Innovative Strategies for Developing Tuberculosis Implementation Research in Sudan

Innovative Strategies for Developing Tuberculosis Implementation Research in Sudan | 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 Innovative Strategies for Developing Tuberculosis Implementation Research in Sudan Ayman Ahmed Elshayeb, Nihad Mohammed Ahmed, Karimeldin Mohammed Salih, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-110381/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 Introduction: Sudan, especially Eastern States are very poor areas at great risk of endemic and communicable diseases particularly tuberculosis. The reasons for the spread and transmission of this disease include medical, economical and geographical issues, besides Sudan’s location in the middle of nine countries in East Africa, its boundaries were affected by free movement, high number of conflicts displaced peoples from boarders’ countries, high illiteracy rates, limited financial resources and shortages in medical services. Objectives: This project is conducted to implement a new developed system for eliminating Tuberculosis infections among eastern Sudanese populations focusing on the eradication of multidrug resistant Mycobacterium tuberculosis including novel methods for the targeted delivery of new therapeutic drugs. Methods: Strategies adopted in this work are proposed to increase access includes to communicable and economic factors. Disease Survey and Laboratorial Investigation for Multi Drug Resistant bacterial strains confirmation. Medical Assessment of TB Patients to facilitate improved efficiencies through metric measurement and enable patients’ relationship management. Established a national level policy of treatment, vaccination and prevention. Administering regular evaluation of the disease situation and control. Results: Implementation outcomes includes the conceptual framework for this project were informed by a combination of the general program logic model, the health system framework of the World Health Organization, WHO, the pillars of the Sudan health agenda, and the framework of the Strategic Elimination Plan. It is assumed that the reduction of TB burden at the national level (long-term output or impact) is preceded by improved case-finding and case-holding practices (short-term output). Impact outcome of the project is derived from the observation that tuberculosis is much more common at the boarders than center of Sudan where no adequate clinical services are available. It is conceivable that, although outbreaks may occur periodically, the control of disease might be easier to overcome than direct medication. Conclusion: A major success of the project accomplishment, is the stimulation of the implementation strategy development for elimination and eradication of Tuberculosis in Sudan with a view to bring diagnostic and surveillance issues much higher up according to the implementation research agenda especially for those areas explored with similar national and international research projects, reports and technical initiatives. Health Economics & Outcomes Research Health Policy Infectious Diseases Conceptual framework Implementation Strategies Sudan Tuberculosis Figures Figure 1 Figure 1 Figure 2 Figure 2 Figure 3 Figure 3 Contributions To The Literature Africa -with its all conflicts- at great risk of endemic, pan-endemic and epidemic of tuberculosis spread and outbreaks Reasons for spread and transmission of these diseases among poor communities are affected by free movement, high number of war displaced peoples beside other demographical issues. Poor health systems coverage in Africa make it very important to interevent with emerging Implementation Research projects taking into account the proportion of clinical cases with underestimating the burden of tuberculosis. Utilizing data on actual burden of tuberculosis is crucial for health authorities to design control programs for developing public health strategies such as surveillance, early warning and quick response system for spread and outbreaks, all can be defined as Implementation Research Conceptual Framework. Introduction Globally, tuberculosis remains one of the top 10 causes of death worldwide. Millions of people continue to fall sick from TB each year( 1 – 3 ). The huge biodiversity in Sudan, has a great bacterial record showed variable characteristics of infections and antibiotics susceptibility, this gives an excellent opportunity to find the effective intervention system( 4 ). This study emphasizes the implementation systems that control, analyze and characterize TB treatment. In Sudan, especially the Eastern States, there are many areas at great risk of endemic, poverty and communicable diseases particularly tuberculosis ( 5 – 7 ). The reasons for the spread and transmission of the disease in Sudan are attributed to medical, economical and geographical location of the country which is bounded by nine Eastern African countries; free movement, high number of Conflicts displaced peoples from boarders’ countries, high illiteracy rates, limited financial resources( 8 ). The human host serves as the only natural reservoir for Mycobacterium tuberculosis of majority of tuberculosis but natural disasters such as aridity and geographical inaccessibility of some areas especially during the dry season can affect the circulation of tuberculosis in the Sudan( 9 ). Poor health system coverage makes it very important to conduct a population-based prevalence survey taking in to account the proportion of clinical cases which is always very few as such as a tip of iceberg underestimating the burden of the disease because most of the cases are asymptomatic infections( 10 – 14 ). b Urban areas have, in general, greater health provider diversity, are socioeconomically and culturally more diverse, and operate under different governmental structures. Furthermore, the transmission pattern and intensity are often different from rural areas. Many of these factors influence health seeking behaviour and perceptions about the disease, as well as case-definition and the epidemiology of tuberculosis, and, in general, methods, points and approaches for potential intervention. Moreover, the symptomatic cases are not adequately reported, so data on the actual burden of the disease is crucial for the public health authorities to design control programs( 15 – 17 ). The prevalence of risk factors of tuberculosis can be used to ascertain the vulnerable groups and develop public health strategies namely adequate surveillance system and early warning and response body to guard particularly against multi-drug resistant tuberculosis. Principally, the risk of anti-drugs resistant disease is very high; this increases the need to find new low-cost drugs( 18 – 20 ). One of the more interesting aspects of the present study into new implementation systems may in fact be the sequencing of their outcomes. The most important outcome is the change into how studying the treatment, vaccination and prevention is approached. It is also quite likely that even if the initial research is relatively not costly, the results may have great benefits in poor communities. General Objective: The general objective of this project is to implement a new developed system for eliminating Tuberculosis infections among Sudanese focusing on the eradication of multidrug resistant Mycobacterium tuberculosis using novel methods for the targeted delivery of new therapeutic drugs. Specific objectives are to : Manage clinical and diagnosis process inside the endemic area. Control drug delivery to patients through direct channels. Utilize stakeholders outsourcing, networking, and connections for serving patients. Management of surveillance and data collection. Assess conceptual, outcomes and evaluation systems. Methods Study area/setting Sudan (1,886,068 km 2 ), has 18 states after separation of South Sudan in 2011. The geostatistical and the socioeconomic model will be an inclusive framework that takes various aspects of the study area, such as economic status, social and the geospatial distribution of TB into consideration. Climate change may have effects in the spread of TB, where the environment can be seen as a biosocial determinant of the diseases, it provides a direct space in which infection can take place, predominantly through increased exposure. Sample Size : Sudan population is 32 million according to 2008 census excluding the separated South Sudan. The prevalence of Tuberculosis is very high especially among Eastern states’ populations; namely Kassala (2,519,071), Al-Gedarif (2,208,385) and The Red Sea (1,482,053) respectively. These populations were chosen for a survey and/or experiment using World Health Organization recommended Sample Size Calculator and Sampling Spreadsheet (The STEPS) that can assist in first determining the size of sample and then in drawing a sample from sampling frame ( https://www.who.int/ncds/surveillance/steps/resources/sampling/en/ ). This will construct a 95% confidence interval with a margin of error of about ± 4.4% (for large populations). Medical intervention for tuberculosis infections: Onsite clinical testing and investigations Tuberculin skin test (TST) and/or interferon-gamma release assay (IGRA) were used to test for LTBI, both tests measure immune sensitization (type IV or delayed-type hypersensitivity) to mycobacterial protein antigens that occurs following infection by M. tuberculosis . Antibiotic susceptibility testing to isoniazid or rifampicin will be done by using CLSI guidelines and the second-line drugs considered are those listed in the WHO Guidelines for the Management of Drug Resistant Tuberculosis( 21 ). Medical Assessment of Tuberculosis Patients: 1- Patient Registration : of both healthy and sick patients. 2- Appointment Management : with routine reminders to notify patients about appointments and delays. 3- Reports and Dashboards : To facilitate improved efficiencies through metric measurement. 4- Computer software : To enable patients’ relationship management especially for chronic patients who visit the clinics more often. Inclusion Criteria : The inclusion criteria included the following: (a) Tuberculosis diagnosis (b) tuberculosis treatment fully conducted at field site during infection pandemic and (c) being African citizens or residents. Exclusion Criteria : The exclusion criteria included the following: (a) death within the first 15 days of treatment, (b) treatment default during the first 30 days after treatment initiation, (c) change of Tuberculosis diagnosis during treatment, (d) transfer to other health unit, or (e) unknown treatment outcome. The project also will provide information on socio-demographic variables, presence of comorbidities, tuberculosis features and treatment, which we included as covariates. Management of Mobile Emergency health intervention: Using well equipped mobile clinics, labs and pharmacies for emergency intervention is essential especially in those areas who lack for regular health facilities, outreach clinic mobiles aim to provide primary and emergency health care services for poor communities. Data Collection methods, instruments used, measurements: Networking and media and communication : Data that has been collected and analyzed must be passed on to decision makers, the staff involved, and partners. This communication aspect is an essential component of a surveillance system and includes: feedback, dissemination of information, specific communications. Surveillance data collection Public health surveillance in points of care for communities/migrants operates inside camps with daily collection of epidemiological data for selected syndromes/health conditions that are important from a public health point of view. Data recorded refer to consultations for each syndrome/condition under surveillance in primary health care facilities in community/migrant reception centers. Data are sent daily to the Department of Surveillance and Intervention of communities by doctors, nurses and other health professionals from services and NGOs staffing primary care facilities. Data quality assurance methods, data management and analysis plans: All official statistical activities shall be conducted in accordance with a Data Quality Framework that shall be developed by the National Centre for Statistics and Information in consultation with other government units that conduct official statistical activities. Once developed, the Data Quality Framework will be promulgated by Regulation/Government Decree (need to specify the legal process involved)” Developing the national level policy of treatment, vaccination and prevention: 1- Developing drug delivery to lower levels and the cost of supervision of the communities. 