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。我们小组和其他小组的数据显示，注射吸毒者中自愿咨询和检测（VCT）和降低风险服务的外显率较低，艾滋病毒诊断较晚，抗逆转录病毒治疗（ART）的接受程度较低，感染艾滋病毒的注射吸毒者死亡率高。需要一项多层次战略，通过综合结构性干预促进获取，利用社会网络传播干预措施，并解决个人障碍（如药物滥用、合并症），以改善注射吸毒者之间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药物滥用和医疗状况并存的人群的预后。我们建议，以IDU为导向的综合护理诊所（ICCs）可以吸引IDU弱势群体，并改善社区层面的结果，沿着“寻求、检测、治疗和保留”（STTR）连续体。目标1：利用民族志方法和受访者驱动抽样（RDS），确定印度15个地理上不同社区的注射吸毒者中艾滋病毒的流行情况，并描述其获得预防和治疗服务的情况。RDS是一种链式转诊抽样方法，其实施方式能够对目标人群中选定因素的患病率进行无偏估计。我们将在目标2中以方法和分析的方式使用这些信息。目的2：通过一项集群随机试验，评估以idu为导向的综合护理诊所（ICCs）在“寻找、检测、治疗和保留”（STTR）连续体中改善结果的有效性。我们将从Aim 1中评估的15个候选社区中选择5对匹配的社区（共10个社区）进行集群随机试验。将根据地理区域和在前12个月基线报告VCT的比例对社区进行匹配。我们将从现有的以静脉注射剂为导向的服务提供者开始，在5个干预社区建立国际中心。国际刑事法院将提供世界卫生组织（世卫组织）“综合一揽子计划”建议的9项IDU服务：艾滋病毒艾滋病毒传播；避孕套分布;咨询教育；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；和艺术。社区层面的结果将在ICC实施24个月后进行第二次（评估）RDS评估。我们假设，建立以idu为导向的icc将增加获得VCT的机会，减少艾滋病毒传播风险行为，并（在艾滋病毒感染者中）增加获得临床护理的机会，增加抗逆转录病毒药物的使用，并降低社区病毒载量。虽然我们提议的研究将在印度进行，但其结果可能适用于全球注射药物普遍存在的地区，因为这些服务的分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.