Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky

摘要 美国农村地区越来越多地受到艾滋病毒的影响，与持续的阿片类药物流行有关， 兴奋剂的使用越来越多，毒品注射也越来越普遍。肯塔基州（KY）是七个确定为 农村艾滋病毒负担沉重，注射吸毒导致艾滋病毒新诊断率上升。农村 最近在肯塔基州的邻国发生了艾滋病毒在注射毒品者（PWID）中的爆发， 强调迫切需要实施行之有效的艾滋病毒预防和减少艾滋病毒对艾滋病患者的危害的战略， 肯塔基州的农村地区。结束艾滋病毒流行病（EHE）的一个关键支柱：美国计划是预防新的艾滋病毒感染。 通过扩大循证干预措施，包括注射器服务方案，控制艾滋病毒感染 暴露前预防（PrEP）我们在肯塔基州阿巴拉契亚地区的R21证明了一致的利用率 高风险PWID的农村地区SSP，使SSP成为扩大全面交付的关键场所 农村地区的艾滋病毒预防服务。在本申请PI进行的既往RCT中，基于强度的 病例管理（SBCM）干预措施被证明是有效的，增加艾滋病毒检测和克服 吸毒者的医疗保健障碍。在此之前的工作和持续合作的基础上 在肯塔基州的农村SSP中，这一R34将在以下方面调整和整合一种新的PrEP启动干预措施： 在肯塔基州的两个县，这两个县是全国十大最容易感染艾滋病毒的县， 在PWID中，并对其功效进行初步测试。具体目标是：1）评估客户， 提供者，组织和结构级促进者以及以PrEP为重点的整合障碍 将SBCM（SBCM-PrEP）干预纳入常规SSP实践。在PRISM模型的指导下，我们将 与PWID、临床护理和减少伤害服务提供者进行半结构化的关键线人访谈，以及 我们目标SSP实施地点的设施管理员，以识别个人、组织和 结构性挑战和机遇，以适应SBCM-PrEP，以提高客户的可接受性，可及性 与临床工作流程的兼容性; 2）采用循证SBCM方案提供PrEP 为SSP站点的PWID提供干预服务。使用目标1中的深度访谈数据，我们将调整、完善 并遵循ADAPT，将PrEP护理中最突出的艾滋病毒预防内容纳入SBCM-PrEP中 ITT框架;以及3）检查适应SBCM的可行性、可接受性和初步功效- 制备型80名受试者将随机分配至：CDC-PrEP（基于CDC的使用中PrEP干预） 主要结果包括可行性和可接受性（通过干预措施衡量） 参与度和满意度），以及对 基线后3个月和6个月开始PrEP（通过分发PrEP处方测量）。拟议 一项研究填补了农村PWID中PrEP研究证据的空白，通过测试简短的干预措施， 个人和结构的挑战，通过综合的，护理点服务提供模式的PrEP吸收。

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.