The Diversion of Antiretroviral Medications to Street Markets

说明(申请人提供)：处方药“转移”--将受管制的药品从合法来源非法转移到非法市场--自1990年代后期以来一直是一个广泛评论的专题，最近的一些研究讨论了麻醉性止痛药滥用和转移的模式。然而，科学文献对HIV的抗逆转录病毒药物(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，在迈阿密涉及毒品的个人中，抗逆转录病毒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较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，这些开出的抗逆转录病毒药物可能没有始终如一地坚持他们的治疗方案，导致他们自己的健康恶化，并增加了出现艾滋病毒耐药毒株的可能性。从公共卫生的角度来看，抗药性艾滋病毒的广泛传播可能会使新感染的人几乎没有可行的治疗方法。在这一背景下，拟议的为期4年的项目的总体目标是研究佛罗里达州迈阿密(戴德县)艾滋病病毒感染者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。这项研究将利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的是：1)通过形成性定性研究描述影响抗逆转录病毒转移的关键个体、提供者和环境因素；以及2)调整和完善卫生服务利用的安徒生模型，以包括在形成定性研究阶段确定的抗逆转录病毒转移的关键维度。目标1和目标2将通过以下方式实现：1)对90名涉及毒品、贫困、艾滋病毒呈阳性的抗逆转录病毒药物转移者和非转移者进行基线和后续深入访谈，以检查随时间的推移转移和不转移的动机；2)对30个“药丸经纪人”进行基线和后续深入访谈，以记录他们随着时间的推移的抗逆转录病毒转移活动；以及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后续访谈，以检查随着时间的推移非法抗逆转录病毒药物购买的动机。定量部分的主要具体目的是：3)比较ARV转向者和非转向者在个人、提供者和环境水平因素上的关键差异，并检验它们对ARV药物分流模式的影响。目标3将通过以下方式实现：1)招募500名贫困、艾滋病毒阳性的当前吸毒者[其中250人转移抗逆转录病毒药物，250人没有]；以及，2)评估假设用于预测抗逆转录病毒转移的个人、提供者和环境因素的星座。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，对于资金和监管机构、行业、公共卫生组织和医疗保健提供者来说至关重要，因为他们试图制定适当的预防、风险管理、治疗和政策倡议。最重要的是，这项研究将为针对抗逆转录病毒病毒转移和高度脆弱人群不遵守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.