A Protocol on "Improving Tuberculosis Detection and Accelerating Elimination through Digital Hand-Held X-Ray Units for Pre-Diagnosis Screening in Rural Communities: An Implementation Research in a Health Block of District Kangra, Himachal Pradesh, India"

A Protocol on "Improving Tuberculosis Detection and Accelerating Elimination through Digital Hand-Held X-Ray Units for Pre-Diagnosis Screening in Rural Communities: An Implementation Research in a Health Block of District Kangra, Himachal Pradesh, India" | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article A Protocol on "Improving Tuberculosis Detection and Accelerating Elimination through Digital Hand-Held X-Ray Units for Pre-Diagnosis Screening in Rural Communities: An Implementation Research in a Health Block of District Kangra, Himachal Pradesh, India" Dr. Sunil Kumar Raina, Dr. Nidhi Chauhan, Dr. Sakshi Supehia This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5922298/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Objective: Given the national imperative to eliminate tuberculosis in India and the need to foster an adaptable healthcare system, an implementation research study is proposed. It aims to enhance access to point-of-care TB screening in underserved populations by strategically deploying hand-held X-ray units while considering the contextual realities of the target population and healthcare system. Study Design : Three-step wedge design of implementation research. Methods: Formative research to gather insights and data, followed by a staggered introduction of the intervention (hand-held X-ray) across different healthcare facilities will be employed. Results: Metrics and processes like the proportion of TB patients screened, improved TB detection rates, and treatment outcomes will be evaluated. Conclusion: The research will evaluate the effectiveness of integrating handheld X-ray units in routine TB screening programs, thereby providing valuable insights into its feasibility and adaptability in our healthcare system to combat TB in India and other resource-limited settings. Figures Figure 1 Introduction Tuberculosis (TB) remains a significant global health threat, with an estimated 10.8 million new cases (95% uncertainty interval [UI]: 10.1–11.7 million) reported worldwide in 2023. 1 India, home to approximately 28% of the global TB burden, bears a disproportionate share of this challenge. 2 The COVID-19 pandemic further exacerbated the situation, severely disrupting TB diagnosis and treatment services. During this period, India saw a dramatic 41% decline in TB notifications—the largest reduction globally. 3 Despite reporting 2.4 million TB cases in 2019, the country is estimated to have missed approximately 540,000 additional cases, highlighting substantial gaps in early detection and care. 4 The urgency of accelerating TB elimination in India has never been greater. The Indian government's National Strategic Plan for Tuberculosis Elimination (NSP 2017–2025) outlines an ambitious target to eliminate TB by 2025. 5 Achieving this goal requires robust public health policies, extensive infrastructure investments, and innovative diagnostic technologies to overcome barriers to early detection, especially in under-resourced areas. In the context of India’s health system, which faces challenges ranging from unequal access to healthcare and inadequate infrastructure to the persistent burden of infectious diseases, a key focus is on creating an adaptable health system - a system that becomes stronger and more adaptive in the face of stressors or disruptions. 6 In the case of TB control, India’s healthcare system needs to be flexible and capable of adapting to unforeseen challenges like pandemics or capital and infrastructural constraints. Emerging technologies like teleradiology, artificial intelligence-based algorithms, and mobile digital imaging units, particularly hand-held X-ray machines, are playing a critical role in making the Indian healthcare system more sustainable by improving the accessibility and efficiency of TB detection, particularly in rural or underserved regions. 7 Hand-held X-ray machines offer a transformative solution in settings where traditional diagnostic tools are limited or difficult to deploy. These portable devices are cost-effective and facilitate rapid point-of-care diagnostics, ensuring that TB screening can occur even in remote areas. The ability to deliver immediate, high-quality diagnostic results in hard-to-reach communities can significantly reduce delays in diagnosis and treatment initiation, directly addressing the issue of underreporting and undetected cases. Global studies highlight the effectiveness of hand-held X-ray devices in TB detection in challenging environments. A study conducted in rural Nigeria demonstrated the successful use of the Delft Light Backpack (DLB) X-ray system for pre-diagnostic TB screening during active case finding (ACF) in the Niger Delta region, uncovering previously undiagnosed TB cases in areas with limited access to conventional healthcare infrastructure. 8 Additionally, a comparative study on image quality found that hand-held X-ray machines produce images at par with traditional, stationary digital X-ray systems, with the added benefit of being portable and easier to deploy in diverse environments. 9 These studies illustrate the potential of hand-held X-ray technology to fill critical gaps in TB detection, particularly in regions where traditional diagnostic methods, such as CXR, may be logistically or financially out of reach. By enabling rapid, on-site screening, hand-held X-rays contribute to a more agile, responsive healthcare system that can proactively address TB cases, especially in high-burden areas. This capability aligns with India’s broader goal of building an adaptive health system—one that can respond dynamically to both routine and unexpected health challenges, ensuring better outcomes for all populations, regardless of geographical or economic barriers. Integrating hand-held X-ray technology into India’s TB control programs is a crucial step as it has the potential to enhance early detection, improve treatment outcomes, and ultimately help the country achieve its ambitious TB elimination goals. Background in the context of the study area Himachal Pradesh's challenging geography and dispersed population present significant barriers to timely tuberculosis (TB) detection and treatment, particularly in remote rural areas. Despite relatively strong healthcare indicators, limited access to diagnostic services leads to delays in diagnosis and treatment, perpetuating TB transmission. Handheld X-ray devices provide a viable solution to these challenges by enabling rapid, high-quality TB screening at the point of care. Their portability and cost-effectiveness make them particularly suited to the state’s mountainous terrain and underserved regions. They support active case finding (ACF) initiatives and facilitate early diagnosis and prompt treatment. Pilot studies in Himachal Pradesh (in district Una) 10 have demonstrated the potential of these devices to reduce diagnostic delays and improve treatment outcomes. Objectives Implementing the inclusion of handheld X-ray devices in tuberculosis screening to accelerate early detection and treatment in remote and underserved areas of Himachal Pradesh. Specific objectives : To enhance access to point-of-care TB screening through the use of handheld X-rays and identify undiagnosed TB cases in high-burden areas and at-risk. To gather data and evidence on the effectiveness and feasibility of handheld X-ray systems for TB detection. Research Plan Study area A low-performing block in Kangra district, identified through an optimization of the local healthcare system’s capacity for TB control, will serve as the study area for this intervention. Study design Implementation research with HCFs-based three-stepped wedge design. Implementation Plan The implementation of an intervention (handheld X-ray technology) for TB screening will follow a structured plan, including Formative research Implementation of EBI (evidence-based intervention) Evaluation Phase I: Formative Research Plan for Optimizing TB Control Formative research will collect information that provides insight into an intervention's effective development and implementation. This will be done to align with the specific cultural, social, and geographic nuances of the target setting. It will also be used to gather information on identifying the vulnerabilities and recommend adaptive strategies that will not only improve outcomes but also strengthen systems, henceforth making them adaptable and thus capable of adapting and thriving amidst challenges, ensuring long-term sustainability and scalability. Driven by this concept and perspective, we will analyze district Kangra’s block-level TB cases and mortality rates, identify the disparities, and seek to optimize outcomes to control TB, in line with the established guidelines and literature. We will use a combination of ethnographic and quantitative methods to gather data and information for this research. Methods A ‘working group ‘will be established to develop standardized methodologies and tools for both qualitative and quantitative data collection. A trained data collector will gather information from health facilities, analyze it, and present it to the working group. Formative research will be carried out: To screen TB among vulnerable populations For the identification and assessment of the resources and capacity of healthcare facilities demonstrating optimal TB control Methodology To achieve the outlined objectives, strategies will be developed to conduct a situational analysis of existing processes and facilitators by utilizing and analyzing the available data within identified thematic areas. (Table 1 ) Assessment of the health-level facilities : The following strategies will be employed for gathering the information: Document review : The block-wise information on TB cases and mortality rates will be retrieved from the district health authorities using the Nikshay ID system, as part of the National TB Elimination Program (NTEP). In addition, the following documents will be reviewed to collate the data: Documents containing