An implementation trial of continuous quality improvement for antenatal syphilis and HIV detection and treatment in Indonesia: The MENJAGA study

The dual elimination of mother-to-child transmission (EMTCT) of HIV and syphilis through screening and treatment of pregnant women has been identified as a global public health priority. Indonesia has set an ambitious EMTCT target of 2030. Currently, only 27% of pregnant women are tested for HIV and 1% for syphilis (using a mixture of rapid tests and laboratory-based testing), this is despite 98% of pregnant women attending antenatal care at least once during pregnancy. Moreover, only 48% of those testing positive for HIV and 30% for syphilis receive treatment. This poses a formidable challenge and is recognised as one of the most significant gaps in antenatal care in Indonesia. Persistent barriers to antenatal screening for HIV/syphilis include (but are not restricted to): limited awareness among health workers of the need for universal screening; some women are fearful of the test; lack of local standard operating procedures at the clinic level; supply chain gaps in tests and treatments; problems with the referral processes; and difficulties tracking women as they move across the health system. Context-specific interventions to better support the integration of HIV and syphilis testing and treatment into the Antenatal care (ANC) platform are urgently needed in Indonesia. Continuous Quality Improvement (CQI), which involves local ANC teams systematically collecting and reflecting on local data to inform the design and implementation of service delivery, has been effectively used to strengthen ANC services in a number of Sub-Saharan African countries. This approach holds considerable promise for Indonesia, a highly populous and diverse country where a 'one size fits all' approach to the delivery of quality ANC rarely applies. Using a cluster-randomised design, we will evaluate the effectiveness, cost-effectiveness, acceptability, fidelity and reach of a multi-faceted CQI intervention to improve antenatal testing and treatment of HIV and syphilis in public and private ANC clinics in 6 districts across 3 Provinces (West Java, South Sumatra and South Kalimantan). This 3-year multi-disciplinary study will involve clinicians, epidemiologists, economists, social scientists, health services researchers and policy-makers from the Indonesian Ministry of Health (research partner), the London School of Hygiene & Tropical Medicine, the Universitas of Gadjah Mada, the University of Sebelas Maret and the Kirby Institute. A range of other stakeholders will be involved throughout the study (e.g. patient advocacy groups; implementing agencies; specialist professional associations; clinics and ANC services) to assess the appropriateness and acceptability of the intervention and barriers and facilitators to scale up. This research has the potential to contribute significantly to improved maternal and child health in Indonesia while also strengthening the underlying health system.

HIV and syphilis screening in pregnancy is universally recommended and is essential to prevent mother-to-child transmission of HIV and syphilis, which can result in lifelong treatment, stillbirth, neonatal death and major malformation. The MENJAGA (Protection) project will be conducted in Indonesia, the fourth most populous country in the world, with numbers of stillbirths among the highest globally; yet screening coverage is among the lowest, with only around 27% of pregnant women tested for HIV and only 2% for syphilis in 2015. Indonesia is targeting elimination by 2030 and is urgently seeking evidence-based, context-specific and low-cost solutions to support the integration of disease-specific elimination efforts within the antenatal care (ANC) service delivery platform, in a way that builds upon existing investments in maternal and child health services. Continuous Quality Improvement (CQI), which involves local ANC teams systematically collecting and reflecting on local data to inform the design and implementation of service delivery, has been effectively used to strengthen ANC services in a number of Sub-Saharan African countries. This approach holds considerable promise for Indonesia, a highly populous and diverse country where a 'one size fits all' approach to the delivery of quality ANC rarely applies. Using a cluster-randomised design, we will evaluate the effectiveness, cost-effectiveness, acceptability, fidelity and reach of a multi-faceted CQI intervention to improve antenatal testing and treatment of HIV/syphilis in ANC clinics in 6 districts across 3 Provinces (West Java, South Sumatra and South Kalimantan). This 3-year multi-disciplinary trial is a partnership between the London School of Hygiene & Tropical Medicine, the Universitas of Gadjah Mada, the University of Sebelas Maret, the Indonesian Ministry of Health and the Kirby Institute.

The global community is committed to the elimination of mother-to-child-transmission (EMTCT) of HIV and syphilis. Indonesia, the 4th most populous country in the world, has the lowest rate of antenatal screening and treatment for HIV/syphilis in South-East Asia and is seeking evidence-based solutions that build upon existing investments in maternal and child health services. We will evaluate a low-cost and locally-driven intervention based on the principles of continuous quality improvement to promote the quality of antenatal care (ANC), including screening and treatment for HIV/syphilis. This new evidence has the potential to improve maternal and child health in Indonesia while strengthening the underlying health system. These results will benefit the following groups:

I. Government of Indonesia
The findings from this study will generate the evidence needed by the Indonesian Ministry of Health (MoH) to design a screening strategy capable of shifting the persistently low rates of HIV and syphilis testing in pregnant women. The information has direct relevance for three Sub-directorates in Indonesia responsible for the health care of pregnant women and control of HIV and syphilis; The HIV AIDS and STI Sub-directorate, Maternal and Neonatal Health Sub-directorate and Primary Care.
II. International stakeholders
Our findings will have implications for strengthening ANC in South East Asia (SEA, where many countries are also aiming for EMTCT but continue to experience very low coverage of syphilis/HIV screening among pregnant women. To date, Thailand is the only SEA country to achieve this goal. WHO holds regular meetings with member countries, providing opportunities to share experiences and learnings. A meeting was held in Cambodia in 2017 that focused on quality assurance systems for HIV and syphilis rapid diagnostic tests, with representatives from the Indonesian MoH, WHO and members of this team (Guy/Probandari). Our findings will also be of interest to the Gates Foundation; WHO; UNITAID; Foundation for Innovative New Diagnostics (FIND) who will value research on strategies to address barriers to EMTCT of HIV/syphilis.
III. Antenatal services, staff and pregnant women
The research will inform the development and refinement of antenatal HIV and syphilis screening strategies. The refinements have the potential to lead to more health care staff being trained, greater staff satisfaction in the screening process, more women being screened and finding the process acceptable, and for those women found to be positive, treated appropriately and reductions in adverse outcomes in newborns.
IV. Non-government organisations (NGOs), private sector and industry
This study engages with a range of stakeholders including NGOs and other community organisations who support women affected by HIV and syphilis in Indonesia. Private clinics, hospitals and pharmacies will be interested in our findings, particularly the acceptability of their screening services from the perspective of pregnant women. Our research will enable us to provide feedback to diagnostic companies on issues around test design, ease of use, and consumer and health worker preferences.
V. Research community
The project will benefit researchers evaluating the quality of health care in low and middle income countries (LMIC) and more specifically, the role of Continuous Quality Improvement interventions in strengthening ANC. Further, the private sector is a major source of treatment in LMIC, but there is considerable concern about the safety and quality of care. Recent years have seen fast growth in small and medium sized private ANC clinics in Indonesia, but their regulation is often poor, and relatively little is known about the effectiveness of interventions to improve the quality of care they provide. Our study examines quality of care in both private and public ANC services. Finally, our work will support 3 junior researchers and 2 early career researchers.