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

描述(申请人提供)：发达国家在预防艾滋病毒母婴传播(母婴传播)方面取得了重大进展，但撒哈拉以南非洲每年有数十万儿童新感染艾滋病毒。在符合条件的孕妇中启动抗逆转录病毒疗法(抗逆转录病毒疗法)可在预防母婴传播努力中发挥关键作用，因为符合抗逆转录病毒疗法条件的妇女最有可能将艾滋病毒传播给其子女，而且自身也面临最大的发病和死亡风险。然而，在南非和非洲大陆开展紧急救援的其他地区，目前孕期启动抗逆转录病毒治疗的方法和服务显然不是最理想的。许多符合条件的女性在怀孕期间不会开始抗逆转录病毒治疗，而那些确实开始抗逆转录病毒治疗的人往往在怀孕时开始得太晚，无法实现充分的好处。我们建议评估一种新的干预措施，以促进在南卡罗来纳州开普敦合格的孕妇中快速启动抗逆转录病毒治疗。Emnon ophele干预(在当地语言isixhosa中的意思是“照顾健康”)代表了一种“快速跟踪”孕期ART启动的新操作范式，它结合了各种策略，以解决目前阻碍快速孕期ART启动的关键卫生系统、临床和患者教育以及依从性问题。干预的特点是在产前诊所(ANC)内由助产士提供ART；使用包含efavirenz的方案，避免与奈韦拉平相关的延迟和毒性；以及调整患者教育，使其在ART开始期间和之后(而不是在开始之前)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领域的领先研究人员组成，与当地的PEPFAR和公共医疗服务机构合作。EI的试点工作已经证明了其在感染艾滋病毒的孕妇和卫生保健提供者中的可行性和可接受性。我们建议进行一项务实的试验，以提供对EI与现有护理标准的严格评估，并将分娩时的艾滋病毒抑制作为主要结果。次要目标包括艾滋病毒母婴传播和产后6个月留存护理，以及这一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资格的孕妇是一个脆弱的高危群体，EI改变了实施预防母婴传播和抗逆转录病毒治疗服务的模式，并解决了在孕期提供抗逆转录病毒治疗以优化孕产妇和儿童健康结果的有据可查的挑战。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是与南非卫生部和当地服务机构合作开发的，有可能加强由PEPFAR支持的地方和全国范围内的预防母婴传播和艾滋病毒治疗服务。此外，EI将提供一个可行和循证的干预平台，以加强孕期抗逆转录病毒药物的使用，直接促进在非洲消除新的儿科艾滋病毒感染的努力。

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.