information about TB from CHCs, PHCs Monthly reports for the last 12 months submitted under NTEP on TB cases and mortality rates Monthly performance data from the laboratory register Monthly distribution of drugs prescribed from the drug register Capital assessment : It will be done to obtain information from CHCs, health and wellness centers PHCs (HWC-PHCs), and sub-centers (HWC-SCs), and the following information will be collected: Physical infrastructure : Patient care areas, rooms, etc Table 1 Thematic areas to conduct situational analysis for formative research Access/Availability • What are the key barriers and facilitators for vulnerable populations to access TB screening services in their communities? • Are TB screening services equitably distributed across urban, rural, and remote areas? • What are the average wait times and distances to access TB screening facilities? • How do seasonal changes or natural calamities impact the availability of TB screening services? • Are mobile screening units or outreach services accessible to populations in hard-to-reach areas? Product Attributes • What features of existing TB screening tools (e.g., sputum tests, X-rays) are seen as acceptable or unacceptable by the target population? • How do individuals perceive the reliability and trustworthiness of TB diagnostic tools? • Is there a preference for non-invasive or faster diagnostic methods among vulnerable populations? Social Support • How does social stigma influence the willingness of individuals to seek TB screening? • What role do family members, peers, or community leaders play in encouraging TB screening? • Are there any community-driven initiatives that effectively support TB screening uptake? • How do gender roles impact access to TB screening and follow-up care? Knowledge • What is the level of awareness among vulnerable populations about TB symptoms and the importance of early detection? • What misconceptions or myths about TB exist in the target communities, and how do they affect screening behavior? • Are people aware of where and how to access TB screening services? • How do health literacy levels influence the ability to follow through with the TB screening process? Affordability • What are the direct and indirect costs (e.g., transportation, lost wages) associated with accessing TB screening? • Are vulnerable populations aware of free or subsidized TB screening programs? • How does financial insecurity affect the likelihood of individuals seeking TB screening? • What is the willingness to pay for private TB screening services, if public options are unavailable or inconvenient? o Workforce: Staffing levels e.g. Doctors, Pulmonologist, NTEP Staff, their training status, and roles in TB management. Smallest health facility unit/ subcentres or HWCs- line listing of ASHAs in block Logistics : Microscopes, gen-expert machines, chest X-ray machines, mobile screening vans, sputum collection containers, drug supply chain Service Delivery Processes : Screening, diagnostic pathways, treatment adherence, and follow-up protocols. Use of Technology : Existing digital TB case management and reporting systems tools. Data Collection Method : Structured facility assessment using a checklist. Review of facility records and reports. Key informant interviews (KIIs) with healthcare facility staff will be carried out separately at CHCs, and PHCs to get specific insights to assess ongoing intervention for TB management at health facilities, gaps for providing community-based care strategic model for screening and treatment of TB, possible facilitators to fill gaps for existing intervention, and possible factors affecting the identified facilitators. Assessment at the Community Level : Systematic screening will be conducted among vulnerable populations with the specified risk factors (mentioned below) to identify individuals at a higher risk of developing TB. Additionally, it aims to assess community knowledge, attitudes, and practices (KAP) regarding TB management and available resources (Table 2 ). This approach will provide valuable contextual insights into the community-level barriers and facilitators influencing TB management efforts. Table 2 Variables to assess and screen TB at community level General Variables Age, gender, socio-economic status, etc Behavioural variables Smoking, alcohol, physical activity Awareness and Perceptions Community understanding of TB symptoms, transmission, and treatment. Health Seeking Behaviour Government, private, and any other traditional methods to manage TB. Barriers to Care Geographic, financial, and cultural obstacles to accessing TB services. Stigma and Social Support Role of stigma in care-seeking behavior and community networks in patient support. The risk factors for systematic screening to identify people who are at higher risk of developing TB: Symptomatic Contacts of Index TB Cases Cancer Patient Diabetes Patient Renal Disease Patients Slum area Dwellers Patients having Malnutrition Patients on Immunosuppressants Smokers COPD Patient Asthmatics Patient PLHIV (People Living with HIV) Miners and stone Crusher Labor Construction Site Workers Extrapulmonary Presumptive Cases Health Care Workers Previously treated TB case (currently having symptoms suggestive of TB) Cardiovascular Patients Liver Impairment Hypertension Other (Elderly more than 60) Data Collection Methods : Community surveys to assess KAP. Focus Group Discussions (FGDs) with people living in the village e.g. community members and ASHA workers to assess ongoing intervention for TB management at health facilities, gaps for providing community-based care strategic model for screening and treatment of TB, possible facilitators to fill gaps for existing intervention, and potential factors affecting the identified facilitators. Participatory social mapping to identify key influencers, resources and factors influencing their dynamics. Optimization of Outcomes : Thirteen health blocks of district Kangra will be ranked based on the TB cases and mortality rates. A benchmark for optimal TB control performance will be set in alignment with district-specific standards. Optimizing TB control outcomes requires leveraging insights from facility- and community-level assessments, as discussed above to address identified gaps and barriers. This level will define and set optimal targets for implementing the intervention, aimed at improving the case detection rates, treatment success rates, and mortality reduction, all while accounting for the local contextual factors. Once the optimal performance level is determined, the health blocks and healthcare facilities will be categorized as high, optimal, or low performing. Phase II: Implementation Phase Intervention: The Evidence-Based Intervention (EBI) will involve deploying handheld X-ray devices for TB screening across low-performing healthcare facilities, that aim to enhance the diagnostic capacity of existing healthcare infrastructure. These portable devices enable rapid, high-quality TB detection at the point of care, especially in remote and underserved areas. The focus of the intervention will be on early TB detection and active case finding (ACF) that will be facilitated by the widespread screening in high-risk communities, thereby reducing diagnostic delays and improving treatment initiation. The intervention will optimize the efficiency and accuracy of TB detection, by supporting the broader goal of TB elimination by 2025 by addressing the gaps in traditional TB diagnostics. Key activities: Training and Capacity Building : Hands-on training of the recruited staff will be consummated by the experts on identifying high-risk TB groups, data collection procedures, and the operation of handheld X-ray devices. Community Awareness Campaign : Awareness campaigns will be conducted to inform the local population about the availability of TB screening using handheld X-rays by utilizing IEC material developed in consultation with an expert panel. ASHA workers and community leaders will facilitate the recruited staff to promote and encourage TB screening particularly among individuals in rural and underserved areas, to enhance early detection and case identification. Data Collection and Monitoring : A systematic data collection framework will be established, incorporating weekly and monthly reports. It will track key metrics, including the number of screenings conducted, cases detected, and treatment initiated, ensuring continuous monitoring of the intervention's progress and impact. Implementing the intervention: The block with the lowest performance in TB control will be identified as the priority area for intervention. A detailed map of this block will be created to identify all healthcare facilities providing services within its boundaries. These facilities will be identified as fixed facilities like Civil Hospitals (CH), Community Health Centers (CHCs), Primary Health Centers (PHCs), and outreach facilities like Health and Wellness Centers (HWC-SCs). HCFs will be then categorized into three groups based on their TB control performance and geographical clustering: optimal, high-performing, and low-performing. Implementation design : Intervention will be deployed across the three groups using a step-wedge design, where the intervention will be progressively introduced to the facilities across the three groups until all are providing it. This progressive implementation will occur in three steps, with a total rollout period of 6 months (Fig. 1 ). Pre-roll-out period (Baseline Phase): A baseline will be established to evaluate the impact of hand-held X-rays by understanding current TB detection rates and screening workflow without the intervention. During this phase, data will be collected, standard care practices (State/District specific) will be documented, and training on hand-held X-ray devices before use will be done. Roll-out period (Staggered introduction of an intervention): The hand-held X-ray devices will be introduced successively to different healthcare facilities in predefined phases or steps. In the first step, HCFs in Group I will use the X-ray device, while HCFs in the remaining two groups will continue with the standard care. In the second step, Group II (in addition to Group