National Tuberculosis Elimination Programme Research Articles

Coverage, delays and implementation challenges of ‘Direct Benefit Transfer’ in the National Tuberculosis Elimination Programme – A mixed methods study

IntroductionFood insecurity and undernutrition both contribute to the large tuberculosis burden in India. Indian government rolled out the direct benefit transfer (DBT) programme “Nikshay Poshan Yojana” on a national scale on April 1, 2018 largely to provide nutritional support. Hence, it was proposed to take up this study in Western Maharashtra (Pune district) to study the coverage, delays and implementation challenges of ‘Direct Benefit Transfer’ in the National Tuberculosis Elimination Programme as there have only been a limited number of studies conducted regarding the same. MethodologyThis mixed methods study was conducted at Tuberculosis Units (TUs) under District Tuberculosis Officer (DTO) in Western Maharashtra (Pune district) for the duration August 2020 to September 2022. A total of 3373 participants were included for the quantitative component. For qualitative component In-depth interviews of key informants (healthcare providers involved in the implementation of Direct Benefit Transfer) and Focus Group Discussion (FGD) for patients and care givers was done and explored using thematic analysis. ResultsThe total coverage was found to be 76.81%. The health providers reported staff related challenges (overburden and non-cooperative staff), bank related issues (local and cooperate banks not involved in the Public Financial Management System (PFMS) loop and lack of bank account), patient related issues (fear of being scammed), the DBT process (lengthy and complex) and software related issues as major hurdles involved in the scheme's implementation. The challenges to the implementation of DBT reported by the beneficiaries (TB patients) were lack of awareness and disbelief about the scheme, bank related issues (lack of bank account and necessary documents to open account), financial challenges (job insecurity, loans), physical challenges (weakness) and delays in delivering the benefit due to software errors. ConclusionIn the present study the DBT coverage was very encouraging. The common challenges identified by the staff members and patients in the implementation of the scheme were lack of awareness about the scheme, bank related issues and software issues. To increase the coverage of DBT, it is vital that these issues be resolved.

Prevalence of latent tuberculosis infection in household contacts of pulmonary tuberculosis, time to treat.

Treatment of latent pulmonary tuberculosis (TB) in household contacts has been included in the National Tuberculosis Elimination Program to achieve the target of TB elimination by the Government of India by 2025. However, there are no clear estimates of the prevalence of latent TB among the contacts that could suggest the impact of this intervention. The study was conducted to determine the prevalence of and factors predicting latent TB among household contacts with pulmonary TB. All microbiologically confirmed pulmonary TB patients registered between January 2020 and July 2021 and their household contacts were enrolled. All contacts underwent Mantoux testing to determine the prevalence of latent TB. All symptomatic patients also underwent chest radiographs and sputum examinations to diagnose active pulmonary TB. Thereafter, different demographic and clinical factors were evaluated to find predictors of latent TB using a logistic regression model. A total of 118 pulmonary TB cases and their 330 household contacts were enrolled. The prevalence of latent TB and active TB among the contacts was found to be 26.36% and 3.03%, respectively. The female gender of index TB cases was independently associated with a high proportion of latent TB cases in the family (adjusted odds ratio 2.32; 95% confidence interval 1.07-5.05; p=0.03). Neither the higher sputum smear positivity nor the severity of the chest radiograph of index TB cases had any association with the number of contacts being diagnosed as latent TB or active TB. The results showed a significant prevalence of latent TB among household contacts with pulmonary TB. The severity of the disease in the index patient had no association with the prevalence of latent TB.

A protocol for feasibility of plasma based GeneXpert platform and Dried Blood Spot (DBS) based Abbott platform for HIV-1 viral load testing among the people living with HIV attending ART centers in India.

