addresses a crucial NIH priority—strengthening care for PLWH at high risk of treatment failure. It will also be among the first studies to use MOST to improve the HIV care continuum in a resource-constrained setting. The study’s combination of different methods of finding nonadherence and supporting good adherence has high potential to identify cost-effective and scaleable evidence-based inter- ventions and improve HIV treatment outcomes. Inclusion of both real-time electronic monitoring and pharmacy refill monitoring as intervention components will increase understanding of the best uses of technology to support adherence. Importantly, our approach can be used as a template for other settings to identify and implement the most appropriate and effective evidence-based interventions for broad, cost-effective impact.

项目摘要 在全球范围内，坚持和保留抗逆转录病毒治疗（ART）的次优水平是导致艾滋病的主要原因。 持续的艾滋病毒传播、治疗失败、疾病和死亡。为了改善ART结果，艾滋病专家同意 临床护理系统必须做两件关键的事情：（1）发现非依从性（识别非依从性患者， （2）支持良好的依从性（实施有效的干预措施， 促进更好的ART保留和依从性）。SUSTAIN研究将通过确定 五个基于证据的早期不依从检测和依从性支持组成的最佳组合， 南非开普敦当地诊所的病人。在这五个组成部分中，有三个侧重于寻找非- 坚持：（1）当标准检测显示病毒未抑制时，立即与患者联系;（2） 药房再填充监测（PRM）和随访;以及（3）实时电子依从性监测（EAM）。两 通过加强开普敦现有的患者支持，重点支持良好的依从性：（4） 运用激励性访谈技术加强同伴群体支持;（5）每周签到 文本.每个组成部分都是可行的，可接受的，有效的监测或支持遵守PLWH 在开普敦或类似的低资源环境中。根据自决理论，每一个地址 行为调节剂，可以增加动机和能力，提高ART依从性， 潴留为了确定组件的最佳组合，我们将利用创新和实用的应用程序 多阶段优化战略（MOST），一个工程启发的方法，是唯一适合于 测试单独的干预成分及其相互作用的组合，以“优化”一个强大的多功能， 组件干预。在MOST的指导下，我们提出了三个具体的目标：（1）采用一个有效的分数 析因设计，以确定五个干预因素对HIV病毒抑制的影响，以及 次要结果;（2）评估干预措施的组成部分，以解决执行，服务和客户 根据普罗克特框架的结果;（3）使用有效性、成本和实施数据 从目标1和目标2出发，为成本效益最佳的多组成部分干预建立模型，并实施- 行动成功。SUSTAIN解决了一个关键的NIH优先事项-加强对高危PLWH的护理， 治疗失败。它也将是第一批利用社会变革管理计划改进艾滋病毒护理连续性的研究之一， 资源有限的环境。该研究结合了不同的发现不依从性的方法， 支持良好的依从性具有很大的潜力来确定具有成本效益且可扩展的循证医学间 预防和改善艾滋病毒治疗结果。包括实时电子监测和药房 作为干预组成部分的再填充监测将增加对技术最佳使用的理解， 支持遵守。重要的是，我们的方法可以用作其他设置的模板，以识别和 实施最适当和最有效的循证干预措施，以产生广泛和具有成本效益的影响。