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

TL;DR

This paper presents a detailed statistical analysis plan for evaluating health outcomes in a cluster randomized trial assessing a multicomponent intervention's impact on increasing IPT uptake and reducing TB incidence in Uganda.

Contribution

It provides a pre-specified, locked statistical analysis plan for the first phase of the SEARCH-IPT study, ensuring transparency and rigor in evaluating intervention effects.

Findings

SAP was finalized before unblinding

Evaluation of intervention effectiveness on IPT uptake

Assessment of TB incidence reduction

Abstract

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.