Over the past several years, a number of studies have been published demonstrating the feasibility, acceptability, and adherence enhancing impact of medication adherence monitoring technologies on TB medication adherence in high-burden regions. However, none of these studies have evaluated health outcomes as a primary endpoint.
Bruce Thomas, Arcady Founder, is a contributing author for recently published design manuscript outlining in detail the research protocol for such a health outcomes-oriented study. The cluster randomised controlled trial, currently well underway in China, aims to evaluate the impact of a medication monitor-based treatment strategy for drug-sensitive TB patients on a composite poor outcome measured over 18 months from start of TB treatment. Composite poor outcome is being defined as either of poor outcome at the end of treatment (death, treatment failure, or loss to follow-up) or subsequent recurrence (culture positive for TB at 12 or 18 months or re-starting TB treatment in the follow-up period). An economic evaluation will also be conducted as part of this study.
The trial will address an important gap in the current evidence base regarding adherence technologies generally and their use in TB patient management more specifically. It is hoped that the publication of this protocol and discussion thereof will assist and inform other studies currently being planned in a wide range of high burden regions.