2- Community based TB care developed together with implementing partners (Conduct situational analysis, establish partnership & coordination mechanism and Developing surveys). 3- Conducting a needs analysis, administering surveys, conducting interviews and developing curriculum. Administering regular evaluation of the disease situation 1- Organize community base and multidisciplinary teams. 2- Regular Survey and Monitoring 3- Quarterly Review Meeting. 4-Dissemination of training materials. 5-Infection Control. Strategies to increase community access : 1- Education : Patient consulting, social marketing, 2- Management : Financial management, business management. 3- Regulation : Standards development, task-shifting. 4- Economic : Insurance plans, pooled procurement. Major workplan and Budget The work plan identified tasks, time and period of the activity took place and executive responsible person as scheduled in appendix (B). An outline of the financial costs involved in implementing the proposed study and any other essential resources was declared in appendix (C). Results And Outcomes The prevalence of tuberculosis among population: The disease total estimations in Sudan were 200,000 cases with 200 new infections annually include 1.9% Multi-Drug-Resistant Mycobacterium tuberculosis and 20.0% of them were previous treated patients (Figure 1). Using World Health Organization Sample Size Calculator, the final sample size = 0.015 for all Eastern States (Appendix A 1,2). Figure-1: National tuberculosis infections baseline Management of mobile health intervention: Management of mobile clinic : Clinic Management Systems to give complete end to end solutions to clinics that are looking for administrative support along with Record Management. The Clinic Management System is focused on bringing in efficiencies into the mobile clinics by streamlining Appointment management, Registration and follow up along with maintaining electronic records for all TB patients. The system was ensuring collection of appropriate data to be able to present dashboards to the key users with a focus on improving clinical and operational efficiencies and reducing costs. B) Management of mobile laboratory: Simple laboratory tests such as microscopy, ICTs blood tests, hemoglobin estimation and urine examination are carried out at camps by regular moving of laboratory with its technicians. The clinics received referrals from the laboratory technicians for the management of medical and surgical emergencies and making etiological diagnosis quick and correct. C) Management of mobile Pharmacy: Quick delivery of health services including treatment and vaccinations attuned to the needs of patients in different area. Monitoring of patients’ health and their outcomes: An important benefit of the project drug delivery is derived from observations that tuberculosis patients at the boarders are suffering from lack of medical services than others. Management of communication network : include coordinate with others. Interagency and interpectoral coordination should be established to ensure comprehensive care for community. Conduct orientation meetings with community leaders; include representatives of social and community services, protection, the police or legal justice system, and security. Depending on the services available in the particular setting, others may need to be included. As a multi-sectoral team, establish referral networks, communication systems, coordination mechanisms, and follow-up strategies as shown in (Table-1). Implementation of service delivery plan: Implement solutions determined in the Improve stage. Comprehend both technical as well as any business process related changes. Implement a comprehensive ‘Change Management’ plan to ensure that all stakeholders are appropriately trained. Data Control Measurement: Verify at periodic intervals that the data is consistent with the business goals and the data rules specified in the Definition Step. Communicate the Data Quality metrics and current status to all stakeholders on a regular basis to ensure that Data Quality discipline is maintained on an ongoing basis across the organization as declared in (Table-2). * Data Quality is not a onetime project but a continuous process and requires the entire organization to be data-driven and data-focused. With appropriate focus from the top, Data Quality Management can reap rich dividends to organizations. Implementation Research Outcomes: The conceptual framework for this project was informed by a combination of the general program logic model, the health system framework of the World Health Organization, the pillars of the Sudan health agenda, and the framework of the Strategic Elimination Plan. It is posited that the reduction of TB burden at the national level (long-term output or impact) is preceded by improved case-finding and case-holding practices (short-term output). Figure-2 Innovative strategies for developing tuberculosis framework. Medical intervention and quick response: These, in turn, require the following inputs and activities: (i) delivery of health services that are consistent with accepted standards, but are also attuned to the needs of the local population; (ii) availability of human, material and financial resources to support program implementation; (iii) evidence-informed decision making; (iv) exercise of administrative oversight, and presence of support from policy-makers and local stakeholders; and (v) effective partnerships that harness contribution from the other government agencies, private sector and civil society. Acceptability: Perception of local policy-makers and decision-makers on their agreement to the TB prevention and control program as cascaded by the national government (and development partners, as applicable). Appropriateness: Perception of local policy-makers and decision-makers on the relevance to their local context of the TB prevention and control program as cascaded by the national government (and development partners, as applicable). Fidelity: The consistency and quality of the intervention’s implementation was implemented as intended due to major plan and conceptual framework (Figures-2, 3) Feasibility: Perception of local policy-makers and decision-makers on the practicality of implementing the TB prevention and control program as cascaded by the national government (and development partners, as applicable). For purposes of the implementation research, the acceptability, appropriateness and feasibility of the package of interventions for TB prevention and control as provided by the national government from the local policy-makers shall be considered as among these potential driving or restraining forces. Implementation research outcomes Socio-(economic, politics, cultural) impact outcome: An important benefit of the project is derived from the observation that tuberculosis is much more common in boarders than center of Sudan where no clinical services. It is conceivable that, although outbreaks may occur periodically, the control of disease might be easier to overcome than direct medication. Figure-3 : Conceptual Diagram ©Elshayeb 2018 Direct health impact outcome Changing the regular health policies and the prevention approach have great benefits in poor communities. Another obvious outcome is the increase of patient’s outreach, treatment and vaccination from 25% up to 75% in Dordabe locality Eastern Sudan Beneficial impact outcome Developing implementation strategy for elimination and eradication of Tuberculosis has stimulated funds from national and (expected international) relevant organizations and academia. Future Prospects Development of future management systems could offer powerful tools for disease management within wider strategies of control The Project is an attempted a grand challenge to identify future risks from tuberculosis across Sudan and neighborhood. Implementation of a new research study and technology that might reduce such risks. Development of alternative therapeutics technology platform against MDR tuberculosis using novel methods for the targeted delivery of Bacteriophage Therapy Discussion Tuberculosis is well-considered as an endemic and economic related disease in many countries as a result of poverty( 22 , 23 ). Many health systems in the Globe depend on clinical, official and governmental efforts without considering other implementation research settings against tuberculosis defeating( 24 ). Although the recent health managerial policies of disease control were successful in the treatment of the disease but they failed in eradication (particularly the MDR tuberculosis) due to the lack of effective implementation research studies and trials( 25 – 27 ). The present study showed the impact of a new empirical, managerial and integrated system for tuberculosis treatment in Sudan using innovative strategies of implementation research and how it is suitable for other countries who have similar conditions of disease epidemiologic. The risk of tuberculosis outbreaks among people fleeing hardship for poor, war’s victims and refugees in Sudan is heightened by the description of the local health response to outbreak of tuberculosis among all those patients ( 28 ). Conflict and war have long been recognized as determinants of infectious disease risk, re-emergence of epidemic tuberculosis and also has coincided with extensive civil conflict in affected regions( 29 ). The needs of Implementation Research are very important for the critical health situation in Eastern Sudan, where the population has been suffering for long time from the endemic TB, beside poverty and long distant has stimulate the need of mobile combo-clinic for patients’ outreach. This emergency facility has been used in many countries as stated by ( 30 – 33 ). The success of such implemented research is obviously seen in the reduction of the disease among the selected populations, this is in agreement with( 34 ) who outlined the implementation challenges around the diagnosis and treatment of TB and described how current TB preventive therapy activities have been shaped and managed. The triangular conceptual framework (World Health Organization, local health authorities, and our innovative Strategic Plan) was implemented as an urgent responded action to eliminate the disease spreading (Figure − 2)( 35 ). The conceptual framework’s inner settings (health services) and outer settings (the financial and sociopolitical environment of local health services) were combined to obtain the highest level of the program perfection( 36 ). This novel framework highlighted the morbidity, disability and heightened mortality that persist after successful treatment completion, in order to appreciate the importance of TB preventive therapy in the overall context of ending the MDR-TB epidemic and ensuring healthy lives( 37 ). The Medical intervention combination (laboratory investigations, patient’s assessment, drug delivery and vaccination) all together trigged an immediate quick response to tuberculosis emerging by implementing new strategies based on acceptability of a functional public network composed of specialist, stakeholders, community leaders who have been informed and connected via different means of media including social media(Table-1)this was previously stated by ( 38 , 39 ). The appropriateness of the program was simplified to local communities by intensive training, lectures and meetings for better understanding, assessment and control of collected data (Table-2). A well-prepared budget for project feasibility was included in the two years plan which has been found it is the minimum period to implement such a project ( 40 ). The fidelity transition from input to impact is influenced by the presence of antecedent factors (i.e., elements that the