HIV-1 Viral load (VL) measures efficiency of the antiretroviral therapy (ART) after treatment initiation and helps to diagnose virological failures at an early stage. Current VL assays require sophisticated laboratory facilities. As well as there are other challenges pertaining to insufficient laboratory access, cold-chain management and sample transportation. Hence the number of HIV-1 VL testing laboratories is inadequate in the resource limited settings. The revised national tuberculosis elimination programme (NTEP) in India has developed a vast network of point of care (PoC) testing facilities for diagnosis of tuberculosis and several GeneXpert platforms are functional under this programme. Both the GeneXpert HIV-1 assay and HIV-1 Abbott real time assay are comparable and GeneXpert HIV-1 assay can be used as PoC for HIV-1 Viral load testing. Also, the dried blood spot (DBS) as a sample type has been considered as a good option for HIV-1 VL testing in hard to reach areas. This protocol is therefore developed to assess the feasibility of integrating HIV-1 VL testing among people living with HIV (PLHIV) attending ART centres using the two public health models under the current programme: 1. HIV-1 VL testing using GeneXpert platform and plasma as a sample type, and 2. HIV-1 VL testing using Abbott m2000 platform and DBS as a sample type. This ethically approved feasibility study will be implemented at two moderate to high burden ART centres where VL testing facility is not available in the town. Under Model-1, arrangements will be made to carry out VL testing on the adjacent GeneXpert facility and under Model-2, DBS will be prepared on site and couriered to identified viral load testing laboratories. In order to assess the feasibility, data will be collected on pretested questionnaire pertaining to number of samples tested for VL testing, number of samples tested for tuberculosis (TB) diagnosis and the turnaround time (TAT). In-depth interviews will be conducted among the service providers at ART centre and different laboratories for addressing any issues regarding the model implementation. The proportion of PLHIV tested for VL at ART centres, total TAT for both models including TAT for sample transportation, sample testing and receipt of results as well as proportion of sample rejections and reasons for the same, correlation coefficient between DBS based and plasma based VL testing will be estimated using various statistical tools. If found promising, these public health approaches will be helpful for the policy makers and program implementation in scaling up HIV-1 viral load testing within India.

Tuberculous Meningitis in Male Child and Cavitary Pulmonary Tuberculosis in Mother: Concurrent Familial Infective Disease as Evidence of Recent Transmission from Mother to Baby!

Tuberculosis (TB) is one of the leading causes of mortality in children worldwide, but there remain significant challenges in diagnosing and treating TB infection and disease. Tuberculous (TB) meningitis is the commonest infectious disease of the central nervous system in paediatric and geriatric cases. Childhood TB is an indication of failing TB control in the community. It allows disease persistence in the population. Tuberculosis can be prevented in children by diagnosing and treating cases of active TB amongst adults, as paediatric cases always acquire it passively from household contact of adults suffering from TB as disease in adults is multibacillary. Although significant data is available for the prevention of childhood extra-pulmonary and disseminated TB, offering Bacillus Calmette-Guerin (BCG) vaccination, it is still not routinely offered during vaccination. In this case report, a two-year child with a history of failure to thrive and constitutional symptoms diagnosed with disseminated extra-pulmonary TB presenting as TB meningitis with a history of contact with the mother suffering from active sputum positive pulmonary TB receiving anti-TB treatment. Child was evaluated with CT brain plain and contrast and documented meningeal enhancement. Cerebrospinal fluid analysis revealed tuberculous etiology in presence of lymphocytic predominance and raised ADA level in fluid. CSF fluid sent for cartridge based nucleic acid amplification test documented MTB genome with rifampicin sensitivity. We retrospectively analysed mothers’ sputum examination and observed higher grades of sputum AFB and her cartridge based nucleic acid amplification test revealed MTB genome with rifampicin sensitivity. Child and mother were treated with standard protocol recommended by NTEP (National Tuberculosis elimination program). In conclusion, we recommend BCG vaccination to all newborns, and tuberculin skin testing and isoniazid prophylaxis to the contact of adults with sputum positive pulmonary TB cases in India to prevent transmission of disease from mother to baby. A high index of suspicion is must while evaluating these cases and all possible measures should be taken to confirm tuberculosis to have successful treatment outcome.

Exploring the tuberculosis medication program in Indonesia as perceived by patients and their families: A qualitative study.

