Adherence Intervention for HIV-infected Drug Users

 描述(申请人提供)：这项K23研究和培训奖推进了改善治疗结果和减少艾滋病毒感染吸毒者中艾滋病毒传播的长期目标。拟议的培训和研究计划将使PI能够发展在非法药物使用和艾滋病毒遵从性干预领域的独立研究生涯所需的技能。这一应用程序的目标是发展实施科学、针对吸毒人群的行为干预开发和评估以及深入的定性数据分析方面的技能，以加快针对艾滋病毒感染吸毒者的干预措施的完善和有效实施。多种共病，如吸毒和艾滋病毒，协同作用，产生更差的健康结果，并增加艾滋病毒的发病率、死亡率和传播。因此，迫切需要适合吸毒者的有效和可持续的干预措施，以提高抗逆转录病毒药物的依从性，减少危险行为。与其他艾滋病毒感染人群相比，吸毒者面临着独特的治疗挑战，包括依从率较低和治疗结果较差。此外，人际因素，包括社会支持，消极的患者-提供者互动，以及社会经济挑战，构成了坚持治疗的重大障碍。因此，目前对吸毒者的依从性干预措施的普遍性是有限的，迫切需要适应艾滋病毒感染的吸毒人群的有效干预措施。这项应用程序通过第一个适应和测试艾滋病毒感染吸毒者联合坚持和简短激励干预的可接受性和有效性来弥补这一差距。具体地说，这项干预将加强既定的生命步骤坚持干预措施，以包括：(1)针对非法吸毒者的独特需求而量身定做的生命步骤单元，旨在改善服药依从性；(2)简短的激励性访谈，以解决药物使用和其他危险行为；以及(3)两次后续强化会议。将进行三阶段、自上而下的研究方法，以适应、改进和试点测试干预措施。第一阶段将包括与目前开出抗逆转录病毒药物处方的艾滋病毒感染吸毒者的焦点小组，以及与社区临床医生的个别访谈。第二阶段将包括手动开发、治疗师培训、试点试验、深入的定性访谈和进一步的手册 修订版。第三阶段将包括一项小型的双臂(干预与健康教育对照)随机对照试验，有60名艾滋病毒感染的吸毒者参加。在1个月、3个月和6个月的随访中，将检查抗逆转录病毒依从性改善和药物使用减少的可行性、可接受性和初步迹象。为了使国际刑警组织能够从事这一长期研究议程，她将与经验丰富的导师合作，建立三个领域的专门知识：(1)精通定性研究方法和分析；(2)制定干预措施和评估非法药物使用人群的技能；(3)先进的纵向数据分析专业知识；(4)实施科学。这项K23提案解决了艾滋病毒治疗科学中的一个关键优先事项，它将使PI为作为艾滋病毒干预科学家的独立研究生涯做好充分准备。

 DESCRIPTION (provided by applicant): This K23 research and training award advances the long-term goal of improving treatment outcomes and reducing transmission of HIV among HIV-infected drug users. The proposed training and research plans will enable the PI to develop the skills needed for an independent research career in the area of illicit drug use and HIV adherence intervention. The objective of this application is to develop skills in implementation science, behavioral intervention development and evaluation with drug using populations, and in-depth qualitative data analysis to accelerate refinement and effective implementation of interventions for HIV-infected drug users. Multiple comorbidities such as drug use and HIV act synergistically to produce poorer health outcomes and increase morbidity, mortality, and transmission of HIV. Consequently, effective and sustainable interventions adapted to drug users to improve antiretroviral medication adherence and reduce risk behaviors are urgently needed. Drug users present unique treatment challenges compared with other HIV-infected populations, including lower rates of adherence and inferior treatment outcomes. Additionally, interpersonal factors, including social support, negative patient-provider interactions, and socioeconomic challenges present significant barriers to adherence. Thus, the generalizability of current adherence interventions to drug users is limited, and there is a pressing need for efficacious interventions adapted to HIV-infected drug using populations. This application addresses this gap by being the first to adapt and test the acceptability and efficacy of a combined adherence and brief motivational intervention for HIV-infected drug users. Specifically, the intervention will augment the established Life Steps adherence intervention to include: (1) a tailored Life Steps module addressing the unique needs of illicit drug users, aimed at improving medication adherence; (2) a brief Motivational Interview to address drug use and other risk behaviors; and (3) two follow-up booster sessions. A three-phase, top-down research approach to adapt, refine, and pilot test the intervention will be conducted. Phase 1 will include focus groups with HIV-infected drug users currently prescribed antiretroviral medications and individual interviews with community-based clinicians. Phase 2 will include manual development, therapist training, a pilot trial, in-depth qualitative interviews, and further manual revisions. Phase 3 will include a small, 2-armed (intervention vs. health education control) randomized controlled trial with 60 HIV-infected drug users. Feasibility, acceptability, and preliminary indication of improvement in antiretroviral adherence and reduction in drug use will be examined at 1-, 3-, and 6-month follow-ups. To enable the PI to pursue this long-term research agenda, she will work with experienced mentors to build three areas of expertise: (1) proficiency in qualitative research methods and analysis; (2) skills in intervention development and evaluation with illicit drug using populations; (3) expertise in advanced longitudinal data analysis; and (4) implementation science. This K23 proposal addresses a key priority in HIV treatment science, and it will fully prepare the PI for an independent research career as an HIV intervention scientist.