Pharmacy Referral Intervention: IDU Access to Services

描述（由申请人提供）：提议进行一项社区随机试验，以评估通过“扩大注射器获取示范计划”（ESAP）向从药房获取注射器的注射吸毒者提供增强药房服务的影响，该计划是一项纽约州公共卫生法2001年通过，允许非处方销售注射器。虽然在一些注射吸毒者群体中，注射吸毒者接受该方案的速度缓慢，但多层次的干预措施显示出增加注射吸毒者利用药店的希望。初步数据表明，药剂师有兴趣扩大作用，大多数报告愿意提供药物治疗和其他健康相关的信息，他们的注射器注射器客户。该研究的目的是：[1]评估加强药房服务（即，在购买注射器期间提供保健/社会服务转介）与ESAP药房标准做法相比，在注射吸毒者中显示出以下结果：（a）增加了重复药房使用（作为注射器来源）;（B）增加了安全处置注射器;（c）增加了获得艾滋病毒和初级保健服务的机会;（d）增加了获得药物治疗的机会（即，积极计划进入治疗，药物治疗进入）;和（e）增加健康保险覆盖的比例;和[2]评价加强药房服务在药房工作人员中更有可能显示以下结果的程度：（a）增加对ESAP的支持;（B）增加对加强注射吸毒者药房服务的支持;（c）增加新的注射吸毒者客户和现有客户的频率;（d）增加处方客户基础。为了实现这些目标，我们将首先在每个目标高风险社区扩大ESAP动员的多组件。同时，我们将从ESAP注册供应商列表中随机选择130家药房，随机分配至干预（增强药房服务+将IDU转诊至研究中心; N=40）、AIM-1对照组（仅标准注射器销售+将IDU转诊至研究中心; N=40）或AIM-2对照组（仅标准注射器销售;无IDU转诊; N=50）。与社区成员和当地药剂师合作，编写了一份“药剂工作人员培训手册”，用于培训干预药剂工作人员。干预药房还将利用创新的针对药物使用者的网上资源指南（www.harlemresourceguide.com）帮助将注射吸毒者与服务（例如艾滋病毒检测、福利/权利服务等）联系起来。为了实现目标1，干预组和AIM-1对照组的药房将把注射吸毒者客户推荐到当地研究中心进行当天/次日预约，其中922名注射吸毒者将接受基线和3个月随访访谈，以记录暴露和结局指标。为了实现目标2，来自40个干预组（N=120）和另外50个药房（N=200）的药房工作人员将接受基线（随机化前）和两次随访电话调查。将使用回归技术和随机效应模型分析结局，以解释相关的药房数据。一项成功的干预措施将提供证据，证明药店不仅可以销售注射器，还可以更积极地使注射吸毒者参与艾滋病毒预防和转诊到保健和社会服务机构。

DESCRIPTION (provided by applicant): Proposed is a community randomized trial to evaluate the impact of providing enhanced pharmacy services to IDUs accessing syringes from pharmacies through the "Expanded Syringe Access Demonstration Program" (ESAP), a New York State public health law passed in 2001 that permits non-prescription sales of syringes. Although IDU uptake of the program had been slow among some IDU populations, a multi-level intervention has shown promise for increasing IDU utilization of pharmacies. Preliminary data indicate pharmacist interest in an expanded role, and a majority reported willingness to provide drug treatment and other health-related information to their IDU syringe customers. The aims of the study are: [1] To evaluate the extent to which enhanced pharmacy services (i.e., provision of health/social service referrals during the syringe purchase), compared to the standard ESAP-pharmacy practice show the following outcomes among IDUs: (a) increased repeat pharmacy use (as a syringe source); (b) increased safe syringe disposal; (c) increased access to HIV and primary care services; (d) increased access to drug treatment (i.e., active planning to enter treatment, drug treatment entry); and (e) increased proportion with health insurance coverage; and [2] To evaluate the extent to which enhanced pharmacy services is more likely to show the following outcomes among pharmacy staff: (a) increased support of ESAP; (b) increased support of enhanced pharmacy services for IDUs; (c) increased new IDU customers and frequency of existing customers; (d) increased prescription customer base. To meet these aims, we will first scale up a multi- component ESAP mobilization in each of our targeted high-risk communities. Concurrently, we will enroll 130 randomly selected pharmacies from a list of ESAP-registered providers to be randomly assigned to the intervention (enhanced pharmacy services + refer IDUs to research site; N=40), AIM-1 control arm (standard syringe sale only + refer IDUs to research site; N=40) or AIM-2 control arm (standard syringe sale only; no IDU referral; N=50). In collaboration with community members and local pharmacists a "Pharmacy Staff Training Manual" has been developed for training intervention pharmacy staff. Intervention pharmacies will also utilize the innovative drug user-specific Web-based Resource Guide (www.harlemresourceguide.com) to help link IDUs to services (e.g. HIV testing, benefits/entitlement services, etc.). To address Aim 1, pharmacies in the intervention and AIM-1 control arm will refer IDU customers to a local research site for a same/next day appointment where 922 IDUs will undergo a baseline and 3-month follow-up interview to record exposure and outcome measures. To address Aim 2, pharmacy staff from the 40 intervention arm (N=120) and those from an additional 50 pharmacies (N=200) will undergo a baseline (prior to randomization) and two follow-up phone surveys. Outcomes will be analyzed using regression techniques and random effect models to account for correlated pharmacy data. A successful intervention will provide evidence that pharmacies can serve beyond mere syringe sales to more active engagement of IDUs for HIV prevention and referrals into health and social services.