A Combination Intervention Package for Isoniazid Preventive Therapy in Ethiopia

描述（由申请人提供）：结核病（TB）是撒哈拉以南非洲艾滋病毒感染者发病和死亡的主要原因。埃塞俄比亚在结核病高负担国家中排名第八，估计发病率为每10万人359人，约有110万人感染艾滋病毒。强有力的科学证据表明，异烟肼预防性治疗（IPT）可降低艾滋病毒感染者患结核病的风险。然而，在高负担环境中实施这一行之有效的干预措施并不理想。在资源有限的情况下，已经确定了许多实施因特网预防和治疗的障碍，迫切需要对循证干预措施进行影响评估，以改善因特网预防和治疗的启动、坚持和完成。我们提出了一项创新的群集随机试验，ENhance启动和保留在IPT护理HIV研究（ENRICH研究），其目的是评估组合干预包（CIP）与标准护理（SOC）的有效性，以改善IPT的启动，依从性和完成在埃塞俄比亚的卫生中心参加HIV护理的HIV感染者。CIP将包含方案、结构和心理社会组成部分，包括：1）卫生保健提供者使用临床算法; 2）使用家庭护理登记表确定有资格接受IPT的HIV感染家庭成员; 3）在每月多学科小组会议期间审查关于IPT启动和依从性的监测数据; 4）报销每月门诊访视的交通费用;以及5）通过移动的电话和受过训练的同伴教育者使用交互式语音响应的实时遵守支持。本研究的具体目的是：1.描述和比较联合干预方案与标准治疗方案在埃塞俄比亚提供IPT的有效性。2.评估CIP与SOC相比对HIV相关结局的影响。3.评估在埃塞俄比亚常规项目条件下，IPT在HIV感染者中的安全性和耐受性。4.确定SOC研究中心与IPT依从性和完成相关的患者和项目特征。参与本提案的研究者团队包括在资源有限的国家（特别是撒哈拉以南非洲）开展大型、协作、前瞻性、多中心研究的各种专业知识和丰富经验。研究人员在埃塞俄比亚和其他地方成功地设计和实施了PEPFAR支持的项目，并在设计和开展关于IPT依从性和结核病/艾滋病毒整合的研究方面拥有丰富的经验。

DESCRIPTION (provided by applicant): Tuberculosis (TB) is a leading cause of morbidity and mortality among people living with HIV in sub-Saharan Africa. Ethiopia ranks eighth among high-burden TB countries, with an estimated incidence rate of 359 per 100,000, and approximately 1.1 million people are living with HIV. Strong scientific evidence demonstrates that isoniazid preventive therapy (IPT) reduces the risk of TB among HIV-infected individuals. However, implementation of this proven intervention in high-burden settings has been suboptimal. Many barriers to IPT implementation in resource-limited settings have been identified, and impact evaluation of evidence-based interventions to improve IPT initiation, adherence and completion are urgently needed. We propose an innovative cluster randomized trial, the ENhance Initiation and Retention in IPT Care for HIV Study (ENRICH Study), which aims to evaluate the effectiveness of a combination intervention package (CIP) versus standard of care (SOC), to improve IPT initiation, adherence, and completion among HIV-infected individuals enrolled in HIV care at health centers in Ethiopia. The CIP will contain programmatic, structural, and psychosocial components including: 1) use of a clinical algorithm by health care providers; 2) identification of HIV-infected family members eligible for IPT using a family care enrollment form; 3) review of monitoring data on IPT initiation and adherence during monthly multidisciplinary team meetings; 4) reimbursement of transportation costs for monthly clinic visits; and 5) real-time adherence support using interactive voice response via mobile phones and trained peer educators. The specific aims of the study are: 1.Characterize and compare the effectiveness of a combination intervention package with standard of care for IPT provision in Ethiopia. 2. Assess the impact of CIP compared with SOC on HIV-related outcomes. 3. Assess the safety and tolerability of IPT among HIV-infected individuals under routine program conditions in Ethiopia. 4. Identify patient and program characteristics associated with IPT adherence and completion at SOC sites. The team of investigators involved in this proposal includes a diversity of expertise and a wealth of experience in large, collaborative, prospective, multicenter studies in resource-limited countries, particularly in sub- Saharan Africa. The investigators have successfully designed and implemented PEPFAR-supported programs in Ethiopia and elsewhere and have extensive experience in designing and conducting studies on IPT adherence and TB/HIV integration in diverse settings.