LINK4HEALTH: A Combination Strategy for Linkage and Retention, Swaziland

描述(由申请人提供)：将患者从艾滋病毒检测到艾滋病毒护理计划的联系以及他们在登记参加护理后的保留对于艾滋病毒计划在预防艾滋病毒相关发病率和死亡率以及防止艾滋病毒传播方面的有效性至关重要。撒哈拉以南非洲(SSA)艾滋病毒项目的联系和保留率并不理想，只有不到一半的检测呈阳性的患者成功联系并在一年内继续接受治疗。我们提出了一项实施科学研究，重点是确定一种有效、务实的多组成部分战略，以改善在PEPFAR支持的斯威士兰艾滋病毒项目中艾滋病毒阳性患者的联系和留住。这项研究设计是一项双臂整群随机试验，目的是比较一种新的循证干预组合方案--组合干预策略(CIS)与护理标准(SOC)在HIV阳性患者从检测点到保留护理期间的联系和保留方面的有效性。CI将包括1)艾滋病毒检测地点的护理点CD4计数分析；2)加快抗逆转录病毒治疗的启动 为符合条件的患者提供以下服务：3)提供基本护理和预防方案(BCPP)；4)为诊所预约提供短信提醒，并主动跟踪错过就诊的患者；以及5)为联系和保留提供财政奖励。主要目的是评估在艾滋病毒检测呈阳性的成年人中，在1个月内与艾滋病毒护理快速联系和在12个月内保留护理的综合结果方面，与SOC相比，CIS的有效性。次要目标包括评估CIS与SOC在每一项与艾滋病毒的联系上的有效性；保持护理；开始抗逆转录病毒治疗的时间；艾滋病毒疾病的进展(世卫组织III或IV期，住院、CD4计数和死亡率)；患者可接受性；基线特征与结果之间的关联，以及关于疾病进展和避免感染的成本效益的比较。拟议的这项名为LINK4HEALTH的研究有几项创新，包括：使用针对多种障碍的循证干预措施的组合，这些障碍阻碍了艾滋病毒护理级联中不同点的患者联系和保持护理；利用多国随机研究设计，严格确定独联体对联系和保留的综合结果的有效性；从疾病进展和避免感染的角度确定独联体的成本效益；将重点放在撒哈拉以南非洲的一个高流行国家；以及与卫生部、防治艾滋病规划署、疾控中心和其他国内合作伙伴合作。我们的研究方法的最终目标是弥合知识差距，确定一种可行的、具有成本效益的战略，用于联系和保留艾滋病毒护理，该战略可以很容易地整合到艾滋病毒项目中，并广泛推广到世界各地由PEPFAR资助的其他艾滋病毒项目。

DESCRIPTION (provided by applicant): Linkage of patients from HIV testing to HIV care programs and their retention once enrolled in care are essential to HIV program effectiveness in terms of prevention of HIV-related morbidity and mortality and prevention of HIV transmission. Linkage and retention rates in HIV programs in Sub-Saharan Africa (SSA) are suboptimal, with less than half of patients who test positive successfully linking and remaining in care at 1 year. We propose an implementation science study focused on identifying an effective pragmatic multicomponent strategy to improve linkage and retention of HIV-positive patients in PEPFAR-supported HIV programs in Swaziland. The study design is a two-arm cluster site-randomized trial to compare the effectiveness of a novel combination package of evidence-based interventions, the combination intervention strategy (CIS), compared to standard of care (SOC) on linkage and retention of HIV-positive patients from point of testing to retention in care. CIS will include 1) point of care CD4+count assays at HIV testing sites; 2) accelerated ART initiation for eligible patients; 3) provision of a basic care and prevention package (BCPP); 4) short message service (SMS) reminders for clinic appointments and active tracking of patients who miss visits; and 5) financial incentives for linkage and retention. The primary aim is to evaluate the effectiveness of CIS as compared to SOC on the combined outcome of rapid linkage to HIV care within 1 month and retention in care at 12 months among adults testing positive for HIV. Secondary aims include evaluation of the effectiveness of CIS compared to SOC on each of linkage to HIV; retention in care; time to ART initiation; HIV disease progression (WHO Stage III or IV, hospitalization, CD4+count, and mortality); patient acceptability; association between baseline characteristics and outcomes, and comparison of cost effectiveness with regards to disease progression and infections averted. The proposed study, LINK4HEALTH, is distinguished by several innovations including: the use of a combination of evidence-based interventions targeting multiple barrier types that impede patient linkage and retention in care across different points in the HIV care cascade; utilization of a cluster site-randomized study design to rigorously determine the effectiveness of CIS on a combined outcome of linkage and retention; determination of cost-effectiveness of CIS in terms of disease progression and infections averted; focus on a high-prevalence country in Sub- Saharan Africa; and collaboration with Ministry of Health, PEPFAR, CDC, and other in-country partners. Our approach to the research has the ultimate goal of bridging the know-do gap in terms of identifying a feasible, cost-effective strategy for linkage and retention in HIV care that can be readily integrated into HIV programs and scaled up widely to other PEPFAR-supported and other HIV programs around the world.