Tuberculosis (TB) remains a significant public health challenge in Indonesia, with the country experiencing one of the highest numbers of lost cases in TB management. Therefore, there is a need to identify the underlying reasons for this problem. This study aimed to explore the experiences of TB-diagnosed patients and their families during the time of diagnosis and while undergoing the TB medication program. This study employed a qualitative descriptive-interpretive approach. The study was conducted in government community health centers (CHC) from May 2022 to July 2022. A total of 22 participants, consisting of 12 TB-diagnosed patients and ten family members, were included in the study. Data were collected through focus group discussions and analyzed thematically. Five themes were developed: (1) Delay in tuberculosis diagnosis, (2) Delay in starting TB treatment, (3) High willingness of patients and their families to recover, (4) Understanding that TB is an infectious disease, and (5) Factors affecting patient recovery. The study findings might contribute to the National TB elimination program. It is recommended that all health workers practicing in the community should be involved in the TB program to improve its management. Collaboration between multiple sectors in the community can also provide an advantage in solving TB problems by increasing new case detection. Additionally, it is suggested that all nurses working with TB patients establish rapport with health cadres and patients' families to enhance medication adherence in patients.

FLUORESCENCE MICROSCOPY VS TRUENAT- WHICH METHOD IS BETTER FOR DIAGNOSIS OF TUBERCULOSIS?

Background: Despite the advent of newer drugs, modern diagnostic techniques and improvement in management strategies, India continues to be the leader in tuberculosis burden. Several methods for diagnosis exist, such as light microscopy, fluorescent microscopy, solid culture, liquid culture (Mycobacterium growth indicator tube [MGIT] culture) to molecular methods. However, each of these methods have variable sensitivity and specificity. Very few studies have been done evaluating the role of TrueNAT with fluorescent microscopy, thereby evaluating the performance of a designated microscopy center under the national tuberculosis elimination programme. Methods and Materials: This is a retrospective observational study performed in a designated microscopy center in Santhiram Medical Center, Nandyal. This is to compare the fluorescence microscopy and TrueNAT provided as part of the National Tuberculosis Elimination programme. A total of 342 patients underwent testing at this center and were diagnosed with tuberculosis. Results:Majority of the study participants were males, smokers, in the age groups of 31-40 years. The mean age of males was found to be higher than that of females. (37.64 vs 32.39 years). 89.42% of patients were diagnosed on fluorescent microscopy, while 94.23% were diagnosed with TrueNAT. Sensitivity of TrueNAT was 91.61%, specificity was 87.80% and accuracy was 90.76%. Conclusion: TrueNAT appears to be superior to Fluorescent microscopy in a setting of a designated microscopy center.This can be used for rapid diagnosis, with high sensitivity with specificity when compared to the traditionally accepted fluorescent microscopy.

Knowledge, Attitude, and Practices Among Healthcare Practitioners in the Context of Multidrug Resistance Tuberculosis: An Appraisal to Disease Elimination.

Tuberculosis (TB) remains one of the leading infectious causes of death worldwide, and India is among the countries with the highest TB burden. TB control is facing several roadblocks in our country with the rapid development of multidrug-resistant (MDR) as well as extensively drug-resistant TB (XDR) and as an after-effect of the global COVID-19 pandemic.With the target of TB elimination by 2025 (National Tuberculosis Elimination Program, NTEP), there is a need that treating physicians in our country be well aware of MDR-TB and be able to diagnose and treat it at an appropriate time. The present study is conducted to explore the knowledge levels, attitudes, and practices concerning MDR-TB amongst healthcare professionals working in different healthcare sectors. A total of 250 allopathic medical practitioners (Bachelor of Medicine and Bachelor of Surgery [MBBS], specialists, and superspecialists) working in any sector (private or government), who are directly involved in managing any form of TB patient and are willing to undertake the assessment, were included in this online questionnaire-based survey that was circulated using various social media platforms like WhatsApp, Facebook, Linked In, and Gmail. Responses to the questionnaires created in Google Forms were analyzed by capturing data in a Microsoft Excel® spreadsheet for further statistical analysis. The data were analyzed using multiple measures of dispersion and cross-tabulations. Among the 250 participants, most of the participants had encountered MDR-TB in their clinical practice, and the majority believe that MDR-TB is a rising problem. Although 88% of the participants did a GeneXpert assay before the start of anti-tubercular therapy (ATT), three-fourths of the participants knew that the assay detects the MTB genome and rifampicin resistance. MDR-TB was suspected in participants after no clinical improvement was observed after 3-6 weeks of a trial of ATT. Two-thirds of the participants knew that linezolid is currently being used as a second-line drug for the treatment of MDR- TB. The respondents in our survey mostly do not themselves treat MDR-TB and refer the patients to an MDR-TB center or a pulmonary medicine specialist. Healthcare practitioners (HCPs) with good knowledge levels can diagnose and treat TB patients appropriately, thus decreasing the rising MDR-TB problem, and they can educate patients and the general population about TB and the emerging MDR-TB situation. With the current level of knowledge about MDR-TB management, there is certainly an urgent need for educational and persuasive measures for the training of doctors in both the public and private sectors so as to achieve TB elimination by 2025.