program starts out with, usually forming part of the local milieu) and the emergence of mediating factors (i.e., influences that arise as the program unfolds) ( 35 ). Borrowing from force field analysis, inputs, antecedent factors and mediating factors can be classified into two: driving forces (i.e., facilitators, or factors, which, when increased, support attainment of the desired output), and restraining forces (i. e., barriers, or factors, which, when increased, support the status quo or detract from attainment of the desired results)( 41 – 43 ). It is noteworthy to mention that a restraining force can be the absence of a particular input or contextual factor( 44 ). Our implementation research outcomes were clearly divided into direct and indirect categories, this agreed ( 45 ) where the direct health impacted outcome was attenuated by changing regular health policies and prevention approached that have great benefits for poor communities resulted in their life hood enhancement as indirect outcomes( 46 ). One major outcome is the increasing of patient’s outreach, treatment and vaccination from 25% up to 75% obviously seen in Dordabe locality Eastern Sudan (Figure-3). The indirect outcomes were assembled in one category contains (economic, politics, cultural outcomes) which highlighted the importance of such approaches that have been credited by stakeholders with leading to greater acceptance of the need to integrate natural and social sciences in disease–related work, where a barrel research projects at the economics explicitly should be continued to explore this link( 41 , 42 ). A number of the experts that worked on the Project have to continue to research the issues raised during the Project and help lead initiatives and organizations that work on associated areas. The study further assesses some of the implementation challenges of TB preventive therapy and propose how activities can be improved and enhanced through research and innovative strategies for future prospects and increasement of beneficial impact outcomes obtained by developing implementation research for elimination and eradication of Tuberculosis, this in agreement with ( 47 ),where the backbone of the project has remained as an enduring point of reference for the ‘One Health’ Agenda. The project also emphasis on the importance of detecting disease and promoting a joined up One Health approach to be reflected in the creation of some new collaborative networks regionally and globally ( 48 ). The establishments of an Inter-departmental and coordination group for high containment facilities is highly needed to develop and have global approach to the procurement of evidence for tuberculosis as stated by( 49 ). The Project also can be credited with the importance that issues concerning the emergence of tuberculosis in Africa should be seen as a global public good, therefore, the extension of the project into Africa was a novel and previously unexplored idea, which in turn will lead to the support and creation of African Centre for Tuberculosis Surveillance directed by African Project team members( 50 , 51 ). Conclusion A major success of the project accomplishment, is the stimulation of the implementation strategy development for elimination and eradication of Tuberculosis in Sudan with a view to bring diagnostic and surveillance issues much higher up according to the research agenda especially for those areas explored with similar national and international research projects, reports and technical initiatives. The Project also highlighted the importance of economic, social and communicable approaches that have been credited by stakeholders with leading to greater acceptance of the need to integrate natural and social sciences in disease –related work. The annual and Mid-term review showed that further and- in some cases- impressive progress which has been made in affecting change and influencing policy. The project successfully stimulated the development of the implementation strategy for elimination and eradication of Tuberculosis in Sudan with a view to bring diagnostic and surveillance issues much higher up than the research agenda expectations, with the area explored in similar national and international research projects, reports and technical initiatives. Declarations Ethics approval and consent to participate : Can be found as separate attachments Ethical approval in English was issued from Elbarkal research committee Consent to participate in Arabic was issued for patients’ participation Consent for publication : An attached license agreement has been signed. Availability of data and materials: All data and materials are available upon request Competing interests: Authors have no competing interests Funding: This work was supported by Elbarkal Multi Activities, Dept. Research & Consultancy [Local fund sources No; 4] for the initiated phase of the project in the selected Dordabe area. To complete al phases the project is applying for international funds. Authors' contributions: A. A. E. (Principle Investigator), manuscript preparation, coordinated and carried out the study, O.A. N. (Social and Economic Evaluator) and A.A. E. Y. (Director) planed and designed the strategies of the project, performed the statistical analysis and participated in drafting the paper. N. M. A. carried out laboratory investigations, literature review and data analysis. K. M. S. designed patient assessment protocols, medical workshops and manuscript methodology arrangement, A. S. A. designed stakeholders training, locals’ lectures, public orientations, paper’s results interpretation and validation. All authors contribute manuscript preparation, read and approved the final draft. Acknowledgements: We would like to acknowledge with gratitude the assistance received from Dr. Mubarak Karsany (Karary University), Federal Ministry of Health, (and their cooperative laboratories staff. The government, the local authorities, tribes’ leaders and population of Kassala, El- Gedarif and Red Sea States. Authors' information (optional) Mr. Ayman Ahmed Elshayeb: MSc, PhD, Microbiologist @ Research and Development, Elbarkal Multi Activities, Khartoum – Sudan. [email protected] Dr. Nihad Mohammed Ahmed: PhD; Microbiologist @ Dept. Tuberculosis, Tropical Medical Research Institute, National Health Centre, Ministry of Health, Khartoum – Sudan. [email protected] Prof. Karimeldin Mohammed Salih: PhD, MD; Paediatrics and Medical Education @ Departments of paediatrics and Medical Education, College of Medicine, University of Bisha, Saudi Arabia. [email protected] Dr. Osama Abu Zaid Nugoud: PhD, Post Doc; Social Scientist @ Dept. Projects and Research Evaluation, Elbarkal Multi Activities, Khartoum – Sudan. [email protected] Mr. Abd Allah Elnayeb Yagoub: General Director. MBA; Business Development @ Dept. Projects and Research Administration, Elbarkal Multi Activities, Khartoum – Sudan. 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Health issues in newly arrived African refugees attending general practice clinics in Melbourne. Med J Aust. 2006;185(11-12):602-6. Iribarren SJ, Rodriguez Y, Lin L, Chirico C, Discacciati V, Schnall R, et al. Converting and expanding a mobile support intervention: Focus group and field-testing findings from individuals in active tuberculosis treatment. Int J Med Inform. 2020;136:104057. Harries AD, Kumar AMV, Satyanarayana S, Thekkur P, Lin Y, Dlodlo RA, et al. The Growing Importance of Tuberculosis Preventive Therapy and How Research and Innovation Can Enhance Its Implementation on the Ground. Trop Med Infect Dis. 2020;5(2). Dorji K, Lestari T, Jamtsho S, Mahendradhata Y. Implementation fidelity of hospital based directly observed therapy for tuberculosis treatment in Bhutan: mixed-method study. BMC Public Health. 2020;20(1):533. de Vries G, Tsolova S, Anderson LF, Gebhard AC, Heldal E, Hollo V, et al. Health system factors influencing management of multidrug-resistant tuberculosis in four European Union countries - learning from country experiences. BMC Public Health. 2017;17(1):334. Marme GD. Barriers and facilitators to effective tuberculosis infection control practices in Madang Province, PNG - a qualitative study. Rural Remote Health. 2018;18(3):4401. Ahmadi A, Nedjat S, Gholami J, Majdzadeh R. Tuberculosis Notification by Private Sector' Physicians in Tehran. Int J Prev Med. 2015;6:129. Dinler G, Sensoy G, Helek D, Kalayci AG. Tuberculous peritonitis in children: report of nine patients and review of the literature. World J Gastroenterol. 2008;14(47):7235-9. Jamaati H, Dastan F, Mirshafiei Langari Z, Haghgoo R, Eskandari R, Marjani M, et al. Study Protocol on Antimicrobial Stewardship in a Tertiary Respiratory Referral Hospital. Tanaffos. 2018;17(3):183-7. Rottenberg ME, Carow B. SOCS3 and STAT3, major controllers of the outcome of infection with Mycobacterium tuberculosis. Semin Immunol. 2014;26(6):518-32. Ferkol T, Schraufnagel D. The global burden of respiratory disease. Ann Am Thorac Soc. 2014;11(3):404-6. Wu K, Koo J, Jiang X, Chen R, Cohen SN, Nathan C. Improved control of tuberculosis and activation of macrophages in mice lacking protein kinase R. PLoS One. 2012;7(2):e30512. Saunders BM, Cooper AM. Restraining mycobacteria: role of granulomas in mycobacterial infections. Immunol Cell Biol. 2000;78(4):334-41. Shin SS, Asencios L, Yagui M, Yale G, Suarez C, Bayona J, et al. Impact of rapid drug susceptibility testing for tuberculosis: program experience in Lima, Peru. Int J Tuberc Lung Dis. 2012;16(11):1538-43. Dey A, Thekkur P, Ghosh A, Dasgupta T, Bandopadhyay S, Lahiri A, et al. Active Case Finding for Tuberculosis through TOUCH Agents in Selected High TB Burden Wards of Kolkata, India: A Mixed Methods Study on Outcomes and Implementation Challenges. Trop Med Infect Dis. 2019;4(4). Wild V, Frick M, Denholm J. WHO ethics guidance on TB care and migration: challenges to the implementation process. Int J Tuberc Lung Dis. 2020;24(5):32-7. Aye LL, Tripathy JP, Maung Maung T, Oo MM, Nwe ML, Thu HMM, et al. Experiences from the pilot implementation of the Package of Essential Non-communicable Disease Interventions (PEN) in Myanmar, 2017-18: A mixed methods study. PLoS One. 2020;15(2):e0229081. Vo LNQ, Vu TN, Nguyen HT, Truong TT, Khuu CM, Pham PQ, et al. Optimizing community screening for tuberculosis: Spatial analysis of localized case finding from door-to-door screening for TB in an urban district of Ho Chi Minh City, Viet Nam. PLoS One. 2018;13(12):e0209290. Chisompola NK, Streicher EM, Muchemwa CMK, Warren RM, Sampson SL. Molecular epidemiology of drug resistant Mycobacterium tuberculosis in Africa: a systematic review. BMC Infect Dis. 2020;20(1):344. Jacobs J, Hardy L, Semret M, Lunguya O, Phe T, Affolabi D, et al. Diagnostic Bacteriology in District Hospitals in Sub-Saharan Africa: At the Forefront of the Containment of Antimicrobial Resistance. Front Med (Lausanne). 2019;6:205. Supplementary Files AppendixA.pdf Appendix A: Sample Size Calculator: Images were from the programmed Microsoft Excel sheet which was used for estimation of population sample size and TB prevalence in Sudan. 1- Initial calculator: 2- Final Calculator: AppendixA.pdf Appendix A: Sample Size Calculator: Images were from the programmed Microsoft Excel sheet which was used for estimation of population sample size and TB prevalence in Sudan. 1- Initial calculator: 2- Final Calculator: AppendixB.pdf Appendix B. Major Work Plan: Research timeframe and estimated time will be divided in four periods during the two years of the project, this depends on the allowed period that given and sample size AppendixB.pdf Appendix B. Major Work Plan: Research timeframe and estimated time will be divided in four periods during the two years of the project, this depends on the allowed period that given and sample size AppendixC.pdf Appendix (C): Budget: The budget is scheduled upon the work plan and research expenses. AppendixC.pdf Appendix (C): Budget: The budget is scheduled upon the work plan and research expenses. ApendixD.TIDieRChecklistWord.pdf Appendix (D): Populated checklist ApendixD.TIDieRChecklistWord.pdf Appendix (D): Populated checklist 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. 