Strategies to optimize ART services for maternal&child health: the MCH-ART study

描述（由申请人提供）：发达国家在预防艾滋病毒母婴传播（PMTCT）方面取得了重大进展，但在撒哈拉以南非洲，每年有数十万儿童新感染艾滋病毒。在符合条件的孕妇（CD4<350细胞/毫升）中开始抗逆转录病毒治疗（ART）可在预防母婴传播工作中发挥关键作用，因为符合条件的妇女最有可能将艾滋病毒传播给其子女，而且她们自身发病和死亡的风险也最大。然而，很明显，在南非和艾滋病紧急救援计划活跃的非洲大陆其他地区，目前在怀孕期间开始抗逆转录病毒治疗的方法和服务并不理想。许多符合条件的妇女在怀孕期间没有开始抗逆转录病毒治疗，而那些在怀孕期间开始治疗的妇女往往太晚，无法充分认识到抗逆转录病毒治疗的好处。我们建议评估一种新的干预措施，以促进南非开普敦符合条件的孕妇快速开始抗逆转录病毒治疗。Emnonophele干预（在当地语言isiXhosa中意为“照顾健康”）代表了妊娠期“快速追踪”抗逆转录病毒治疗启动的一种新的操作范式，它结合了解决目前阻碍妊娠期快速启动抗逆转录病毒治疗的关键卫生系统、临床和患者教育以及依从性问题的战略。干预措施的特点是在产前诊所提供助产士提供的抗逆转录病毒治疗（ANC）；使用含有依非韦伦的方案，避免与奈韦拉平相关的延迟和毒性；调整患者教育，使之在抗逆转录病毒治疗开始期间和之后（而不是之前）立即提供。我们的团队由预防母婴传播、抗逆转录病毒治疗和患者教育方面的主要研究人员组成，与当地PEPFAR和公共卫生保健服务机构合作。在感染艾滋病毒的孕妇和保健服务提供者中开展的教育干预试点工作证明了其可行性和可接受性。我们建议进行一项实用的试验，以分娩时HIV病毒抑制为主要结果，对EI与现有护理标准进行严格评估。次要目标包括艾滋病毒母婴传播和产后6个月的护理，以及这种干预措施的可接受性和成本效益。通过认识到符合抗逆转录病毒治疗条件的孕妇是一个脆弱的高风险群体，EI改变了预防母婴传播和抗逆转录病毒治疗服务的实施模式，并解决了在怀孕期间提供抗逆转录病毒治疗以优化孕产妇和儿童健康结果的充分记录的挑战。我们建议对EI的可行性、实施、影响和成本效益进行严格的评估。EI是与南苏丹卫生部和地方服务机构合作开发的，有可能在地方和全国加强总统防治艾滋病紧急救援计划支持的预防母婴传播和艾滋病毒治疗服务。此外，EI将提供一个可行的、以证据为基础的干预平台，以加强怀孕期间抗逆转录病毒药物的使用，直接有助于消除非洲儿童艾滋病新发感染。

DESCRIPTION (provided by applicant): There have been major advances in the prevention of mother-to-child transmission (PMTCT) of HIV in developed countries, but hundreds of thousands of children are newly infected with HIV every year in sub- Saharan Africa. Initiation of antiretroviral therapy (ART) in eligible pregnant women (CD4<350 cells/uL) can play a critical role in PMTCT efforts, as women who are eligible for ART are most likely to transmit HIV to their children and also are at the greatest risk of morbidity and mortality themselves. However it is clear that current approaches and services for ART initiation in pregnancy are suboptimal in South Africa (SA) and other parts of the continent where PEPFAR is active. Many eligible women do not start ART while pregnant, and those who do often begin too late in pregnancy to realize the full benefits. We propose to evaluate a new intervention to promote rapid ART initiation among eligible pregnant women in Cape Town, SA. The Emnonophele Intervention (meaning "taking care of health" in isiXhosa, the local language) represents a new operational paradigm for "fast tracking" ART initiation in pregnancy that combines strategies to address the key health systems, clinical, and patient education and adherence issues that currently act as barriers to rapid ART initiation in pregnancy. The intervention features midwife-delivered ART within the antenatal clinic (ANC); using an efavirenz-containing regimen that avoids the delays and toxicities associated with nevirapine; and adapting patient education to be delivered during and immediately after (rather than before) ART initiation. Our team consists of leading researchers in PMTCT, ART and patient education working in partnership with local PEPFAR and public health care services. Pilot work on EI has demonstrated its feasibility and acceptability among HIV-infected pregnant women and health care providers. We propose a pragmatic trial to provide a rigorous evaluation of EI versus the existing standard of care, with HIV viral suppression at the time of delivery as the primary outcome. Secondary aims include the transmission of HIV from mother-to-child and retention in care through 6 months postpartum, as well as the acceptability and cost-effectiveness of this intervention. By recognizing that ART-eligible pregnant women are a vulnerable, high risk group EI shifts the paradigm for implementation of PMTCT and ART services, and addresses well-documented challenges to delivering ART in pregnancy to optimize both maternal and child health outcomes. We propose a rigorous evaluation of the feasibility, implementation, impact and cost-effectiveness of EI. Developed in partnership with SA DOH and local services, EI has the potential to strengthen PEPFAR-supported PMTCT and HIV treatment services locally and nationally. Furthermore, EI will provide a feasible and evidence-based intervention platform to enhance ART use during pregnancy, contributing directly to efforts to eliminate new pediatric HIV infections in Africa.