Data collection and outcome measures
AIDS, viral suppression
AIDS, SECONDARY
﻿Follow-up for data extraction was passive, by medical record review only, from the date of an enrolled mother’s first visit for prenatal care up to 72-weeks postpartum (and 76 weeks of age for her infant). Viral load test dates and results for mothers and infant early-infant diagnosis (EID) HIV DNA PCR test dates and results were extracted from the national database maintained by Kenya’s National AIDS Control Program (NASCOP).The primary outcomes (PO) for mothers as defined in the original study protocol were: the proportion of mothers who received an uninterrupted supply of ART from treatment initiation to delivery (PO1) and from delivery to 24 weeks post-partum (PO2). ﻿To operationalize an “uninterrupted supply”, the proportion of days covered (PDC) with ART was used, with coverage at least 90% considered an uninterrupted supply. PDC is a standard indirect measure of adherence to chronic medications [The 24-week prenatal and postnatal periods for PO1 and PO2 were informed by Kenyan guidelines and information on time-to-viral-suppression after ART initiation. For PO1, viral suppression within 24 weeks of initiation is highly likely with good adherence [The 90% threshold for PO1 and PO2 was chosen for two reasons. First, prior literature suggests that high coverage (e.g., ≥ 95%) is required for long-term viral suppression [Study specified secondary outcomes for infant HIV testing were the proportion of infants completing HIV testing at 6, 24, and 48 weeks (+ -4 weeks for each). In addition, the number testing positive are also reported.Viral load test results over specific time periods were not included as original study outcomes because routine viral load monitoring was introduced in Kenya after the original study protocol was developed but before enrollment began. In short, viral load testing should occur approximately every six months after presenting for prenatal care (given rapid ART initiation for WLWH not on ART when presenting) through cessation of breast feeding [