I) will begin using the X-ray device, and Group III will continue with standard care. (cross-over point) In the final step, all Groups will be using the X-ray devices. During each step, outcomes will be monitored and any challenges and facilitators during the implementation will be identified and documented. Post-roll-out period (Intervention sustained): The long-term impact on patient outcomes and scalability will be assessed, along with the sustainability and adaptability of the intervention in healthcare practices. It will evaluate the intervention's effectiveness over time and refine the implementation process for potential scaling to additional facilities or regions. Implementation strategy The Dynamic Sustainability Framework (DSF) offers a structured approach to implementing hand-held X-ray technology for TB screening while addressing the challenges of maintaining long-term impact amid evolving healthcare contexts. The framework emphasizes adaptability, continuous learning, and alignment with dynamic systems to optimize intervention outcomes. (Table 3 ) Table 3 Dynamic Sustainability Framework (DSF) for implementing hand-held X-ray technology for TB screening Component Key Aspects Actions Intervention Design adaptability, context sensitivity, and scalability. - Technology will be updated regularly to meet user needs (e.g., AI diagnostics, portability). - Deployment in healthcare settings will be tailored to fit in both rural and urban areas. - Implementation will ensure scalability to other regions and diseases. Contextual Fit Dynamic context assessment, stakeholder involvement, and equity focus. - Periodical assessment of the facility’s needs, including infrastructure and staffing will be done. - To ensure alignment in contextual settings, stakeholders, such as healthcare providers and policymakers, will be engaged. - Efforts will focus on reaching marginalized populations. Facilitation Process Continuous improvement, learning systems, and sustainment infrastructure. - To ensure iterative improvement, PDSA cycles will be used. - For training healthcare workers, adaptive learning platforms will be developed. - For device maintenance and feedback, local systems will be established. Sustainability Over Time Ongoing adaptation, long-term monitoring, and policy alignment. - To assure sustainability, technology updates and advancements such as solar charging and AI tools, will be focussed. - For long-term monitoring purposes, metrics like TB detection rates and patient outcomes will be tracked. - Funding will be secured, and the technology will be integrated into TB control policies. Framework Workflow Deployment, monitoring and adaptation, scaling, and feedback integration. - Piloting of the device and technology in selected regions to gather insights will be done. - Monitoring of device usage and associated outcomes will be conducted continuously. - Aligned with the existing policies, the intervention will be scaled to new regions. - For iterative refinements, real-time feedback systems will be implemented. Phase III: Evaluation RE-AIM Framework : The REAIM evaluation framework will be used to assess the implementation of hand-held X-ray technology in TB screening, focusing on five key domains: Reach, Effectiveness, Adoption, Implementation, and Maintenance. It will evaluate how effectively the technology will reach target populations, its impact on TB detection rates, how widely it will be adopted by healthcare providers, the challenges encountered during implementation, and its long-term sustainability in various settings. This comprehensive approach will ensure a thorough assessment of the technology's success and scalability. (Table 4 ) Table 4 RE-AIM Framework to assess the implementation of hand-held X-ray technology for TB screening RE-AIM Dimension Application to Hand-Held X-ray Technology Implementation Evaluation Metrics Reach The intervention will aim to target and include a significant proportion of the TB-burdened population, with a focus on high-priority regions. - Proportion of the TB-burdened population that will access screening using hand-held X-ray technology. - Will the screening initiatives effectively cover the marginalized and high-risk populations? Effectiveness The impact of technology on TB detection rates, treatment initiation, and patient health outcomes will be assessed. -Assessment of improvement in TB detection accuracy and diagnostic timelines compared to the standard methods. - Impact on treatment outcomes and patient recovery rates. Adoption The willingness and readiness of healthcare facilities and staff to incorporate the intervention will be evaluated. - Proportion of healthcare facilities that will integrate the technology into routine workflows. - Proportion of healthcare workers will adopt and use the device effectively in their practice? Implementation The quality and fidelity of intervention delivery across diverse healthcare contexts will be monitored and adjusted as needed. - Will the protocols for using the technology be implemented consistently across various sites? - What variations in implementation will arise, and how will they be addressed? Maintenance To ensure the long-term sustainability and integration of the intervention into healthcare systems, strategies will be developed. - Will the technology continue to be used effectively in facilities over time? - Plans to secure financial and technical support to ensure sustained implementation and updates? Baseline and end-line assessment: Baseline assessment will be carried out during phase 1 and the pre-roll-out period of phase 2 of the study. It will focus on collecting under mentioned variables; Basic characteristics: Age, gender, socio-economic status, etc High-risk groups: Diabetes, cancer, PLHIV, COPD, malnutrition, etc. Measuring processes at baseline : Number of TB cases registered in last 12 months Number of TB patients on ATT TB Mortality rate Logistics like microscopes, gen-expert machines, chest X-ray machines, mobile screening vans, sputum collection containers Measuring processes at cross-over points : Number of persons screened Number of TB suspects identified Number/proportion of hand-held X-rays done at fixed and outreach facilities Number of chest symptomatic identified Number of chest symptomatic referred for molecular testing Number of TB patients diagnosed by molecular testing Number of TB patients diagnosed by either X-ray or molecular testing Number of diagnosed TB patients started on ATT Measuring processes at the endline : Number of TB cases registered during the study period Number of TB patients on ATT TB Mortality rate Contact tracing: Number of TB contacts identified Number of contacts screened Number of contacts put on TPT Conclusion The proposed implementation of hand-held X-ray technology for tuberculosis (TB) screening in Himachal Pradesh is expected to overcome significant barriers in early TB detection, particularly in remote and underserved regions. By employing a structured three-step wedge design, the phased rollout will facilitate a systematic introduction of the intervention, enable continuous monitoring, and allow for iterative refinement of the intervention. This aims to align with India’s TB elimination target by 2025 by enhancing diagnostic accessibility and efficiency, empowering healthcare workers to identify high-risk cases promptly, and reducing diagnostic delays. Through formative research, strategic implementation, and comprehensive evaluation, this protocol is anticipated to generate valuable insights for scaling portable X-ray technology across similar settings. It will contribute to building an adaptable, anti-fragile healthcare system capable of addressing the challenges of TB elimination and improving health outcomes in resource-limited contexts. Declarations Funding: No involvement of any funding source Declarations : Ethics, Consent to Participate, and Consent to Publish declarations are not applicable. Data Availability Statement : Given that this is a protocol, data has not yet been collected, and no dataset is available. Therefore, a data availability statement is not applicable. Author Contribution Dr. Sunil K Raina: Conceptualized the research project, developed the data collection and analysis methodology, revised the manuscript, and contributed critical feedback, overall supervision, and guided the research teamDr. Nidhi Chauhan: Drafted the initial manuscript, developed the theoretical framework underlying the research, Developed data collection methodology, prepared figures and tablesDr. Sakshi Supehia: Developed data collection methodology Acknowledgement I sincerely thank other authors for their valuable insights and expert reviews, which significantly contributed to the development of this protocol. References Global tuberculosis report 2024. Geneva: World Health Organization; 2024. Licence: CC BY-NC-SA 3.0 IGO. World Health Organisation Global Tuberculosis Report 2022. 2022. Available from: https://www.who.int/teams/global-tuberculosis-programme/tb-reports/global-tuberculosis-report-2022, last accessed on 2nd December 2024. WHO. Tuberculosis deaths rise for the first time in more than a decade due to the COVID-19 pandemic. Available from: https://www.who.int/news/item/14-10-2021-tuberculosis-deaths-rise-for-the-first-timeinmore-than-a-decade-due-to-the-covid-19-pandemic, last accessed on 2nd December 2024. Central Tuberculosis Division. India TB Report 2020. Available from: https://tbcindia.gov.in/showfile, last accessed on 2nd December 2024. Central Tuberculosis Division. National Strategic Plan to End TB in India 2020–25. Available from: https://tbcindia.gov.in/index, last accessed on 2nd December 2024. Taleb, N. N. (2012). Antifragile: Things That Gain from Disorder. Random House. Chandramohan A, Krothapalli V, Augustin A, Kandagaddala M, Thomas HM, Sudarsanam TD, Jagirdar A, Govil S, Kalyanpur A. Teleradiology and technology innovations in radiology: status in India and its role in increasing access to primary health care. Lancet Reg Health Southeast Asia. 2023 Apr 14;23:100195. Odume B, Chukwu E, Fawole T, Nwokoye N, Ogbudebe C, Chukwuogo O, Useni S, Dim C, Ubochioma E, Nongo D, Eneogu R, Lagundoye Odusote T, Oyelaran O, Anyaike C. Portable digital X-ray for TB pre-diagnosis screening in rural communities in Nigeria. Public Health Action. 