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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-110381","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":4905699,"identity":"a3f817c3-fdec-4fb7-bbeb-9d8a21eb789f","order_by":0,"name":"Ayman Ahmed Elshayeb","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABBklEQVRIiWNgGAWjYBADGQYJIMnYYMMAZhADeKBa0kjXcpiwFv4Z2YmfCxhseORnNz+T+LjjfGL/7OaDDxhqbKJxaZG4kbtZegZDGo/BnWNmkjPP3E6ccedYsgHDsbTcBlx6buRukOZhOMxjIJFgJs3bdjux4UaOmQTQhTi1yANt+c3D8J9Hfkb6N+m/becS5xPSYnAjdxvQlgM8DECV0oxtBxI3ENJieObtNmsehmQegxs5xZa9Z5KNN95ISzZIwOMXueO5m2/zMNjJAR228cbPHXay824kH3zwocYGt/cFEoDR8Q/MZAHFiCNYZQIu5SDAfwDOZP4AJOzxKR4Fo2AUjIKRCQDStl5k8eDUAQAAAABJRU5ErkJggg==","orcid":"https://orcid.org/0000-0002-9942-9549","institution":"Karary University","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"Ayman","middleName":"Ahmed","lastName":"Elshayeb","suffix":""},{"id":4905700,"identity":"5e7d1b88-4a1c-42dc-84bc-476e3eb4cdaf","order_by":1,"name":"Nihad Mohammed Ahmed","email":"","orcid":"","institution":"National Health Center","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Nihad","middleName":"Mohammed","lastName":"Ahmed","suffix":""},{"id":4905701,"identity":"6990cc20-f08a-4ae6-913f-ebdf9f6d21f1","order_by":2,"name":"Karimeldin Mohammed Salih","email":"","orcid":"","institution":"University of Bisha","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Karimeldin","middleName":"Mohammed","lastName":"Salih","suffix":""},{"id":4905702,"identity":"d5b1044f-d8bc-4f61-8095-7bf440fbf8a8","order_by":3,"name":"Osama Abu Zaid Nugoud","email":"","orcid":"","institution":"Elbarkal Multi Activities","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Osama","middleName":"Abu Zaid","lastName":"Nugoud","suffix":""},{"id":4905703,"identity":"7ec2f76d-f4f5-4430-a6e1-b8f940d231cc","order_by":4,"name":"Abd Allah Elnayeb Yagoub","email":"","orcid":"","institution":"Elbarkal Multi Activities","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Abd","middleName":"Allah Elnayeb","lastName":"Yagoub","suffix":""},{"id":4905704,"identity":"8c6fa617-6a41-4265-a731-f2399d5b198d","order_by":5,"name":"Abdel Karim Sabir Ali","email":"","orcid":"","institution":"Al-Nahrain University","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Abdel","middleName":"Karim Sabir","lastName":"Ali","suffix":""}],"badges":[],"createdAt":"2020-11-17 17:07:24","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-110381/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-110381/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":3729794,"identity":"de86483d-88d3-4d4d-952a-c83428c0dfa8","added_by":"auto","created_at":"2020-11-20 17:59:58","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":45269,"visible":true,"origin":"","legend":"National tuberculosis infections baseline","description":"","filename":"1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-110381/v1/d94af28ea3819ad9591b5202.jpg"},{"id":3729778,"identity":"806aa799-66f3-4214-930f-2e2241f8c895","added_by":"auto","created_at":"2020-11-20 17:59:52","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":45269,"visible":true,"origin":"","legend":"National tuberculosis infections baseline","description":"","filename":"1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-110381/v1/36a07a5e1f6c1e652559a641.jpg"},{"id":3729796,"identity":"325a718f-56aa-4427-9c6d-4b0a15f1ece2","added_by":"auto","created_at":"2020-11-20 17:59:59","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":153723,"visible":true,"origin":"","legend":"Innovative strategies for developing tuberculosis framework.","description":"","filename":"2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-110381/v1/08f9943aae99a025a3935daa.jpg"},{"id":3729780,"identity":"5c010c66-c797-4a64-b386-7c817ab167f6","added_by":"auto","created_at":"2020-11-20 17:59:53","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":153723,"visible":true,"origin":"","legend":"Innovative strategies for developing tuberculosis framework.","description":"","filename":"2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-110381/v1/3818446a1b1a223d68d10649.jpg"},{"id":3729798,"identity":"c8a0be64-6fc4-4305-9aa3-aa7a277b1bcd","added_by":"auto","created_at":"2020-11-20 17:59:59","extension":"jpg","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":113632,"visible":true,"origin":"","legend":"Conceptual Diagram ©Elshayeb 2018","description":"","filename":"3.jpg","url":"https://assets-eu.researchsquare.com/files/rs-110381/v1/62d406207080d42215d344ab.jpg"},{"id":3729782,"identity":"04f9d83a-f8d1-4f8f-bdf3-478126d5f99d","added_by":"auto","created_at":"2020-11-20 17:59:53","extension":"jpg","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":113632,"visible":true,"origin":"","legend":"Conceptual Diagram ©Elshayeb 2018","description":"","filename":"3.jpg","url":"https://assets-eu.researchsquare.com/files/rs-110381/v1/33a6002b176be2b40c85558d.jpg"},{"id":13617756,"identity":"aa02da61-8b80-49df-b3a7-4f67e7929af5","added_by":"auto","created_at":"2021-09-17 06:54:02","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1247945,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-110381/v1/3ae99b7f-2661-4a67-8c99-9e76acc2ccc9.pdf"},{"id":3729795,"identity":"c2a4c36e-2771-444d-a6ce-7b87497890b0","added_by":"auto","created_at":"2020-11-20 17:59:58","extension":"pdf","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":133856,"visible":true,"origin":"","legend":"Appendix A: Sample Size Calculator:\n* Images were from the programmed Microsoft Excel sheet which was used for estimation of population sample size and TB prevalence in Sudan. \n1-\tInitial calculator:\n2-\tFinal Calculator: ","description":"","filename":"AppendixA.pdf","url":"https://assets-eu.researchsquare.com/files/rs-110381/v1/6aacd943882359885c2232d9.pdf"},{"id":3729779,"identity":"1795e9a8-c5a5-49cd-b3bc-0193dd72f666","added_by":"auto","created_at":"2020-11-20 17:59:52","extension":"pdf","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":133856,"visible":true,"origin":"","legend":"Appendix A: Sample Size Calculator:\n* Images were from the programmed Microsoft Excel sheet which was used for estimation of population sample size and TB prevalence in Sudan. \n1-\tInitial calculator:\n2-\tFinal Calculator: ","description":"","filename":"AppendixA.pdf","url":"https://assets-eu.researchsquare.com/files/rs-110381/v1/f3237239122293667284cd62.pdf"},{"id":3729797,"identity":"5dea5e02-08f8-4682-857e-e0f847557579","added_by":"auto","created_at":"2020-11-20 17:59:59","extension":"pdf","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":116781,"visible":true,"origin":"","legend":"Appendix B. Major Work Plan:\n* Research timeframe and estimated time will be divided in four periods during the two years of the project, this depends on the allowed period that given and sample size\n","description":"","filename":"AppendixB.pdf","url":"https://assets-eu.researchsquare.com/files/rs-110381/v1/06b11101d1442a1264da92f0.pdf"},{"id":3729781,"identity":"fbe9b0a1-acf4-4240-a6dc-4dd26e57f525","added_by":"auto","created_at":"2020-11-20 17:59:53","extension":"pdf","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":116781,"visible":true,"origin":"","legend":"Appendix B. Major Work Plan:\n* Research timeframe and estimated time will be divided in four periods during the two years of the project, this depends on the allowed period that given and sample size\n","description":"","filename":"AppendixB.pdf","url":"https://assets-eu.researchsquare.com/files/rs-110381/v1/400c959a23a8ec56e9d93912.pdf"},{"id":3729799,"identity":"70ef7cac-7c86-48f9-9060-de42f6f9e239","added_by":"auto","created_at":"2020-11-20 17:59:59","extension":"pdf","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":131838,"visible":true,"origin":"","legend":"Appendix (C): Budget:\n* The budget is scheduled upon the work plan and research expenses.","description":"","filename":"AppendixC.pdf","url":"https://assets-eu.researchsquare.com/files/rs-110381/v1/03f8bed700e92799f57b63f9.pdf"},{"id":3729783,"identity":"ea1f0b72-8ff7-4a1e-b150-6cb9aca101eb","added_by":"auto","created_at":"2020-11-20 17:59:53","extension":"pdf","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":131838,"visible":true,"origin":"","legend":"Appendix (C): Budget:\n* The budget is scheduled upon the work plan and research expenses.","description":"","filename":"AppendixC.pdf","url":"https://assets-eu.researchsquare.com/files/rs-110381/v1/10b24615267ecf1b9acd2d7a.pdf"},{"id":3729800,"identity":"1e56e5fc-543c-4307-af4c-695fb7b4d1cf","added_by":"auto","created_at":"2020-11-20 17:59:59","extension":"pdf","order_by":4,"title":"","display":"","copyAsset":false,"role":"supplement","size":241650,"visible":true,"origin":"","legend":"Appendix (D): Populated checklist ","description":"","filename":"ApendixD.TIDieRChecklistWord.pdf","url":"https://assets-eu.researchsquare.com/files/rs-110381/v1/58a64a5eb002c7f64cbe7581.pdf"},{"id":3729784,"identity":"9302edc3-23c2-4110-8da2-3c80ce5c696a","added_by":"auto","created_at":"2020-11-20 17:59:53","extension":"pdf","order_by":4,"title":"","display":"","copyAsset":false,"role":"supplement","size":241650,"visible":true,"origin":"","legend":"Appendix (D): Populated checklist ","description":"","filename":"ApendixD.TIDieRChecklistWord.pdf","url":"https://assets-eu.researchsquare.com/files/rs-110381/v1/c66190673a362bee7f23e6da.pdf"}],"financialInterests":"","formattedTitle":"Innovative Strategies for Developing Tuberculosis Implementation Research in Sudan","fulltext":[{"header":"Contributions To The Literature","content":"\u003cul\u003e\n\u003cli\u003eAfrica -with its all conflicts- at great risk of endemic, pan-endemic and epidemic of tuberculosis spread and outbreaks\u003c/li\u003e\n\u003cli\u003eReasons for spread and transmission of these diseases among poor communities are affected by free movement, high number of war displaced peoples beside other demographical issues.\u003c/li\u003e\n\u003cli\u003ePoor health systems coverage in Africa make it very important to interevent with emerging \u003cstrong\u003eImplementation Research\u003c/strong\u003e projects taking into account the proportion of clinical cases with underestimating the burden of tuberculosis.\u003c/li\u003e\n\u003cli\u003eUtilizing data on actual burden of tuberculosis is crucial for health authorities to design control programs for developing public health strategies such as surveillance, early warning and quick response system for spread and outbreaks, all can be defined as Implementation Research Conceptual Framework.