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)和过量死亡人数正在增加；但80%的 阿片类药物使用者仍然得不到治疗。在33个州开展业务，实施注射器交换计划 为注射毒品的人提供无菌注射器和其他健康服务的(SEPS)是 一个接触非治疗阿片类药物使用者的关键场所。SEP参与者经常要求转介 我们的治疗，但护理的结构性障碍，如等待名单或交通需求，限制了 参与治疗。因此，医疗保健提供中的结构性干预是 这是提高治疗参与度所必需的。丁丙诺啡维持治疗(BMT) 安全有效，减少非法阿片类药物使用、艾滋病毒危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，我们开发了一个模型来启动 SEPS的现场BMT(O-BMT)是增加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。在一个 一项24周的随机对照试验，研究对象为大城市中的高发病率人群 HIV，我们将招募250名使用SEP的停用阿片类药物使用者，并将1：1随机分配给O- BMT或增强型转介。在两周内，O-BMT条件下的参与者将看到 丁丙诺啡提供者现场提供两次，每周接受泡剂包药物，然后他们的 护理将被转移到社区卫生中心(CHC)进行BMT维护。在控件中 在条件允许的情况下，参与者将得到加强转诊至CHC进行BMT。主要结果是 这项研究将参与BMT，定义为在接下来的30天内接受BMT 随机化(有效性)，一个重要的次要结果将是艾滋病毒风险的降低 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。 关于方案费用和参与者的服务利用情况(成本效益)。具体的 这项建议的目的是：1.测试现场注射丁丙诺啡的效果 治疗(O-BMT)在注射器更换计划中；2.通过以下方法测试O-BMT的安全性 确定丁丙诺啡转移的频率；以及3.确定成本- 通过比较研究组之间的成本和卫生服务利用来实现O-BMT的有效性。

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.