In Indonesia, a single finger-prick test that checks for both HIV and syphilis is about to be rolled out in antenatal clinics for the first time, but researchers need to prove it works in routine care before the government will adopt it widely. Syphilis causes more than 200,000 stillbirths and newborn deaths globally each year, yet it remains drastically underdiagnosed. In Indonesia, HIV testing in pregnancy rose from 2% to 27% after a rapid test was introduced in 2013, but syphilis testing barely budged—from 0.45% to 0.9%. The dual test was approved for use in Indonesia in 2019 but has never been implemented, partly because syphilis receives far less political attention and funding than HIV, and partly because there is no local evidence on its effectiveness or cost-effectiveness. This cluster-randomised trial, the first of its kind in Southeast Asia, will test the dual test alongside capacity-building measures—training staff, improving supply chains, and strengthening referral systems—across four Indonesian districts. If the intervention succeeds, it could prevent an estimated 10,169 stillbirths and build lasting health system capacity to detect and treat syphilis, quietly saving lives through a routine antenatal visit that many women currently receive without this simple test.
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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.
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