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Statistical Analysis Plan for Health Outcomes in Phase 1 of the SEARCH-IPT Study

19 Nov 2021arXiv:2111.10467links table onlyarchive 2025-07-28

Laura B. Balzer, Joshua Nugent, Diane V. Havlir, Gabriel Chamie

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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.

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