2022 Jun 21;12(2):85-89. Kamal Raj, Singh Manjula, Roy Sudipto, Adhikari Tulsi, Gupta Anil Kumar, Singh Hari, Rao Vishnu Vardhan, Panda Samiran, Khan A. M., Bhargava Balram. A comparison of the quality of images of chest X-ray between handheld portable digital X-ray & routinely used digital X-ray machines. Indian Journal of Medical Research 157(2&3):p 204-210, Feb–Mar 2023. Una gets portable X-ray machines. Available from: https://www.tribuneindia.com/news/himachal/una-gets-portable-x-ray-machine, last accessed on 16th December 2024. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-5922298","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":440425295,"identity":"3b8e6a5d-3eaf-45e1-a656-d3cf3cd2757c","order_by":0,"name":"Dr. Sunil Kumar Raina","email":"","orcid":"","institution":"Dr. Rajendra Prasad Government Medical College","correspondingAuthor":false,"prefix":"Dr.","firstName":"Sunil","middleName":"Kumar","lastName":"Raina","suffix":""},{"id":440425297,"identity":"e6398186-02e5-4c01-aa63-aac772b1a7e9","order_by":1,"name":"Dr. Nidhi Chauhan","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA3klEQVRIiWNgGAWjYFACxgYgIcHAx8B8AMSQIV4LGwNbAojBQ7xlbAw8BiCasBb+2YcbH/74YxHNxn7m86sbNRY8DOyHj27Ap0XiXGKzMW+bRG4bT+4265xjQIfxpKXdwGvNGcY2acYGoBaG3G3GOWxALRI8Zni1yJ9hbP/54w9QC/+bZ8Y5/4jQYgC0hYGHDahFIof5MZAkrMXwDGOzNNgvEs/MmHP7JHjYCPlF7gz7w48//tTl9vMnP/6c861Ojp/98DH83kcCbBJgkljlIMD8gRTVo2AUjIJRMHIAAFQ3QvkGS8O0AAAAAElFTkSuQmCC","orcid":"","institution":"Dr. Rajendra Prasad Government Medical College","correspondingAuthor":true,"prefix":"Dr.","firstName":"Nidhi","middleName":"","lastName":"Chauhan","suffix":""},{"id":440425299,"identity":"d63fbec3-b340-4d97-9810-0421a8577da3","order_by":2,"name":"Dr. Sakshi Supehia","email":"","orcid":"","institution":"Dr. Rajendra Prasad Government Medical College","correspondingAuthor":false,"prefix":"Dr.","firstName":"Sakshi","middleName":"","lastName":"Supehia","suffix":""}],"badges":[],"createdAt":"2025-01-29 06:53:15","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-5922298/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5922298/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":80580204,"identity":"8f017f27-85e0-4db9-b213-c91aea311d58","added_by":"auto","created_at":"2025-04-14 23:13:59","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":16244,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eIntervention step wedged rollout over time\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"floatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-5922298/v1/f806e9912aa0aecc4632e2b1.png"},{"id":80809352,"identity":"a7b03ade-533a-47a0-8e69-62100a3b0cfe","added_by":"auto","created_at":"2025-04-17 10:02:14","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1484162,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5922298/v1/696450cf-8bb5-43c6-85ad-9ab62d5da865.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"A Protocol on \"Improving Tuberculosis Detection and Accelerating Elimination through Digital Hand-Held X-Ray Units for Pre-Diagnosis Screening in Rural Communities: An Implementation Research in a Health Block of District Kangra, Himachal Pradesh, India\"","fulltext":[{"header":"Introduction","content":"\u003cp\u003eTuberculosis (TB) remains a significant global health threat, with an estimated 10.8 million new cases (95% uncertainty interval [UI]: 10.1\u0026ndash;11.7 million) reported worldwide in 2023.\u003csup\u003e1\u003c/sup\u003e India, home to approximately 28% of the global TB burden, bears a disproportionate share of this challenge.\u003csup\u003e2\u003c/sup\u003e The COVID-19 pandemic further exacerbated the situation, severely disrupting TB diagnosis and treatment services. During this period, India saw a dramatic 41% decline in TB notifications\u0026mdash;the largest reduction globally.\u003csup\u003e3\u003c/sup\u003e Despite reporting 2.4 million TB cases in 2019, the country is estimated to have missed approximately 540,000 additional cases, highlighting substantial gaps in early detection and care.\u003csup\u003e4\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003eThe urgency of accelerating TB elimination in India has never been greater. The Indian government\u0026apos;s National Strategic Plan for Tuberculosis Elimination (NSP 2017\u0026ndash;2025) outlines an ambitious target to eliminate TB by 2025.\u003csup\u003e5\u003c/sup\u003e Achieving this goal requires robust public health policies, extensive infrastructure investments, and innovative diagnostic technologies to overcome barriers to early detection, especially in under-resourced areas.\u003c/p\u003e\n\u003cp\u003eIn the context of India\u0026rsquo;s health system, which faces challenges ranging from unequal access to healthcare and inadequate infrastructure to the persistent burden of infectious diseases, a key focus is on creating an adaptable health system - a system that becomes stronger and more adaptive in the face of stressors or disruptions.\u003csup\u003e6\u003c/sup\u003e In the case of TB control, India\u0026rsquo;s healthcare system needs to be flexible and capable of adapting to unforeseen challenges like pandemics or capital and infrastructural constraints. Emerging technologies \u0026nbsp;like teleradiology, artificial intelligence-based algorithms, and mobile digital imaging units, particularly hand-held X-ray machines, are playing a critical role in making the Indian healthcare system more sustainable by improving the accessibility and efficiency of TB detection, particularly in rural or underserved regions. \u003csup\u003e7\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003eHand-held X-ray machines offer a transformative solution in settings where traditional diagnostic tools are limited or difficult to deploy. These portable devices are cost-effective and facilitate rapid point-of-care diagnostics, ensuring that TB screening can occur even in remote areas. The ability to deliver immediate, high-quality diagnostic results in hard-to-reach communities can significantly reduce delays in diagnosis and treatment initiation, directly addressing the issue of underreporting and undetected cases.\u003c/p\u003e\n\u003cp\u003eGlobal studies highlight the effectiveness of hand-held X-ray devices in TB detection in challenging environments. A study conducted in rural Nigeria demonstrated the successful use of the Delft Light Backpack (DLB) X-ray system for pre-diagnostic TB screening during active case finding (ACF) in the Niger Delta region, uncovering previously undiagnosed TB cases in areas with limited access to conventional healthcare infrastructure.\u003csup\u003e8\u003c/sup\u003e Additionally, a comparative study on image quality found that hand-held X-ray machines produce images at par with traditional, stationary digital X-ray systems, with the added benefit of being portable and easier to deploy in diverse environments.\u003csup\u003e9\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003eThese studies illustrate the potential of hand-held X-ray technology to fill critical gaps in TB detection, particularly in regions where traditional diagnostic methods, such as CXR, may be logistically or financially out of reach. By enabling rapid, on-site screening, hand-held X-rays contribute to a more agile, responsive healthcare system that can proactively address TB cases, especially in high-burden areas. This capability aligns with India\u0026rsquo;s broader goal of building an adaptive health system\u0026mdash;one that can respond dynamically to both routine and unexpected health challenges, ensuring better outcomes for all populations, regardless of geographical or economic barriers.\u003c/p\u003e\n\u003cp\u003eIntegrating hand-held X-ray technology into India\u0026rsquo;s TB control programs is a crucial step as it has the potential to enhance early detection, improve treatment outcomes, and ultimately help the country achieve its ambitious TB elimination goals.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eBackground in the context of the study area\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eHimachal Pradesh\u0026apos;s challenging geography and dispersed population present significant barriers to timely tuberculosis (TB) detection and treatment, particularly in remote rural areas. Despite relatively strong healthcare indicators, limited access to diagnostic services leads to delays in diagnosis and treatment, perpetuating TB transmission.\u003c/p\u003e\n\u003cp\u003eHandheld X-ray devices provide a viable solution to these challenges by enabling rapid, high-quality TB screening at the point of care. Their portability and cost-effectiveness make them particularly suited to the state\u0026rsquo;s mountainous terrain and underserved regions. They support active case finding (ACF) initiatives and facilitate early diagnosis and prompt treatment.\u003c/p\u003e\n\u003cp\u003ePilot studies in Himachal Pradesh (in district Una)\u003csup\u003e10\u003c/sup\u003e have demonstrated the potential of these devices to reduce diagnostic delays and improve treatment outcomes.\u0026nbsp;\u003c/p\u003e"},{"header":"Objectives","content":"\u003cp\u003eImplementing the inclusion of handheld X-ray devices in tuberculosis screening to accelerate early detection and treatment in remote and underserved areas of Himachal Pradesh.\u003c/p\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003e\u003cb\u003eSpecific objectives\u003c/b\u003e:\u003c/h2\u003e \u003cp\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eTo enhance access to point-of-care TB screening through the use of handheld X-rays and identify undiagnosed TB cases in high-burden areas and at-risk.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eTo gather data and evidence on the effectiveness and feasibility of handheld X-ray systems for TB detection.\u003c/p\u003e \u003c/li\u003e \u003c/ul\u003e \u003c/p\u003e \u003c/div\u003e"},{"header":"Research Plan","content":"\u003cp\u003e \u003cstrong\u003eStudy area\u003c/strong\u003e \u003cp\u003eA low-performing block in Kangra district, identified through an optimization of the local healthcare system\u0026rsquo;s capacity for TB control, will serve as the study area for this intervention.