A cluster-randomised trial of a continuous quality improvement intervention to support the triple elimination of antenatal syphilis, HIV and Hepatitis B in Indonesia: protocol for the MENJAGA (“Protection”) study

Introduction:

Prevention of mother-to-child-transmission (PMTCT) of human immunodeficiency virus HIV, syphilis and hepatitis B (HBV) is a key priority for the Indonesian government. Despite national guidelines and strong antenatal care (ANC) attendance, screening for these diseases among pregnant women remains relatively low in Indonesia. Continuous Quality Improvement (CQI) – an approach involving an iterative development and testing process of data-driven intervention to achieve improvement, has been effectively used to strengthen ANC in a number of Sub-Saharan African countries. This protocol describes a study that aims to evaluate the effectiveness, cost-effectiveness and implementation process of a CQI intervention designed to promote antenatal screening for HIV, syphilis, and HBV in primary health care (PHCs) in Indonesia.

Methods and analysis: The study will be conducted as a two-arm, parallel cluster randomised control trial in 40 PHCs in two districts in West Java province (Bandung and Bogor). PHCs randomized to the intervention arm (n=10 per district) will receive targeted and enhanced support in line with the CQI approach. PHCs randomized to the control arm (n=10 per district) will continue to provide HIV, syphilis, and hepatitis B testing as per the existing standard of care for the PMTCT. The primary outcome (proportion of pregnant women tested for HIV, syphilis, and Hepatitis B at the first trimester) will be evaluated at pre-baseline, baseline, and endline. Secondary clinical outcomes include the proportion of women tested for HIV/syphilis/HBV during their first ANC visit and during pregnancy, also, proportion of pregnant women that tested positive and commenced treatment. The process evaluation will examine intervention implementation, acceptability, reach and possible causal pathways. The economic evaluation will calculate programme costs and incremental cost-effectiveness ratios (ICERs). Ethics and dissemination Ethical approval has been granted by the Observational/Interventions Research Ethics Committee London School of Hygiene and Tropical Medicine Ethics (approval number: 28328), and from Medical and Health Research Ethics Committee Universitas Gadjah Mada (approval number: KE/FK/0485/EC/2023). Written informed consent is obtained from the heads of all participating clinics, CQI advocates and coaches, staff, and women participating in interviews for the evaluation. There is no individual consent process for the outcome evaluation due to the reliance on anonymous routine data. Results will be published in international journals.

Trial registration: NCT06058286; ISRCTN 11251878