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: 10433886
• 负责人: Shruti H Mehta
• 金额: $ 106.17万
• 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/10433886
• 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; Persons; 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; antiretroviral therapy; base; condoms; cost effective; cost effectiveness; cost-effectiveness evaluation; evidence base; implementation facilitation; implementation facilitators; implementation outcomes; improved; individualized medicine; low and middle-income countries; mortality; novel; opioid agonist therapy; peer; person centered; point of care testing; prevention service; programs; response; serosurvey; social stigma; synergism; system-level barriers; transmission process; treatment center; treatment services

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。项目摘要 /摘要 随着获得抗逆转录病毒疗法（ART）的机会扩大，患有艾滋病毒的人的寿命更长，HCV死亡率已有 注入毒品的人（PWID）的负担特别高。 高效的药物导致呼吁在以人口为中心 艾滋病毒流行病，微占领可以通过将HCV服务与艾滋病毒和伤害相结合来实现 减少同时改善HIV和HCV成果的服务。 整个印度PWID的综合护理中心（ICC）提供了垂直综合的蜂巢预防和 独立的独立污名场所中的治疗服务。 在HCV测试和意识上有显着改善。 缺少组件。 量身定制的治疗支持为7个PWID的ICC。 可以通过调整治疗来优化HCV单和HIV/HCV共同感染的PWID的治疗结果 在7个以PWID为重点的综合HIV/HCV预防/治疗中心的支持。 PWID中的病毒学反应（SVR）接受了基于DAA的HCV治疗，由“精确临床 试验“用于使用算法量身定制的不同水平（低，中，高）治疗支持的方法 基于与HIV病毒抑制相关的因素。 在PWID中恢复艾滋病毒状况，达到SVR 1C。 艾滋病毒/HCV共同感染的PWID的病毒抑制。 通过混合方法整合HCV量身定制的治疗支持和HIV服务 评估以促进其他环境的实施。 将HCV测试和治疗与基本蜂巢预防和信任整合的成本效益 服务。 慢性HCV和HIV患病率和艾滋病毒的患病率以及使用流行病建模建模建模建模模型数据数据。 Subaim 3b：评估综合HCV/HIV测试和治疗的成本效益，并确定最多 具有成本效益的HCV治疗支持策略。 在7个ICC ACCS印度的治疗中，已经为约10,000个PWID提供了基本的HIV服务。 支持将使用基于早期HIV病毒抑制分类客户的AngorithM个性化支持分为两个 地层：使用新型不平衡方法的失败风险最小和升高。 低（自我管理），培养基（同伴导航器）和高强度（DOT）治疗支持的功效 治疗失败风险和总体成果的策略。 传输将通过横断面调查，流行病和成本效益的建模进行评估。