\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"Introduction","content":"\u003cp\u003eGlobally, tuberculosis remains one of the top 10 causes of death worldwide. Millions of people continue to fall sick from TB each year(\u003cspan class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e3\u003c/span\u003e). The huge biodiversity in Sudan, has a great bacterial record showed variable characteristics of infections and antibiotics susceptibility, this gives an excellent opportunity to find the effective intervention system(\u003cspan class=\"CitationRef\"\u003e4\u003c/span\u003e). This study emphasizes the implementation systems that control, analyze and characterize TB treatment. In Sudan, especially the Eastern States, there are many areas at great risk of endemic, poverty and communicable diseases particularly tuberculosis (\u003cspan class=\"CitationRef\"\u003e5\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e7\u003c/span\u003e). The reasons for the spread and transmission of the disease in Sudan are attributed to medical, economical and geographical location of the country which is bounded by nine Eastern African countries; free movement, high number of Conflicts displaced peoples from boarders\u0026rsquo; countries, high illiteracy rates, limited financial resources(\u003cspan class=\"CitationRef\"\u003e8\u003c/span\u003e). The human host serves as the only natural reservoir for \u003cem\u003eMycobacterium tuberculosis\u003c/em\u003e of majority of tuberculosis but natural disasters such as aridity and geographical inaccessibility of some areas especially during the dry season can affect the circulation of tuberculosis in the Sudan(\u003cspan class=\"CitationRef\"\u003e9\u003c/span\u003e). Poor health system coverage makes it very important to conduct a population-based prevalence survey taking in to account the proportion of clinical cases which is always very few as such as a tip of iceberg underestimating the burden of the disease because most of the cases are asymptomatic infections(\u003cspan class=\"CitationRef\"\u003e10\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e14\u003c/span\u003e). b Urban areas have, in general, greater health provider diversity, are socioeconomically and culturally more diverse, and operate under different governmental structures. Furthermore, the transmission pattern and intensity are often different from rural areas. Many of these factors influence health seeking behaviour and perceptions about the disease, as well as case-definition and the epidemiology of tuberculosis, and, in general, methods, points and approaches for potential intervention. Moreover, the symptomatic cases are not adequately reported, so data on the actual burden of the disease is crucial for the public health authorities to design control programs(\u003cspan class=\"CitationRef\"\u003e15\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e17\u003c/span\u003e). The prevalence of risk factors of tuberculosis can be used to ascertain the vulnerable groups and develop public health strategies namely adequate surveillance system and early warning and response body to guard particularly against multi-drug resistant tuberculosis. Principally, the risk of anti-drugs resistant disease is very high; this increases the need to find new low-cost drugs(\u003cspan class=\"CitationRef\"\u003e18\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e20\u003c/span\u003e). One of the more interesting aspects of the present study into new implementation systems may in fact be the sequencing of their outcomes. The most important outcome is the change into how studying the treatment, vaccination and prevention is approached. It is also quite likely that even if the initial research is relatively not costly, the results may have great benefits in poor communities.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eGeneral Objective:\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eThe general objective of this project is to implement a new developed system for eliminating Tuberculosis infections among Sudanese focusing on the eradication of multidrug resistant Mycobacterium tuberculosis using novel methods for the targeted delivery of new therapeutic drugs.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSpecific objectives are to\u003c/strong\u003e:\u003c/p\u003e\n\u003col\u003e\n\u003cli\u003e\n\u003cp\u003eManage clinical and diagnosis process inside the endemic area.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eControl drug delivery to patients through direct channels.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eUtilize stakeholders outsourcing, networking, and connections for serving patients.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eManagement of surveillance and data collection.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eAssess conceptual, outcomes and evaluation systems.\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Methods","content":"\u003cp\u003e\u003cstrong\u003eStudy area/setting\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSudan (1,886,068\u0026nbsp;km\u003csup\u003e2\u003c/sup\u003e), has 18 states after separation of South Sudan in 2011. The geostatistical and the socioeconomic model will be an inclusive framework that takes various aspects of the study area, such as economic status, social and the geospatial distribution of TB into consideration. Climate change may have effects in the spread of TB, where the environment can be seen as a biosocial determinant of the diseases, it provides a direct space in which infection can take place, predominantly through increased exposure.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSample Size\u003c/strong\u003e: Sudan population is 32\u0026nbsp;million according to 2008 census excluding the separated South Sudan. The prevalence of Tuberculosis is very high especially among Eastern states\u0026rsquo; populations; namely Kassala (2,519,071), Al-Gedarif (2,208,385) and The Red Sea (1,482,053) respectively. These populations were chosen for a survey and/or experiment using World Health Organization recommended Sample Size Calculator and Sampling Spreadsheet (The STEPS) that can assist in first determining the size of sample and then in drawing a sample from sampling frame (\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.who.int/ncds/surveillance/steps/resources/sampling/en/\u003c/span\u003e\u003c/span\u003e). This will construct a 95% confidence interval with a margin of error of about\u0026thinsp;\u0026plusmn;\u0026thinsp;4.4% (for large populations).\u003c/p\u003e\n\u003cdiv id=\"Sec4\" class=\"Section2\"\u003e\n\u003cp\u003e\u003cstrong\u003eMedical intervention for tuberculosis infections:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eOnsite clinical testing and investigations\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTuberculin skin test (TST) and/or interferon-gamma release assay (IGRA) were used to test for LTBI, both tests measure immune sensitization (type IV or delayed-type hypersensitivity) to mycobacterial protein antigens that occurs following infection by \u003cem\u003eM. tuberculosis\u003c/em\u003e. Antibiotic susceptibility testing to isoniazid or rifampicin will be done by using CLSI guidelines and the second-line drugs considered are those listed in the WHO Guidelines for the Management of Drug Resistant Tuberculosis(\u003cspan class=\"CitationRef\"\u003e21\u003c/span\u003e).\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec5\" class=\"Section2\"\u003e\n\u003cp\u003e\u003cstrong\u003eMedical Assessment of Tuberculosis Patients:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e1-\u003cstrong\u003ePatient Registration\u003c/strong\u003e: of both healthy and sick patients. 2-\u003cstrong\u003eAppointment Management\u003c/strong\u003e: with routine reminders to notify patients about appointments and delays. 3- \u003cstrong\u003eReports and Dashboards\u003c/strong\u003e: To facilitate improved efficiencies through metric measurement. 4-\u003cstrong\u003eComputer software\u003c/strong\u003e: To enable patients\u0026rsquo; relationship management especially for chronic patients who visit the clinics more often.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInclusion Criteria\u003c/strong\u003e: The inclusion criteria included the following: (a) Tuberculosis diagnosis (b) tuberculosis treatment fully conducted at field site during infection pandemic and (c) being African citizens or residents.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eExclusion Criteria\u003c/strong\u003e: The exclusion criteria included the following: (a) death within the first 15 days of treatment, (b) treatment default during the first 30 days after treatment initiation, (c) change of Tuberculosis diagnosis during treatment, (d) transfer to other health unit, or (e) unknown treatment outcome. The project also will provide information on socio-demographic variables, presence of comorbidities, tuberculosis features and treatment, which we included as covariates.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec6\" class=\"Section2\"\u003e\n\u003cp\u003e\u003cstrong\u003eManagement of Mobile Emergency health intervention:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eUsing well equipped mobile clinics, labs and pharmacies for emergency intervention is essential especially in those areas who lack for regular health facilities, outreach clinic mobiles aim to provide primary and emergency health care services for poor communities.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData Collection methods, instruments used, measurements:\u003c/strong\u003e\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec7\" class=\"Section2\"\u003e\n\u003cp\u003e\u003cstrong\u003eNetworking and media and communication\u003c/strong\u003e: Data that has been collected and analyzed must be passed on to decision makers, the staff involved, and partners. This communication aspect is an essential component of a surveillance system and includes: feedback, dissemination of information, specific communications.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSurveillance data collection\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePublic health surveillance in points of care for communities/migrants operates inside camps with daily collection of epidemiological data for selected syndromes/health conditions that are important from a public health point of view. Data recorded refer to consultations for each syndrome/condition under surveillance in primary health care facilities in community/migrant reception centers. Data are sent daily to the Department of Surveillance and Intervention of communities by doctors, nurses and other health professionals from services and NGOs staffing primary care facilities.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData quality assurance methods, data management and analysis plans:\u003c/strong\u003e\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\n\u003cp\u003eAll official statistical activities shall be conducted in accordance with a Data Quality Framework that shall be developed by the National Centre for Statistics and Information in consultation with other government units that conduct official statistical activities. Once developed, the Data Quality Framework will be promulgated by Regulation/Government Decree (need to specify the legal process involved)\u0026rdquo;\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec9\" class=\"Section2\"\u003e\n\u003cp\u003e\u003cstrong\u003eDeveloping the national level policy of treatment, vaccination and prevention:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e1-\u003c/strong\u003eDeveloping drug delivery to lower levels and the cost of supervision of the communities. 2- Community based TB care developed together with implementing partners (Conduct situational analysis, establish partnership \u0026amp; coordination mechanism and Developing surveys). 3- Conducting a needs analysis, administering surveys, conducting interviews and developing curriculum.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAdministering regular evaluation of the disease situation\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e1- Organize community base and multidisciplinary teams. 2- Regular Survey and Monitoring 3- Quarterly Review Meeting. 4-Dissemination of training materials. 5-Infection Control.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStrategies to increase community access\u003c/strong\u003e: 1- \u003cstrong\u003eEducation\u003c/strong\u003e: Patient consulting, social marketing, 2-\u003cstrong\u003eManagement\u003c/strong\u003e: Financial management, business management. 3-\u003cstrong\u003eRegulation\u003c/strong\u003e: Standards development, task-shifting. 4-\u003cstrong\u003eEconomic\u003c/strong\u003e: Insurance plans, pooled procurement.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMajor workplan and Budget\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe work plan identified tasks, time and period of the activity took place and executive responsible person as scheduled in appendix (B). An outline of the financial costs involved in implementing the proposed study and any other essential resources was declared in appendix (C).\u003c/p\u003e\n\u003c/div\u003e"},{"header":"Results And Outcomes","content":"\u003cp\u003e\u003cstrong\u003eThe prevalence of tuberculosis among population: \u003c/strong\u003eThe disease total estimations in Sudan were 200,000 cases with 200 new infections annually include 1.9% Multi-Drug-Resistant \u003cem\u003eMycobacterium tuberculosis \u003c/em\u003eand 20.0% of them were previous treated patients (Figure 1). Using World Health Organization Sample Size Calculator, the final sample size = 0.015 for all Eastern States (Appendix A 1,2).