Integrating HCV services into HIV programs for PWID in India

将 HCV 服务纳入印度针对注射吸毒者的艾滋病毒项目

• 批准号: 10210233
• 负责人: Shruti H Mehta
• 金额: $ 114.42万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-08 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10210233
• 关键词: AIDS prevention; Algorithms; Antiviral Agents; Awareness; Caring; Chronic; Cities; Client; Clinic; Clinical Trials; Cluster randomized trial; Collaborations; Communities; Counseling; Cross-Sectional Studies; Data; Directly Observed Therapy; Drug usage; Effectiveness; Ensure; Epidemic; Evaluation; Failure; Future; General Population; Geographic Locations; Government; HIV; HIV/HCV; Harm Reduction; Health; Hepatitis C Antibodies; Hepatitis C Incidence; Hepatitis C Prevalence; Hepatitis C Therapy; Hepatitis C co-infection; Hepatitis C virus; Human immunodeficiency virus test; Incidence; India; Individual; Infrastructure; Injecting drug user; Intervention; Medical; Methods; Modeling; Needle-Exchange Programs; Oral; Outcome; Patient Triage; Patients; Pharmaceutical Preparations; Population; Positioning Attribute; Prevalence; Prevention; Preventive service; Private Sector; Provider; Public Health; Public Sector; Randomized; Resources; Risk; Sampling; Self Administration; Services; Site; Target Populations; Testing; Time; Treatment Failure; Treatment outcome; Triage; Viral; antibody test; antiretroviral therapy; base; condoms; cost effective; cost effectiveness; cost-effectiveness evaluation; evidence base; implementation facilitation; implementation outcomes; improved; individualized medicine; low and middle-income countries; mortality; novel; opioid agonist therapy; peer; point of care testing; prevention service; programs; response; serosurvey; social stigma; synergism; system-level barriers; transmission process; treatment center; treatment services; virology

7. PROJECT SUMMARY / ABSTRACT As access to antiretroviral therapy (ART) has expanded and people live longer with HIV, HCV mortality has increased. The burden is particularly high in people who inject drugs (PWID). However, HCV can be cured with highly efficacious medications resulting in calls for microelimination. In settings with key population-focused HIV epidemics, microelimination may be achieved by integrating HCV services with existing HIV and harm reduction services to simultaneously improve HIV and HCV outcomes. Our team has successfully scaled integrated care centers (ICCs) for PWID across India. ICCs provide vertically integrated, HIV prevention and treatment services in stand-alone stigma-free venues. We integrated HCV point-of-care testing in 2015 and demonstrated significant improvements in HCV testing and awareness. However, HCV treatment remains a missing component. Accordingly, we investigate the impact of the integration of HCV treatment with individually tailored treatment support into 7 PWID focused ICCs. Our Aims are to: Aim 1: Evaluate whether individual treatment outcomes in HCV mono- and HIV/HCV co-infected PWID can be optimized by tailoring treatment support in 7 PWID-focused integrated HIV/HCV prevention/treatment centers. Subaim 1A: Compare sustained virologic response (SVR) in PWID undergoing DAA-based HCV therapy randomized by a “precision clinical trial” approach to varying levels (low, medium, high) of treatment support tailored to need using an algorithm based on factors associated with early HIV viral suppression. Subaim 1B: Estimate the incidence of HCV- reinfection by HIV status among PWID achieving SVR. Subaim 1C: Evaluate the impact of HCV cure on HIV viral suppression among HIV/HCV co-infected PWID. Aim 2: Characterize barriers and facilitators to integration of HCV treatment with tailored treatment support and HIV services through a mixed-methods evaluation to facilitate implementation in other settings. Aim 3: Estimate population-level effectiveness and cost-effectiveness of integrating HCV testing and treatment with essential HIV prevention and treatment services. Subaim 3A: Assess the observed and future impact of integrated HCV/HIV testing and treatment on chronic HCV and HIV prevalence and incidence among PWID using epidemic modeling and serosurvey data. Subaim 3B: Evaluate the cost-effectiveness of integrated HCV/HIV testing and treatment and identify the most cost-effective HCV treatment support strategies. To achieve these aims, we will scale on-site HCV testing and treatment in 7 ICCs across India that already deliver essential HIV services to ~10,000 PWID. Treatment support will be personalized using an algorithm based on early HIV viral suppression to triage clients into two strata: minimal and elevated risk for failure. Using a novel unbalanced randomization approach, we will assess efficacy of low (self-administered), medium (peer navigator) and high intensity (DOT) treatment support strategies within strata of treatment failure risk and overall. Population outcomes including reduced transmission will be evaluated through cross-sectional surveys, epidemic and cost-effectiveness modeling.

7.项目总结/摘要 随着抗逆转录病毒治疗（ART）的普及和艾滋病毒感染者的寿命延长，HCV死亡率 增加注射毒品的人（PWID）的负担特别高。然而，HCV可以治愈， 高效药物导致需要微量消除。在以人口为重点的环境中， 艾滋病毒流行，通过将HCV服务与现有的艾滋病毒和危害相结合， 减少服务，同时改善艾滋病毒和丙型肝炎的结果。我们的团队已经成功地 在印度各地的PWID综合护理中心（ICC）。国际社区中心提供纵向一体化的艾滋病毒预防和 在独立的无污名场所提供治疗服务。我们在2015年整合了HCV即时检测， 在HCV检测和认知方面取得了显著进步。然而，HCV治疗仍然是一个 缺少组件。因此，我们研究了HCV治疗与个体化治疗相结合的影响。 为7个以PWID为重点的ICC提供量身定制的治疗支持。我们的目标是：目标1：评估个人是否 HCV单感染和HIV/HCV合并感染的PWID的治疗结果可以通过定制治疗来优化 在7个以艾滋病毒/艾滋病感染者为重点的综合预防/治疗中心提供支助。Subaim 1A：比较持续 接受基于DAA的HCV治疗的PWID中的病毒学应答（SVR）， 试验”方法，使用算法根据需要定制不同水平（低、中、高）的治疗支持 基于与早期HIV病毒抑制相关的因素。Subaim 1B：估计HCV的发病率- 达到SVR的PWID中的HIV状态再感染。Subaim 1C：评估HCV治愈对HIV的影响 HIV/HCV合并感染的PWID中的病毒抑制。目标2：描述障碍和促进因素， 通过混合方法将HCV治疗与定制的治疗支持和艾滋病毒服务相结合 评价，以促进在其他环境中的执行。目标3：估计人口一级的效力， 将HCV检测和治疗与基本的HIV预防和治疗相结合的成本效益 服务Subaim 3A：评估HCV/HIV综合检测和治疗对 使用流行病模型和血清调查数据在PWID中的慢性HCV和HIV流行率和发病率。 Subaim 3B：评估HCV/HIV综合检测和治疗的成本效益， 具有成本效益的HCV治疗支持策略。为了实现这些目标，我们将扩大现场HCV检测， 在印度各地的7个国际社区中心提供治疗，这些中心已经为约10，000名艾滋病毒感染者提供了基本的艾滋病毒服务。治疗 将使用基于早期艾滋病毒病毒抑制的算法将客户分类为两种，从而提供个性化支持 分层：失败风险最小和升高。使用一种新的不平衡随机化方法，我们将评估 低强度（自我管理）、中等强度（同伴导航）和高强度（DOT）治疗支持的疗效 治疗失败风险分层和总体策略。人口成果，包括减少 将通过横断面调查、流行病和成本效益模型评估传播情况。