\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eStudy design\u003c/strong\u003e \u003cp\u003eImplementation research with HCFs-based three-stepped wedge design.\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eImplementation Plan\u003c/strong\u003e \u003cp\u003eThe implementation of an intervention (handheld X-ray technology) for TB screening will follow a structured plan, including\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eFormative research\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eImplementation of EBI (evidence-based intervention)\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eEvaluation\u003c/p\u003e \u003c/li\u003e \u003c/ul\u003e \u003c/p\u003e\n\u003ch3\u003ePhase I: Formative Research Plan for Optimizing TB Control\u003c/h3\u003e\n\u003cp\u003eFormative research will collect information that provides insight into an intervention's effective development and implementation. This will be done to align with the specific cultural, social, and geographic nuances of the target setting. It will also be used to gather information on identifying the vulnerabilities and recommend adaptive strategies that will not only improve outcomes but also strengthen systems, henceforth making them adaptable and thus capable of adapting and thriving amidst challenges, ensuring long-term sustainability and scalability.\u003c/p\u003e \u003cp\u003eDriven by this concept and perspective, we will analyze district Kangra\u0026rsquo;s block-level TB cases and mortality rates, identify the disparities, and seek to optimize outcomes to control TB, in line with the established guidelines and literature. We will use a combination of ethnographic and quantitative methods to gather data and information for this research.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eA \u0026lsquo;working group \u0026lsquo;will be established to develop standardized methodologies and tools for both qualitative and quantitative data collection. A trained data collector will gather information from health facilities, analyze it, and present it to the working group.\u003c/p\u003e\n\u003cp\u003eFormative research will be carried out:\u003c/p\u003e\n\u003col\u003e\n\u003cli\u003e\n\u003cp\u003eTo screen TB among vulnerable populations\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eFor the identification and assessment of the resources and capacity of healthcare facilities demonstrating optimal TB control\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ol\u003e\n\u003ch3\u003eMethodology\u003c/h3\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eTo achieve the outlined objectives, strategies will be developed to conduct a situational analysis of existing processes and facilitators by utilizing and analyzing the available data within identified thematic areas. (Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e)\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cstrong\u003eAssessment of the health-level facilities\u003c/strong\u003e: The following strategies will be employed for gathering the information:\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cstrong\u003eDocument review\u003c/strong\u003e: The block-wise information on TB cases and mortality rates will be retrieved from the district health authorities using the Nikshay ID system, as part of the National TB Elimination Program (NTEP). In addition, the following documents will be reviewed to collate the data:\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eDocuments containing information about TB from CHCs, PHCs\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eMonthly reports for the last 12 months submitted under NTEP on TB cases and mortality rates\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eMonthly performance data from the laboratory register\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eMonthly distribution of drugs prescribed from the drug register\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cstrong\u003eCapital assessment\u003c/strong\u003e: It will be done to obtain information from CHCs, health and wellness centers PHCs (HWC-PHCs), and sub-centers (HWC-SCs), and the following information will be collected:\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cem\u003ePhysical infrastructure\u003c/em\u003e: Patient care areas, rooms, etc\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003cdiv class=\"gridtable\"\u003e\n\u003cdiv class=\"colspec\" align=\"left\"\u003e\u0026nbsp;\u003c/div\u003e\n\u003cdiv class=\"colspec\" align=\"left\"\u003e\u0026nbsp;\u003c/div\u003e\n\u003ctable id=\"Tab1\" border=\"1\"\u003e\u003ccaption\u003e\n\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\n\u003cdiv class=\"CaptionContent\"\u003e\n\u003cp\u003eThematic areas to conduct situational analysis for formative research\u003c/p\u003e\n\u003c/div\u003e\n\u003c/caption\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eAccess/Availability\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e\u0026bull; What are the key barriers and facilitators for vulnerable populations to access TB screening services in their communities?\u003c/p\u003e\n\u003cp\u003e\u0026bull; Are TB screening services equitably distributed across urban, rural, and remote areas?\u003c/p\u003e\n\u003cp\u003e\u0026bull; What are the average wait times and distances to access TB screening facilities?\u003c/p\u003e\n\u003cp\u003e\u0026bull; How do seasonal changes or natural calamities impact the availability of TB screening services?\u003c/p\u003e\n\u003cp\u003e\u0026bull; Are mobile screening units or outreach services accessible to populations in hard-to-reach areas?\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003c/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eProduct Attributes\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026bull; What features of existing TB screening tools (e.g., sputum tests, X-rays) are seen as acceptable or unacceptable by the target population?\u003c/p\u003e\n\u003cp\u003e\u0026bull; How do individuals perceive the reliability and trustworthiness of TB diagnostic tools?\u003c/p\u003e\n\u003cp\u003e\u0026bull; Is there a preference for non-invasive or faster diagnostic methods among vulnerable populations?\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eSocial Support\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026bull; How does social stigma influence the willingness of individuals to seek TB screening?\u003c/p\u003e\n\u003cp\u003e\u0026bull; What role do family members, peers, or community leaders play in encouraging TB screening?\u003c/p\u003e\n\u003cp\u003e\u0026bull; Are there any community-driven initiatives that effectively support TB screening uptake?\u003c/p\u003e\n\u003cp\u003e\u0026bull; How do gender roles impact access to TB screening and follow-up care?\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eKnowledge\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026bull; What is the level of awareness among vulnerable populations about TB symptoms and the importance of early detection?\u003c/p\u003e\n\u003cp\u003e\u0026bull; What misconceptions or myths about TB exist in the target communities, and how do they affect screening behavior?\u003c/p\u003e\n\u003cp\u003e\u0026bull; Are people aware of where and how to access TB screening services?\u003c/p\u003e\n\u003cp\u003e\u0026bull; How do health literacy levels influence the ability to follow through with the TB screening process?\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eAffordability\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026bull; What are the direct and indirect costs (e.g., transportation, lost wages) associated with accessing TB screening?\u003c/p\u003e\n\u003cp\u003e\u0026bull; Are vulnerable populations aware of free or subsidized TB screening programs?\u003c/p\u003e\n\u003cp\u003e\u0026bull; How does financial insecurity affect the likelihood of individuals seeking TB screening?\u003c/p\u003e\n\u003cp\u003e\u0026bull; What is the willingness to pay for private TB screening services, if public options are unavailable or inconvenient?\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\n\u003ch2\u003eo Workforce:\u003c/h2\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eStaffing levels e.g. Doctors, Pulmonologist, NTEP Staff, their training status, and roles in TB management.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eSmallest health facility unit/ subcentres or HWCs- line listing of ASHAs in block\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cem\u003eLogistics\u003c/em\u003e: Microscopes, gen-expert machines, chest X-ray machines, mobile screening vans, sputum collection containers, drug supply chain\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cem\u003eService Delivery Processes\u003c/em\u003e: Screening, diagnostic pathways, treatment adherence, and follow-up protocols.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cem\u003eUse of Technology\u003c/em\u003e: Existing digital TB case management and reporting systems tools.\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003cdiv class=\"BlockQuote\"\u003e\n\u003cp\u003e\u003cstrong\u003eData Collection Method\u003c/strong\u003e:\u003c/p\u003e\n\u003c/div\u003e\n\u003col\u003e\n\u003cli\u003e\n\u003cp\u003eStructured facility assessment using a checklist.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eReview of facility records and reports.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eKey informant interviews (KIIs) with healthcare facility staff will be carried out separately at CHCs, and PHCs to get specific insights to assess ongoing intervention for TB management at health facilities, gaps for providing community-based care strategic model for screening and treatment of TB, possible facilitators to fill gaps for existing intervention, and possible factors affecting the identified facilitators.