End-user global study to identify countries’ challenges and solutions in the uptake and implementation of new tuberculosis treatment regimens

We read with interest the study by BÉRANGER et al. [1] and the related editorial [2], which raised once more the issue of improving existing anti-tuberculosis (TB) regimens. With 10.7 million cases and 1.23 million deaths estimated for 2024, tuberculosis (TB) remains a clinical and public health challenge [3, 4]. Poor access to TB treatment regimens and suboptimal treatment outcomes ( particularly for persons with TB/HIV co-infection and with rifampicin- and multidrug-resistant TB) underscore the urgent need for new regimens that are safe, effective, shorter and affordable. Such improvements are essential to curb the TB epidemic and prevent post-treatment sequalae [5–8]. Despite the high health burden carried by TB, the process of translating clinical trial results into programmatic action is often hampered or delayed by different factors, spanning from evidence limitations (e.g. trials that do not include country-specific data or key populations) to the complex regulatory and normative environment at national level [9–11]. In the past few years, several new drugs and regimens have entered the TB research and development pipeline for treatment of disease and infection [3–5]. To effectively translate new evidence into clinical and programmatic practice, research studies investigating end users’ needs and expectations are required. “End-users” include all the actors involved in the implementation and delivery of TB care and prevention, such as National TB Programme managers and staff, academics and scientific experts (e.g. in the field of pulmonology, infectious diseases, microbiology, paediatrics and public health), clinicians, general practitioners and other care providers, non-governmental organisation staff, and, especially, people and communities affected by TB. Engaging end-users in discussion and decision-making regarding available options also involves exploring additional dimensions of translating future evidence into policy and practice. Critical aspects include feasibility, acceptability, economic burden, sustainability, benefits and harms of any new TB treatment regimen. Considerations on equity, ethics, human rights, gender inequities, stigma and broader social determinants are also crucial to meeting GRADE (Grading of Recommendations Assessment, Development, and Evaluation) and GRADE-like assessment criteria, which are key to promoting uptake and supporting wide-scale implementation. Within FAST-TB, a project supported by the US National Institute of Allergy and Infectious Diseases (NIAID/NIH) in collaboration with the Civilian Research and Development Foundation (CRDF) Global, the ReLAY (Research to Translate and Yield Evidence into Practice) Track aims to generate comprehensive evidence to accelerate the rapid uptake, adoption and implementation of new TB regimens. A global study that reasonably represents the variety of end-users and influential stakeholders investigating the above-mentioned domains has never been conducted. This assessment is of paramount importance to inform the ReLAY’s strategic actions and to fulfil its specific objectives to: 1) engage with end-users to understand the needs and preferences for new TB regimens; 2) identify research priorities to inform quick introduction of new TB regimens; 3) promote operational research to assess solutions; and 4) establish a communication platform, enhancing interaction among stakeholders. This study aims at rigorously collecting opinions on preferences, challenges and needs from end- users to inform research priorities and foster the rapid uptake, adoption and implementation of new TB regimens. The end-user survey has three main objectives: 1) To understand needs and preferences of end-users for new TB regimens. 2) To identify existing operational challenges towards the rapid adoption of new regimens and potential solutions to these bottlenecks. 3) To determine strategic research priorities that address end-users’ needs and support the rapid uptake of new regimens. The study will collect information on different types of new TB regimens to treat disease (drug-susceptible and drug-resistant forms, including TB/HIV co-infection) and infection. Therefore, the project uses a structured framework in administering an online survey to a vast audience (∼1000 people) complemented by individual interviews of a sample of >400 selected end-users, with particular emphasis on people affected by TB, mainly from high-burden countries. In the absence of existing guidance on sample size calculations for qualitative research, we aimed to reach a number large enough to allow normalisation of data and stratified analysis for the most relevant variables (e.g. gender, age, country, rural or urban residence and religion). A Delphi technique approach will also be used to enhance the significance of the expected outcomes. This exercise will be facilitated by the existing Global Tuberculosis Network that currently operates in more than 50 countries and has extensive experience in conducting global surveys. The study will involve all eight countries with the highest TB burden, which together account for two-thirds of global cases (India, Indonesia, China, the Philippines, Pakistan, Nigeria, Bangladesh and the Democratic Republic of the Congo) as well as at least 22 additional high-burden countries and other countries, to reach a total of at least 50. This selection is expected to cover more than 80% of the global TB population.