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFigure-1: National tuberculosis infections baseline\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eManagement of mobile health intervention:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eManagement of mobile clinic\u003c/strong\u003e:\u0026nbsp; Clinic Management Systems to give complete end to end solutions to clinics that are looking for administrative support along with Record Management. The Clinic Management System is focused on bringing in efficiencies into the mobile clinics by streamlining Appointment management, Registration and follow up along with maintaining electronic records for all TB patients. The system was ensuring collection of appropriate data to be able to present dashboards to the key users with a focus on improving clinical and operational efficiencies and reducing costs.\u003c/p\u003e\n\u003cp\u003eB) \u003cstrong\u003eManagement of mobile laboratory:\u003c/strong\u003e Simple laboratory tests such as microscopy, ICTs blood tests, hemoglobin estimation and urine examination are carried out at camps by regular moving of laboratory with its technicians. The clinics received referrals from the laboratory technicians for the management of medical and surgical emergencies and making etiological diagnosis quick and correct.\u003c/p\u003e\n\u003cp\u003eC) \u003cstrong\u003eManagement of mobile Pharmacy:\u003c/strong\u003e Quick delivery of health services including treatment and vaccinations attuned to the needs of patients in different area. Monitoring of patients\u0026rsquo; health and their outcomes: An important benefit of the project drug delivery is derived from observations that tuberculosis patients at the boarders are suffering from lack of medical services than others.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eManagement of communication network\u003c/strong\u003e: include coordinate with others. Interagency and interpectoral coordination should be established to ensure comprehensive care for community.\u003c/p\u003e\n\u003cp\u003eConduct orientation meetings with community leaders; include representatives of social and community services, protection, the police or legal justice system, and security. Depending on the services available in the particular setting, others may need to be included. As a multi-sectoral team, establish referral networks, communication systems, coordination mechanisms, and follow-up strategies as shown in (Table-1).\u003c/p\u003e\u003cp\u003e\u003cimg src=\"https://myfiles.space/user_files/58653_1b1c6aeb34a62c68/58653_custom_files/img1605889936.jpg\"\u003e\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eImplementation of service delivery plan: \u003c/strong\u003eImplement solutions determined in the Improve stage. Comprehend both technical as well as any business process related changes. Implement a comprehensive \u0026lsquo;Change Management\u0026rsquo; plan to ensure that all stakeholders are appropriately trained.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData Control Measurement: \u003c/strong\u003eVerify at periodic intervals that the data is consistent with the business goals and the data rules specified in the Definition Step. Communicate the Data Quality metrics and current status to all stakeholders on a regular basis to ensure that Data Quality discipline is maintained on an ongoing basis across the organization as declared in (Table-2).\u003c/p\u003e\u003cp\u003e\u003cimg src=\"https://myfiles.space/user_files/58653_1b1c6aeb34a62c68/58653_custom_files/img1605889990.jpg\"\u003e\u003c/p\u003e\u003cp\u003e* Data Quality is not a onetime project but a continuous process and requires the entire organization to be data-driven and data-focused. With appropriate focus from the top, Data Quality Management can reap rich dividends to organizations.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eImplementation Research Outcomes: \u003c/strong\u003eThe conceptual framework for this project was informed by a combination of the general program logic model, the health system framework of the World Health Organization, the pillars of the Sudan health agenda, and the framework of the Strategic Elimination Plan. It is posited that the reduction of TB burden at the national level (long-term output or impact) is preceded by improved case-finding and case-holding practices (short-term output).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFigure-2 Innovative strategies for developing tuberculosis framework.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMedical intervention and quick response: \u003c/strong\u003eThese, in turn, require the following inputs and activities: (i) delivery of health services that are consistent with accepted standards, but are also attuned to the needs of the local population; (ii) availability of human, material and financial resources to support program implementation; (iii) evidence-informed decision making; (iv) exercise of administrative oversight, and presence of support from policy-makers and local stakeholders; and (v) effective partnerships that harness contribution from the other government agencies, private sector and civil society.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcceptability:\u003c/strong\u003e Perception of local policy-makers and decision-makers on their agreement to the TB prevention and control program as cascaded by the national government (and development partners, as applicable).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAppropriateness:\u003c/strong\u003e\u0026nbsp;\u0026nbsp;\u0026nbsp; Perception of local policy-makers and decision-makers on the relevance to their local context of the TB prevention and control program as cascaded by the national government (and development partners, as applicable).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFidelity:\u003c/strong\u003e The consistency and quality of the intervention\u0026rsquo;s implementation was implemented as intended due to major plan and conceptual framework (Figures-2, 3)\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFeasibility: \u003c/strong\u003ePerception of local policy-makers and decision-makers on the practicality of implementing the TB prevention and control program as cascaded by the national government (and development partners, as applicable). For purposes of the implementation research, the acceptability, appropriateness and feasibility of the package of interventions for TB prevention and control as provided by the national government from the local policy-makers shall be considered as among these potential driving or restraining forces.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eImplementation research outcomes\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSocio-(economic, politics, cultural) impact outcome: \u003c/strong\u003eAn important benefit of the project is derived from the observation that tuberculosis is much more common in boarders than center of Sudan where no clinical services. It is conceivable that, although outbreaks may occur periodically, the control of disease might be easier to overcome than direct medication.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFigure-3\u003c/strong\u003e\u003cstrong\u003e: Conceptual Diagram \u0026copy;Elshayeb 2018\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDirect health impact outcome\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eChanging the regular health policies and the prevention approach have great benefits in poor communities. Another obvious outcome is the increase of patient\u0026rsquo;s outreach, treatment and vaccination from 25% up to 75% in Dordabe locality Eastern Sudan\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eBeneficial impact outcome\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eDeveloping implementation strategy for elimination and eradication of Tuberculosis has stimulated funds from national and (expected international) relevant organizations and academia.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFuture Prospects\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eDevelopment of future management systems could offer powerful tools for disease management within wider strategies of control\u003c/li\u003e\n\u003cli\u003eThe Project is an attempted a grand challenge to identify future risks from tuberculosis across Sudan and neighborhood.\u003c/li\u003e\n\u003cli\u003eImplementation of a new research study and technology that might reduce such risks.\u003c/li\u003e\n\u003cli\u003eDevelopment of alternative therapeutics technology platform against MDR tuberculosis using novel methods for the targeted delivery of Bacteriophage Therapy\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"Discussion","content":"\u003cp\u003eTuberculosis is well-considered as an endemic and economic related disease in many countries as a result of poverty(\u003cspan class=\"CitationRef\"\u003e22\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e23\u003c/span\u003e). Many health systems in the Globe depend on clinical, official and governmental efforts without considering other implementation research settings against tuberculosis defeating(\u003cspan class=\"CitationRef\"\u003e24\u003c/span\u003e). Although the recent health managerial policies of disease control were successful in the treatment of the disease but they failed in eradication (particularly the MDR tuberculosis) due to the lack of effective implementation research studies and trials(\u003cspan class=\"CitationRef\"\u003e25\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e27\u003c/span\u003e). The present study showed the impact of a new empirical, managerial and integrated system for tuberculosis treatment in Sudan using innovative strategies of implementation research and how it is suitable for other countries who have similar conditions of disease epidemiologic. The risk of tuberculosis outbreaks among people fleeing hardship for poor, war\u0026rsquo;s victims and refugees in Sudan is heightened by the description of the local health response to outbreak of tuberculosis among all those patients (\u003cspan class=\"CitationRef\"\u003e28\u003c/span\u003e). Conflict and war have long been recognized as determinants of infectious disease risk, re-emergence of epidemic tuberculosis and also has coincided with extensive civil conflict in affected regions(\u003cspan class=\"CitationRef\"\u003e29\u003c/span\u003e). The needs of Implementation Research are very important for the critical health situation in Eastern Sudan, where the population has been suffering for long time from the endemic TB, beside poverty and long distant has stimulate the need of mobile combo-clinic for patients\u0026rsquo; outreach. This emergency facility has been used in many countries as stated by (\u003cspan class=\"CitationRef\"\u003e30\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e33\u003c/span\u003e). The success of such implemented research is obviously seen in the reduction of the disease among the selected populations, this is in agreement with(\u003cspan class=\"CitationRef\"\u003e34\u003c/span\u003e) who outlined the implementation challenges around the diagnosis and treatment of TB and described how current TB preventive therapy activities have been shaped and managed. The triangular conceptual framework (World Health Organization, local health authorities, and our innovative Strategic Plan) was implemented as an urgent responded action to eliminate the disease spreading (Figure \u0026minus;\u0026thinsp;2)(\u003cspan class=\"CitationRef\"\u003e35\u003c/span\u003e). The conceptual framework\u0026rsquo;s inner settings (health services) and outer settings (the financial and sociopolitical environment of local health services) were combined to obtain the highest level of the program perfection(\u003cspan class=\"CitationRef\"\u003e36\u003c/span\u003e). This novel framework highlighted the morbidity, disability and heightened mortality that persist after successful treatment completion, in order to appreciate the importance of TB preventive therapy in the overall context of ending the MDR-TB epidemic and ensuring healthy lives(\u003cspan class=\"CitationRef\"\u003e37\u003c/span\u003e). The Medical intervention combination (laboratory investigations, patient\u0026rsquo;s assessment, drug delivery and vaccination) all together trigged an immediate quick response to tuberculosis emerging by implementing new strategies based on acceptability of a functional public network composed