An implementation science approach to the design and evaluation of tuberculosis self-testing

Johns Hopkins University, Baltimore MD

Investigators

Abstract

Tuberculosis (TB) remains a major global health crisis, causing 10 million new cases in 2023. Despite extensive efforts by the global community to identify TB cases, 30% of new cases went undiagnosed. Current strategies focus on active case finding, which is costly and hard to implement practically. One potential solution to these challenges is self-testing. Although self-testing for TB has not been widely adopted so far, partly due to a lack of suitable testing options and studies evaluating this method, recent advances in diagnostic technology make self-testing a feasible option. This development opens a new avenue for patient-centered TB care. I propose a type 3 hybrid implementation-effectiveness study to assess the feasibility of implementing self-testing for active TB. I will use a currently available diagnostic tool—oral swab specimens for molecular testing—which are easy to self-collect and sensitive but require shipping to a laboratory. I have identified barriers to TB self-testing implementation and will refine strategies to address these barriers through qualitative interviews and quantitative surveys (Aim 1). I will conduct a prospective study in high-burden community settings in Baltimore, U.S., where known TB contacts and/or working-age individuals are less likely to seek care, distributing oral swab kits in intervention facilities while maintaining TB training standards in comparison facilities (Aim 2). I will evaluate the implementation and effectiveness of each strategy guided by the Reach, Effectiveness, Adopt, Implementation, and Maintenance (RE-AIM) framework. My primary outcome will be an increase in the proportion of individuals receiving microbiological testing results, reflecting the acceptability and fidelity of TB self-testing. To achieve these aims, I will employ a highly pragmatic study design in which the research team minimizes contact with study households. This approach will allow me to evaluate whether TB self-testing implementation can impact case detection and improve health outcomes for individuals in a “real-world” setting. Completing this study will provide pragmatic, preliminary data on the potential implementation and effectiveness of TB self-testing in high-burden settings. If successful, it will justify a larger trial; if not, it will inform alternative strategies to overcome barriers to seeking TB care. In either case, the findings will motivate a larger R01 proposal at the end of the five-year grant period and advance the field of TB self-testing. While this proposal will assess self-testing using an available tool, a broader goal is to develop a self-testing strategy for TB disease that can be applied to future tools. This approach aims to advance patient-initiated or patient-centered TB care. Additionally, the study will help me gain skills in mixed methods research and implementation science, positioning me as a future leader in implementing patient-centered TB interventions globally. Modified