Long term outcomes of therapy in women initiated on lifelong ART because of pregnancy in DR Congo

 描述(由申请人提供)：美国总统艾滋病紧急救援计划(PEPFAR)在PEPFAR 3.0中再次强调了无艾滋病一代的目标，如果在资源有限的情况下，妇幼保健诊所(MCH)妇女对艾滋病毒护理连续性的坚持没有实质性的改善，就不会实现这一目标。在最近的一项关于预防艾滋病毒母婴传播(PMTCT)级联的LTFU的荟萃分析中，大约50%的艾滋病毒携带者孕妇已经通过分娩获得了LTFU；在分娩后3个月内，33.9%的母婴对也是LTFU。因此，目前估计有一半的儿科感染发生在产后母乳喂养期间，只有不到40%的HEI在2-3个月时进行了艾滋病毒检测。这种糟糕表现的决定因素发生在多个层面：医疗保健提供系统、提供者和受益者(感染艾滋病毒的母亲)。目前的证据表明，除了个人层面的因素外，医疗保健提供系统层面的因素是最重要的。质量改进(QI)协作是在全球医院和门诊实践中组织持续改进工作的最流行的方法之一。在突破系列方法中，也称为持续质量改进(CQI)，来自一个地区或国家的多个地点的10个QI团队聚集在一起，专注于一个共同的问题。在一到两年的时间里，临床和绩效改进方面的专家会定期向团队提供指导，并鼓励团队分享经验教训和最佳实践。然而，它的受欢迎程度、CQI的有效性从未在随机试验或精心设计的比较研究中得到证明。这项拟议研究的目的是：1)评估CQI干预措施在改善在妇幼保健诊所开始终身抗逆转录病毒治疗的妇女的长期护理和病毒学抑制方面的有效性，以及2)确定与在妇幼保健诊所开始终身抗逆转录病毒治疗的妇女保持护理和持续病毒学抑制相关的可改变的健康提供系统因素。这项研究将在刚果民主共和国的金沙萨实施：这是一个资源极其有限的国家，几十年来一直在努力摆脱严重的管理不善、猖獗的腐败和战争，这些战争使其卫生基础设施一团糟。我们将以卫生区为随机单位进行整群随机试验。干预组中的妇幼保健诊所将采用参与性数据驱动的方法和现场监测和监督支持，进行CQI倡议。我们将利用对卫生设施的调查，包括选定的工作人员和服务受益者(感染艾滋病毒的母亲)，收集有关提供服务的组织和提供者的主要特征以及患者对艾滋病毒护理提供业绩的看法的数据。主要结果将是产后24个月评估的LTFU/保留护理、病毒学抑制和MTCT率。

 DESCRIPTION (provided by applicant): The US President's Emergency Plan for AIDS Relief (PEPFAR) goal of an AIDS-free generation, re-emphasized in PEPFAR 3.0, will not be achieved without substantial improvement in the adherence to the HIV care continuum among women in maternal and child health clinics (MCH) in resource-limited settings. In a recent meta-analysis of loss to follow-up (LTFU) across the prevention of mother-to-child transmission of HIV (PMTCT) cascade, about 50% of HIV+ pregnant women are already LTFU by delivery; within 3 months of delivery 33.9% of mother-infant pairs are also LTFU. Consequently, half of pediatric infections are currently estimated to occur in the postpartum period during breastfeeding and fewer than 40% of HEI are tested for HIV at 2-3 months. Determinants of this poor performance occur at multiple levels: healthcare delivery systems, providers, and beneficiaries (HIV- infected mothers). Current evidence suggest that beyond individual-level factors, healthcare delivery system level factors are paramount. Quality Improvement (QI) Collaborative is one of the most popular methods for organizing sustained improvement efforts at hospitals and ambulatory practices worldwide. In the Breakthrough Series approach also refer to as continuous quality improvement (CQI),10 QI teams from multiple sites across a region or country are brought together to focus on a common problem. Over one or two years, experts in clinical and performance improvement provide the group with periodic instructions and encourage the teams to share lessons learned and best practices. However, its popularity, CQI effectiveness has never been demonstrated in a randomized trial or a well-designed comparative study. The aims of the proposed study are: 1) to evaluate the effectiveness of CQI interventions in improving long-term retention in care and virological suppression in women who start lifelong ART in MCH clinics and 2) to identify modifiable health delivery system factors associated with retention in care and sustained virological suppression in women who start lifelong ART in MCH clinics. The study will be implemented in Kinshasa, Democratic Republic of Congo (DRC): an extremely resource-limited country that has struggled to emerge from decades of gross mismanagement, rampant corruption, and wars that have left its health infrastructures in shambles. We will conduct a cluster-randomized trial with health districts as the randomization unit. MCH clinics in the intervention group, will undergo CQI initiatives using participatory data- driven approaches and on-site monitoring and supervisory support. We will use surveys of health facilities, including selected staff, and service beneficiaries (HIV infected mothers) to collect data on key characteristics of the service delivery's organization and providers' and patients' perspective of the HIV care delivery performance. The main outcomes will be LTFU/retention in care, virological suppression and MTCT rates evaluated at 24 months postpartum.