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

 描述(申请人提供)：抗逆转录病毒疗法(ART)在降低艾滋病毒相关死亡率和减少艾滋病毒携带者(PLH)传播方面有效。物质使用障碍，特别是可卡因使用障碍(CUDS)极大地降低了对ART的坚持和对治疗的坚持性。由于像CUDS这样的兴奋剂不适用于药物辅助治疗，而且在大多数情况下，直接实施抗逆转录病毒治疗既昂贵又笨拙，因此迫切需要循证干预措施，以提高PLWH合并CUDS患者对ART的依从性和持久性。国际指南现在建议，下一代遵守干预措施将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战略，以提高抗逆转录病毒治疗的依从性和优化艾滋病毒治疗结果。这种技术由于其低成本和无处不在的性质，在资源有限的环境中具有很大的适用性。移动健康(MHealth)工具已被证明可以改善包括糖尿病、结核病和艾滋病毒在内的各种慢性病患者的依从性；然而，目前还没有发表关于mHealth干预措施对PLH和CUD患者依从性的影响的研究。因此，根据PA-14-181《慢性病患者使用mHealth工具促进有效的患者-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，以评估实施mHealth干预措施的可接受性和可行性，然后进行试点可行性研究，以考察mHealth工具对ART依从性的影响。这项研究特别具有创新性，因为它建议使用mHealth干预，结合各种类型的反馈，对PLH和共生CUD-一组有问题的ART坚持和坚持-进行干预。具体目标是：(1)利用使用可卡因的公共卫生机构和医疗保健提供者的焦点小组进行定性评估，评估实施移动健康干预措施的可接受性、可行性、促进者和障碍；并将帮助制定自动和临床医生反馈的最终设计和内容，为设计试验性可行性研究做准备；以及(2)在同时发生CUD的PLH中进行为期12周的可行性随机对照试验，考察mHealth工具(蜂窝支持的智能药盒和手机)和反馈(无反馈与自动反馈与自动+临床医生反馈)对主要结果(抗逆转录病毒治疗的依从性和持久性)和次要结果(艾滋病毒病毒抑制、可卡因使用、艾滋病毒护理中的滞留)的影响。这项初步研究的结果将有助于完善干预措施，发展一项研究 未来R01的协议，并为更大规模的RCT提供数据。这项研究将对在存在严重健康差异的人群中使用mHealth工具作为一种创新的坚持策略具有广泛的影响。

 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.