\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ol\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cstrong\u003eAssessment at the Community Level\u003c/strong\u003e: Systematic screening will be conducted among vulnerable populations with the specified risk factors (mentioned below) to identify individuals at a higher risk of developing TB. Additionally, it aims to assess community knowledge, attitudes, and practices (KAP) regarding TB management and available resources (Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e). This approach will provide valuable contextual insights into the community-level barriers and facilitators influencing TB management efforts.\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003cdiv class=\"gridtable\"\u003e\n\u003cdiv class=\"colspec\" align=\"left\"\u003e\u0026nbsp;\u003c/div\u003e\n\u003cdiv class=\"colspec\" align=\"left\"\u003e\u0026nbsp;\u003c/div\u003e\n\u003ctable id=\"Tab2\" border=\"1\"\u003e\u003ccaption\u003e\n\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\n\u003cdiv class=\"CaptionContent\"\u003e\n\u003cp\u003eVariables to assess and screen TB at community level\u003c/p\u003e\n\u003c/div\u003e\n\u003c/caption\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eGeneral Variables\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eAge, gender, socio-economic status, etc\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003c/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eBehavioural variables\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eSmoking, alcohol, physical activity\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eAwareness and Perceptions\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eCommunity understanding of TB symptoms, transmission, and treatment.\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eHealth Seeking Behaviour\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eGovernment, private, and any other traditional methods to manage TB.\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eBarriers to Care\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eGeographic, financial, and cultural obstacles to accessing TB services.\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eStigma and Social Support\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eRole of stigma in care-seeking behavior and community networks in patient support.\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003eThe risk factors for systematic screening to identify people who are at higher risk of developing TB:\u003c/p\u003e\n\u003col\u003e\n\u003cli\u003e\n\u003cp\u003eSymptomatic Contacts of Index TB Cases\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eCancer Patient\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eDiabetes Patient\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eRenal Disease Patients\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eSlum area Dwellers\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003ePatients having Malnutrition\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003ePatients on Immunosuppressants\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eSmokers\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eCOPD Patient\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eAsthmatics Patient\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003ePLHIV (People Living with HIV)\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eMiners and stone Crusher Labor\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eConstruction Site Workers\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eExtrapulmonary Presumptive Cases\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eHealth Care Workers\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003ePreviously treated TB case (currently having symptoms suggestive of TB)\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eCardiovascular Patients\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eLiver Impairment\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eHypertension\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eOther (Elderly more than 60)\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ol\u003e\n\u003cdiv class=\"BlockQuote\"\u003e\n\u003cp\u003e\u003cstrong\u003eData Collection Methods\u003c/strong\u003e:\u003c/p\u003e\n\u003c/div\u003e\n\u003col\u003e\n\u003cli\u003e\n\u003cp\u003eCommunity surveys to assess KAP.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eFocus Group Discussions (FGDs) with people living in the village e.g. community members and ASHA workers to assess ongoing intervention for TB management at health facilities, gaps for providing community-based care strategic model for screening and treatment of TB, possible facilitators to fill gaps for existing intervention, and potential factors affecting the identified facilitators.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eParticipatory social mapping to identify key influencers, resources and factors influencing their dynamics.\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ol\u003e\n\u003c/div\u003e\n\u003cul\u003e\n\u003cli\u003e\u003cstrong\u003eOptimization of Outcomes\u003c/strong\u003e:\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eThirteen health blocks of district Kangra will be ranked based on the TB cases and mortality rates. A benchmark for optimal TB control performance will be set in alignment with district-specific standards.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eOptimizing TB control outcomes requires leveraging insights from facility- and community-level assessments, as discussed above to address identified gaps and barriers. This level will define and set optimal targets for implementing the intervention, aimed at improving the case detection rates, treatment success rates, and mortality reduction, all while accounting for the local contextual factors.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eOnce the optimal performance level is determined, the health blocks and healthcare facilities will be categorized as high, optimal, or low performing.\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003ch3\u003ePhase II: Implementation Phase\u003c/h3\u003e\n\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\n\u003ch2\u003eIntervention:\u003c/h2\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eThe Evidence-Based Intervention (EBI) will involve deploying handheld X-ray devices for TB screening across low-performing healthcare facilities, that aim to enhance the diagnostic capacity of existing healthcare infrastructure.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eThese portable devices enable rapid, high-quality TB detection at the point of care, especially in remote and underserved areas.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eThe focus of the intervention will be on early TB detection and active case finding (ACF) that will be facilitated by the widespread screening in high-risk communities, thereby reducing diagnostic delays and improving treatment initiation. The intervention will optimize the efficiency and accuracy of TB detection, by supporting the broader goal of TB elimination by 2025 by addressing the gaps in traditional TB diagnostics.\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\n\u003ch2\u003eKey activities:\u003c/h2\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cstrong\u003eTraining and Capacity Building\u003c/strong\u003e: Hands-on training of the recruited staff will be consummated by the experts on identifying high-risk TB groups, data collection procedures, and the operation of handheld X-ray devices.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cstrong\u003eCommunity Awareness Campaign\u003c/strong\u003e: Awareness campaigns will be conducted to inform the local population about the availability of TB screening using handheld X-rays by utilizing IEC material developed in consultation with an expert panel. ASHA workers and community leaders will facilitate the recruited staff to promote and encourage TB screening particularly among individuals in rural and underserved areas, to enhance early detection and case identification.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cstrong\u003eData Collection and Monitoring\u003c/strong\u003e: A systematic data collection framework will be established, incorporating weekly and monthly reports. It will track key metrics, including the number of screenings conducted, cases detected, and treatment initiated, ensuring continuous monitoring of the intervention's progress and impact.\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec13\" class=\"Section2\"\u003e\n\u003ch2\u003eImplementing the intervention:\u003c/h2\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eThe block with the lowest performance in TB control will be identified as the priority area for intervention. A detailed map of this block will be created to identify all healthcare facilities providing services within its boundaries.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eThese facilities will be identified as fixed facilities like Civil Hospitals (CH), Community Health Centers (CHCs), Primary Health Centers (PHCs), and outreach facilities like Health and Wellness Centers (HWC-SCs).\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eHCFs will be then categorized into three groups based on their TB control performance and geographical clustering: \u003cem\u003eoptimal, high-performing, and low-performing.\u003c/em\u003e\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cstrong\u003eImplementation design\u003c/strong\u003e: Intervention will be deployed across the three groups using a step-wedge design, where the intervention will be progressively introduced to the facilities across the three groups until all are providing it. This progressive implementation will occur in three steps, with a total rollout period of 6 months (Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cstrong\u003ePre-roll-out period\u003c/strong\u003e (Baseline Phase): A baseline will be established to evaluate the impact of hand-held X-rays by understanding current TB detection rates and screening workflow without the intervention. During this phase, data will be collected, standard care practices (State/District specific) will be documented, and training on hand-held X-ray devices before use will be done.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cstrong\u003eRoll-out period\u003c/strong\u003e (Staggered introduction of an intervention): The hand-held X-ray devices will be introduced successively to different healthcare facilities in predefined phases or steps.