Integrating HCV services into HIV programs for PWID in India

7.项目摘要/摘要 随着获得抗逆转录病毒治疗(ART)的机会扩大，艾滋病毒携带者的寿命延长，丙型肝炎病毒的死亡率 增加了。对于注射毒品(PWID)的人来说，负担尤其高。然而，丙型肝炎病毒可以通过以下方法治愈 高效的药物导致了对微量消除的呼唤。在以主要人群为重点的环境中 在艾滋病毒流行方面，可以通过将丙型肝炎病毒服务与现有的艾滋病毒和危害相结合来实现微消除 减少服务，以同时改善艾滋病毒和丙型肝炎的结果。我们的团队成功地扩大了规模 印度各地的残疾人综合护理中心(ICCs)。ICCS提供垂直整合的艾滋病毒预防和 在独立的、没有污名的场所提供治疗服务。我们在2015年集成了丙型肝炎病毒护理点检测，并 在丙型肝炎病毒检测和意识方面显示出显著的进步。然而，丙型肝炎的治疗仍然是一种 缺少组件。因此，我们调查了丙型肝炎病毒治疗与单独治疗相结合的影响。 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 通过量身定制治疗可以优化丙型肝炎病毒单一感染和艾滋病毒/丙型肝炎合并感染的PWID的治疗结果 支持7个以PWID为重点的艾滋病毒/丙型肝炎综合预防/治疗中心。Subaim 1A：比较持续 用“精确临床”随机抽样的PWID患者接受基于DAA的丙型肝炎病毒治疗的病毒学应答(SVR) 使用算法为不同级别(低、中、高)的治疗支持量身定做“试验”方法 基于与早期艾滋病毒病毒抑制相关的因素。Subaim 1B：估计丙型肝炎的发病率- 在达到SVR的PWID中，HIV再感染状况。Subaim 1C：评估丙型肝炎治愈对HIV的影响 HIV/HCV混合感染的PWID患者的病毒抑制。目标2：确定障碍和促进者的特征 通过混合方法将丙型肝炎病毒治疗与量身定制的治疗支持和艾滋病毒服务相结合 评估，以促进在其他环境中的实施。目标3：评估人口一级的有效性和 将丙型肝炎病毒检测和治疗与基本艾滋病毒预防和治疗相结合的成本效益 服务。Subaim 3A：评估综合丙型肝炎病毒/艾滋病毒检测和治疗对以下方面的观察和未来影响 应用流行病学模型和血清调查数据研究PWID人群中慢性丙型肝炎病毒和艾滋病病毒的流行率和发病率。 Subaim 3B：评估整合的丙型肝炎病毒/艾滋病毒检测和治疗的成本效益，并确定最 具有成本效益的丙型肝炎病毒治疗支持策略。为了实现这些目标，我们将扩大现场丙型肝炎病毒检测和 在印度各地的7个ICC接受治疗，这些ICC已经向约10,000名残疾人提供基本的艾滋病毒服务。治疗 支持将使用基于早期艾滋病毒病毒抑制的算法进行个性化，将客户分类为两个 STRANTS：最低和最高的失败风险。使用一种新的非平衡随机方法，我们将评估 低(自我管理)、中(同伴导航员)和高强度(DOT)治疗支持的疗效 治疗失败风险和总体层面内的策略。人口结果，包括减少 将通过横断面调查、流行病和成本效益模型来评估传播情况。

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.