LINK4HEALTH: A Combination Strategy for Linkage and Retention, Swaziland

描述（由申请人提供）：从艾滋病毒检测到艾滋病毒护理计划的患者的联系，以及他们一旦参加护理，对艾滋病毒计划在预防艾滋病毒相关的发病率和死亡率以及预防艾滋病毒传播方面的有效性至关重要。在撒哈拉以南非洲（SSA）的艾滋病毒项目的连接和保留率是次优的，只有不到一半的患者谁测试阳性成功连接和保持在1年的护理。我们提出了一个实施科学研究的重点是确定一个有效的务实的多组分战略，以改善艾滋病毒阳性患者的联系和保留在斯威士兰总统艾滋病紧急救援计划支持的艾滋病毒项目。本研究设计为一项双组随机临床试验，目的是比较一种新型的循证干预组合方案（组合干预策略（CIS））与标准治疗（SOC）相比，在HIV阳性患者从检测到治疗期间的联系和保留方面的有效性。CIS将包括1）在HIV检测中心进行的护理点CD 4+计数检测; 2）加速ART启动 合格患者; 3）提供基本护理和预防包（BCPP）; 4）短信服务（SMS）提醒诊所预约和主动跟踪错过就诊的患者;以及5）对联系和保留的财务奖励。主要目的是评估CIS与SOC相比，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12个月后继续护理的综合结果方面的有效性。次要目的包括评价CIS与SOC相比在以下各方面的有效性：与HIV的关联;继续护理;开始ART的时间; HIV疾病进展（WHO III或IV期、住院、CD 4+计数和死亡率）;患者可接受性;基线特征与结局之间的关联，以及疾病进展和避免感染方面的成本效益比较。拟议的研究，LINK 4 HEALTH，是区别于几个创新，包括：使用一个组合的循证干预措施，针对多种障碍类型，阻碍病人的联系和保留在护理跨不同点的艾滋病毒护理级联;利用一个集群现场随机研究设计，以严格确定CIS的有效性的联系和保留的综合结果;确定CIS在疾病进展和避免感染方面的成本效益;重点关注撒哈拉以南非洲的一个高流行率国家;与卫生部、PEPFAR、CDC和其他国内伙伴合作。 我们的研究方法的最终目标是弥合知识差距，确定一个可行的，具有成本效益的艾滋病毒护理联系和保留战略，可以很容易地融入艾滋病毒方案，并广泛扩大到其他PEPFAR支持的艾滋病毒方案和世界各地的其他艾滋病毒方案。

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.