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eIn the first step, HCFs in Group I will use the X-ray device, while HCFs in the remaining two groups will continue with the standard care.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eIn the second step, Group II (in addition to Group I) will begin using the X-ray device, and Group III will continue with standard care. (cross-over point)\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eIn the final step, all Groups will be using the X-ray devices.\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003cdiv class=\"BlockQuote\"\u003e\n\u003cp\u003eDuring each step, outcomes will be monitored and any challenges and facilitators during the implementation will be identified and documented.\u003c/p\u003e\n\u003c/div\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003e\u003cstrong\u003ePost-roll-out period\u003c/strong\u003e (Intervention sustained): The long-term impact on patient outcomes and scalability will be assessed, along with the sustainability and adaptability of the intervention in healthcare practices. It will evaluate the intervention's effectiveness over time and refine the implementation process for potential scaling to additional facilities or regions.\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec14\" class=\"Section2\"\u003e\n\u003ch2\u003eImplementation strategy\u003c/h2\u003e\n\u003cp\u003eThe Dynamic Sustainability Framework (DSF) offers a structured approach to implementing hand-held X-ray technology for TB screening while addressing the challenges of maintaining long-term impact amid evolving healthcare contexts. The framework emphasizes adaptability, continuous learning, and alignment with dynamic systems to optimize intervention outcomes. (Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003e)\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\n\u003cdiv class=\"colspec\" align=\"left\"\u003e\u0026nbsp;\u003c/div\u003e\n\u003cdiv class=\"colspec\" align=\"left\"\u003e\u0026nbsp;\u003c/div\u003e\n\u003cdiv class=\"colspec\" align=\"left\"\u003e\u0026nbsp;\u003c/div\u003e\n\u003ctable id=\"Tab3\" border=\"1\"\u003e\u003ccaption\u003e\n\u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\n\u003cdiv class=\"CaptionContent\"\u003e\n\u003cp\u003eDynamic Sustainability Framework (DSF) for implementing hand-held X-ray technology for TB screening\u003c/p\u003e\n\u003c/div\u003e\n\u003c/caption\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eComponent\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eKey Aspects\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eActions\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003c/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eIntervention\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eDesign adaptability, context sensitivity, and scalability.\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e- Technology will be updated regularly to meet user needs (e.g., AI diagnostics, portability).\u003c/p\u003e\n\u003cp\u003e- Deployment in healthcare settings will be tailored to fit in both rural and urban areas.\u003c/p\u003e\n\u003cp\u003e- Implementation will ensure scalability to other regions and diseases.\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eContextual Fit\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eDynamic context assessment, stakeholder involvement, and equity focus.\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e- Periodical assessment of the facility\u0026rsquo;s needs, including infrastructure and staffing will be done.\u003c/p\u003e\n\u003cp\u003e- To ensure alignment in contextual settings, stakeholders, such as healthcare providers and policymakers, will be engaged.\u003c/p\u003e\n\u003cp\u003e- Efforts will focus on reaching marginalized populations.\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eFacilitation Process\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eContinuous improvement, learning systems, and sustainment infrastructure.\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e- To ensure iterative improvement, PDSA cycles will be used.\u003c/p\u003e\n\u003cp\u003e- For training healthcare workers, adaptive learning platforms will be developed.\u003c/p\u003e\n\u003cp\u003e- For device maintenance and feedback, local systems will be established.\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eSustainability Over Time\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eOngoing adaptation, long-term monitoring, and policy alignment.\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e- To assure sustainability, technology updates and advancements such as solar charging and AI tools, will be focussed.\u003c/p\u003e\n\u003cp\u003e- For long-term monitoring purposes, metrics like TB detection rates and patient outcomes will be tracked.\u003c/p\u003e\n\u003cp\u003e- Funding will be secured, and the technology will be integrated into TB control policies.\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eFramework Workflow\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eDeployment, monitoring and adaptation, scaling, and feedback integration.\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e- Piloting of the device and technology in selected regions to gather insights will be done.\u003c/p\u003e\n\u003cp\u003e- Monitoring of device usage and associated outcomes will be conducted continuously.\u003c/p\u003e\n\u003cp\u003e- Aligned with the existing policies, the intervention will be scaled to new regions.\u003c/p\u003e\n\u003cp\u003e- For iterative refinements, real-time feedback systems will be implemented.\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec15\" class=\"Section2\"\u003e\n\u003ch2\u003ePhase III: Evaluation\u003c/h2\u003e\n\u003cp\u003e\u003cstrong\u003eRE-AIM Framework\u003c/strong\u003e: The REAIM evaluation framework will be used to assess the implementation of hand-held X-ray technology in TB screening, focusing on five key domains: Reach, Effectiveness, Adoption, Implementation, and Maintenance. It will evaluate how effectively the technology will reach target populations, its impact on TB detection rates, how widely it will be adopted by healthcare providers, the challenges encountered during implementation, and its long-term sustainability in various settings. This comprehensive approach will ensure a thorough assessment of the technology's success and scalability. (Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e4\u003c/span\u003e)\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\n\u003cdiv class=\"colspec\" align=\"left\"\u003e\u0026nbsp;\u003c/div\u003e\n\u003cdiv class=\"colspec\" align=\"left\"\u003e\u0026nbsp;\u003c/div\u003e\n\u003cdiv class=\"colspec\" align=\"left\"\u003e\u0026nbsp;\u003c/div\u003e\n\u003ctable id=\"Tab4\" border=\"1\"\u003e\u003ccaption\u003e\n\u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e\n\u003cdiv class=\"CaptionContent\"\u003e\n\u003cp\u003eRE-AIM Framework to assess the implementation of hand-held X-ray technology for TB screening\u003c/p\u003e\n\u003c/div\u003e\n\u003c/caption\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eRE-AIM Dimension\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eApplication to Hand-Held X-ray Technology Implementation\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eEvaluation Metrics\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003c/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eReach\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eThe intervention will aim to target and include a significant proportion of the TB-burdened population, with a focus on high-priority regions.\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e- Proportion of the TB-burdened population that will access screening using hand-held X-ray technology.\u003c/p\u003e\n\u003cp\u003e- Will the screening initiatives effectively cover the marginalized and high-risk populations?\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eEffectiveness\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eThe impact of technology on TB detection rates, treatment initiation, and patient health outcomes will be assessed.\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e-Assessment of improvement in TB detection accuracy and diagnostic timelines compared to the standard methods.\u003c/p\u003e\n\u003cp\u003e- Impact on treatment outcomes and patient recovery rates.\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eAdoption\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eThe willingness and readiness of healthcare facilities and staff to incorporate the intervention will be evaluated.\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e- Proportion of healthcare facilities that will integrate the technology into routine workflows.\u003c/p\u003e\n\u003cp\u003e- Proportion of healthcare workers will adopt and use the device effectively in their practice?\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eImplementation\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eThe quality and fidelity of intervention delivery across diverse healthcare contexts will be monitored and adjusted as needed.\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e- Will the protocols for using the technology be implemented consistently across various sites?\u003c/p\u003e\n\u003cp\u003e- What variations in implementation will arise, and how will they be addressed?\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eMaintenance\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eTo ensure the long-term sustainability and integration of the intervention into healthcare systems, strategies will be developed.\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e- Will the technology continue to be used effectively in facilities over time?\u003c/p\u003e\n\u003cp\u003e- Plans to secure financial and technical support to ensure sustained implementation and updates?