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项目的患者联系，以及他们在登记后的保留，对于艾滋病毒项目在预防艾滋病毒相关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。撒哈拉以南非洲（SSA）艾滋病项目的联系率和保留率并不理想，不到一半的检测呈阳性的患者成功联系率并在1年后继续接受治疗。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成分战略，以改善斯威士兰总统防治艾滋病紧急救援计划支持的艾滋病毒阳性患者的联系和保留。该研究设计是一项双组随机试验，旨在比较一种新型循证干预组合方案的有效性，即联合干预策略（CIS），与标准护理（SOC）相比，在hiv阳性患者从检测点到护理保留的联系和保留方面。CIS将包括1)HIV检测点的护理点CD4+计数分析；2)加速抗逆转录病毒治疗的启动

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.