This study examines the impact of an intervention (COMBIND) on uptake of the four major components of the prevention of mother-to-child transmission (PMTCT) program, using a cluster- randomized trial design in four HIV high-burden districts of Maharashtra, India. A total of 117 Integrated Counseling and Testing Centers (ICTCs) were included in the study, randomized equally to either the Standard of Care (Arm 1) or to the COMBIND intervention (Arm 2). Each arm was stratified equally to rural or urban ICTCs. There were 900 HIV-positive pregnant and breastfeeding women recruited over a period of six to nine months at the participating ICTCs. After delivery, each participant and infant was followed for 24 weeks. The RTI International team performed quality assurance (QA) visits to verify regulatory adherence and protocol fidelity and to validate data integrity for the COMBIND study.