Translating efficacious interventions to prevent mother-to-child HIV transmission (PMTCT) into effective programs has been slow and uneven. Despite high antenatal care (ANC) utilization, bottlenecks occur at each step of the pMTCT cascade, like HIV testing of pregnant women, uptake of antiretrovirals (ARVs) or combination antiretroviral therapy (cART), infant early diagnosis, and adoption and maintenance of appropriate infant feeding. In low-income countries, only half of HIV-infected pregnant women receive ARVs or cART to prevent HIV transmission to their infants, despite United Nation targets of 80%. Effective, affordable and scalable delivery strategies are urgently needed to improve PMTCT service delivery, including approaches to maximize lifelong maternal adherence to cART initiated prior to onset of HIV symptoms, and to retain women and infants in care beyond the postpartum period. Economic analyses based on effectiveness studies are needed to inform policies and strategies for efficient PMTCT service delivery in resource-limited settings.
In 2014, a cluster randomized controlled trial (RCT) in Mozambique, Côte d’Ivoire and Kenya collected data to evaluate a standardized Systems Analysis Improvement Approach (SAIA) that applies industrial and systems engineering techniques to PMTCT service delivery. The SAIA intervention will facilitate understanding and improvement of the complex, interconnected components that comprise PMTCT, thereby supporting the translation of evidence on efficacious interventions that prevent vertical HIV transmission into effective programs at scale. An additional supplemental study, building off of the SAIA trial, was funded by the National Institutes of Health in mid-2014. Through this supplemental study, Health Alliance International will incorporate biological and other patient-level outcomes into the SAIA trial in Mozambique, and model cost effectiveness of the SAIA intervention.
Specific aims of this study are to:
- Evaluate SAIA effectiveness on HIV-free infant survival, and identify maternal and program-level determinants of HIV-free infant survival relevant for Option B+;
- Evaluate SAIA effectiveness on maternal ART adherence, retention in care, and viral suppression, and identify patient and program-level determinants of maternal outcomes relevant for Option B+; and
- Evaluate SAIA cost effectiveness as well as provide relevant cost data on Option B+.