Post exposure prophylaxis among IDU syringe customers-Pharmacy pilot intervention

IDU 注射器顾客的暴露后预防——药房试点干预

• 批准号: 8133982
• 负责人: CRYSTAL FULLER LEWIS
• 金额: $ 69.91万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-01 至 2015-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8133982
• 关键词: AIDS prevention; AIDS/HIV problem; Accounting; Acquired Immunodeficiency Syndrome; Address; Adherence; Adverse effects; Attitude; Behavior; Behavioral; Caring; Centers for Disease Control and Prevention (U.S.); Characteristics; Cities; Clinical; Communities; Counseling; Data; Diagnosis; Disease; Drug usage; Education; Educational Materials; Effectiveness; Enrollment; Ethics; Event; Exposure to; Goals; HIV; HIV Infections; HIV Seropositivity; Health Personnel; Health Services; Health Services Accessibility; Healthcare; Hispanics; Injecting drug user; Injection of therapeutic agent; Intervention; Interview; Knowledge; Low income; Medical; Mind; Modeling; Needle Sharing; Needle-Exchange Programs; Needlestick Injuries; Neighborhoods; New York; New York City; Newly Diagnosed; Occupational; Participant; Perception; Persons; Pharmaceutical Services; Pharmacists; Pharmacy facility; Phase; Prevalence; Prevention approach; Prevention strategy; Printing; Probability; Prophylactic treatment; Protocols documentation; Public Health; Randomized Controlled Trials; Recommendation; Regimen; Reporting; Research; Research Personnel; Risk; Risk Behaviors; Risk Reduction; Sales; Services; Shares syringes; Site; Social Network; Source; Sterility; Structure; Subgroup; Surveys; Syringes; Target Populations; Techniques; Testing; Time; Toxic effect; United States Dept. of Health and Human Services; Unsafe Sex; Visit; antiretroviral therapy; base; case-by-case basis; community burden; demographics; design; eligible participant; experience; follow-up; high risk; high risk behavior; informant; innovation; men who have sex with men; peer; prevent; prevention service; programs; public health relevance; sex; sex risk; standard of care; success; transmission process

DESCRIPTION (provided by applicant): The purpose of this research is to evaluate a structural pilot intervention which aims to expand pharmacy services to include provision of non-occupational HIV post exposure prophylaxis (nPEP) and risk reduction information to injection drug users (IDUs) who buy syringes at two pharmacies registered with the New York State Expanded Syringe Access Program (ESAP), a program allowing pharmacies to sell syringes without a prescription to help reduce the spread of HIV among IDUs. PEP is the standard of care for health care workers who experience an accidental needle stick. The probability of HIV transmission in IDUs through sharing syringes is either similar to or higher than the risk of an occupational needle stick, which supports the use of nPEP in these cases. There is a preponderance of data supporting PEP (i.e., antiretroviral therapy) as an effective strategy to prevent HIV infection. Thus, PEP is recommended by the U.S. Department of Health and Human Services in non-occupational cases (exposure via high risk sex or injection behavior) when the exposure source is HIV positive or when the source is unknown but from a HIV prevalent community (e15%). ESAP's success creates a new window of opportunity to offer nPEP as a medically-based HIV prevention approach to low-risk IDUs such as ESAP participants who mostly access sterile syringes but may have an unplanned exposure. By targeting pharmacies in low-income, black and Hispanic communities where HIV burden is highest, a pharmacy-based nPEP program has the potential to create a more comprehensive HIV prevention plan that addresses the long-standing problem of racial disparities in HIV/AIDS. Thus, we aim to qualitatively and quantitatively evaluate a pharmacy-based nPEP program by comparing IDU syringe customers who would agree to pharmacy-based nPEP vs. those who would decline (in the event of an accidental exposure) with respect to demographics, risk behaviors, perceptions of health care access/needs among IDU syringe customers. Using a pre/post design targeted to syringe customers and their peers we will determine if IDUs/peers who receive nPEP information and risk reduction counseling are more likely to 1) have increased and accurate knowledge of nPEP as an HIV prevention strategy (over time), and 2) more frequently share accurate information about nPEP, risk reduction, and HIV prevention with peers (over time) with respect to baseline demographics, risk behavior, and healthcare needs and access (Aim 2). Among those request nPEP and eligible (i.e., low injection/sex risk IDUs) we will assess side effects and nPEP adherence, risk behavior, social networks, and attitudes and opinions about nPEP via clinical follow up. We will conduct key- informant interviews among key stakeholders (n=15) and enroll IDU syringe customers (and referred peers) from pharmacies providing nPEP information/risk reduction counseling via print materials and video followed by a baseline A-CASI survey (n=638). A peer-driven intervention component will facilitate recruitment and dissemination of nPEP information. Participants will return in 3-months to assess behavior, knowledge, and spread of nPEP information. Analysis will include standard qualitative and quantitative regression techniques. PUBLIC HEALTH RELEVANCE: The proposed research is highly significant and innovative in that it aims to explore new venues for HIV prevention for injection drug users (IDUs), namely pharmacies participating in a nonprescription syringe sales program aimed at increasing sterile syringe access among IDUs in New York City (NYC). This new HIV prevention strategy adds a medical model to the current HIV prevention strategy. This new strategy includes delivery of post exposure prophylaxis (PEP) in non-occupational situations such as following injection or sexual exposure to HIV which has been recommended by CDC and evaluated among men who have sex with men but never before among IDUs. Our goal is to specifically tackle HIV racial disparities by targeting our pilot intervention to the black and Hispanic communities most heavily burdened with HIV/AIDS. Building on years of IDU and pharmacy-based research, we have selected two public health-minded pharmacies with a sizable and consistent IDU syringe purchasing customer base as the initial PEP delivery venue (as opposed to a visit to a medical setting to obtain a prescription) since IDUs typically experience challenges in accessing care. If successful, this model can be duplicated not only throughout other high-risk neighborhoods in New York, but in several other cities and states where similar pharmacy syringe access programs exist. Broader public health impact could also follow, for example, pharmacists can partner with clinicians and other health care providers, including community based organizations to offer these expanded services to groups with limited access to health care services.

