The Diversion of Antiretroviral Medications to Street Markets

描述（由申请人提供）：处方药“转移”——将受管制药品从合法来源非法转移到非法市场——自20世纪90年代后期以来一直是广泛评论的话题，最近的一些研究已经解决了麻醉性镇痛药滥用和转移的模式。然而，科学文献对艾滋病病毒抗逆转录病毒药物（ARV）的转移几乎保持沉默。然而，这项应用的调查人员进行的试点工作表明，在迈阿密吸毒的个人中，抗逆转录病毒药物转移是一个日益严重的问题，而且很可能发生在艾滋病毒感染率高的其他大城市中心。这种转移的后果可能是重大的。重要的是，那些处方的抗逆转录病毒药物可能没有始终如一地坚持其治疗方案，导致其自身健康恶化，并增加出现耐药艾滋病毒菌株的可能性。从公共卫生的角度来看，耐药艾滋病毒的广泛传播可能会使新感染者几乎没有可行的治疗方法。在此背景下，拟议的4年项目的总体目标是检查佛罗里达州迈阿密（戴德县）涉及药物的艾滋病毒阳性个体中抗逆转录病毒药物转移的模式和预测因素，并描述抗逆转录病毒药物转移到当地街头市场的动态。本研究将采用理论驱动的混合方法来实现这些目标。拟议研究的定性部分的具体目标是：1)通过形成性定性研究描述影响抗逆转录病毒药物转移的关键个人、提供者和环境因素；2)调整和完善卫生服务利用的Andersen模型，以包括在形成性定性研究阶段确定的抗逆转录病毒药物转移的关键维度。目标1和目标2将通过以下方式实现：1)对90名涉毒、贫困、艾滋病毒阳性的抗逆转录病毒药物转用者和非转用者进行基线和后续深度访谈，以检查转用和非转用的动机；2)对30名“药丸经纪人”进行基线和后续深度访谈，记录他们长期以来的抗逆转录病毒药物转移活动；3)对45名艾滋病毒阳性的非法抗逆转录病毒药物购买者进行深入的基线和随访访谈，以检查长期非法购买抗逆转录病毒药物的动机。本研究定量部分的主要具体目的是：3)比较ARV分流者与非ARV分流者在卫生服务利用改进的Andersen模型所描述的个人、提供者和环境层面因素上的主要差异，并研究它们对ARV分流模式的影响。目标3将通过以下方式实现：1)招募500名目前吸毒的贫困艾滋病毒阳性个体作为样本[其中250人转移抗逆转录病毒药物治疗，250人不转移]；2)评估预测ARV转移的个体、提供者和环境因素组合。公共卫生相关性：全面了解抗逆转录病毒药物转移的性质、动机和机制对资助和监管机构、行业、公共卫生组织和卫生保健提供者至关重要，因为他们试图制定适当的预防、风险管理、治疗和政策举措。最重要的是，这项研究将为针对高度脆弱人群的抗逆转录病毒药物转移和不坚持治疗的重大健康后果的干预措施提供信息。

DESCRIPTION (provided by applicant): Prescription drug "diversion" -- the unlawful channeling of regulated pharmaceuticals from legal sources to the illicit marketplace -- has been a topic of widespread commentary since the latter part of the 1990s, and a number of recent studies have addressed patterns of narcotic analgesic abuse and diversion. The scientific literature, however, has been virtually silent regarding the diversion of antiretroviral medications (ARV) for HIV. Nevertheless, pilot work conducted by the investigators of this application suggests that ARV diversion is a growing problem among drug-involved individuals in Miami, and is likely occurring in other large urban centers where rates of HIV infection are high. The ramifications of this diversion are potentially significant. Importantly, those prescribed ARV medications may not be consistently adhering to their treatment regimens, resulting in a deterioration of their own health and increasing the potential for the emergence of medication-resistant strains of HIV. From a public health perspective, the widespread transmission of drug-resistant HIV could leave newly-infected individuals with few viable treatments. Within this context, the overall goals of the proposed 4-year project are to examine the patterns and predictors of ARV diversion among drug-involved HIV-positive individuals in Miami (Dade County), Florida, and to describe the dynamics of ARV medication diversion to local street markets. The study will utilize a theory-driven, mixed method approach to achieve these goals. The specific aims of the qualitative component of the proposed research are to: 1) Describe the key individual, provider, and environmental factors that influence ARV diversion through formative qualitative research; and, 2) Adapt and refine the Andersen model of health services utilization to include the key dimensions of ARV diversion identified in the formative qualitative research phase. Aims 1 and 2 will be accomplished by: 1) Conducting baseline and follow-up in-depth interviews with 90 drug-involved, indigent, HIV positive ARV diverters and non-diverters to examine motivations for diversion and non-diversion over time; 2) Conducting baseline and follow-up in-depth interviews with 30 "pill brokers" to document their ARV diversion activities over time; and, 3) Conducting in-depth baseline and follow-up interviews with 45 HIV positive buyers of illicit ARVs to examine motivations for illicit ARV purchases over time. The primary specific aim of the quantitative component of the research is to: 3) Compare the key differences between ARV diverters and non-diverters on individual, provider, and environmental level factors described by the modified Andersen Model of health services utilization, and examine their effects on patterns of ARV medication diversion. Aim 3 will be accomplished by: 1) Recruiting a sample of 500 indigent, HIV positive individuals who are current drug users [250 of whom divert ARV medications and 250 who do not]; and, 2) assessing the constellation of individual, provider and environmental factors hypothesized to predict ARV diversion. PUBLIC HEALTH RELEVANCE: A comprehensive understanding of the nature, motivations for, and mechanisms of ARV medication diversion is critical for funding and regulatory agencies, industry, public health organizations, and health care providers as they attempt to develop appropriate prevention, risk management, treatment, and policy initiatives. Most importantly, this study will inform interventions targeting the significant health consequences of ARV diversion and non-adherence by highly vulnerable populations.