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

描述（由申请人提供）：在发达国家，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。对符合条件的孕妇（CD 4 <350个细胞/uL）开始抗逆转录病毒疗法可在防止母婴传播工作中发挥关键作用，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染给其子女，而且她们本身也面临最大的发病和死亡风险。然而，在南非和非洲大陆其他积极开展“总统艾滋病紧急救援计划”的地区，目前在怀孕期间开始抗逆转录病毒疗法的方法和服务显然不够理想。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，而那些开始抗逆转录病毒治疗的妇女往往在怀孕时开始太晚，无法充分实现其益处。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中的意思是“照顾健康”）代表了一种新的“快速跟踪”怀孕期间开始抗逆转录病毒治疗的操作模式，它结合了解决关键卫生系统、临床和患者教育以及坚持问题的战略，这些问题目前是怀孕期间快速开始抗逆转录病毒治疗的障碍。干预措施的特点是在产前诊所（ANC）内由助产士提供ART;使用含依法韦仑的方案，避免与奈韦拉平相关的延迟和毒性;并在ART开始期间和之后立即（而不是之前）调整患者教育。我们的团队由PMTCT、ART和患者教育领域的领先研究人员组成，与当地PEPFAR和公共医疗保健服务机构合作。免疫接种的试点工作已证明其可行性，并为感染艾滋病毒的孕妇和保健提供者所接受。我们提出了一个务实的试验，以提供一个严格的评价EI与现有的标准护理，与艾滋病毒的抑制在交付时的主要成果。第二个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疗法条件的孕妇是一个脆弱的高风险群体，消除艾滋病方案改变了实施防止母婴传播和抗逆转录病毒疗法服务的模式，并解决了有充分证据证明的在怀孕期间提供抗逆转录病毒疗法的挑战，以优化孕产妇和儿童健康成果。我们提出了一个严格的可行性评估，实施，影响和成本效益的EI。该方案是与南非卫生部和地方服务部门合作开发的，有可能加强总统艾滋病紧急救援计划支持的地方和国家预防母婴传播和艾滋病毒治疗服务。此外，EI将提供一个可行的循证干预平台，以加强妊娠期间ART的使用，直接有助于消除非洲儿童艾滋病毒新感染的努力。 公共卫生相关性：在南非和许多其他积极开展“总统艾滋病紧急救援计划”的国家，在怀孕期间有效地使用抗逆转录病毒疗法是减少艾滋病毒母婴传播努力的一个关键部分。然而，我们知道目前的服务面临着许多问题，开始对孕妇的ART，并在怀孕期间跟踪他们，所以我们提出了一个创新的新方法，在怀孕期间开始ART强调ART合格的孕妇作为一个高危人群谁需要特别关注。我们将研究一种新的模式，彻底改变怀孕期间开始抗逆转录病毒治疗的做法，并将为改善艾滋病毒常见的南非等国家的孕产妇和儿童健康作出重大贡献。

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. PUBLIC HEALTH RELEVANCE: Using antiretroviral therapy (ART) effectively in pregnancy is a critical part of efforts to reduce the mother-to- child transmission of HIV infection in South Africa and many other countries where PEPFAR is active. However we know there are many problems facing current services to start pregnant women on ART and follow them during pregnancy, so we propose an innovative new approach for ART initiation in pregnancy that emphasizes ART-eligible pregnant women as a high-risk population who need special attention. We will study a new model to revolutionize ART initiation in pregnancy and will make a major contribution to improving maternal and child health in countries like South Africa where HIV is common.