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

使用梅毒快速双重检测扩大印度尼西亚孕妇梅毒筛查

• 批准号: MR/Y004825/1
• 负责人: Virginia Wiseman
• 金额: $ 221.9万
• 依托单位: London School of Hygiene & Tropical Medicine
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2024
• 资助国家: 英国
• 起止时间: 2024 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FY004825%2F1
• 关键词: Expanding; syphilis; screening; among; pregnant

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.

梅毒或先天性梅毒的母婴传播 (MTCT) 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，但梅毒却并非如此。 2016年，先天性梅毒病例超过50万例（约66.1万例），导致超过20万例死产和新生儿死亡。作为高质量产前护理 (ANC) 的一部分，为所有妇女提供早期梅毒筛查和治疗至关重要。通过使用负担得起且可靠的快速检测来支持怀孕期间的早期诊断和治疗，艾滋病毒和梅毒向新生儿的传播基本上是可以预防的。 2013 年，印度尼西亚的 MTCT HIV 计划中增加了一项梅毒快速检测。虽然自那时以来，妊娠期 HIV 检测水平逐渐上升，从 2% 上升到 27%，但梅毒检测几乎没有从 0.45% 上升到 0.9% 。根据估计的 1.2% 梅毒患病率，预计通过提高印度尼西亚产前梅毒筛查的覆盖率，可以避免 10,169 例死产病例。 针对孕妇的艾滋病毒/梅毒即时检测双重检测已已被证明是一种有效且节省成本的工具，可加速几个低收入和中等收入国家的梅毒检测普及率。它于 2019 年获准在印度尼西亚使用，但尚未实施。部分原因是与艾滋病毒相比，梅毒在政治上的优先地位较低，政府和捐助者的投资水平较低，以及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匮乏。在这项研究中，我们与印度尼西亚卫生部、世界卫生组织印度尼西亚和社区非政府组织合作，评估双重测试及其支持要素（包括筛查程序、库存管理、工作人员和患者参与等领域的能力建设）的影响，印度尼西亚 4 个地区的数据管理和转介、标准操作程序、采购和供应）。这项整群随机试验将是东南亚第一个评估常规 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。这项干预措施有可能大大有助于改善印度尼西亚的孕产妇和儿童健康，同时建设卫生系统能力以加强梅毒的预防、检测和治疗。