Incidence, Diagnosis and Treatment of Otorhinolaryngological, Head and Neck Tuberculosis: A Prospective Clinical Study.

Introduction Tuberculosis is a disease of diversified presentation. It affects almost all organs in the body, and otorhinolaryngological, head and neck involvement is not an exception. Objective To increase awareness about the different clinical presentations of otorhinolaryngological, head and neck tuberculosis, the techniques employed to diagnose it, and to assess the response to the treatment. Methods We conducted a prospective study of 114 patients who presented primarily with otorhinolaryngological, head and neck tuberculosis. Routine blood investigations, chest radiographs, the tuberculin test, and sputum examination for the presence of acid-fast bacilli were performed in all cases. Site-specific investigations were performed in relevant cases only. The patients were treated according to the antitubercular treatment (ATT) regimen recommended by the Indian Ministry of Health and Family Welfare's National Tuberculosis Elimination Program (NTEP), and they were followed up clinically two and six months after starting the ATT. Results Tubercular cervical lymphadenopathy was the most common clinical presentation (85.96%), followed by deep neck abscess (5.27%). Fine-needle aspiration cytology proved to be a reliable tool for the diagnosis of tubercular lymphadenopathy. Improvement at the end of 2 and 6 months of the ATT was observed in 90.35% and 96.50% of the cases respectively. Conclusion The diagnosis of otorhinolaryngological, head and neck tuberculosis requires a high index of clinical suspicion, and the ATT proved to be very effective in reducing the severity of the disease.

Baseline Assessments of TB Detection Centres in Selected Public and Private Laboratories in India and Need for Introducing Quality Management Systems

Quality is sine qua non of healthcare services. Laboratory driven Quality Management Systems (QMS) are key to provide quality diagnosis. Missed diagnosis due to laboratory lacunae stymies Tuberculosis (TB) control measures, amplifies morbidity, mortality and, disease transmission. Hence, a pilot was conceptualized with Central TB Division, National TB Elimination Program (NTEP), Ministry of Health and Family Welfare, Government of India and Indian Council of Medical Research (ICMR) to perform baseline assessments for QMS at four laboratories from public and private centers at Delhi and Odisha. Data was collected using a standardized checklist. Scores were compiled for compliance to quality standards for attributes assessed across seven thematic domains. The assessment helped identify current status in terms of performance, processes followed and, areas requiring improvement. TB laboratories were found lacking in human resources and, backup staff that disrupted service delivery. Other gaps included quality aspects in documents, records, process controls in smear microscopy, optimum resource utilization and laboratory safety. Adage for missed TB diagnosis included laboratory errors, failure to document, collect and, test repeat samples for Nucleic Acid Amplification Tests (NAAT), lack of patient centric laboratory signages, equipment handling and, maintenance. Baseline assessments of quality at TB laboratories mainly focused attention on areas of greatest need to ameliorate the health system challenges and, develop roadmaps to accelerate improvement. By adapting to local context, QMS can be enacted through a shared vision in quality care to positively impact TB case finding and, optimize utilization of NAAT for diagnosis thereby setting stage for nationwide adoption and, scaleup.

Quantum of Stress Hyperglycemia at the Time of Initial Diagnosis of Tuberculosis.

Background India has a high burden of both tuberculosis (TB) and diabetes mellitus (DM). The National TB Elimination Program recommends testing for glycemic status at the initiation of therapy; however, some individuals with elevated sugar levels might have stress hyperglycemia (SH) instead of true DM. Our aim was to perform a longitudinal glycemic assessment of individuals with TB to identify those with true newly diagnosed DM and those with SH. Methods We identified newly diagnosed adults with TB and abstracted information about demography, co-morbidities, disease severity, and glucose-lowering agents. A glycemic assessment was performed at baseline and at the end of six months. Results We included 150 patients with TB, and based on their initial HbA1c values, 82 (54.6%, 95% CI: 46-62%) had dysglycemia (30% had HbA1c levels above 6.4% and 24.6% had values between 5.9% and 6.4%) and 31 (20.7%, 95% CI: 14-18%) had SH. Among individuals with both baseline and follow-up glycemic values, 30% of the individuals previously defined as DM were characterized as SH. The proportion of true SH was 43% (95% CI: 33-60%). Conclusion Most individuals who have dysglycemia at the time of their TB diagnosis have SH. A close follow-up of such individuals will identify those who really require long-term glucose-lowering therapy.

