Designing, Development, and Evaluation of an Informatics Platform for Enhancing Treatment Adherence in Latent Tuberculosis Infection Patients: A Study Protocol

Introduction: Digital health interventions are gradually being incorporated into the management of tuberculosis to ensure treatment adherence, but only a small number of trials focusing on latent tuberculosis infection (LTBI) care have tested and evaluated them. It is anticipated that 170 million persons with LTBI may eventually develop active TB; thus, treatment of LTBI patients is an important aspect, along with ensuring treatment adherence. Digital platforms can be beneficial to ensure treatment adherence in LTBI patients, as various studies have shown the positive impact of digital interventions in improving patients’ treatment adherence and treatment outcome. This study aims to explore the various available digital interventions worldwide for treatment adherence in LTBI patients and develop an informatics platform for enhancing treatment adherence in LTBI patients. Methods: This will be a quasi-experimental study divided into three phases. In the first phase, a scoping review method will be used to conduct a systematic literature review using the PRISMA tool to report on various digital interventions focused on treatment adherence in LTBI patients. In the second phase, a text message-based digital platform will be developed, and in the third phase of the study, an evaluation of the digital platform will be done using qualitative and quantitative questionnaires. The study will be conducted using a mixed-methods approach between January 2023 and December 2023. The sample size will be 162 participants, of whom 81 will be assigned to an intervention group and 81 will receive the usual care from the respective chest clinic as a control group. Results: A descriptive analysis of demographic variables and other variables will be done. Continuous variables will be described as mean ± standard deviation (M ± SD), medians (inter-quartile ranges) (M (IQR)), and medians (5th percentile to 95th percentile) (P5-P95). A two-sample independent T-test, the chi-square test, and the Mann-Whitney test will be used for comparisons between groups. Treatment success between control and intervention will be compared through a chi-square test. Conclusions: The key finding of the study will be an understanding of the efficiency of digital platforms for improving treatment adherence in latent TB patients in India.