Expanding syphilis screening among pregnant women in Indonesia using the rapid dual test for syphilis & HIV with capacity building: The DUALIS Study

梅毒或先天性梅毒的母婴传播是全球可预防死产的第二大原因，仅次于疟疾。虽然过去十年在预防艾滋病毒母婴传播方面取得了重大进展，但在预防梅毒方面却没有取得同样的进展。2016年，有50多万例（约66.1万例）先天性梅毒病例，导致20多万例死产和新生儿死亡。作为高质量产前保健的一部分，向所有妇女提供早期梅毒筛查和治疗至关重要。艾滋病毒和梅毒向新生儿的传播基本上可以通过使用负担得起和可靠的快速检测来预防，以支持怀孕期间的早期诊断和治疗。2013年，印度尼西亚的母婴传播艾滋病毒规划增加了一种梅毒快速检测方法。从那时起，怀孕期间的艾滋病毒检测水平从2%逐渐上升到27%，而梅毒检测却几乎没有从0.45%上升到0.9%。根据估计的1.2%的梅毒患病率，预计通过增加印度尼西亚产前梅毒筛查的覆盖率，可以避免10169例死产病例。在一些低收入和中等收入国家，对孕妇进行艾滋病毒/梅毒即时检测的双重检测已被证明是一种有效和节省成本的工具，可加快梅毒检测的普及。它于2019年被批准在印度尼西亚使用，但尚未实施。这在一定程度上是由于与艾滋病毒相比，对梅毒的政治重视程度较低，政府和捐助者的投资水平较低，以及缺乏关于印度尼西亚常规护理中双重检测的有效性和成本效益的证据。在这项研究中，我们与印度尼西亚卫生部、世卫组织印度尼西亚办事处和一个社区非政府组织合作，在印度尼西亚4个地区评估双重检测的影响，并提供支持要素（包括筛查程序、库存管理、工作人员和患者参与、数据管理和转诊、标准操作程序、采购和供应等领域的能力建设）。这一集群随机试验将是东南亚首个评估常规ANC服务中艾滋病毒和梅毒双重检测的有效性、可接受性、成本效益和可负担性的试验。这一干预措施有可能为改善印度尼西亚的孕产妇和儿童健康作出重大贡献，同时建设卫生系统加强梅毒预防、检测和治疗的能力。

Mother-to-child transmission (MTCT) of syphilis, or congenital syphilis, is the second leading cause of preventable stillbirth globally, preceded only by malaria. While significant progress has been made over the past decade in preventing MTCT of HIV, the same cannot be said for syphilis. In 2016, there were more than half a million (about 661,000) cases of congenital syphilis, resulting in over 200,000 stillbirths and neonatal deaths. It is crucial that all women are provided with early syphilis screening and treatment as part of high-quality antenatal care (ANC). Transmission of HIV and syphilis to newborns is essentially preventable through the use of affordable and reliable rapid tests to support early diagnosis and treatment in pregnancy. A single rapid test for syphilis was added to Indonesia's MTCT HIV programme in 2013. While the level of HIV testing in pregnancy has been gradually rising since that time from 2% to 27%, testing for syphilis has barely shifted from 0.45% to 0.9%. Based on an estimated syphilis prevalence rate of 1.2%, it is predicted that 10,169 stillbirth cases could potentially be averted by increasing the coverage of antenatal syphilis screening in Indonesia.The dual test for HIV/syphilis point-of-care testing for pregnant women has been shown to be an effective and cost-saving tool for accelerating syphilis testing uptake in several low- and middle-income countries. It was approved for use in Indonesia in 2019 but is yet to be implemented. This is in part due to the low political priority given to syphilis compared with HIV, low levels of investment by the government and donors, and a paucity of evidence on the effectiveness and cost-effectiveness of the dual test in routine care in Indonesia. For this study, we have partnered with the Indonesian Ministry of Health, WHO Indonesia, and a community NGO to evaluate the impact of the dual test with supporting elements (including capacity building the areas of screening procedures, inventory management, staff and patient engagement, data management and referrals, standard operating procedures, procurement and supply) in 4 districts of Indonesia. This cluster-randomised trial will be the first in Southeast Asia to assess the effectiveness, acceptability, cost-effectiveness, and affordability of the dual test for HIV and syphilis in routine ANC services. This intervention has the potential to contribute significantly to improved maternal and child health in Indonesia while building health system capacity to strengthen the prevention, detection, and treatment of syphilis.