Is tuberculosis epidemic riding upon the waves of COVID-19 pandemic? A time-trend study from South India.

National Tuberculosis Elimination Programme (NTEP) activities have decelerated due to the COVID-19 pandemic. Doubt is raising globally on emerging tuberculosis (TB) epidemic related to COVID-19 pandemic. In this study, we aim to identify the trends in incidence and patterns of TB during the pandemic (2020-2022). A single-institution retrospective study was conducted. All data including demography, site of involvement, and the time trends of TB cases registered under NTEP between January 2019 and June 2022 at our hospital were retrieved from the prospective register. Statistical analysis was done using SPSS version 20.0. Total 381 cases were registered. The mean age was 43 years (±17). The male: female ratio was 1.2:1. Majority of females (40%) and males (37%) were in the age of 11-30 years and 31-50 years, respectively. The TB cases' frequency in 2019, 2020, 2021, and 2022 (till June) were 38.3% (146), 11.8% (45), 29.4% (112), and 20.5% (78), respectively. The most common site involved was pulmonary (50%) followed by cervical lymph node (19.9%). A significant reduction in TB cases was noted in 2020 during the first wave of COVID-19. The estimated total TB cases in 2022 are similar to pre-COVID-19 year 2019. The ratio of pulmonary versus extrapulmonary TB was 1:1 during 2020. We found a significant reduction of TB cases during the first wave of COVID-19, but cases have started to rise again and yet to reach pre-COVID-19 status in 2022. No definite evidence of TB epidemic in the background of COVID-19 pandemic was found. Young females within 11-30 years were found to be more affected and need to be the main focus of TB preventive efforts. COVID-19 pandemic has affected the ratio between extrapulmonary and pulmonary TB significantly.

Fluoroquinolone resistance mutations among Mycobacterium tuberculosis and their interconnection with treatment outcome.

Fluoroquinolone (FQ) antibiotics are among the most potent second-line antitubercular drugs these days. The aim of the study was to analyze the frequency and pattern of genetic mutation in preextensive (pre-XDR) and extensively drug-resistant Mycobacterium tuberculosis using second-line line probe assay (LPA) and to compare drug-resistant mutations with different treatment outcomes. Sputum, lymph node aspirate, and cold accesses from patients with rifampicin-resistant Tuberculosis (TB) were subjected to first-line and second-line LPA (Genotype MTBDRsl by Hain Life Science, Germany) to assess additional drug resistance to fluoroquinolones (levofloxacin and moxifloxacin). Final treatment outcomes as per the National TB Elimination Program were assessed and compared with the mutation profile. One hundred and fifty subjects were observed to have mutations associated with resistance to FQs and constituted the final study population. The most frequent mutation observed among GyrA drug resistance mutation was D94G (Gyr A MUT3C, 44/150, 66%) corresponding to high-level resistance to levofloxacin and moxifloxacin. The same mutation was associated with poor treatment outcome as died or treatment failure (odds ratio 2.50, relative risk 1.67, P = 0.043). The most common hetero-resistance mutation pattern observed in GyrA gene was wild type plus Asp94Gly mutation in 24.6% of isolates. GyrA MUT3C hybridization corresponding to single-point mutation of aspartic acid to glycine at codon 94 constitutes the most common mutation in GyrA gene locus in M. tuberculosis with significant association with treatment outcome as died compared to those with treatment outcome as cured.

