[Draft] Course for Senior DR-TB TB-HIV Supervisor on NTEP

​

Resources

• Global Tuberculosis Report, 2020; Geneva: World Health Organization, 2020
• Training Modules (1-4) for Programme Managers and Medical Officers India: Central TB Division, MoHFW, Government of India,July 2020

• Globally, an estimated 11 million people fell ill with TB (incidence) in 2021.
• Historically, it has been the top infectious disease killer. In 2021, there were an estimated 1.4 million TB deaths and an additional 187 000 deaths among HIV-positive people.
• Three countries accounted for 42% of global cases in 2021: India (26%), the Russian Federation (8.5%) and Pakistan (7.9%).

Image Figure: Estimated TB incidence in 2021, for countries with at least 100 000 incident cases; Source: Global TB Report, 2022.

Resources​

• Global tuberculosis report 2022.

TB is one of the top burdensome infectious diseases in India. It is estimated that, around 1/4th (26%) of the world's TB cases are in India, translating to about 30 Lakhs new TB cases emerging each year (TB incidence). Against this estimated incidence the National TB Elimination program reported around 19 lakh new and relapse cases in the year 2021.

An estimated 5 Lakhs deaths occur due to TB each year in the country, translating to about 1 case of TB death every one-two minutes. Compared to this, there are only about 60 thousand deaths due to HIV and about 77 deaths due to Malaria each year.

TB diagnosis and treatment services although provided free of cost in the public sector, the cost of accessing these services and related loss of wages drive the affected people with poverty (catastrophic costs). TB also has a huge impact on the world's and the country's economy because of loss of workdays (100 million workdays per year).

Assessment

Resources:

• ^*WHO Global TB Report 2021
• ^{^}Status of National AIDS Response
• ^$PIB MOHFW

TB is caused due to the infection by a bacterium called Mycobacterium tuberculosis.

It often affects the lungs, and in such cases it is called Pulmonary Tuberculosis. But, it can affect almost any part of the body (except the hair and the nails), in which it is known as Extra-Pulmonary Tuberculosis.

Resources:

• Technical and Operational Guidelines for TB Control in India 2016

Tuberculosis is transmitted mainly through the air via droplet nuclei generated when a TB patient coughs or sneezes. 

It is estimated that every sputum smear-positive patient spreads the infection to 10 – 15 persons annually, if untreated..

Figure: Transmission of TB bacteria through air via droplet

Resources:

• Technical and Operational Guidelines for TB Control in India 2016
• WHO - Fact sheet details on Tuberculosis

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Tuberculosis (TB) is an infectious, chronic, granulomatous disease caused by Mycobacterium tuberculosis. It usually involves the lungs but may affect any organ or tissue in the body.

The pathogenesis of TB in a previously unexposed immunocompetent individual is centred on the development of cell-mediated immunity. This confers resistance to the organism and results in the development of tissue hypersensitivity to tubercular antigens.

The pathologic features of TB, such as caseating granulomas and cavitation, result from the destructive tissue hypersensitivity that is part and parcel of the host immune response.

The sequence of events from inhalation of the infectious droplets to the containment of the primary focus of infection is as follows:

Figure: Pathogenesis of Tuberculosis

In many individuals, the stage 5 response (from above) halts the infection before significant tissue destruction or illness occur (Latent TB Infection). In other individuals with immune deficits due to age or immunosuppression, the infection progresses to stage 5, and the ongoing immune response results in caseation necrosis (Active TB Disease). The figure above provides more details on the progression of TB disease.

Resources

• Robbins Basic Pathology, 10^th Edition.
• Transmission and Pathogenesis of Tuberculosis, CDC.

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The Epidemiologic Triad is a model used in the field of epidemiology to study diseases and how they are spread. It consists of a triangle with three vertices or corners. 

The three vertices for infectious diseases consist of:

1. Agent, or microbe that is the factor causing the disease.

2. Host, or organism harbouring the disease.

3. Environment, or those external factors that cause or allow disease transmission. 

In the Epidemiological Triad of TB (Figure), the agent is the TB causing bacteria Mycobacterium tuberculosis; the host refers to humans that are susceptible to TB. Susceptibility or the risk factors for acquiring TB can be:

• Close contact with a person having TB disease
• Nutritional status of the host
• Existing co-morbidities
• Low immunity.

Susceptibility of the host can also vary due to age, gender, genetic composition, race, ethnicity, etc. 

As TB is an airborne disease, environmental factors come into play for the transmission of TB. These include crowding, poor ventilation, bad sanitation, indoor air pollution, etc. 

The understanding between the interplay of agent, host and environment is essential to understanding the epidemiology of TB and taking measures to control it. The risk of TB due to environmental factors can be reduced by practising airborne infection prevention measures like good ventilation, hand hygiene and cough etiquette. 

Figure: Epidemiological Triad of TB

Resources

• Understanding the Epidemiologic Triangle through Infectious Disease, CDC. 

• Epidemiological Triad of TB.

   

Assessment

Mycobacterium tuberculosis (M. tuberculosis) belonging to the family Mycobacteriaceae cause Tuberculosis (TB).

These are rod shaped bacilli and require oxygen to survive (aerobic bacteria).

