Pharmacy Referral Intervention: IDU Access to Services

描述(由申请人提供)：建议进行一项社区随机试验，以评估通过2001年通过的纽约州公共卫生法律--允许非处方药销售注射器--向从药房获得注射器的注射吸毒者提供增强药房服务的影响。虽然IDU在一些IDU人群中接受该计划的速度很慢，但多层次的干预措施已经显示出增加IDU对药店的利用的希望。初步数据显示，药剂师有兴趣扩大作用，大多数人报告愿意向他们的注射吸毒器客户提供药物治疗和其他与健康有关的信息。研究的目的是：[1]评估与标准的ESAP-药房做法相比，加强药房服务(即在购买注射器期间提供卫生/社会服务转介)在注射吸毒者中显示以下结果的程度：(A)增加重复使用药房(作为注射器来源)；(B)增加安全的注射器处置；(C)更多地获得艾滋病毒和初级保健服务；(D)更多地获得药物治疗(即积极计划进入治疗、药物治疗进入)；和(E)增加医疗保险覆盖面的比例；[2]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成果：(A)增加对ESAP的支持；(B)增加对注射吸毒者的加强药房服务；(C)增加注射吸毒者的新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由多个组成部分组成的ESAP动员。同时，我们将从ESAP注册的提供者名单中随机挑选130家药店，随机分配到干预措施(加强药房服务+将静脉注射者转诊到研究现场；N=40)、AIM-1控制组(仅销售标准注射器+将静脉注射者转介到研究站点；N=40)或AIM-2控制组(仅销售标准注射器；不转介IDU；N=50)。与社区成员和当地药剂师合作，编写了《药房工作人员培训手册》，以培训干预药房工作人员。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.harlemresource cguide.com)来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，干预和AIM-1控制分支机构的药店将转介注射吸毒者到当地研究地点进行相同/次日的预约，922名注射吸毒者将接受基线和为期3个月的后续访谈，以记录接触情况和结果措施。为实现目标2，来自40个干预部门(N=120)的药房工作人员和来自另外50家药房(N=200)的药房工作人员将接受基线(在随机化之前)和两次后续电话调查。结果将使用回归技术和随机效应模型进行分析，以说明相关的药学数据。成功的干预措施将提供证据，表明药房不仅可以销售注射器，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卫生和社会服务中。

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.