Pharmacy Referral Intervention: IDU Access to Services

描述（由申请人提供）：拟议的是一项社区随机试验，以评估通过“扩大注射器获取示范计划”（ESAP）向从药店获得注射器的注射吸毒者提供增强的药房服务的影响，ESAP是2001年通过的纽约州公共卫生法，允许非处方注射器销售。尽管在一些注射过量人群中，该计划的使用速度缓慢，但多层次干预已显示出增加药房使用注射过量的希望。初步数据表明，药剂师有兴趣发挥更大的作用，大多数人报告愿意向他们的IDU注射器客户提供药物治疗和其他健康相关信息。本研究的目的是：评估与esap -药房标准做法相比，加强的药房服务（即在购买注射器期间提供卫生/社会服务转诊）在多大程度上显示了注射吸毒者的以下结果：(a)增加了重复使用药房（作为注射器来源）；(b)增加安全注射器处置；(c)增加获得艾滋病毒和初级保健服务的机会；(d)增加获得药物治疗的机会（即积极计划进入治疗，进入药物治疗）；(e)增加医疗保险覆盖率的比例；评估加强药房服务在多大程度上更有可能在药房工作人员中显示以下结果：(a)增加对ESAP的支持；(b)进一步支持加强对注射吸毒者的药房服务；(c)增加新的IDU客户和现有客户的频率；(d)增加处方客户群。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的多部分动员。同时，我们将从esap注册的供应商名单中随机选择130家药店，随机分配到干预组（加强药房服务+将IDU转介到研究地点，N=40）、AIM-1对照组（仅标准注射器销售+将IDU转介到研究地点，N=40）或AIM-2对照组（仅标准注射器销售，不转介IDU， 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络资源指南（www.harlemresourceguide.com），帮助将注射吸毒者与服务（例如艾滋病毒检测、福利/应享权利服务等）联系起来。为了解决目标1，干预组和目标1控制组的药房将把IDU客户转介到当地研究站点进行同一天/第二天的预约，其中922名IDU患者将接受基线和3个月的随访访谈，以记录暴露和结果测量。为了实现目标2，来自40个干预组（N=120）和来自另外50个药房（N=200）的药房工作人员将接受基线（随机化之前）和两次随访电话调查。结果将使用回归技术和随机效应模型来分析相关的药房数据。一项成功的干预措施将提供证据，证明药店不仅可以提供注射器销售服务，还可以更积极地让注射吸毒者参与艾滋病毒预防和转介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.