Study design and setting
WEST
The EMMA study was a site-randomized, pragmatic clinical trial. A clustered design (at the clinic level) was used because the intervention in the study was a quality-improvement intervention implemented at MCH clinics, rather than at an individual patient level [The study was implemented in 12 public MCH clinics within the Kenya Medical Research Institute (KEMRI)/Walter Reed Project (WRP) PEPFAR program (South Rift Valley and Kisumu West). These facilities provided the majority of PMTCT services for HIV-infected pregnant and post-partum women in the region. Sites were stratified into six pairs based on size and location. A simple randomization to standard care or the intervention arm for each pair of clinics was completed by the study Principal Investigator. At each clinic, mothers meeting eligibility criteria and providing written informed consent where then enrolled sequentially overtime at each clinic in the study. After enrollment, other than interactions with the Mentor Mother as part of EMMA activities in the intervention arm, study staff had no contact with study participants.