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

基本信息

批准号：
10364785
负责人：
Aaron D Fox
金额：
$ 9.38万
依托单位：
ALBERT EINSTEIN COLLEGE OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-08-01 至 2023-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10364785
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 Structure 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

项目摘要

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) 和服用过量的死亡人数仍在增加，但仍有 80% 的人因阿片类药物滥用而死亡。阿片类药物使用者仍未接受治疗，33 个州正在实施注射器交换计划。（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）限制了因此，医疗保健提供中的结构性干预措施是必要的。丁丙诺啡维持治疗 (BMT) 是提高治疗参与度所必需的。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，以及因此，法规允许在不同的环境中进行治疗。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 的创新和通用方法本研究的目的是测试 O-BMT 的有效性和安全性。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 或增强转介在两周内，O-BMT 条件的参与者将看到一个结果。丁丙诺啡提供者两次到现场，每周收到药物泡罩包装，然后他们的护理将被转移到社区卫生中心 (CHC) 进行维持 BMT 控制。如果情况如此，参与者将收到更多转诊至 CHC 进行 BMT。本研究将进行 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）。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. 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. 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。