Statistical Analysis Plan for the Primary and Selected Secondary Endpoints in the ENHANCED-SPS Study

Abstract

This document provides the statistical analytic plan (SAP) for the ENHANCED-SPS study, a cluster randomized trial to evaluate the effects of peer-led, multicomponent intervention on viral suppression and other care outcomes among pregnant and breastfeeding women with HIV in South Western Uganda (Clinicaltrials.gov:NCT04122144). The SAP was locked prior to unblinding and effect estimation. This SAP was embargoed until August 31, 2023 when it was submitted to medRxiv.