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（IDUs）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）和降低风险服务的覆盖率很低，以及艾滋病毒诊断较晚，抗逆转录病毒治疗（ART）的接受率很低，感染艾滋病毒的注射吸毒者死亡率很高。多层次战略-通过综合结构性干预措施促进获得服务，通过利用社交网络传播干预措施，并解决个人障碍（例如，药物滥用、合并症），以改进注射吸毒者中的艾滋病毒预防和治疗。我们小组和其他人先前的工作表明，综合护理模式可以改善药物滥用和医疗条件并存的人群的结果。我们建议，以注射吸毒者为导向的综合护理诊所（ICC）可以使弱势注射吸毒者群体参与进来，并沿着“寻求，测试，治疗和保留”（STTR）连续体改善社区一级的结果。目标1：使用人种学方法和应答者驱动抽样（RDS），确定印度15个地理上不同的社区注射吸毒者中艾滋病毒流行率并描述其获得预防和治疗服务的情况。RDS是一种连锁转诊抽样方法，其实施方式能够对目标人群中的选定因素进行无偏的患病率估计。我们将在目标2中从方法论和分析上使用这些信息。目标二：使用随机分组试验评价以注射吸毒者为导向的综合护理诊所（ICC）在改善“寻求、测试、治疗和保留”（STTR）连续体沿着结局方面的有效性。我们将在目标1中评估的15个候选社区中选择的5对匹配社区（共10个社区）中进行聚类随机试验。社区将根据地理区域和基线前12个月内报告VCT的比例进行匹配。从现有的面向注射吸毒者的服务提供者开始，我们将在5个干预社区建立国际社区中心。ICC将提供世界卫生组织（WHO）“综合包”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;针具交换计划;阿片类药物替代治疗;性传播感染、结核病和病毒性肝炎的管理;以及ART。我们假设，建立面向注射吸毒者的ICC将导致获得更多的VCT，减少艾滋病毒传播的风险行为，并（在艾滋病毒感染者中）增加获得临床护理，增加使用ART，并减少社区病毒载量。虽然我们拟议的研究将在印度进行，但其结果可能适用于全世界注射吸毒者流行地区，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。 公共卫生相关性：注射吸毒者往往难以获得艾滋病毒预防服务和艾滋病毒治疗。在这个项目中，我们建议测试是否建立面向注射毒品使用者的综合护理诊所可以改善艾滋病毒预防和治疗结果，在这个脆弱的人群。虽然这一项目将在印度进行，但它与注射吸毒是艾滋病毒传播的一种重要方式的发展中国家和发达国家的地区有关，并可能适用于这些地区。

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. PUBLIC HEALTH RELEVANCE: Injection drug users often have poor access to HIV prevention services and HIV treatment. In this project, we propose to test whether establishing integrated care clinics that are oriented to injection drug users can improve HIV prevention and treatment outcomes in this vulnerable population. While this project will be conducted in India, it is relevant and potentially applicable to areas in both the developing and developed world where injection drug use is an important mode of HIV transmission.