Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky

摘要 美国农村地区日益受到艾滋病毒的影响，与持续的阿片类药物流行有关， 越来越多的兴奋剂使用，以及广泛的毒品注射。肯塔基州(KY)是被认定为 农村艾滋病毒负担沉重，注射吸毒导致的艾滋病毒新诊断率不断上升。农村 注射吸毒者(PWID)中的艾滋病毒疫情最近在肯塔基州的邻国发生， 强调迫切需要在#年为残疾人实施行之有效的艾滋病毒预防和减少危害战略 肯塔基州的农村地区。结束艾滋病毒流行(EHE)的关键支柱：美国的计划是预防新的 通过扩大循证干预措施，包括注射器服务计划(SSP)，感染艾滋病毒 和暴露前预防(PrEP)。我们在肯塔基州阿巴拉契亚地区的R21显示出持续的利用率 通过高风险PWID对农村地区的SSP进行分析，使SSP成为扩展全面交付的关键场所 农村地区的艾滋病毒预防服务。在此应用程序的PI执行的先前RCT中，基于优势 病例管理(SBCM)干预措施被证明在增加艾滋病毒检测和克服艾滋病毒方面有效 吸毒者的医疗保健障碍。以之前的工作和持续的协作为基础 随着肯塔基州的农村SSP，R34将在以下点调整和集成新的PrEP启动干预 在肯塔基州两个县的农村SSP提供护理，这两个县是全国最容易感染艾滋病毒的十大县之一 并对其疗效进行初步测试。具体目标是：1)评估客户， 专注于PrEP的提供商、组织和结构级别的促进者和集成障碍 常规SSP实践中的SBCM(SBCM-PrEP)干预。在棱镜模式的指导下，我们将进行 对PWID、临床护理和减少伤害服务提供商的半结构化关键线人访谈，以及 我们目标SSP实施地点的设施管理员，以确定个人、组织和 调整SBCM-PrEP以提高客户可接受性、可获得性的结构性挑战和机遇 并与临床工作流程兼容；2)采用基于循证的SBCM协议提供PrEP SSP站点的PWID干预服务。使用来自目标1的深度访谈数据，我们将适应、改进 并将PrEP护理最突出的艾滋病毒预防内容纳入SBCM-PrEP ITT框架；以及3)检查调整后的SBCM的可行性、可接受性和初步效果- 准备好了。80名参与者将被随机分为：CDC-PrEP(基于CDC的正在使用的PrEP干预 指南)，或SBCM-PrEP。主要结果包括可行性和可接受性(通过干预来衡量 出勤率、参与度和满意度)，以及初步疗效 基线后3个月和6个月开始准备(由配发的PrEP处方测量)。建议数 研究填补了农村PWID中PrEP研究的证据空白，测试了解决这两个问题的简短干预措施 通过集成的护理点服务交付模式，PrEP的个人和结构性挑战。

ABSTRACT Rural areas in the United States are increasingly impacted by HIV, tied to the ongoing opioid epidemic, growing stimulant use, and widespread drug injection. Kentucky (KY) is among seven states identified with heavy rural HIV burden and increasing rates of new HIV diagnoses attributable to injection drug use. Rural HIV outbreaks among people who inject drugs (PWID) have occurred recently in KY’s neighboring states, highlighting the urgent need to implement proven HIV prevention and harm reduction strategies for PWID in KY’s rural areas. A key pillar of Ending the HIV Epidemic (EHE): A Plan for America is the prevention of new HIV infections through scale up of evidence-based interventions, including syringe service programs (SSPs) and Pre-exposure prophylaxis (PrEP). Our R21 in KY’s Appalachian region demonstrated consistent utilization of rurally located SSPs by high-risk PWID, making SSPs a critical venue to scale delivery of comprehensive HIV prevention services in rural areas. In a prior RCT conducted by the PI of this application, strengths-based case management (SBCM) interventions were shown to be effective in increasing HIV testing and overcoming barriers to medical care among people who use drugs. Building on this prior work and ongoing collaboration with rural SSPs in KY, this R34 will adapt and integrate a novel PrEP initiation intervention at point of care in rural SSPs, in two KY counties that are among the nation’s top 10 most vulnerable to HIV among PWID, and conduct a preliminary test of its efficacy. The Specific Aims are to: 1) Assess client, provider, organization, and structural-level facilitators and barriers to integration of a PrEP focused SBCM (SBCM-PrEP) intervention into routine SSP practice. Guided by the PRISM model, we will conduct semi-structured key informant interviews with PWID, clinical care and harm reduction service providers, and facility administrators in our targeted SSP implementation locations, to identify individual, organizational, and structural challenges and opportunities to adapt the SBCM-PrEP to enhance client acceptability, accessibility and compatibility with clinical workflow; 2) Adapt an evidence-based SBCM protocol to provide PrEP intervention services for PWID in SSP sites. Using in-depth interview data from Aim 1, we will adapt, refine and incorporate HIV prevention content most salient to PrEP care into the SBCM-PrEP, following the ADAPT ITT framework; and 3) Examine feasibility, acceptability and preliminary efficacy of the adapted SBCM- PrEP. 80 participants will be randomized into: CDC-PrEP (an in-use PrEP intervention based on CDC guidelines), or SBCM-PrEP. Primary outcomes include feasibility and acceptability (measured by intervention attendance, engagement, and satisfaction) during the active intervention period, and preliminary efficacy on PrEP initiation (measured by dispensed PrEP prescription) 3- and 6- months post-baseline. The proposed study fills a gap in evidence for PrEP studies among rural PWID by testing brief interventions that address both individual and structural challenges to PrEP uptake through an integrated, point of care service delivery model.