\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec16\" class=\"Section2\"\u003e\n\u003ch2\u003eBaseline and end-line assessment:\u003c/h2\u003e\n\u003cp\u003eBaseline assessment will be carried out during phase 1 and the pre-roll-out period of phase 2 of the study. It will focus on collecting under mentioned variables;\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eBasic characteristics: Age, gender, socio-economic status, etc\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eHigh-risk groups: Diabetes, cancer, PLHIV, COPD, malnutrition, etc.\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec17\" class=\"Section2\"\u003e\n\u003ch2\u003e\u003cstrong\u003eMeasuring processes at baseline\u003c/strong\u003e:\u003c/h2\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eNumber of TB cases registered in last 12 months\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eNumber of TB patients on ATT\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eTB Mortality rate\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eLogistics like microscopes, gen-expert machines, chest X-ray machines, mobile screening vans, sputum collection containers\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec18\" class=\"Section2\"\u003e\n\u003ch2\u003e\u003cstrong\u003eMeasuring processes at cross-over points\u003c/strong\u003e:\u003c/h2\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eNumber of persons screened\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eNumber of TB suspects identified\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eNumber/proportion of hand-held X-rays done at fixed and outreach facilities\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eNumber of chest symptomatic identified\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eNumber of chest symptomatic referred for molecular testing\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eNumber of TB patients diagnosed by molecular testing\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eNumber of TB patients diagnosed by either X-ray or molecular testing\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eNumber of diagnosed TB patients started on ATT\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec19\" class=\"Section2\"\u003e\n\u003ch2\u003e\u003cstrong\u003eMeasuring processes at the endline\u003c/strong\u003e:\u003c/h2\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eNumber of TB cases registered during the study period\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eNumber of TB patients on ATT\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eTB Mortality rate\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec20\" class=\"Section2\"\u003e\n\u003ch2\u003eContact tracing:\u003c/h2\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eNumber of TB contacts identified\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eNumber of contacts screened\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eNumber of contacts put on TPT\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003c/div\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThe proposed implementation of hand-held X-ray technology for tuberculosis (TB) screening in Himachal Pradesh is expected to overcome significant barriers in early TB detection, particularly in remote and underserved regions. By employing a structured three-step wedge design, the phased rollout will facilitate a systematic introduction of the intervention, enable continuous monitoring, and allow for iterative refinement of the intervention.\u003c/p\u003e \u003cp\u003eThis aims to align with India\u0026rsquo;s TB elimination target by 2025 by enhancing diagnostic accessibility and efficiency, empowering healthcare workers to identify high-risk cases promptly, and reducing diagnostic delays.\u003c/p\u003e \u003cp\u003eThrough formative research, strategic implementation, and comprehensive evaluation, this protocol is anticipated to generate valuable insights for scaling portable X-ray technology across similar settings. It will contribute to building an adaptable, anti-fragile healthcare system capable of addressing the challenges of TB elimination and improving health outcomes in resource-limited contexts.\u003c/p\u003e"},{"header":"Declarations","content":"\u003ch2\u003eFunding:\u003c/h2\u003e \u003cp\u003eNo involvement of any funding source\u003c/p\u003e \u003cp\u003e \u003cb\u003eDeclarations\u003c/b\u003e: Ethics, Consent to Participate, and Consent to Publish declarations are not applicable.\u003c/p\u003e \u003cp\u003e \u003cb\u003eData Availability Statement\u003c/b\u003e: Given that this is a protocol, data has not yet been collected, and no dataset is available. Therefore, a data availability statement is not applicable.\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eDr. Sunil K Raina: Conceptualized the research project, developed the data collection and analysis methodology, revised the manuscript, and contributed critical feedback, overall supervision, and guided the research teamDr. Nidhi Chauhan: Drafted the initial manuscript, developed the theoretical framework underlying the research, Developed data collection methodology, prepared figures and tablesDr. Sakshi Supehia: Developed data collection methodology\u003c/p\u003e\u003ch2\u003eAcknowledgement\u003c/h2\u003e\u003cp\u003eI sincerely thank other authors for their valuable insights and expert reviews, which significantly contributed to the development of this protocol.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eGlobal tuberculosis report 2024. Geneva: World Health Organization; 2024. Licence: CC\u0026nbsp;BY-NC-SA\u0026nbsp;3.0\u0026nbsp;IGO.\u003c/li\u003e\n\u003cli\u003eWorld Health Organisation Global Tuberculosis Report 2022. 2022. Available from:\u0026nbsp;https://www.who.int/teams/global-tuberculosis-programme/tb-reports/global-tuberculosis-report-2022, last accessed on 2nd December 2024.\u003c/li\u003e\n\u003cli\u003eWHO. Tuberculosis deaths rise for the first time in more than a decade due to the COVID-19 pandemic. Available from: https://www.who.int/news/item/14-10-2021-tuberculosis-deaths-rise-for-the-first-timeinmore-than-a-decade-due-to-the-covid-19-pandemic, last accessed on 2nd December 2024.\u003c/li\u003e\n\u003cli\u003eCentral Tuberculosis Division. India TB Report 2020. Available from: https://tbcindia.gov.in/showfile, last accessed on 2nd December 2024.\u003c/li\u003e\n\u003cli\u003eCentral Tuberculosis Division. National Strategic Plan to End TB in India 2020\u0026ndash;25. Available from: https://tbcindia.gov.in/index, last accessed on 2nd December 2024.\u003c/li\u003e\n\u003cli\u003eTaleb, N. N. (2012). Antifragile: Things That Gain from Disorder. Random House.\u003c/li\u003e\n\u003cli\u003eChandramohan A, Krothapalli V, Augustin A, Kandagaddala M, Thomas HM, Sudarsanam TD, Jagirdar A, Govil S, Kalyanpur A. Teleradiology and technology innovations in radiology: status\u0026nbsp;in India and its role in increasing access to primary health care. Lancet Reg Health Southeast Asia. 2023 Apr 14;23:100195.\u003c/li\u003e\n\u003cli\u003eOdume B, Chukwu E, Fawole T, Nwokoye N, Ogbudebe C, Chukwuogo O, Useni S, Dim C, Ubochioma E, Nongo D, Eneogu R, Lagundoye Odusote T, Oyelaran O, Anyaike C. Portable digital X-ray for TB pre-diagnosis screening in rural communities in Nigeria. Public Health Action. 2022 Jun 21;12(2):85-89.\u003c/li\u003e\n\u003cli\u003eKamal Raj, Singh Manjula, Roy Sudipto, Adhikari Tulsi, Gupta Anil Kumar, Singh Hari, Rao Vishnu Vardhan, Panda Samiran, Khan A. M., Bhargava Balram.\u0026nbsp;A comparison of the quality of images of chest X-ray between handheld portable digital X-ray \u0026amp; routinely used digital X-ray machines. Indian Journal of Medical Research 157(2\u0026amp;3):p 204-210, Feb\u0026ndash;Mar 2023.\u003c/li\u003e\n\u003cli\u003e Una gets portable X-ray machines. Available from: https://www.tribuneindia.com/news/himachal/una-gets-portable-x-ray-machine, last accessed on 16th December 2024.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-5922298/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5922298/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eObjective: \u003c/strong\u003eGiven the national imperative to eliminate tuberculosis in India and the need to foster an adaptable healthcare system, an implementation research study is proposed. It aims to enhance access to point-of-care TB screening in underserved populations by strategically deploying hand-held X-ray units while considering the contextual realities of the target population and healthcare system.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy Design\u003c/strong\u003e: Three-step wedge design of implementation research.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods: \u003c/strong\u003eFormative research to gather insights and data, followed by\u003cstrong\u003e \u003c/strong\u003ea staggered introduction of the intervention (hand-held X-ray) across different healthcare facilities will be employed.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults: \u003c/strong\u003eMetrics and processes like the proportion of TB patients screened, improved TB detection rates, and treatment outcomes will be evaluated.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion: \u003c/strong\u003eThe research will evaluate the effectiveness of integrating handheld X-ray units in routine TB screening programs, thereby providing valuable insights into its feasibility and adaptability in our healthcare system to combat TB in India and other resource-limited settings.\u003c/p\u003e","manuscriptTitle":"A Protocol on \"Improving Tuberculosis Detection and Accelerating Elimination through Digital Hand-Held X-Ray Units for Pre-Diagnosis Screening in Rural Communities: An Implementation Research in a Health Block of District Kangra, Himachal Pradesh, India\"","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-04-14 23:13:55","doi":"10.21203/rs.3.rs-5922298/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"61ffde88-c8d8-4aad-8ade-da07bc1418ed","owner":[],"postedDate":"April 14th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-04-17T09:54:07+00:00","versionOfRecord":[],"versionCreatedAt":"2025-04-14 23:13:55","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-5922298","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5922298","identity":"rs-5922298","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}