Department of Psychiatry, The University of Texas at Austin Dell Medical School, 1912 Speedway, Austin, TX, USA.
Department of Medicine, Alpert Medical School of Brown University, Providence, RI, USA.
Addict Sci Clin Pract. 2018 Apr 2;13(1):12. doi: 10.1186/s13722-018-0113-5.
HIV-infected people who use drugs (PWUD) exhibit the highest rates of non-adherence to antiretroviral therapy (ART) among people living with HIV. This contributes to poor treatment outcomes, increased morbidity and mortality, and HIV transmission. However, current interventions fail to address the unique barriers to adherence faced by this population. Life Steps is a brief, single session intervention that demonstrated increased ART adherence among HIV-infected individuals. This study protocol seeks to improve clinical practice by adapting Life Steps for HIV-infected PWUD and adding a brief motivational intervention addressing drug use. This intervention will incorporate educational, motivational, and behavioral skills components specifically aimed at improving adherence and linkage to substance use treatment among HIV-infected PWUD.
This project will consist of three phases using a mixed-methods approach. In Phase 1, qualitative interviews with HIV-infected PWUD and community providers, coupled with feedback from an expert review panel, will be used to enhance the existing Life Steps manual and interventionist training protocol. In Phase 2, the prototype will be pilot tested and qualitative exit interviews with HPWUD will identify the strengths and limitations of the intervention. Data regarding feasibility, acceptability, and barriers to delivery will guide modifications to finalize a modified Life Steps-Drug Use (LS-DU) protocol. In Phase 3, a pilot type 1 hybrid effectiveness-implementation trial will examine the effectiveness of LS-DU relative to a health education intervention control condition on ART adherence and viral load data at 1-, 3-, and 6-months. Data regarding clinic readiness for implementation and intervention sustainability potential will be collected.
This protocol will adapt and evaluate an intervention to improve adherence among HIV-infected PWUD. Results of this study will provide significant data on the acceptability, initial effectiveness, and sustainability potential of an adherence intervention for a high risk and underserved population. Trial registration NCT02907697.
在感染艾滋病毒的人群中，吸毒者（PWUD）的抗逆转录病毒疗法（ART）依从性最低。这导致治疗效果不佳、发病率和死亡率增加以及艾滋病毒传播。然而，目前的干预措施未能解决这一人群所面临的独特的依从性障碍。Life Steps 是一种简短的单次干预措施，已证明其能提高感染艾滋病毒者的 ART 依从性。本研究方案旨在通过将 Life Steps 应用于感染艾滋病毒的吸毒者，并添加一个解决吸毒问题的简短动机干预措施，从而改善临床实践。该干预措施将纳入专门针对提高感染艾滋病毒的吸毒者的依从性和与药物使用治疗相联系的教育、动机和行为技能成分。
该项目将使用混合方法，分三个阶段进行。在第 1 阶段，将对感染艾滋病毒的吸毒者和社区提供者进行定性访谈，并结合专家审查小组的反馈意见，以增强现有的 Life Steps 手册和干预者培训方案。在第 2 阶段，将对原型进行试点测试，并对感染艾滋病毒的吸毒者进行定性退出访谈，以确定干预措施的优势和局限性。关于可行性、可接受性和提供障碍的数据将指导对最终修改 Life Steps-药物使用（LS-DU）方案进行修改。在第 3 阶段，将进行一项试点类型 1 混合有效性-实施试验，以检验 LS-DU 相对于健康教育干预对照条件对 1、3 和 6 个月时的 ART 依从性和病毒载量数据的有效性。将收集关于实施准备情况和干预可持续性潜力的数据。
本方案将改编和评估一项提高感染艾滋病毒的吸毒者依从性的干预措施。这项研究的结果将提供有关针对高风险和服务不足人群的依从性干预措施的可接受性、初步有效性和可持续性潜力的重要数据。试验注册 NCT02907697。
