Opioid Use Disorder Treatment Linkage at STD Clinics using Buprenorphine (OUTLAST-B)

摘要 未经治疗的阿片使用障碍(OUD)在美国是一个持续的公共卫生紧急情况。OUD是 与严重的发病率和死亡率有关，包括服药过量死亡。丁丙诺啡是一种有效的 治疗，但大多数需要这种治疗的人得不到这种治疗。 公立性病诊所是大容量、间歇性护理的医疗机构，服务于高危人群，通常是在 无需预约的基础设施。性病门诊患者存在较高的OUD和危害健康行为。 这项名为《在性病诊所使用丁丙诺啡的阿片类药物使用障碍治疗联动》的拟议研究 (OutLast-B)，将为寻求服务的阿片依赖患者研究OUD治疗联动策略 在公立性病诊所。这项三组平行随机临床试验(RCT)将比较普通护理(UC)、 通过患者导航(PN)转诊，与性病门诊启动丁丙诺啡(PN+BUP)的患者导航相比。 UC ARM将包括性病诊所的标准服务。PN ARM将包括所有UC ARM服务， 增加了一名患者导航员，帮助参与者选择社区OUD治疗 方案，促进入院预约，帮助解决障碍和协调我们的治疗进入，以及 支持在OUD治疗中早期保留。PN+BUP ARM将包括所有PN ARM服务，此外 与性病诊所的丁丙诺啡豁免提供者(通常是护士)会面，以启动 丁丙诺啡治疗，作为一个桥梁，直到成功转移到乌德治疗在社区。 由结构化访谈和药物使用和性传播疾病生物标志物组成的研究评估将 在基线、3个月和6个月的随访时进行。选定的结果将在12个月内进行审查 通过健康记录链接方法。这项研究将考察参与者在以下领域的结果：(1)OUD 治疗进入和保留，(2)阿片类药物的使用和相关问题(包括致命和非致命的过量用药)， 以及(3)与艾滋病毒/性传播疾病相关的结果。 这项创新的研究可以确定让高危患者参与OUD的新方法 治疗。这项研究可能会产生很大的影响，因为研究结果可能会扩展到全国各地的性病诊所 国家，刺激两个传统上独立的服务部门--性病护理和妇幼保健--的新型整合 治疗。

Abstract Untreated opioid use disorder (OUD) is a continuing public health emergency in the United States. OUD is associated with significant morbidity and mortality, including overdose death. Buprenorphine is an effective treatment for OUD, but most individuals who need such treatment do not access it. Public STD clinics are high-volume, episodic care medical settings that serve a high-risk population, often on a walk-in basis. STD clinic patients have high prevalence of OUD and health-risking behaviors. This proposed study, entitled Opioid Use Disorder Treatment Linkage at STD Clinics using Buprenorphine (OUTLAST-B), will examine OUD treatment linkage strategies for opioid-dependent patients seeking services at public STD clinics. This three-arm, parallel randomized clinical trial (RCT) will compare Usual Care (UC), vs. referral via Patient Navigation (PN), vs. Patient Navigation with STD-clinic initiated buprenorphine (PN+BUP). The UC Arm will include standard services at the STD clinic. The PN Arm will include all UC Arm services, with the addition of a Patient Navigator who will assist the participant in selecting a community OUD treatment program, facilitate an intake appointment, help to resolve barriers and coordinate OUD treatment entry, and support early retention in OUD treatment. The PN+BUP Arm will include all PN Arm services, with the addition of meeting with the STD clinic’s buprenorphine-waivered provider (typically a nurse practitioner) to initiate buprenorphine treatment, as a bridge until successful transfer to OUD treatment in the community. Research assessments consisting of a structured interview battery and biomarkers for drug use and STDs will be conducted at baseline, 3-, and 6-month follow-up. Selected outcomes will be examined through 12-months via health record linkage methods. The study will examine participant outcomes in the domains of: (1) OUD treatment entry and retention, (2) Opioid use and related problems (including fatal and non-fatal overdose), and (3) HIV/STD-related outcomes. This innovative study could identify new approaches to engaging a high-risk patient population in OUD treatment. The study could have high impact because findings could be scaled to STD clinics throughout the nation, spurring novel integration across two traditionally separate service sectors of STD care and OUD treatment.