Impact of COVID-19 on the National Tuberculosis Elimination Program in Uttarakhand, India: A Mixed-Methods Research Study

The COVID-19 pandemic has had adverse effects on tuberculosis (TB) management in high-burden countries. We conducted a qualitative study to assess the impact of COVID-19 on Uttarakhand's TB elimination program. A mixed-methods study was conducted to assess the impact of COVID-19 on the National Tuberculosis Elimination Program (NTEP) in Uttarakhand, India. We collected secondary data through the NIKSHAY portal from April 1, 2019, to March 31, 2021, interviewed program managers for the qualitative part of the study, and documented changes in some of the program core indicators during the study period. The study showed a decrease in TB case notification, an increase in the proportion of missing cases, and a fall in the treatment success rate of new cases during the ongoing COVID-19 pandemic by 17%, 54%, and 45%, respectively. Content analysis of in-depth interviews showed disruption in TB-care services because of COVID-19. TB care services in Uttarakhand have been impacted by measures taken to curb the spread of COVID-19. Both the quantitative and qualitative aspects of the study showed a serious impact on notification rates, diagnostic services, and treatment outcomes for TB patients. In addition, some negative changes have been observed when documenting program indicators (annual case notifications, success rate, treatment success rate) of the National Tuberculosis Elimination Program (NTEP). It is thus predicted that COVID-19 will undermine the Government of India's goal to eradicate TB by 2025 and will negatively affect the TB Program.

Deaths among tuberculosis patients of the western state of India: A secondary record based analytical study on its determinants

IntroductionIndia has a significant TB burden, and ongoing attempts are being made to eradicate the disease. Globally, the number of TB deaths is declining, but not quickly enough to meet the End TB Goals. The National Strategic Plan (NSP) 2017–2025 in India set in motion an ambitious effort to expand the scope and efficacy of the National Tuberculosis Elimination Program (NTEP). MethodsA descriptive retrospective study based on secondary data was conducted on information obtained from the electronic TB notification register for 2019, abstracted from Ni-kshay. Further, descriptive analysis was undertaken to identify the factors associated with deaths and successful treatment outcomes. The binomial logistic regression model estimates the crude relative risk and a 95% confidence interval to describe the association between predictor variables and TB treatment outcomes. ResultsAfter applying the eligibility criteria for the study population, a total of 1,44,643 (88%) TB patients were included in the study. 1,35,934 (94%) TB patients had completed the treatment and survived, while 8709 (6%) TB patients died. A significant association of treatment outcomes was observed in age, gender, key population, site of diseases, type of case, type of health facilities, HIV and Diabetes. When a logistic regression was applied, the model showed the association of the independent variables with the risk of death in TB patients. ConclusionThe epidemiological factors associated with treatment outcomes among TB patients should be audited systematically. A structure of TB death surveillance and response system should be established with a mortality audit, including a community-based death review (CBDR) and a facility-based medical audit (FBMA) in case the patient is hospitalized or discharged from a hospital.

Treatment outcomes and associated factors among patients with drug-sensitive tuberculosis on daily fixed-dose combination drugs: A cohort study from Ahmedabad, India.

The National Tuberculosis Elimination Program (NTEP) has been progressive in addressing the issues related to tuberculosis (TB) control in the country, with constant programmatic changes based on evidence available from operational research. Our objectives were 1. to assess the sociodemographic and clinical characteristics, and the treatment outcomes of patients on fixed-dose combination (FDC) daily regimen and 2. to assess the factors associated with unsuccessful treatment outcomes among patients with DS-TB. A retrospective cohort study was conducted based on record review. The study population included all patients with drug-sensitive TB, registered and initiated on treatment under NTEP "new category" from January to June 2018 and under "previously treated category" from January to March 2018. Quantitative data downloaded from Nikshay in Excel format was imported. A total of 8301 patients with DS-TB registered under NTEP. Mean (standard deviation [SD]) age of DS-TB patients was 35.3 + 16.9 years, and 63.2% were in the age group of 15-44 years. Also, 60.1% were male, 2.5% were human immunodeficiency virus (HIV) positive, 65.3% were pulmonary TB cases, and 70.4% obtained treatment from public providers. Proportion of "successful" and "unsuccessful" outcomes was 87.9% and 12.1%, respectively, in the new treatment category and 78.3% and 21.7%, respectively, in the previously treated category. Among the patients classified under new category, the unsuccessful treatment outcome remained significantly high after adjustments with known confounders among patients aged 45-54 years (adjusted relative risks [aRR] 1.59, 95% confidence interval [CI] 1.31-1.93) and 55-64 years (aRR 1.67, 95% CI 1.36-2.05) compared to patients aged <15 years. Unsuccessful treatment outcome was significantly high among patients aged 45-54 years. Various adherence mechanisms implemented can be evaluated for further upscaling and improving the program effectiveness.

