Addressing Barriers to the Comprehensive Use of Statins in HIV: The ABACUS-HIV Study

项目摘要/摘要 随着有效抗逆转录病毒疗法的推广使用，艾滋病毒携带者的健康状况有所改善。 尽管有这些改善，但PWH的动脉粥样硬化性心血管疾病(ASCVD)的风险仍在上升 比那些没有感染艾滋病毒的人高出一倍。Pwh承载ASCVD高危因素如血脂异常 糖尿病，随着PWH寿命的延长而增加。他汀类药物已被证明可以预防ASCVD。 与未感染HIV的患者相比，PWH对他汀类药物的需求更大，但对他汀类药物的充分反应率更低 很大程度上是由于不坚持。需要以患者为中心的干预措施来改善他汀类药物 坚持充分纳入特定于PWH的障碍，如艾滋病毒污名、低ASCVD风险认知、 HIV治疗与ASCVD预防的优先顺序，以及抗逆转录病毒药物疲劳和药物相互作用的恐惧 心理治疗。这项K01拨款的目标是调整一种干预措施，以促进他汀类药物的普遍依从性 对威斯康星医院的人群进行干预，并在HIV诊所评估适应干预措施的可接受性和可行性。我们 假设STIC2IT(远程药房干预慢性病以改善治疗的研究 坚持，“坚持下去”)可以适应威斯康星医院。STIC2IT是一种药剂师提供的干预措施，已在 通过激励性访谈改善包括他汀类药物在内的普通人群的慢性用药依从性 和量身定制的资源，以减少遵守障碍。我们将分析艾滋病中心现有的数据 综合临床系统(CNICs)研究网络，并对威尔斯亲王医院进行深入采访 北卡罗来纳大学艾滋病研究中心艾滋病临床队列(UCHCC)。我们将使用访谈 研究结果以适应干预措施，并在加州大学旧金山分校进行试点。这个职业发展奖将为PI提供 接受过以下方面的培训：1)定性研究方法；2)干预适应和评估；3)ASCVD 预防和流行病学。国际和平倡议将由一个跨学科的专家指导小组密切指导 健康行为、流行病学、心脏病学、艾滋病毒护理和干预试验。具体目标是：1)在 PWH，确定他汀类药物使用和有效性的当代纵向模式，以及更多的患者组 次优他汀类药物使用的风险；2)系统地使STIC2IT干预措施适应患者的需求和偏好 以及3)评估HIV诊所中适应性干预措施的可接受性和可行性。开展工作 这些研究目标将加强培训活动并利用PI在艾滋病毒、临床方面的现有技能 流行病学和药物流行病学研究，使用基于电子健康记录的大型临床队列。 这项研究将为未来的研究计划和准备好的适应干预的原型提供初步数据 在R级助学金中接受疗效评估。这个奖项将支持PI成为一名 处于创新研究前沿的独立研究员，以改善对重症肝炎的ASCVD预防。

PROJECT SUMMARY/ABSTRACT The health of persons with HIV (PWH) has improved with the expanded use of effective antiretroviral therapy. Despite these improvements, the risk of atherosclerotic cardiovascular disease (ASCVD) for PWH remains up to twice as high as for those without HIV. PWH bear a high burden of ASCVD risk factors such dyslipidemia and diabetes mellitus, which is increasing as PWH live longer. Statins have proven efficacy to prevent ASCVD. PWH have a greater statin need but lower rates of adequate response to statins than those without HIV, in large part due to nonadherence. There is a need for patient-centered interventions for improving statin adherence that adequately incorporate PWH-specific barriers, such as HIV stigma, low ASCVD risk perception, HIV treatment vs. ASCVD prevention prioritization, and pill fatigue and drug interaction fears from antiretroviral therapy. The objective of this K01 grant is to adapt an intervention promoting statin adherence from the general population to PWH and evaluate the adapted intervention’s acceptability and feasibility in an HIV clinic. We hypothesize that STIC2IT (Study of a Tele-pharmacy Intervention for Chronic diseases to Improve Treatment adherence, “Stick to it”) can be adapted to PWH. STIC2IT is a pharmacist-delivered intervention proven in the general population to improve chronic medication adherence including to statins, via motivational interviewing and tailored resources to reduce adherence barriers. We will analyze existing data from the Centers for AIDS Research Network of Integrated Clinical Systems (CNICS) and conduct in-depth interviews of PWH in the University of North Carolina Center for AIDS Research HIV Clinical Cohort (UCHCC). We will use interview findings to adapt the intervention and pilot it in the UCHCC. This career development award will provide the PI with training in: 1) qualitative research methods; 2) intervention adaptation and evaluation; and 3) ASCVD prevention and epidemiology. The PI will be closely guided by an interdisciplinary mentoring team of experts in health behavior, epidemiology, cardiology, HIV care, and intervention trials. The Specific Aims are: 1) Among PWH, identify contemporary longitudinal patterns of statin use and effectiveness, and patient groups at greater risk of suboptimal statin use; 2) Systematically adapt the STIC2IT intervention to the needs and preferences of PWH; and 3) Evaluate the acceptability and feasibility of the adapted intervention in an HIV clinic. Carrying out these research aims will reinforce training activities and leverage the PI’s existing skills in HIV, clinical epidemiology, and pharmacoepidemiology studies using large, electronic health records-based clinical cohorts. The study will produce preliminary data for future study planning and a prototype adapted intervention ready to be evaluated for efficacy in R-level grants. This award will support the PI’s career goal of becoming an independent investigator at the forefront of innovative research to improve ASCVD prevention for PWH.