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

刚果民主共和国因怀孕而开始终身抗逆转录病毒治疗的妇女治疗的长期结果

• 批准号: 9117083
• 负责人: EMILE OKITOLONDA WEMAKOY
• 金额: $ 57.64万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-06-01 至 2021-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9117083
• 关键词: AIDS prevention; Acquired Immunodeficiency Syndrome; Address; Adherence; Breast Feeding; CD4 Lymphocyte Count; Caring; Characteristics; Childhood; Clinic; Clinic Visits; Clinical; Cluster randomized trial; Comparative Study; Congo; Continuity of Patient Care; Country; Data; Democratic Republic of the Congo; Effectiveness; Emergency Situation; Generations; Goals; HIV; HIV Seropositivity; Health; Health care facility; Health system; Hospitals; Human immunodeficiency virus test; Individual; Infant; Infection; Instruction; Intervention; Learning; Left; Long-Term Care; Maternal and Child Health; Meta-Analysis; Methods; Modeling; Monitor; Mother-to-child HIV transmission; Mothers; Outcome; Patients; Performance; Play; Postpartum Period; Pregnancy; Pregnant Women; Prevention; Provider; Published Comment; Randomized; Recommendation; Research Infrastructure; Resources; Series; Services; Site; South Africa; South African; Structure; Surveys; System; Testing; Time; Viral; Visit; War; Woman; antiretroviral therapy; beneficiary; care delivery; cluster trial; design; experience; follow-up; group intervention; health care delivery; improved; improved outcome; pregnant; programs; public health relevance; randomized trial; scale up; success; therapy outcome; treatment program

 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.

 描述（由申请人提供）：美国总统艾滋病紧急救援计划（PEPFAR）的目标是无艾滋病的一代，在PEPFAR 3.0中再次强调，如果在资源有限的情况下，在孕产妇和儿童保健诊所（MCH）的妇女中坚持艾滋病毒护理连续性方面没有实质性的改善，就无法实现。在最近一项针对预防艾滋病毒母婴传播（PMTCT）级联反应的失访（LTFU）荟萃分析中，约50%的艾滋病毒+孕妇在分娩时已经是失访（LTFU）;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，不到40%的HEI在2-3个月时进行HIV检测。造成这种不良表现的决定因素存在于多个层面：保健服务提供系统、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，医疗服务系统层面的因素是至关重要的。质量改进（QI）协作是组织全球医院和门诊实践持续改进工作的最流行方法之一。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站点的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，临床和性能改进专家定期向小组提供指导，并鼓励小组分享经验教训和最佳实践。然而，它的普及，CQI的有效性从来没有在随机试验或设计良好的比较研究中得到证明。拟议研究的目的是：1）评价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保留和病毒学抑制方面的有效性; 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的护理保留和持续病毒学抑制相关的可修改的卫生服务系统因素。该研究将在刚果民主共和国（DRC）的金沙萨实施：这个资源极其有限的国家一直在努力摆脱数十年的严重管理不善，猖獗的腐败和战争，这些战争使其卫生基础设施陷入混乱。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方法和现场监测和监督支持进行CQI倡议。我们将对卫生设施，包括选定的工作人员和服务受益者（感染艾滋病毒的母亲）进行调查，以收集有关服务提供组织的主要特征以及提供者和患者对艾滋病毒护理提供绩效的看法的数据。主要结果将是产后24个月时评估的LTFU/护理保留率、病毒学抑制率和母婴传播率。