Improving Antiretroviral Adherence and Persistence using mHealth Tools in HIV-infected Cocaine Users

使用移动医疗工具提高感染艾滋病毒的可卡因使用者的抗逆转录病毒治疗依从性和持久性

• 批准号: 9064337
• 负责人: FREDERICK LEWIS ALTICE
• 金额: $ 20.94万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-01 至 2018-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9064337
• 关键词: Address; Adherence; Agonist; Anti-Retroviral Agents; Area; Asthma; Back; Behavioral Model; Boxing; Caring; Cellular Phone; Chronic; Clinical effectiveness; Cocaine Users; Communication; Communities; Data; Diabetes Mellitus; Disease; Dose; Drug usage; Effectiveness; Evidence based intervention; Feasibility Studies; Feedback; Focus Groups; Future; Grant; Guidelines; HIV; Health; Health Personnel; Health Technology; Healthcare Systems; High Prevalence; Human Resources; Individual; Intake; International; Intervention; Life; Malaria; Monitor; Morbidity - disease rate; Motivation; NIH Program Announcements; Nature; Opioid; Outcome; Patient Self-Report; Patients; Pharmaceutical Preparations; Pilot Projects; Population; Preparation; Procedures; Protocols documentation; Provider; Publishing; Qualitative Research; Research; Research Design; Resources; Risk; Sampling; Self Management; Societies; Substance Use Disorder; Surveys; Technology; Testing; Text; Time; Treatment outcome; Triad Acrylic Resin; Tuberculosis; Underserved Population; Viral; Voice; antiretroviral therapy; cocaine use; cost; cost effective; design; directly administered antiretroviral therapy; evidence base; health disparity; improved; improved outcome; innovation; interactive feedback; interest; mHealth; medication compliance; mobile computing; mortality; next generation; pill; primary outcome; public health relevance; response; secondary outcome; therapy adherence; tool; transmission process; treatment adherence

 DESCRIPTION (provided by applicant): Antiretroviral therapy (ART) is effective at lowering HIV-related mortality and reducing transmission among people living with HIV (PLH). Substance use disorders, especially cocaine use disorders (CUDs) greatly reduce ART adherence and persistence on treatment. Because stimulants like CUDs are not amenable to medication-assisted therapy and directly administered antiretroviral therapy is costly and unwieldy in most settings, evidence-based interventions are urgently needed to improve ART adherence and persistence in PLWH with co-occurring CUDs. International guidelines now suggest that the next generation of adherence interventions will need to be scaled back in terms of cost and personnel. Mobile technologies can provide innovative, efficacious and cost-effective strategies to improve ART adherence and optimize HIV treatment outcomes. Such technologies have great applicability in resource-limited settings due to their low cost and ubiquitous nature. Mobil health (mHealth) tools have been shown to improve adherence in patients with various chronic conditions including diabetes, tuberculosis, and HIV; however currently, no published research exists on the impact of mHealth interventions on adherence among PLH and CUDs. Thus, in response to PA- 14-181, "mHealth Tools for Individuals with Chronic Conditions to Promote Effective Patient-Provider Communication, Adherence to Treatment and Self-Management", we intend to first conduct qualitative research to assess the acceptability and feasibility of implementing mHealth interventions followed by a pilot feasibility study to examine the effect of mHealth tools on ART adherence. This study is particularly innovative as it proposes to use mHealth intervention with various types of feedback, on PLH with co-occurring CUDs - a group with problematic ART adherence and persistence. The specific aims are: (1) to conduct qualitative assessments using focus groups of PLH who use cocaine and healthcare providers that will assess the acceptability, feasibility, facilitators and barriers of implementing mHealth interventions; and will aid in developing the final design and content of both automated and clinician feedback in preparation for designing a pilot feasibility study; and (2) to conduct a 12-week pilot feasibility RCT among PLH with co-occurring CUDs that will examine the impact of mHealth tools (cellular-enabled smart pill boxes and cell phones) and feedback (no feedback vs. automated feedback vs. automated + clinician feedback) on primary (ART adherence and persistence) and secondary outcomes (HIV viral suppression, cocaine use, retention in HIV care). Findings from this pilot study will help in refining the intervention, developing a research protocol for a future R01 and providing data for a larger-scale RCT. This research will have widespread implications for the use of mHealth tools as an innovative adherence strategy in a population with profound health disparities.

 说明（由申请人提供）：抗逆转录病毒疗法 (ART) 可有效降低 HIV 相关死亡率并减少 HIV 感染者 (PLH) 的传播。物质使用障碍，特别是可卡因使用障碍 (CUD) 会大大降低 ART 的依从性和持续性。由于像 CUD 这样的兴奋剂不适合药物辅助治疗，并且在大多数情况下直接进行抗逆转录病毒治疗既昂贵又笨拙，因此迫切需要基于证据的干预措施来改善。 PLWH 中 ART 的依从性和持续性与同时发生的 CUD 目前的国际指南表明，下一代依从性干预措施需要在成本和人员方面进行缩减，移动技术可以提供创新、有效和具有成本效益的策略来改进。 ART 依从性和优化 HIV 治疗结果。由于其低成本和普遍性，此类技术在资源有限的环境中具有很大的适用性，Mobil health (mHealth) 工具已被证明可以提高各种慢性病患者的依从性，包括。糖尿病、结核病和艾滋病毒；然而，目前尚无关于移动医疗干预对 PLH 和 CUD 依从性的影响的已发表研究，因此，针对 PA-14-181，“针对慢性病患者促进有效患者的移动医疗工具”。 -提供者沟通、坚持治疗和自我管理”，我们打算首先进行定性研究，评估实施移动医疗干预措施的可接受性和可行性，然后进行试点可行性研究以检验效果这项研究特别具有创新性，因为它建议对同时发生 CUD 的 PLH（存在 ART 依从性和持续性问题的群体）使用移动医疗干预和各种类型的反馈。使用使用可卡因的 PLH 焦点小组和医疗保健提供者进行定性行为，评估实施移动医疗干预措施的可接受性、可行性、促进因素和障碍，并帮助制定准备中的自动反馈和临床反馈的最终设计和内容；设计一项试点可行性研究；(2) 在 PLH 中进行为期 12 周的试点可行性随机对照试验，并同时进行 CUD，以检查移动医疗工具（支持蜂窝的智能药盒和手机）和反馈（无反馈与自动反馈与自动+临床医生反馈）主要（ART依从性和持久性）和次要结果（HIV病毒抑制、可卡因使用、HIV护理保留）的结果将有助于完善干预措施、制定治疗方案。一项研究 这项研究将为未来的 R01 方案提供数据，并为更大规模的随机对照试验提供数据。这项研究将对使用移动医疗工具作为在健康差异巨大的人群中的创新依从策略产生广泛的影响。