描述(由申请人提供)：这项研究的目的是评估一项结构性试点干预措施，旨在扩大药房服务，包括向在纽约州扩大注射器获取计划(ESAP)注册的两家药店购买注射器的注射吸毒者提供非职业性艾滋病毒暴露后预防(NPEP)和降低风险信息，该计划允许药房在没有处方的情况下销售注射器，以帮助减少艾滋病毒在注射吸毒者中的传播。PEP是经历意外针扎的医护人员的标准护理。注射吸毒者通过共用注射器传播艾滋病毒的可能性与职业性针头相似或高于职业性针头，这支持在这些情况下使用nPEP。有大量数据支持PEP(即抗逆转录病毒疗法)是预防艾滋病毒感染的有效策略。因此，美国卫生与公众服务部建议在非职业性情况下(通过高危性行为或注射行为暴露)，当接触来源为艾滋病毒阳性或来源不明但来自艾滋病毒流行社区(e15%)时，建议使用PEP。ESAP的成功创造了一个新的机会之窗，将nPEP作为一种基于医学的艾滋病毒预防方法提供给低风险注射吸毒者，如ESAP参与者，他们大多使用无菌注射器，但可能有计划外接触。通过将艾滋病毒负担最重的低收入、黑人和西班牙裔社区的药店作为目标，以药房为基础的nPEP计划有可能创建更全面的艾滋病毒预防计划，解决艾滋病毒/艾滋病中长期存在的种族差异问题。因此，我们的目标是通过比较同意基于药房的nPEP的IDU注射器客户和那些拒绝(在意外暴露的情况下)IDU注射器客户的人口统计学、风险行为、对医疗服务可获得性/需求的看法来定性和定量地评估基于药房的nPEP计划。使用针对注射器客户和他们的同龄人的事前/事后设计，我们将确定接受nPEP信息和降低风险咨询的注射吸毒者/同龄人是否更有可能1)增加和准确地了解nPEP作为艾滋病毒预防策略的知识，以及2)更频繁地与同龄人分享关于nPEP、风险降低和艾滋病毒预防的准确信息(随着时间的推移)，涉及基线人口统计、风险行为、医疗保健需求和获取(目标2)。在那些要求nPEP和符合条件的(即低注射/性风险注射吸毒者)中，我们将通过临床随访评估副作用和nPEP依从性、风险行为、社会网络以及对nPEP的态度和意见。我们将在主要利益相关者中进行关键信息人访谈(n=15)，并从药房招募IDU注射器客户(和推荐的同行)，通过印刷材料和视频提供nPEP信息/降低风险咨询，然后进行基线A-CASI调查(n=638)。由同行推动的干预部分将促进nPEP信息的招募和传播。参与者将在3个月后返回，评估nPEP信息的行为、知识和传播情况。分析将包括标准的定性和定量回归技术。 公共卫生相关性：拟议的研究具有重要意义和创新性，因为它旨在探索注射吸毒者预防艾滋病毒的新场所，即药店参与旨在增加纽约市注射吸毒者获得无菌注射器的非处方药注射器销售计划。这一新的艾滋病毒预防战略为目前的艾滋病毒预防战略增加了一种医学模式。这一新战略包括在非职业情况下提供暴露后预防，例如在注射或性接触艾滋病毒之后，这是疾控中心建议的，并在与男性发生性行为的男性中进行评估，但以前从未在注射吸毒者中进行过评估。我们的目标是通过将我们的试点干预针对艾滋病毒/艾滋病负担最重的黑人和西班牙裔社区，具体解决艾滋病毒种族差距问题。在多年的注射吸毒者和基于药房的研究的基础上，我们选择了两家关注公共健康的药店，拥有相当大和一致的注射吸毒者注射器购买客户群作为最初的PEP交付地点(而不是访问医疗环境以获得处方)，因为注射吸毒者在获得护理方面通常会遇到挑战。如果成功，这种模式不仅可以在纽约其他高危社区复制，也可以在其他几个存在类似药房注射器准入计划的城市和州复制。更广泛的公共卫生影响也可能随之而来，例如，药剂师可以与临床医生和其他卫生保健提供者合作，包括以社区为基础的组织，向获得卫生保健服务的有限群体提供这些扩大的服务。