Rare adverse effects of anti tuberculous therapy − a case series

Tuberculosis is prevalent throughout the world and is a major public health problem in most developing countries. Standardized and directly observed treatment under NTEP (National Tuberculosis Elimination Programme) is currently recommended for drug-sensitive pulmonary tuberculosis in India. It is generally well tolerated, with few minor side effects. Severe side effects necessitating discontinuation of therapy are rare with standard TB treatment regimens. Drug-resistant tuberculosis (DR-TB) has become more common in recent years, posing a challenge to global efforts to control the disease. Therapy for DR-TB has been associated with many adverse effects. Therefore, close monitoring of patients on DR-TB therapy is necessary to ensure that adverse effects of drugs are recognized early by healthcare personnel and treated accordingly. This will improve drug compliance and, hence, treatment goals. Here we report three cases of tuberculosis who had unusual adverse effects while receiving anti-tuberculous medication, prompting drug discontinuation.

Drug resistance patterns and treatment outcomes in DR-TB patients at a tertiary care centre in Mumbai

BackgroundDrug-resistant tuberculosis (DR-TB) is a major health problem and threatens Tuberculosis (TB) control and outcomes globally. India holds one-fourth of global DR-TB burden.1 Aims1- To study drug resistance patterns and outcomes in DR-TB patients under National Tuberculosis Elimination Programme (NTEP) at a tertiary care-centre. 2- To correlate outcome of DR-TB with drug resistance patterns. MethodsIt is a retrospective study of 302 Drug Resistant Tuberculosis patients from Jan 2020 to May 2022. Common mutations of drug resistance, pyrazinamide resistance in DR-TB patients, correlation of High dose Moxifloxacin sensitivity by Line Probe Assay (LPA) and drug sensitivity test (DST), outcome of DR-TB patients with drug resistance patterns and correlation of outcome of DR-TB patients with their initial body-weight were studied. ResultsKat G was the most common mutation in Isoniazid (96%) resistance for MDR TB as well as Isoniazid Mono-resistance TB (p = 0.001). 91% cases with MDR-TB were resistant to pyrazinamide. 51.2% cases had low dose Fluroquinolone resistance. 18.8% cases had low and high dose Fluroquinolone resistance. 8.5% cases had resistance to injectables. 21.7% of cases who were resistant to High dose Moxifloxacin on second line LPA were found to be sensitive on DST. Outcomes were not dependent on the LPA resistance patterns. Body-weight greater than 45 Kg at the time of initiation of treatment was associated with better outcomes (p = 0.007). ConclusionDR-TB patients are resistant to pyrazinamide in nearly all cases; hence pyrazinamide is not suitable for initial replacement sequence. Second line resistance doesn't impact outcome in DR-TB patients.

Association Between Cycle Threshold Value of Cartridge-Based Nucleic Acid Amplification Test and Clinical Severity of Pulmonary Tuberculosis: A Cross-sectional Study

