Statistical Analysis Plan for the Drinkers' Intervention to Prevent Tuberculosis (DIPT Study)

TL;DR

This paper presents a detailed statistical analysis plan for the DIPT randomized controlled trial, which investigates whether incentive-based interventions can reduce alcohol use and enhance TB preventive therapy adherence among HIV/TB co-infected heavy drinkers in Uganda.

Contribution

It introduces a comprehensive SAP specifically designed for analyzing outcomes of an incentive-based intervention in a high-risk HIV/TB co-infected population.

Findings

Detailed description of primary and secondary outcomes

Statistical methods tailored for the trial's objectives

Framework for analyzing intervention effectiveness

Abstract

The Drinkers' Intervention to Prevent TB (DIPT) is a randomized controlled trial designed to determine if incentive-based approaches can reduce alcohol use and improve medication adherence to isoniazid (INH) preventive therapy in persons with HIV (PWH) co-infected with tuberculosis (TB) who engage in heavy drinking in Uganda. This statistical analysis plan (SAP) provides a detailed descriptions of the primary and secondary outcomes in the study and the corresponding statistical analyses.