RTI International, 3040 E Cornwallis Rd, Research Triangle, Research Triangle Park, NC, 27709, USA.
Department of Medicine, Division Global Public Health, UCSD, 9500 Gilman Dr, La Jolla, CA, 92093, USA.
Implement Sci. 2023 Aug 3;18(1):33. doi: 10.1186/s13012-023-01288-x.
More than half a million Americans died of an opioid-related overdose between 1999 and 2020, the majority occurring between 2015 and 2020. The opioid overdose mortality epidemic disproportionately impacts Black, Indigenous, and people of color (BIPOC): since 2015, overdose mortality rates have increased substantially more among Black (114%) and Latinx (97%) populations compared with White populations (32%). This is in part due to disparities in access to naloxone, an opioid antagonist that can effectively reverse opioid overdose to prevent death. Our recent pilot work determined that many barriers to naloxone access can be identified and addressed by syringe service programs (SSPs) using the Systems Analysis and Improvement Approach to Naloxone distribution (SAIA-Naloxone). This randomized controlled trial will test SAIA-Naloxone's ability to improve naloxone distribution in general and among BIPOC specifically.
We will conduct a trial with 32 SSPs across California, randomly assigning 16 to the SAIA-Naloxone arm and 16 to receive implementation as usual. SAIA-Naloxone is a multifaceted, multilevel implementation strategy through which trained facilitators work closely with SSPs to (1) assess organization-level barriers, (2) prioritize barriers for improvement, and (3) test solutions through iterative change cycles until achieving and sustaining improvements. SSPs receiving SAIA-Naloxone will work with a trained facilitator for a period of 12 months. We will test SAIA-Naloxone's ability to improve SSPs' naloxone distribution using an interrupted time series approach. Data collection will take place during a 3-month lead-in period, the 12-month active period, and for an additional 6 months afterward to determine whether impacts are sustained. We will use a structured approach to specify SAIA-Naloxone to ensure strategy activities are clearly defined and to assess SAIA-Naloxone fidelity to aid in interpreting study results. We will also assess the costs associated with SAIA-Naloxone and its cost-effectiveness.
This trial takes a novel approach to improving equitable distribution of naloxone amid the ongoing epidemic and associated racial disparities. If successful, SAIA-Naloxone represents an important organizational-level solution to the multifaceted and multilevel barriers to equitable naloxone distribution.
1999 年至 2020 年间，超过 50 万美国人死于阿片类药物相关的过量用药，其中大部分发生在 2015 年至 2020 年。阿片类药物过量用药死亡率的流行不成比例地影响着黑人和土著以及有色人种（BIPOC）：自 2015 年以来，黑人和拉丁裔（114%）人群的过量死亡率大幅上升，而与白人（32%）相比。这部分是由于获得纳洛酮的差异造成的，纳洛酮是一种阿片类拮抗剂，可以有效逆转阿片类药物过量用药以防止死亡。我们最近的试点工作确定，通过使用系统分析和改进纳洛酮分配方法（SAIA-Naloxone），可以发现和解决许多纳洛酮获取方面的障碍。这项随机对照试验将测试 SAIA-Naloxone 提高一般人群和 BIPOC 人群中纳洛酮分布的能力。
我们将在加利福尼亚州的 32 个 SSP 中进行一项试验，将 16 个随机分配到 SAIA-Naloxone 组，16 个接受常规实施。SAIA-Naloxone 是一种多方面、多层次的实施策略，通过培训人员与 SSP 密切合作，（1）评估组织层面的障碍，（2）确定需要改进的障碍，（3）通过迭代变更周期测试解决方案，直到实现并维持改进。接受 SAIA-Naloxone 的 SSP 将与一名经过培训的人员合作 12 个月。我们将使用中断时间序列方法测试 SAIA-Naloxone 提高 SSP 纳洛酮分布的能力。数据收集将在 3 个月的引导期、12 个月的活动期和之后的 6 个月进行，以确定影响是否持续。我们将使用结构化方法指定 SAIA-Naloxone，以确保策略活动得到明确界定，并评估 SAIA-Naloxone 的保真度，以帮助解释研究结果。我们还将评估与 SAIA-Naloxone 相关的成本及其成本效益。
这项试验采用了一种新颖的方法来改善阿片类药物流行和相关种族差异背景下纳洛酮的公平分配。如果成功，SAIA-Naloxone 代表了一种重要的组织层面解决方案，以解决公平分配纳洛酮的多方面和多层次障碍。