Introduction: Tuberculosis (TB) is a major global health problem caused by Mycobacterium tuberculosis (MTB). The National Tuberculosis Elimination Programme (NTEP) emphasises early diagnosis and treatment of TB cases. The Cartridge-Based Nucleic Acid Amplification Test (CBNAAT) is a semi-automated molecular assay that rapidly detects MTB Deoxyribonucleic Acid (DNA) and Rifampicin (RIF) resistance-associated mutations using Real-Time Polymerase Chain Reaction (RT-PCR). Aim: This cross-sectional study aims to assess the association between the Cycle Threshold (Ct) value of CBNAAT and the clinical severity of Pulmonary Tuberculosis (PTB). Materials and Methods: The study was conducted at the Department of Respiratory Medicine, Navodaya Medical College Hospital and Research Centre-Raichur, from January 2020 to July 2021. A sample size of 106 participants, aged ≥18 years and meeting the NTEP guidelines for presumptive PTB cases, were enrolled. Participants underwent chest radiography, sputum smear microscopy for Acid-Fast Bacilli (AFB), and CBNAAT testing. Clinical severity of PTB was categorised as mild, moderate, or severe using the Bandim TB score. Data was entered into Microsoft Excel 2017, and statistical analysis was performed using SPSS version 23. Descriptive statistics, frequencies, percentages, means, and standard deviations were calculated, and the chi-square test was utilised to assess associations between qualitative variables. Results: Among the participants, the majority (55.7%, n=59) had moderate clinical severity. Of these, 12.3% (n=13) had high CBNAAT Ct values, 20.8% (n=22) had medium Ct values, 11.3% (n=12) had low Ct values, and 11.3% (n=12) had very low Ct values. A total of 31.1% (n=33) had severe clinical severity, with 13.2% (n=6) having high Ct values, 12.3% (n=13) having medium Ct values, and 6.6% (n=7) each having low and very low Ct values. Additionally, 13.2% (n=14) had mild clinical severity, with 0.9% (n=1) having high Ct values, 3.8% (n=4) having medium Ct values, 5.7% (n=6) having low Ct values, and 2.8% (n=3) having very low Ct values. The chi-square value was 4.697, with a p-value of 0.58. Conclusion: There is no association between the Ct value of CBNAAT and the clinical severity of PTB.

Changing trends in the diagnosis of genitourinary tuberculosis in post Covid-19 pandemic era

efforts to achieve a TB-free world by 2030. The health professionals and the health care support team suffered a major setback in reaching out to the patients due to various restrictions imposed on them during this pandemic period. Patients found it difficult to reach out to the health care team, owing largely to the fear factor and also due to inaccessibility to health care services. The delay in TB notifications, emergence of drug resistant strains and restrictions in the supply- chain added further to the difficulties faced. India is a nation with one of the largest numbers of TB victims. The strategic measures taken by the Government of India (GOI) took a sudden jolt with the onset of the COVID-19 pandemic. The TB elimination measures reverted back to TB containment measures. Various African countries including Ethiopia recorded a massive fall out of more than 75% during the various lockdown measures imposed. However, India took collateral measures to combat this setback. Its National Tuberculosis Elimination Programme (NTEP) involved private players to combat TB epidemic, recruited Patient provider support agencies and actively engaged Private Sectors through innovative patient provider incentives to bring down numbers of the TB victims. The diagnostic methods that took about 4 to 6 weeks to confirm the diagnosis of TB had earlier put the diagnosis and management of TB to the back seat. However, recent innovations in the molecular biology, immunology and genomic sequencing techniques have greatly aided an earlier and accurate diagnosis of tuberculosis. One individual, one health agency or one Government cannot achieve the goal TB elimination by 2030. A global effort is the basic pre-requisite, incorporating advanced molecular diagnosis and appropriate treatment would ensure achieving a TB free world by 2030.

Cost-Effectiveness of Currently Available Diagnostic Tools for Diagnosis of Pediatric Tuberculosis Under National Tuberculosis Elimination Program.

In India, children do not get diagnosed with tuberculosis (TB) for reasons such as lack of screening modality at the health-care settings, inadequate sputum sample, and low detection rate. This study aims to assess various modalities for diagnosis of pediatric TB and their cost-effectiveness. Cost-effectiveness was found for various diagnostic modalities for TB diagnosis in children of India below 15 years of age. TrueNat MTB was the intervention being compared to GeneXpert MTB and sputum microscopy. Evidence pertinent to effectiveness and cost per test, and health benefits in terms of disability adjusted life years were researched and documented. Modeling a cohort of children through a decision tree and assimilating costs and disability-adjusted life years (DALYs) at each step gave results in the form of cost-effectiveness. Interventions were compared by calculating the cost-effectiveness ratio. The results revealed that TrueNat is more cost effective (Rs. 9450/DALY averted) compared to GeneXpert MTB/RIF (Rs. 9750/DALY averted). The incremental cost effectiveness ratio of TrueNat with respect to GeneXpert was found to be Rs. 5925 per DALY averted. Diagnosis through TrueNat point of care (POC) will avert 962 more DALYs compared to GeneXpert. As is evident from the results, TrueNat does alleviate disability caused by TB in children as more DALYs are averted. At an additional cost of Rs. 5925 to avert one DALY, which is below the gross domestic product (GDP) per capita for India (for 2021, it was $2277), TrueNat can have significant health benefits.