STUDY PROTOCOL article
Front. Public Health
Sec. Infectious Diseases: Epidemiology and Prevention
This article is part of the Research TopicWorld TB Day 2025: Yes! We Can End TB: Commit, Invest, DeliverView all 12 articles
A pragmatic parallel cluster-randomized trial to evaluate the implementation and effectiveness of optimized electronic monitors in improving tuberculosis patients' treatment adherence in China: study protocol
Provisionally accepted
Liming Yang
Min Su*- School of Public Management, Inner Mongolia University, Hohhot, China
Select one of your emails
You have multiple emails registered with Frontiers:
Notify me on publication
Please enter your email address:
If you already have an account, please login
You don't have a Frontiers account ? You can register here
Background: Treatment non-adherence poses a serious risk to survival and hinders the improvement of tuberculosis (TB) control effectiveness in Inner Mongolia, China. To improve treatment adherence and health outcomes in Inner Mongolia, this study aims to maximize the impact of an electronic monitor and smartphone app (EM program) by developing interventions that optimize the EM program, putting it into practice and evaluating it, and developing scale-up activities of the optimized EM program. Methods: First, a Consolidated Framework for Implementation Research will be used to assess the implementation of electronic monitors to improve treatment adherence and health outcomes for TB patients in China and identify the facilitators and barriers. Second, we will use the Expert Recommendations for Implementing Change protocol to identify appropriate implementation strategies to optimize the EM program in the Inner Mongolian context. Third, the optimized EM program will be implemented and assessed during a 12-month pragmatic, parallel, cluster-randomized trial in three chosen cities in Inner Mongolia. The treatment adherence of TB patients will be the main result. The secondary outcomes will be TB treatment outcomes as defined by the World Health Organization, including the treatment completion rate, loss to follow-up rate, treatment failure rate, and treatment-related deaths. Based on the RE-AIM framework, the impact of the improved EM program will also be assessed in comparison to standard care for the subsequent secondary outcomes (reach, effectiveness, adoption, implementation, and maintenance). Discussion: This study will be the first to develop and implement interventions that improve the treatment adherence and health outcomes of TB patients in addition to developing strategic options for the scalability and generalizability of the optimized interventions in remote areas of China and other low-and middle-income countries. All intervention activities will be developed for incorporation into regular TB care, with strong local ownership. Through the trial, we hope to uncover more information about the long-term effects, efficacy, cost-effectiveness, and practicability of our intervention.
Keywords: realistic evaluation, Tuberculosis patient, Treatment Adherence, electronicmonitors, optimized EM program, CFIR, ERIC, re-aim
Received: 28 Apr 2025; Accepted: 12 Nov 2025.
Copyright: © 2025 Yang and Su. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Min Su, 111989029@imu.edu.cn
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.