Discussion
HIV and presenting for prenatal care
The EMMA study was a pragmatic, two-arm, cluster-randomized trial in western Kenya examining the effects of two adjustments to Mentor Mother services to support PMTCT services for pregnant women living with HIV and presenting for prenatal care. Potential ART adherence for mothers, based on PDC with antiretroviral medication, and rates of infant HIV testing according to guidelines were not different between study groups.The lack of impact for this behavioral intervention is relatively consistent with a now existing and large literature evaluating strategies to improve service delivery and mother-infant outcomes along the PMTCT care cascade that did not exist when the study was developed (see, e.g. [The EMMA intervention was designed as a low to no incremental cost intervention that was a modest addition to the full package of PMTCT services outlined above and that could be implemented as routine practice outside of a study setting. In comparison, for example, the MOTIVATE trial completed also in western Kenya evaluated a more complex package of services provided by community-based Mentor Mothers (cMMs), including up to 13 home-based visits during prenatal and postnatal care, with about 75% of the intervention arm having 8 or more home visits (hired by the study, along with additional study nurses providing support to cMMs) [Retention in the MOTIVATE trial and adherence in the WiseMama study were improved in both studies for per-protocol analyses, but a large share of patients were excluded in the per-protocol analyses, in which case self-selection complicates interpretation of the per-protocol results (MOTIVATE: about 50% of intervention groups excluded; WiseMama: about 65% excluded in intervention arm and 54% excluded in standard care arm). Fidelity of implementing the EMMA intervention, unfortunately, cannot be evaluated at this time. The study was designed to be implemented under routine conditions with little to no direct incremental costs. Due to technical failures experienced when using a free text messaging application, data on text messaging between Mentor Mothers and clients was lost. In addition, due to funding issues, the study team did not complete data entry from the study’s Mentor-Mother/patient visit record form (specifically data on the completion of one-on-one sessions at clinic visits along with SMS or phone call reminders based on consent at each visit). Given the study was implemented as part of routine services at the intervention clinics by clinic staff (not study staff), less than perfect implementation is to be expected. The limited data that are available suggest that study participants generally consented to text message or phone call follow ups, but few women consented to follow up visits at home if late for clinic visits.The study faced important limitations beyond those already discussed (funding, inability to complete data collection for ART coverage after 24 weeks postpartum or for infant HIV testing at 18 months, inability to assess implementation fidelity). Study data for medication coverage (visit dates, quantities and types of medications prescribed), and date of delivery came from the mother’s paper-based medical file at the clinic. Data from paper-based clinical files may contain errors or omissions (including possible missing information for clinic visits). As clinics in Kenya and elsewhere develop and expand electronic pharmacy records, such potentially easier to access and better-quality data will allow for easier and more precise estimates of medication coverage over time. Data for viral load testing and early infant HIV testing (dates and results) were extracted from the national testing database maintained by NASCOP. Matching clinic-based IDs for mothers and infants to those in the NASCOP database was laborious because of the different number formats and non-unique identification numbers in the NASCOP database. In the future, with standardization of identification numbers used at clinics, laboratories, and databases, follow up over time should continue to improve.Despite the lack of effectiveness of the EMMA intervention observed in this study, the basic results for both study groups provide useful information for future evaluation of PMTCT programs and outcomes. First, as electronic medical and pharmacy records become more common, obtaining data to measure the proportion of days covered with medications will become substantially easier to use for evaluation purposes rather than, or in addition to, simple measures of retention at some point in time. Second, women presented relatively late in their pregnancy for prenatal care (20 + weeks gestation), consistent with prior literature [Also going forward, the result presented here highlight that a significant share of “potential PMTCT” time during a pregnancy occurs before the first prenatal visit. Given that an important share of women present late for prenatal care (mean/median presentation at 24 + weeks gestation remains common with a large share presenting after week 30 weeks [