An Implementation Trial of Continuous Quality Improvement for Antenatal Syphilis, HIV and Hepatitis B Detection and Treatment in Indonesia

Using a cluster-randomized design, we will evaluate the effectiveness, cost-effectiveness, acceptability, fidelity and reach of a multi-faceted Continuous Quality Improvement (CQI) intervention to improve antenatal testing and treatment of HIV, syphilis and hepatitis B at primary level healthcare facilities in Indonesia. Under the CQI approach, facility staff drive the development of solutions to quality of care shortcomings that they feel are best suited to the local context, working within existing resource constraints It is expected that through their engagement in the CQI intervention, ANC facilities will be in a stronger position to identify and address barriers to antenatal testing and treatment of HIV/syphilis/hepatitis B while also helping to strengthen the underlying health system. The study will take place in two districts in West Java, Indonesia. Clusters will consist of twenty facilities in each of the two districts (40 facilities total) that will be randomized with a 1:1 allocation ratio to the intervention arm (trained in CQI methods) and the control arm (providing usual care) using a computer-generated randomization schedule stratified by district. Intervention and control arms will be balanced with respect to the following covariates: type of facility (puskesmas -and facility size (number of antenatal care registrations in the previous year). In each district, the study team will train three district-level CQI coaches in quality improvement methods. The CQI coaches, using a train-the-trainer approach, will then train representatives from the 20 intervention arm facilities. Over approximately 12 months, intervention facilities will receive enhanced support in line with the CQI approach to promote implementation of the national guidelines and sustained provision of routine testing for HIV, syphilis and hepatitis B at least once during pregnancy. Facilities randomised to the control arm will continue to provide ANC services and HIV, syphilis and Hepatitis B testing as per the existing standard of care. The primary outcome is the proportion of women tested for HIV,syphilis and hepatitis during their current pregnancy. Current Indonesian guidelines recommend antenatal screening and treatment for HIV/syphilis/hepatitis B according to clinical protocols (for syphilis this is a single rapid test with no further confirmation of positive tests before commencing treatment using one injection of penicillin at an ANC clinic; for HIV there are three sequential rapid tests with confirmed cases initiating HIV antiretroviral therapy from the closest Care Support and Treatment clinic within the pregnancy period, and for hepatitis B, pregnant women with a reactive hepatitis B serum antigen test will be referred to a hospital for management based on clinical features). The overall aim of this study is to eliminate newborn infection with HIV/syphilis/hepatitis B in Indonesia through improved detection and treatment in pregnant women.