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

基本信息

批准号：
10651729
负责人：
Shruti H Mehta
金额：
$ 90.71万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
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/10651729
关键词：
AIDS prevention Algorithms Antiviral Agents Awareness 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 Infections 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 Persons Pharmaceutical Preparations Population Positioning Attribute Prevalence Prevention Preventive service Private Sector Public Health Public Sector Randomized Resources Risk Sampling Self Administration Services Site Target Populations Testing Treatment Failure Treatment outcome Triage Viral antiretroviral therapy condoms cost effective cost effectiveness cost-effectiveness evaluation efficacy evaluation evidence base implementation facilitation implementation facilitators implementation outcomes improved individualized medicine integrated care low and middle-income countries mortality novel opioid agonist therapy patient-level barriers peer person centered point of care testing prevention service programs provider-level barriers response serosurvey social stigma synergism system-level barriers transmission process treatment center treatment services

项目摘要

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死亡率已有增加。注射毒品（PWID）的人的燃烧特别高。但是，HCV可以治愈高效的药物，导致呼吁微淘汰。在以关键人群为中心的设置中艾滋病毒流行病，微占领可以通过将HCV服务与现有艾滋病毒和伤害相结合来实现减少服务以同时改善HIV和HCV结果。我们的团队已经成功扩展了整个印度PWID的综合护理中心（ICC）。 ICC提供垂直整合，预防HIV和独立的无污名场所的治疗服务。我们在2015年整合了HCV护理点测试，在HCV测试和意识上显示出显着改善。但是，HCV治疗仍然缺少组件。彼此之间，我们研究了HCV处理与单独的整合的影响量身定制的治疗支持为7个PWID集中的ICC。我们的目标是：目标1：评估个人是否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 7个以PWID为重点的综合HIV/HCV预防/治疗中心的支持。 Subaim 1A：比较持续通过基于DAA的HCV治疗的PWID病毒学反应（SVR）随机通过“精确临床试验“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早期HIV病毒抑制有关的因素。 Subaim 1B：估计HCV-的事件 PWID实现SVR的HIV状态再感染。 Subaim 1C：评估HCV治疗对艾滋病毒的影响 HIV/HCV共感染的PWID中的病毒抑制。目标2：将障碍和促进者描述为通过混合方法将HCV治疗与量身定制的治疗支持和HIV服务整合评估以在其他设置中实施托管。目标3：估计人口水平的有效性和将HCV测试和治疗与基本HIV预防和治疗相结合的成本效益服务。 Subaim 3a：评估综合HCV/HIV测试和治疗对观察到的影响和未来影响使用流行病建模和Serasurvey数据，PWID之间的慢性HCV和HIV患病率和入射。 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。为了实现这些目标，我们将扩展现场HCV测试，并印度7个ICC的治疗已经为大约10,000个PWID提供了基本的HIV服务。治疗支持将使用基于早期HIV病毒抑制的算法来个性化，以分类为两个地层：失败的风险最小和升高。使用一种新颖的不平衡随机化方法，我们将评估低（自我管理），培养基（同伴导航器）和高强度（DOT）治疗支持的效率治疗失败风险和整体策略中的策略。人口结果包括减少传播将通过横断面调查，流行病和成本效益建模来评估。