Statistical Analysis Plan for Health Outcomes in Phase 1 of the SEARCH-IPT Study
Laura B. Balzer, Joshua R. Nugent, Diane V. Havlir, Gabriel Chamie · arXiv (Cornell University) · 2021
This document provides the statistical analytic plan (SAP) for evaluating health outcomes in Phase 1 of the SEARCH-IPT Study, a cluster randomized trial to evaluate whether a multicomponent intervention increases uptake of isoniazid (INH) preventive therapy (IPT) and reduces the incidence of tuberculosis (TB) in Uganda (Clinicaltrials.gov: NCT03315962). The SAP was locked prior to unblinding and effect estimation. This SAP was embargoed until November 19, 2021 when it was submitted to arXiv.