Integrated Care Clinics for IDUs in India: a cluster randomized trial

描述(由申请人提供)：印度是全球第三大艾滋病毒感染者的家园，也是约110万注射吸毒者的家园。来自我们小组和其他人的数据显示，注射吸毒者中自愿咨询和检测(VCT)和降低风险服务的渗透率很低，艾滋病毒诊断较晚，抗逆转录病毒疗法(ART)接受程度较低，艾滋病毒感染者的死亡率很高。需要一个多层次的战略--通过综合结构干预促进获取，通过利用社会网络传播干预，并解决个人障碍(例如，药物滥用、共病)--以改进注射吸毒者的艾滋病毒预防和治疗。我们小组和其他人之前的工作表明，综合护理模式可以改善同时患有药物滥用和医疗条件的人群的结果。我们建议，面向IDU的综合护理诊所(ICCs)可以让IDU弱势人群参与进来，并沿着“寻求、测试、治疗和保留”(STTR)的连续过程改善社区一级的成果。目标1：使用人种志方法和受访者驱动的抽样方法，确定印度15个地理不同社区的注射吸毒者中艾滋病毒流行率和获得预防和治疗服务的情况。RDS是一种链式转介抽样方法，其实施方式能够对目标人群中选定因素的流行情况进行无偏见的估计。我们将在目标2中以方法和分析的方式使用这些信息。目标2：通过整群随机试验，评估以IDU为导向的综合护理诊所(ICCs)在改善“寻求、测试、治疗和保留”(STTR)连续体方面的效果。我们将在目标1评估的15个候选社区中选择5对匹配社区(共10个社区)进行整群随机试验。社区将根据基线前12个月的地理区域和报告VCT的比例进行匹配。从现有的IDU服务提供者开始，我们将在5个干预社区建立ICC。ICCS将提供世界卫生组织(WHO)“综合一揽子计划”中推荐的9项注射吸毒者服务：艾滋病毒VCT；安全套分发；咨询和教育；针头交换计划；阿片类药物替代疗法；性传播感染、结核病和病毒性肝炎的管理；以及抗逆转录病毒治疗。社区一级的成果将在国际商会实施24个月后进行第二次(评价)RDS评估。我们假设，建立面向IDU的ICC将增加获得VCT的机会，减少艾滋病毒传播危险行为，并(在艾滋病毒感染者中)增加获得临床护理的机会，增加ART的使用，并降低社区病毒载量。虽然我们拟议的研究将在印度进行，但其结果可能适用于世界各地IDU流行的地区，因为这些服务的零散提供在发达国家和发展中国家都是常态。

DESCRIPTION (provided by applicant): India is home to the third largest population of HIV-infected persons globally and also to ~ 1.1 million injection drug users (IDUs). Data from our group and others show poor penetrance of voluntary counseling and testing (VCT) and risk-reduction services among IDUs, as well as late HIV diagnosis, poor uptake of antiretroviral therapy (ART), and high mortality among HIV-infected IDUs. A multi-level strategy - which facilitates access through an integrated structural intervention, disseminates the intervention by leveraging social networks, and addresses individual barriers (e.g., substance abuse, comorbidities) - is needed to improve HIV prevention and treatment among IDUs. Prior work from our group and others suggests that integrated models of care can improve outcomes in populations with comorbid substance abuse and medical conditions. We propose that IDU-oriented integrated care clinics (ICCs) can engage vulnerable IDU populations and improve community-level outcomes along the "seek, test, treat and retain" (STTR) continuum. Aim 1: Determine HIV prevalence and characterize access to preventive and treatment services among IDUs in 15 geographically distinct communities in India using ethnographic approaches and respondent-driven sampling (RDS). RDS is a chain-referral sampling method that is implemented in a manner that enables unbiased prevalence estimates of selected factors in the target population. We will use this information methodologically and analytically in Aim 2. Aim 2: Evaluate the effectiveness of IDU-oriented integrated care clinics (ICCs) for improving outcomes along the "seek, test, treat, and retain" (STTR) continuum using a cluster-randomized trial. We will conduct a cluster-randomized trial among 5 pairs of matched communities (10 communities total) selected from the 15 candidate communities assessed in Aim 1. Communities will be matched according to geographic region and proportion reporting VCT in the prior 12 months at baseline. Starting with existing IDU-oriented service providers, we will establish ICCs in the 5 intervention communities. ICCs will provide the 9 IDU services recommended in the World Health Organization (WHO) 'comprehensive package': HIV VCT; condom distribution; counseling and education; needle exchange programs; opioid substitution therapy; management of sexually transmitted infections, tuberculosis, and viral hepatitis; and ART. Community-level outcomes will be assessed with a second (evaluation) RDS conducted 24 months after ICC implementation. We hypothesize that establishing IDU-oriented ICCs will lead to increased access to VCT, reduced HIV transmission risk behaviors, and (among HIV-infected persons) increased access to clinical care, increased use of ART, and decreased community viral load. While our proposed study will be conducted in India, its results may be applicable to IDU-prevalent areas worldwide as fragmented delivery of these services is the norm in both developed and developing countries.