of specialist, stakeholders, community leaders who have been informed and connected via different means of media including social media(Table-1)this was previously stated by (\u003cspan class=\"CitationRef\"\u003e38\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e39\u003c/span\u003e). The appropriateness of the program was simplified to local communities by intensive training, lectures and meetings for better understanding, assessment and control of collected data (Table-2). A well-prepared budget for project feasibility was included in the two years plan which has been found it is the minimum period to implement such a project (\u003cspan class=\"CitationRef\"\u003e40\u003c/span\u003e). The fidelity transition from input to impact is influenced by the presence of antecedent factors (i.e., elements that the program starts out with, usually forming part of the local milieu) and the emergence of mediating factors (i.e., influences that arise as the program unfolds) (\u003cspan class=\"CitationRef\"\u003e35\u003c/span\u003e). Borrowing from force field analysis, inputs, antecedent factors and mediating factors can be classified into two: driving forces (i.e., facilitators, or factors, which, when increased, support attainment of the desired output), and restraining forces (i. e., barriers, or factors, which, when increased, support the status quo or detract from attainment of the desired results)(\u003cspan class=\"CitationRef\"\u003e41\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e43\u003c/span\u003e). It is noteworthy to mention that a restraining force can be the absence of a particular input or contextual factor(\u003cspan class=\"CitationRef\"\u003e44\u003c/span\u003e). Our implementation research outcomes were clearly divided into direct and indirect categories, this agreed (\u003cspan class=\"CitationRef\"\u003e45\u003c/span\u003e) where the direct health impacted outcome was attenuated by changing regular health policies and prevention approached that have great benefits for poor communities resulted in their life hood enhancement as indirect outcomes(\u003cspan class=\"CitationRef\"\u003e46\u003c/span\u003e). One major outcome is the increasing of patient\u0026rsquo;s outreach, treatment and vaccination from 25% up to 75% obviously seen in Dordabe locality Eastern Sudan (Figure-3). The indirect outcomes were assembled in one category contains (economic, politics, cultural outcomes) which highlighted the importance of such approaches that have been credited by stakeholders with leading to greater acceptance of the need to integrate natural and social sciences in disease\u0026ndash;related work, where a barrel research projects at the economics explicitly should be continued to explore this link(\u003cspan class=\"CitationRef\"\u003e41\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e42\u003c/span\u003e). A number of the experts that worked on the Project have to continue to research the issues raised during the Project and help lead initiatives and organizations that work on associated areas. The study further assesses some of the implementation challenges of TB preventive therapy and propose how activities can be improved and enhanced through research and innovative strategies for future prospects and increasement of beneficial impact outcomes obtained by developing implementation research for elimination and eradication of Tuberculosis, this in agreement with (\u003cspan class=\"CitationRef\"\u003e47\u003c/span\u003e),where the backbone of the project has remained as an enduring point of reference for the \u0026lsquo;One Health\u0026rsquo; Agenda. The project also emphasis on the importance of detecting disease and promoting a joined up One Health approach to be reflected in the creation of some new collaborative networks regionally and globally (\u003cspan class=\"CitationRef\"\u003e48\u003c/span\u003e). The establishments of an Inter-departmental and coordination group for high containment facilities is highly needed to develop and have global approach to the procurement of evidence for tuberculosis as stated by(\u003cspan class=\"CitationRef\"\u003e49\u003c/span\u003e). The Project also can be credited with the importance that issues concerning the emergence of tuberculosis in Africa should be seen as a global public good, therefore, the extension of the project into Africa was a novel and previously unexplored idea, which in turn will lead to the support and creation of African Centre for Tuberculosis Surveillance directed by African Project team members(\u003cspan class=\"CitationRef\"\u003e50\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e51\u003c/span\u003e).\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eA major success of the project accomplishment, is the stimulation of the implementation strategy development for elimination and eradication of Tuberculosis in Sudan with a view to bring diagnostic and surveillance issues much higher up according to the research agenda especially for those areas explored with similar national and international research projects, reports and technical initiatives. The Project also highlighted the importance of economic, social and communicable approaches that have been credited by stakeholders with leading to greater acceptance of the need to integrate natural and social sciences in disease \u0026ndash;related work. The annual and Mid-term review showed that further and- in some cases- impressive progress which has been made in affecting change and influencing policy. The project successfully stimulated the development of the implementation strategy for elimination and eradication of Tuberculosis in Sudan with a view to bring diagnostic and surveillance issues much higher up than the research agenda expectations, with the area explored in similar national and international research projects, reports and technical initiatives.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003cstrong\u003e:\u003c/strong\u003e Can be found as separate attachments\u003c/p\u003e\n\u003cp\u003eEthical approval in English was issued from Elbarkal research committee\u003c/p\u003e\n\u003cp\u003eConsent to participate in Arabic was issued for patients\u0026rsquo; participation\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e: An attached license agreement has been signed.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials:\u003c/strong\u003e All data and materials are available upon request\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests:\u003c/strong\u003e Authors have no competing interests\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u003c/strong\u003e This work was supported by Elbarkal Multi Activities, Dept. Research \u0026amp; Consultancy [Local fund sources No; 4] for the initiated phase of the project in the selected Dordabe area. To complete al phases the project is applying for international funds.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors' contributions: \u003c/strong\u003eA. A. E. (Principle Investigator), manuscript preparation, coordinated and carried out the study, O.A. N. (Social and Economic Evaluator) and A.A. E. Y. (Director) planed and designed the strategies of the project, performed the statistical analysis and participated in drafting the paper. N. M. A. carried out laboratory investigations, literature review and data analysis. K. M. S. designed patient assessment protocols, medical workshops and manuscript methodology arrangement, A. S. A. designed stakeholders training, locals\u0026rsquo; lectures, public orientations, paper\u0026rsquo;s results interpretation and validation. \u0026nbsp;All authors contribute manuscript preparation, read and approved the final draft.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements:\u003c/strong\u003e We would like to acknowledge with gratitude the assistance received from Dr. Mubarak Karsany (Karary University), Federal Ministry of Health, (and their cooperative laboratories staff. The government, the local authorities, tribes\u0026rsquo; leaders and population of Kassala, El- Gedarif and Red Sea States. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors' information (optional)\u003c/strong\u003e\u003c/p\u003e\n\u003col\u003e\n\u003cli\u003e\u003cstrong\u003eMr. Ayman Ahmed Elshayeb:\u003c/strong\u003e \u0026nbsp;MSc, PhD, Microbiologist @ Research and Development, Elbarkal Multi Activities, Khartoum \u0026ndash; Sudan. \u003ca href=\"mailto:[email protected]\"\[email protected]\u003c/a\u003e\u003c/li\u003e\n\u003cli\u003e\u003cstrong\u003eDr. Nihad Mohammed Ahmed:\u003c/strong\u003e PhD; Microbiologist @ Dept. Tuberculosis, Tropical Medical Research Institute, National Health Centre, Ministry of Health, Khartoum \u0026ndash; Sudan. \u003ca href=\"mailto:[email protected]\"\[email protected]\u003c/a\u003e\u003c/li\u003e\n\u003cli\u003e\u003cstrong\u003eProf. Karimeldin Mohammed Salih:\u003c/strong\u003e PhD, MD; Paediatrics and Medical Education @ Departments of paediatrics and Medical Education, College of Medicine, University of Bisha, Saudi Arabia. \u003ca href=\"mailto:[email protected]\"\[email protected]\u003c/a\u003e\u003c/li\u003e\n\u003cli\u003e\u003cstrong\u003eDr. \u0026nbsp;Osama Abu Zaid Nugoud:\u003c/strong\u003e PhD, Post Doc; Social Scientist @ Dept. Projects and Research Evaluation, Elbarkal Multi Activities, Khartoum \u0026ndash; Sudan. \u003ca href=\"mailto:[email protected]\"\[email protected]\u003c/a\u003e\u003c/li\u003e\n\u003cli\u003e\u003cstrong\u003eMr. Abd Allah Elnayeb \u0026nbsp;Yagoub:\u003c/strong\u003e General Director. MBA; Business Development @ Dept. Projects and Research Administration, Elbarkal Multi Activities, Khartoum \u0026ndash; Sudan. \u003ca href=\"mailto:[email protected]\"\[email protected]\u003c/a\u003e\u003c/li\u003e\n\u003cli\u003e\u003cstrong\u003eProf.\u003c/strong\u003e \u003cstrong\u003eAbdel Karim Sabir Ali: \u003c/strong\u003ePhD; Environmentalist @ Dean College, Faculty of Science and Technology, Al Neelain University, Khartoum \u0026ndash; Sudan. \u003ca href=\"mailto:[email protected]\"\[email protected]\u003c/a\u003e\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eRens NE, Uyl-de Groot CA, Goldhaber-Fiebert JD, Croda J, Andrews JR. Cost-Effectiveness of a Pharmacogenomic Test for Stratified Isoniazid Dosing in Treatment of Active Tuberculosis. Clin Infect Dis. 2020.\u003c/li\u003e\n\u003cli\u003eNour-Neamatollahi A, Siadat SD, Yari S, Tasbiti AH, Ebrahimzadeh N, Vaziri F, et al. 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The challenges of the Philippines' social health insurance programme in the era of Universal Health Coverage. Public Health Action. 2018;8(4):175-80.\u003c/li\u003e\n\u003cli\u003eRanabhat CL, Kim CB, Singh A, Acharya D, Pathak K, Sharma B, et al. Challenges and opportunities towards the road of universal health coverage (UHC) in Nepal: a systematic review. Arch Public Health. 2019;77:5.\u003c/li\u003e\n\u003cli\u003ede Souza RA, Nery JS, Rasella D, Guimaraes Pereira RA, Barreto ML, Rodrigues L, et al. Family health and conditional cash transfer in Brazil and its effect on tuberculosis mortality. Int J Tuberc Lung Dis. 2018;22(11):1300-6.\u003c/li\u003e\n\u003cli\u003eVerguet S, Jamison DT. Health Policy Analysis: Applications of Extended Cost-Effectiveness Analysis Methodology in Disease Control Priorities, Third Edition. In: rd, Jamison DT, Gelband H, Horton S, Jha P, Laxminarayan R, et al., editors. Disease Control Priorities: Improving Health and Reducing Poverty. Washington (DC)2017.\u003c/li\u003e\n\u003cli\u003eDurovni B, Saraceni V, Puppin MS, Tassinari W, Cruz OG, Cavalcante S, et al. The impact of the Brazilian Family Health Strategy and the conditional cash transfer on tuberculosis treatment outcomes in Rio de Janeiro: an individual-level analysis of secondary data. J Public Health (Oxf). 2018;40(3):e359-e66.\u003c/li\u003e\n\u003cli\u003eRagonnet R, Underwood F, Doan T, Rafai E, Trauer J, McBryde E. Strategic Planning for Tuberculosis Control in the Republic of Fiji. Trop Med Infect Dis. 2019;4(2).\u003c/li\u003e\n\u003cli\u003ePng ME, Yoong J, Ong CWM, Fisher D, Bagdasarian N. A screening strategy for latent tuberculosis in healthcare workers: Cost-effectiveness and budget impact of universal versus targeted screening. Infect Control Hosp Epidemiol. 