A Combination Intervention Package for Isoniazid Preventive Therapy in Ethiopia

描述(申请人提供)：结核病(TB)是撒哈拉以南非洲艾滋病毒携带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10万人中有359人，约有110万人感染艾滋病毒。强有力的科学证据表明，异烟肼预防疗法(IPT)降低了艾滋病毒感染者中的结核病风险。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。已查明在资源有限的情况下实施因特网技术的许多障碍，迫切需要对循证干预措施进行影响评估，以改进因特网技术的启动、遵守和完成。我们提出了一项创新的整群随机试验，名为Enhance Initiation and Return in IPT Care for HIV Study(Enhance Study)，旨在评估组合干预方案(CIP)与护理标准(SOC)的有效性，以改善埃塞俄比亚卫生中心登记的HIV感染者的IPT启动、依从性和完成情况。CIP将包含方案、结构和心理社会部分，包括：1)医疗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的艾滋病毒感染家庭成员；3)在每月的多学科团队会议期间审查关于IPT启动和遵守的监测数据；4)报销每月诊所就诊的交通费；以及5)通过移动电话和受过培训的同行教育人员的互动语音响应，提供实时遵守支持。这项研究的具体目的是：1.描述和比较埃塞俄比亚综合干预方案和护理标准在埃塞俄比亚提供的综合干预方案的有效性。2.评估CIP与SOC对艾滋病毒相关结果的影响。3.在埃塞俄比亚的常规项目条件下，评估艾滋病毒感染者接受IPT的安全性和耐受性。4.确定与SOC站点的IPT遵守和完成相关的患者和计划特征。参与这项提议的调查小组包括在资源有限的国家，特别是在撒哈拉以南非洲进行的大型、协作、前瞻性、多中心研究中的各种专业知识和丰富的经验。研究人员在埃塞俄比亚和其他地方成功地设计和实施了由PEPFAR支持的项目，并在设计和开展关于在不同环境下遵守IPT和结核病/艾滋病毒整合的研究方面拥有丰富的经验。 公共卫生相关性：结核病是撒哈拉以南非洲艾滋病毒携带者发病和死亡的主要原因。强有力的科学证据表明，异烟肼预防疗法(IPT)降低了艾滋病毒感染者中的结核病风险；然而，在高负担、资源有限的环境中实施这一经证明的干预措施并不是最理想的。这项拟议的研究将严格评估埃塞俄比亚艾滋病毒项目中IPT提供的综合干预方案的有效性；结果将为整个PEPFAR项目的规划和政策制定提供参考。

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. PUBLIC HEALTH RELEVANCE: Tuberculosis (TB) is a leading cause of morbidity and mortality among people living with HIV in sub-Saharan Africa. 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, resource-limited settings has been suboptimal. The proposed study will rigorously evaluate the effectiveness of a combination intervention package for IPT provision in HIV programs in Ethiopia; the results will inform programming and policy making across PEPFAR programs.