Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky

针对肯塔基州农村地区注射毒品者的综合 PrEP 干预措施

基本信息

批准号：
10320665
负责人：
HILARY L SURRATT
金额：
$ 19.49万
依托单位：
UNIVERSITY OF KENTUCKY
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-08-01 至 2024-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10320665
关键词：
AIDS prevention Address Administrator Americas Appalachian Region Caring Case Management Centers for Disease Control and Prevention (U.S.)Client Clinical Collaborations County Data Disease Outbreaks Drug user Education Environment Epidemic Equipment Evidence based intervention Guidelines HIV HIV Infections HIV diagnosis Harm Reduction Human immunodeficiency virus test Incidence Indiana Individual Infrastructure Injecting drug user Injections Intervention Interview Kentucky Knowledge Literature Location Measures Medical Monitor Needle-Exchange Programs North Carolina Participant Pharmaceutical Preparations Practical, Robust Implementation and Sustainability Model Prevention Protocols documentation Provider Randomized Risk Rural Rural Community Service delivery model Services Site Sterility Structure Syringes Testing United States West Virginia Woman Work acceptability and feasibility barrier to care base brief intervention clinical care drug testing evidence base health care availability high risk informant injection drug use men novel opioid epidemic organizational structure point of care pre-exposure prophylaxis prevention service preventive intervention primary outcome risk perception rural area satisfaction scale up screening service intervention service providers social stigma stimulant use tool transmission process uptake

项目摘要

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.

抽象的美国农村地区日益受到艾滋病毒的影响，这与持续的阿片类药物流行有关，肯塔基州 (KY) 是被确定存在兴奋剂使用和广泛注射毒品问题的七个州之一。农村艾滋病毒负担沉重，并且因注射吸毒而导致的新艾滋病毒诊断率不断上升。最近，肯塔基州邻近各州的注射吸毒者（PWID）中爆发了艾滋病毒疫情，强调迫切需要为注射吸毒者实施行之有效的艾滋病毒预防和减少伤害战略肯塔基州农村地区“结束艾滋病毒流行 (EHE)：美国计划”的一个关键支柱是预防新的艾滋病毒流行。通过扩大循证干预措施（包括注射器服务计划（SSP））来控制艾滋病毒感染我们在肯塔基州阿巴拉契亚地区的 R21 表现出一致的利用率。农村地区的 SSP 受到高风险吸毒者的影响，使 SSP 成为扩大提供综合性服务的关键场所在该应用程序的 PI 先前进行的随机对照试验中，农村地区的艾滋病毒预防服务基于优势。病例管理 (SBCM) 干预措施被证明可以有效增加艾滋病毒检测和克服艾滋病毒感染基于之前的工作和正在进行的合作，解决吸毒者的医疗护理障碍。与肯塔基州的农村 SSP 合作，该 R34 将在以下时间点调整和整合新颖的 PrEP 启动干预措施：肯塔基州两个县的农村 SSP 的护理，这两个县是全国最容易感染艾滋病毒的前 10 个县并对其功效进行初步测试。具体目标是： 1) 评估客户，提供者、组织和结构层面的促进者和障碍，以 PrEP 为重点的整合 SBCM（SBCM-PrEP）干预常规SSP实践，以PRISM模型为指导，进行。对注射吸毒者、临床护理和减少伤害服务提供者进行半结构化的关键知情人访谈，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和可及性的结构性挑战和机遇以及与临床工作流程的兼容性；2) 采用基于证据的 SBCM 方案来提供 PrEP 使用目标 1 中的深入访谈数据，我们将调整、完善 SSP 站点中的吸毒者干预服务。并将 PrEP 护理最重要的 HIV 预防内容纳入 SBCM-PrEP，遵循 ADAPT ITT 框架；以及 3) 检查改编后的 SBCM 的可行性、可接受性和初步功效 PrEP。80 名参与者将被随机分配到：CDC-PrEP（基于 CDC 的正在使用的 PrEP 干预措施）主要结局包括可行性和可接受性（通过干预指南衡量）或 SBCM-PrEP。积极干预期间的出勤率、参与度和满意度），以及初步效果基线后 3 个月和 6 个月开始 PrEP（通过分配的 PrEP 处方进行测量）建议。该研究通过测试针对以下两个问题的简短干预措施，填补了农村吸毒者 PrEP 研究的证据空白：通过集成的护理点服务提供模式，个人和结构性的 PrEP 面临挑战。