2019;40(3):341-9.\u003c/li\u003e\n\u003cli\u003eDiaw MM, Ndiaye M, Riccardi N, Ungaro R, Alagna R, Cirillo DM, et al. Implementing TB control in a rural, resource-limited setting: the stop-TB Italia project in Senegal. Multidiscip Respir Med. 2018;13:41.\u003c/li\u003e\n\u003cli\u003eElduma AH, Mansournia MA, Foroushani AR, Ali HMH, Elegail AMA, Elsony A, et al. Assessment of the risk factors associated with multidrug-resistant tuberculosis in Sudan: a case-control study. Epidemiol Health. 2019;41:e2019014.\u003c/li\u003e\n\u003cli\u003eBayoumi RR, van der Poel S, El Samani EZ, Boivin J. An evaluation of comprehensiveness, feasibility and acceptability of a fertility awareness educational tool. Reprod Biomed Soc Online. 2018;6:10-21.\u003c/li\u003e\n\u003cli\u003eSobe Jermano Boyong C, Kankya C, James M, Munyeme M, Jubara AS, Ndoboli D, et al. Dynamics of tuberculosis in Wau, South Sudan during a period of armed conflict. J Clin Tuberc Other Mycobact Dis. 2018;12:54-65.\u003c/li\u003e\n\u003cli\u003eFalzon D, Jaramillo E, Schunemann HJ, Arentz M, Bauer M, Bayona J, et al. WHO guidelines for the programmatic management of drug-resistant tuberculosis: 2011 update. Eur Respir J. 2011;38(3):516-28.\u003c/li\u003e\n\u003cli\u003ePloubidis GB, Palmer MJ, Blackmore C, Lim TA, Manissero D, Sandgren A, et al. Social determinants of tuberculosis in Europe: a prospective ecological study. Eur Respir J. 2012;40(4):925-30.\u003c/li\u003e\n\u003cli\u003eWeiss MG, Somma D, Karim F, Abouihia A, Auer C, Kemp J, et al. Cultural epidemiology of TB with reference to gender in Bangladesh, India and Malawi. Int J Tuberc Lung Dis. 2008;12(7):837-47.\u003c/li\u003e\n\u003cli\u003eLin HH, Langley I, Mwenda R, Doulla B, Egwaga S, Millington KA, et al. A modelling framework to support the selection and implementation of new tuberculosis diagnostic tools. Int J Tuberc Lung Dis. 2011;15(8):996-1004.\u003c/li\u003e\n\u003cli\u003eRaftery P, Kodmon C, van der Werf MJ, Nikolayevskyy V. European Union training programme for tuberculosis laboratory experts: design, contribution and future direction. BMC Health Serv Res. 2020;20(1):413.\u003c/li\u003e\n\u003cli\u003eMekebeb MB, Von Pressentin K, Jenkins LS. Institutional tuberculosis infection control in a rural sub-district in South Africa: A quality improvement study. Afr J Prim Health Care Fam Med. 2019;11(1):e1-e8.\u003c/li\u003e\n\u003cli\u003eVerkuijl S, Middelkoop K. Protecting Our Front-liners: Occupational Tuberculosis Prevention Through Infection Control Strategies. Clin Infect Dis. 2016;62 Suppl 3:S231-7.\u003c/li\u003e\n\u003cli\u003eWalker TM, Merker M, Knoblauch AM, Helbling P, Schoch OD, van der Werf MJ, et al. A cluster of multidrug-resistant Mycobacterium tuberculosis among patients arriving in Europe from the Horn of Africa: a molecular epidemiological study. Lancet Infect Dis. 2018;18(4):431-40.\u003c/li\u003e\n\u003cli\u003eBerrang Ford L. Civil conflict and sleeping sickness in Africa in general and Uganda in particular. Confl Health. 2007;1:6.\u003c/li\u003e\n\u003cli\u003eLee JH, Han CD, Cho SN, Yang IH, Lee WS, Baek SH, et al. How Long Does Antimycobacterial Antibiotic-loaded Bone Cement Have In Vitro Activity for Musculoskeletal Tuberculosis? Clin Orthop Relat Res. 2017;475(11):2795-804.\u003c/li\u003e\n\u003cli\u003eHepple P, Novoa-Cain J, Cheruiyot C, Richter E, Ritmeijer K. Implementation of liquid culture for tuberculosis diagnosis in a remote setting: lessons learned. Int J Tuberc Lung Dis. 2011;15(3):405-7.\u003c/li\u003e\n\u003cli\u003eTiong AC, Patel MS, Gardiner J, Ryan R, Linton KS, Walker KA, et al. Health issues in newly arrived African refugees attending general practice clinics in Melbourne. Med J Aust. 2006;185(11-12):602-6.\u003c/li\u003e\n\u003cli\u003eIribarren SJ, Rodriguez Y, Lin L, Chirico C, Discacciati V, Schnall R, et al. Converting and expanding a mobile support intervention: Focus group and field-testing findings from individuals in active tuberculosis treatment. Int J Med Inform. 2020;136:104057.\u003c/li\u003e\n\u003cli\u003eHarries AD, Kumar AMV, Satyanarayana S, Thekkur P, Lin Y, Dlodlo RA, et al. The Growing Importance of Tuberculosis Preventive Therapy and How Research and Innovation Can Enhance Its Implementation on the Ground. Trop Med Infect Dis. 2020;5(2).\u003c/li\u003e\n\u003cli\u003eDorji K, Lestari T, Jamtsho S, Mahendradhata Y. Implementation fidelity of hospital based directly observed therapy for tuberculosis treatment in Bhutan: mixed-method study. BMC Public Health. 2020;20(1):533.\u003c/li\u003e\n\u003cli\u003ede Vries G, Tsolova S, Anderson LF, Gebhard AC, Heldal E, Hollo V, et al. Health system factors influencing management of multidrug-resistant tuberculosis in four European Union countries - learning from country experiences. BMC Public Health. 2017;17(1):334.\u003c/li\u003e\n\u003cli\u003eMarme GD. Barriers and facilitators to effective tuberculosis infection control practices in Madang Province, PNG - a qualitative study. Rural Remote Health. 2018;18(3):4401.\u003c/li\u003e\n\u003cli\u003eAhmadi A, Nedjat S, Gholami J, Majdzadeh R. Tuberculosis Notification by Private Sector' Physicians in Tehran. Int J Prev Med. 2015;6:129.\u003c/li\u003e\n\u003cli\u003eDinler G, Sensoy G, Helek D, Kalayci AG. Tuberculous peritonitis in children: report of nine patients and review of the literature. World J Gastroenterol. 2008;14(47):7235-9.\u003c/li\u003e\n\u003cli\u003eJamaati H, Dastan F, Mirshafiei Langari Z, Haghgoo R, Eskandari R, Marjani M, et al. Study Protocol on Antimicrobial Stewardship in a Tertiary Respiratory Referral Hospital. Tanaffos. 2018;17(3):183-7.\u003c/li\u003e\n\u003cli\u003eRottenberg ME, Carow B. SOCS3 and STAT3, major controllers of the outcome of infection with Mycobacterium tuberculosis. Semin Immunol. 2014;26(6):518-32.\u003c/li\u003e\n\u003cli\u003eFerkol T, Schraufnagel D. The global burden of respiratory disease. Ann Am Thorac Soc. 2014;11(3):404-6.\u003c/li\u003e\n\u003cli\u003eWu K, Koo J, Jiang X, Chen R, Cohen SN, Nathan C. Improved control of tuberculosis and activation of macrophages in mice lacking protein kinase R. PLoS One. 2012;7(2):e30512.\u003c/li\u003e\n\u003cli\u003eSaunders BM, Cooper AM. Restraining mycobacteria: role of granulomas in mycobacterial infections. Immunol Cell Biol. 2000;78(4):334-41.\u003c/li\u003e\n\u003cli\u003eShin SS, Asencios L, Yagui M, Yale G, Suarez C, Bayona J, et al. Impact of rapid drug susceptibility testing for tuberculosis: program experience in Lima, Peru. Int J Tuberc Lung Dis. 2012;16(11):1538-43.\u003c/li\u003e\n\u003cli\u003eDey A, Thekkur P, Ghosh A, Dasgupta T, Bandopadhyay S, Lahiri A, et al. Active Case Finding for Tuberculosis through TOUCH Agents in Selected High TB Burden Wards of Kolkata, India: A Mixed Methods Study on Outcomes and Implementation Challenges. Trop Med Infect Dis. 2019;4(4).\u003c/li\u003e\n\u003cli\u003eWild V, Frick M, Denholm J. WHO ethics guidance on TB care and migration: challenges to the implementation process. Int J Tuberc Lung Dis. 2020;24(5):32-7.\u003c/li\u003e\n\u003cli\u003eAye LL, Tripathy JP, Maung Maung T, Oo MM, Nwe ML, Thu HMM, et al. Experiences from the pilot implementation of the Package of Essential Non-communicable Disease Interventions (PEN) in Myanmar, 2017-18: A mixed methods study. PLoS One. 2020;15(2):e0229081.\u003c/li\u003e\n\u003cli\u003eVo LNQ, Vu TN, Nguyen HT, Truong TT, Khuu CM, Pham PQ, et al. Optimizing community screening for tuberculosis: Spatial analysis of localized case finding from door-to-door screening for TB in an urban district of Ho Chi Minh City, Viet Nam. PLoS One. 2018;13(12):e0209290.\u003c/li\u003e\n\u003cli\u003eChisompola NK, Streicher EM, Muchemwa CMK, Warren RM, Sampson SL. Molecular epidemiology of drug resistant Mycobacterium tuberculosis in Africa: a systematic review. BMC Infect Dis. 2020;20(1):344.\u003c/li\u003e\n\u003cli\u003eJacobs J, Hardy L, Semret M, Lunguya O, Phe T, Affolabi D, et al. Diagnostic Bacteriology in District Hospitals in Sub-Saharan Africa: At the Forefront of the Containment of Antimicrobial Resistance. Front Med (Lausanne). 2019;6:205.\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":"Conceptual framework, Implementation, Strategies, Sudan, Tuberculosis","lastPublishedDoi":"10.21203/rs.3.rs-110381/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-110381/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eIntroduction: \u003c/strong\u003eSudan, especially Eastern States are very poor areas at great risk of endemic and communicable diseases particularly tuberculosis. The reasons for the spread and transmission of this disease include medical, economical and geographical issues, besides Sudan’s location in the middle of nine countries in East Africa, its boundaries were affected by free movement, high number of conflicts displaced peoples from boarders’ countries, high illiteracy rates, limited financial resources and shortages in medical services. \u003c/p\u003e\u003cp\u003e\u003cstrong\u003eObjectives: \u003c/strong\u003eThis project is conducted to implement a new developed system for eliminating Tuberculosis infections among eastern Sudanese populations focusing on the eradication of multidrug resistant \u003cem\u003eMycobacterium tuberculosis \u003c/em\u003eincluding novel methods for the targeted delivery of new therapeutic drugs. \u003c/p\u003e\u003cp\u003e\u003cstrong\u003eMethods: \u003c/strong\u003eStrategies adopted in this work are proposed to increase access includes to communicable and economic factors. Disease Survey and Laboratorial Investigation for Multi Drug Resistant bacterial strains confirmation. Medical Assessment of TB Patients to facilitate improved efficiencies through metric measurement and enable patients’ relationship management.\u0026nbsp;Established a national level policy of treatment, vaccination and prevention.\u0026nbsp;Administering regular evaluation of the disease situation and control.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eResults: \u003c/strong\u003eImplementation outcomes includes the conceptual framework for this project were informed by a combination of the general program logic model, the health system framework of the World Health Organization, WHO, the pillars of the Sudan health agenda, and the framework of the Strategic Elimination Plan. It is assumed that the reduction of TB burden at the national level (long-term output or impact) is preceded by improved case-finding and case-holding practices (short-term output). Impact outcome of the project is derived from the observation that tuberculosis is much more common at the boarders than center of Sudan where no adequate clinical services are available. It is conceivable that, although outbreaks may occur periodically, the control of disease might be easier to overcome than direct medication.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eConclusion: \u003c/strong\u003e\u0026nbsp;A major success of the project accomplishment, is the stimulation of the implementation strategy development for elimination and eradication of Tuberculosis in Sudan with a view to bring diagnostic and surveillance issues much higher up according to the implementation research agenda especially for those areas explored with similar national and international research projects, reports and technical initiatives.\u0026nbsp;\u003c/p\u003e","manuscriptTitle":"Innovative Strategies for Developing Tuberculosis Implementation Research in Sudan","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2020-11-20 17:59:50","doi":"10.21203/rs.3.rs-110381/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":"4b305c9c-bb30-4418-b689-d7b24c083d76","owner":[],"postedDate":"November 20th, 2020","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":1155781,"name":"Health Economics \u0026 Outcomes Research"},{"id":1155782,"name":"Health Policy"},{"id":1155783,"name":"Infectious Diseases"}],"tags":[],"updatedAt":"2020-11-20T21:55:04+00:00","versionOfRecord":[],"versionCreatedAt":"2020-11-20 17:59:50","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-110381","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-110381","identity":"rs-110381","version":["v1"]},"buildId":"7rjqhiLT3MXkJMwkYKINL","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}