Adapting the HITSystem to Support PMTCT in Kenya: Protocol of an intervention development study (Preprint)

UNSTRUCTURED Background: Despite progress to expand access to HIV testing and treatment during pregnancy in Kenya, gaps still remain in prevention of mother-to-child transmission of HIV (PMTCT) services. This study addresses the need for effective and scalable interventions to support women throughout the continuum of care for PMTCT services in low resource settings. Our research team has successfully implemented the HIV Infant Tracking System (HITSystem), a web-based, system-level intervention to improve early infant diagnosis (EID) outcomes. This study will expand the scope of the HITSystem to address PMTCT services to bridge the gap between maternal and pediatric HIV services and improve outcomes. This paper describes the intervention development protocol to adapt and pilot a HITSystem version 2.0 to assess acceptability, feasibility, and preliminary PMTCT outcomes in Kenya. Methods/design: This is a three-year intervention development study to adapt the current HITSystem intervention to support a range of PMTCT outcomes including: retention in care, ART adherence, hospital deliveries, and integration of maternal and pediatric HIV services in low-resource settings. The study will be conducted in three phases. Phase 1 will elicit feedback from intervention users (patients and providers) to guide development and refinement of the new PMTCT components and inform optimal implementation. In Phase 2, we will design and develop the HITSystem 2.0 features to support key PMTCT outcomes guided by clinical content experts and findings from Phase 1. Phase 3 will assess complete PMTCT retention (before, during, and after delivery) using a matched randomized pilot study design in two hospitals over 18-months. A total of n=108 HIV+ pregnant women (n=54 per site) will be enrolled and followed from their first PMTCT appointment until infant HIV DNA PCR testing at the target age of 6 weeks (< 7 weeks) postnatal. Discussion: This protocol will extend, adapt, and pilot a HITSystem 2.0 version to improve attendance of PMTCT appointments, increase ART adherence and hospital-based deliveries, and prompt early infant diagnosis by 6 weeks postnatal. The HITSystem 2.0 aims improve the integration of maternal and pediatric HIV services. Trial registration: ClinicalTrials.gov: NCT02726607. Registered on April 1, 2016.