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

注射器交换时丁丙诺啡治疗可减少阿片类药物滥用和艾滋病毒风险

• 批准号: 10363611
• 负责人: Aaron D Fox
• 金额: $ 66.55万
• 依托单位: ALBERT EINSTEIN COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-01 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10363611
• 关键词: Accident and Emergency department; Address; American; Attitude; Behavioral Model; Bulla; Buprenorphine; Caring; Cessation of life; Clinic; Communities; Data; Data Collection; Drug user; Economics; Effectiveness; Emergency treatment; Frequencies; Goals; HIV; HIV Infections; HIV risk; Health Personnel; Health Services; Health system; Hospitals; Individual; Injecting drug user; Inpatients; Intervention; Jail; Maintenance; Measures; Medical; Modeling; Monitor; Needle-Exchange Programs; Neighborhood Health Center; Outcome; Outcome Study; Overdose; Participant; Patient Self-Report; Pharmaceutical Preparations; Pharmacy facility; Physicians; Pilot Projects; Provider; Public Health; Puerto Rico; Quality of life; Questionnaires; Randomized; Randomized Controlled Trials; Recovery; Regulation; Reporting; Research; Risk; Risk Behaviors; Safety; Sampling; Self Efficacy; Sterility; Surveys; Syringes; Testing; Training; Transportation; Treatment Effectiveness; Treatment outcome; United States; Urine; Vulnerable Populations; Waiting Lists; addiction; arm; barrier to care; base; buprenorphine treatment; community setting; cost; cost effective; cost effectiveness; data format; drug testing; effectiveness testing; experience; follow-up; health care delivery; health service use; heroin use; high risk; illicit opioid; improved; innovation; interest; medication compliance; opioid misuse; opioid overdose; opioid use; opioid use disorder; opioid user; overdose death; overdose risk; patient registry; primary outcome; recruit; safety testing; secondary outcome; service utilization; social stigma; transmission process; urban area; waiver

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.

抽象的 在美国，阿片类药物使用障碍（OUD）和过量死亡人数正在增加；然而80%的 阿片类药物使用者仍未接受治疗。注射器交换计划在 33 个州开展 （SEP），为注射吸毒者提供无菌注射器和其他卫生服务 接触停止治疗的阿片类药物使用者的重要场所。 SEP 参与者经常要求转介 OUD 治疗，但护理的结构性障碍（例如等候名单或交通需求）限制了 参与治疗。因此，医疗保健提供的结构性干预措施 提高治疗参与度所必需的。丁丙诺啡维持治疗 (BMT) 安全有效，减少阿片类药物的非法使用、艾滋病毒危险行为和阿片类药物过量，以及 法规允许在不同环境下进行治疗。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 SEP 的现场 BMT (O-BMT) 作为增加 BMT 的创新和通用方法 订婚。本研究的目的是测试 O-BMT 的有效性和安全性。在一个 在 OUD 发生率较高的大城市地区进行的 24 周随机对照试验 HIV，我们将招募 250 名未接受治疗的阿片类药物使用者，他们利用 SEP 并按 1:1 随机分配至 O- BMT 或增强转诊。两周内，O-BMT 条件下的参与者将看到 丁丙诺啡提供者两次到现场，每周收到药物泡罩包装，然后他们的 护理将转移至社区卫生中心 (CHC) 进行维持 BMT。在控制中 如果条件允许，参与者将收到更多转介至 CHC 进行 BMT。主要结果 本研究将参与 BMT，定义为在 30 天后接受 BMT 随机化（有效性），一个重要的次要结果是降低艾滋病毒风险 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 关于计划成本和参与者的服务利用率（成本效益）。具体的 该提案的目的是： 1. 测试启动现场丁丙诺啡的有效性 注射器交换计划中的治疗（O-BMT）； 2. 测试O-BMT的安全性 确定丁丙诺啡转移的频率； 3. 确定成本- 通过比较研究组之间的成本和卫生服务利用率来评估 O-BMT 的有效性。

项目成果

"The Doctor Says You Cannot Have [Buprenorphine]" Autonomy and Use of Prescribed or Non-Prescribed Buprenorphine.

• DOI: 10.1080/10826084.2021.1908360
• 发表时间: 2021
• 期刊: Substance use & misuse
• 影响因子: 2
• 作者: Hayes BT;Jakubowski A;Fitzsimmons C;Garcia B;Ramirez F;Fox AD
• 通讯作者: Fox AD

Implementation of buprenorphine services in NYC syringe services programs: a qualitative process evaluation.

• DOI: 10.1186/s12954-022-00654-0
• 发表时间: 2022-07-10
• 期刊: HARM REDUCTION JOURNAL
• 影响因子: 4.4
• 作者: Jakubowski, Andrea;Rath, Caroline;Harocopos, Alex;Wright, Monique;Welch, Alice;Kattan, Jessica;Behrends, Czarina Navos;Lopez-Castro, Teresa;Fox, Aaron D.
• 通讯作者: Fox, Aaron D.