Buprenorphine treatment at syringe exchanges to reduce opioid misuse and HIV risk

摘要 在美国，阿片类药物使用障碍（OUD）和过量死亡正在增加;但80%的 阿片类药物使用者仍然无法接受治疗。在33个州开展的注射器交换项目 为注射毒品者提供无菌注射器和其他卫生服务的SEPs， 这是接触阿片类药物治疗结束后使用者的一个关键场所。SEP参与者经常要求转介 OUD治疗，但护理的结构性障碍，如等待名单或交通需求， 参与治疗。因此，在提供保健服务方面的结构性干预是 改善参与治疗的必要性。丁丙诺啡维持治疗（BMT） 安全有效，减少非法阿片类药物使用，艾滋病毒风险行为和阿片类药物过量， 法规允许在不同的环境中进行治疗。因此，基于行为模型， 弱势群体和我们的形成性研究，我们已经开发了一个模型， SEPs的现场BMT（O-BMT）作为增加BMT的创新和可推广的方法 订婚本研究的目的是测试O-BMT的有效性和安全性。中 24周随机对照试验，基于OUD发生率高的大城市地区， 艾滋病毒，我们将招募250名使用SEP的阿片类药物使用者，并将其1：1随机分配至O- BMT或增强转诊。在两周内，O-BMT条件下的参与者将看到一个 丁丙诺啡提供者两次现场，每周接受药物泡罩包装，然后他们 护理将转移到社区卫生中心（CHC）进行维持BMT。对照 如有需要，参加者可获加强转介往社区健康中心接受骨髓移植。主要结局 参与BMT，定义为在研究结束后30天接受BMT 随机化（有效性），一个重要的次要结局将是降低HIV风险 行为（有效性）。我们还将评估丁丙诺啡转移（安全性）并收集数据 方案费用和参与人的服务利用情况（成本效益）。具体 这项建议的目的是：1。为了测试现场使用丁丙诺啡的有效性， 注射器交换计划中的O-BMT治疗; 2.通过以下方式测试O-BMT的安全性： 确定丁丙诺啡转移的频率;以及3.为了确定成本- O-BMT的有效性，通过比较研究组之间的成本和卫生服务利用。

Abstract In the United States, opioid use disorder (OUD) and overdose deaths are increasing; yet 80% of opioid users remain out of treatment. Operating in 33 states, syringe exchange programs (SEPs), which provide sterile syringes and other health services to people who inject drugs, are a key venue to reach out-of-treatment opioid users. SEP participants often request referrals for OUD treatment, but structural barriers to care, such as waiting lists or transportation needs, limit engagement in treatment. Therefore structural interventions in health care delivery are necessary to improve engagement in treatment. Buprenorphine maintenance treatment (BMT) is safe and effective, reducing illicit opioid use, HIV risk behaviors, and opioid overdose, and regulations allow for treatment in diverse settings. Therefore, based on the Behavioral Model for Vulnerable Populations and our formative research, we have developed a model to initiate onsite BMT (O-BMT) at SEPs as an innovative and generalizable way to increase BMT engagement. The objectives of this study are to test the effectiveness and safety of O-BMT. In a 24 week randomized controlled trial based in a large urban area with high rates of OUD and HIV, we will recruit 250 out-of-treatment opioid users who utilize SEPs and randomize 1:1 to O- BMT or enhanced referral. Over two weeks, participants in the O-BMT condition will see a buprenorphine provider twice onsite, receive weekly blister packs of medication, and then their care will be transferred to a community health center (CHC) for maintenance BMT. In the control condition, participants will receive enhanced referral to the CHC for BMT. The primary outcome for this study will be engagement in BMT, defined as receiving BMT at 30 days following randomization (effectiveness), and an important secondary outcome will be reduction in HIV risk behaviors (effectiveness). We will also assess buprenorphine diversion (safety) and collect data on programmatic costs and participants’ service utilization (cost-effectiveness). The specific aims for this proposal are: 1. To test the effectiveness of initiating onsite buprenorphine treatment (O-BMT) at syringe exchange programs; 2. To test the safety of O-BMT by determining the frequency of buprenorphine diversion; and 3. To determine the cost- effectiveness of O-BMT by comparing costs and health service utilization between study arms.