The following characteristics of these bacilli help them to survive in human body for a long time and resist the action of drugs:

• Slow growing bacteria (replicates every 12-24 hours)
• Tough, hydrophobic cell wall rich in mycolic acid that resists action of many drugs including antibiotics.
• Ability to remain in dormant stage inside host tissues for many years in conditions with limited oxygen and nutrition (facultative anaerobes). They can revert to active state when favourable conditions (reduced host immune response, undernutrition etc.) ensue. The persistence of the bacteria in the host tissue for long duration of time is responsible for prolonged incubation period and re-activation of infection.
• The multiple mechanisms of drug resistance by the bacteria give rise to multi-drug resistant and extensively drug-resistant tuberculosis.

 These characteristics make tuberculosis a chronic granulomatous disease that requires special antibiotics for treatment. 

Resources

• Antimicrobial Resistance in Mycobacterium tuberculosis: Mechanistic and Evolutionary Perspectives, FEMS Microbiology Reviews, May 2017.
• The Biology of Mycobacterium tuberculosis Infection, Mediterranean Journal of Hematology and Infectious Diseases, 2013.

Assessment

Host factors in TB disease are various factors/attributes of the host(person who is developing TB disease/infection).

The various host factors are as follows:

• Age: TB can affect people of any age. Young adults (15-30 years of age) are seen to have high rates of disease in India. Children and the elderly are also high-risk groups for the contraction of the disease. 
• Gender: TB affects all genders, but males have higher disease rates, probably owing to higher levels of exposure to the bacteria in occupational settings. 
• Immunity status: Individuals with compromised immunity status, like those on corticosteroid therapy/ immunosuppressants after organ transplant, HIV infection, diabetes mellitus etc., are more prone to TB infection and disease.
• Nutritional status: Undernutrition causes weakening of the immune system and hence predisposes to TB. Risk of TB increases by about 14% with each unit reduction in Body Mass Index (BMI).
• Previous TB infection: Individuals who are close/ household contacts of confirmed pulmonary TB patients; individuals residing in TB high-prevalence regions; high-risk groups like healthcare workers, homeless people, HIV infected etc., have high chances of being already infected with TB and hence, would progress to disease.

Resources

• India TB Report 2021, Central TB Division, MoHFW, Government of India. 
• TB Risk Factors, Centers for Disease Control and Prevention.

Assessment

Environmental conditions have a huge role in the development of TB disease and are an important component of the epidemiological triad for TB disease.

The various environmental factors influencing TB are:

• Poor housing and ventilation: Damp homes, often resulting from condensation due to inadequate ventilation, allow the growth of mold, fungi, and other microorganisms. This adversely affects the respiratory health of individuals and increases the chances of the spread of TB from a patient to his/her household contacts.
• Overcrowding: More people living within a single space restricts movement, gives scope for lack of privacy and limits hygiene. The extent and persistence of contact with an infected person increases. The droplet nuclei (due to coughing) from infected individuals can stay in the air for a long time and transmit the disease easily to contacts.
• Indoor air pollution: The use of traditional biomass fuels like cow dung, wood etc. for energy generation (especially for cooking) in poorly ventilated households pose serious risks to the lung health of individuals. Damaged lungs are more susceptible to TB infection/ disease.
• Occupational environment: Healthcare workers, miners etc. are at a high risk of TB. Inadequate air change rates, negative airflow and recirculation of air have been identified as occupational hazards in hospitals with respect to TB transmission.

Resources

1. Role of Environmental Factors in Transmission of Tuberculosis, Dynamics of Human Health, 2015. 
2. Housing and Public Health, Annual Review of Public Health, 2004.

Assessment:

• TB Infection (or previously known as Latent TB infection) is a stage in between uninfected and having active TB. In this stage the person has no symptoms and can only be identified using laboratory tests.

• The vast majority of infected people may never develop TB disease. However, to achieve TB elimination, it is important to treat TB infection in people at risk of developing active TB disease.

• It is a state of persistent immune response to stimulation by Mycobacterium tuberculosis antigens with no evidence of clinically manifested active TB.

• There is no single acceptable/reliable test for direct identification of Mycobacterium tuberculosis infection in humans. Tuberculin Skin Test (TST) and Interferon-gamma release assay (IGRA) are commonly used tests for identifying TB infection.

Resources:

• Latent Tuberculosis Infection Guideline

• Guideline for Programmatic Management of Tuberculosis Preventive Treatment in India

After exposure to infective droplets containing M.TB, only a small proportion gets infected and further progresses to active TB disease.

• Majority of those that get infected persist in a stage of clinical latency known as TB infection (previously known as Latent TB infection). They do not have TB disease and do not show any symptoms of TB and no evidence of any TB related changes on chest X-ray.
• A small proportion of those with prior infection may progress to active TB disease due to various environmental/ agent/ host factors.

Figure: Flow chart for TB disease progression

Resources:

• Understanding delayed T-Cell Priming, Lung Recruitment, and AirwayLuminal T-Cell Responses in Host defence against Pulmonary Tuberculosis

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Resources:

• Technical and Operational Guidelines for TB Control in India 2016

Determinants are any characteristics that affect the health of a patient.

Socioeconomic determinants of health include the conditions in which people are born, grow, live, work, and age. These determinants play an important role in increasing the risk of acquiring TB infection, its progression into active TB disease and further transmission to contacts.

Socio-economic factors affect health-seeking behaviour and access to TB services

Figure: Socioeconomic factors that are affecting the health of TB patients

There may be difficulties in transportation to health facilities and lack of social support to seek care when they fall sick. This delays the contact with health systems for appropriate diagnosis and initiation of treatment.

TB can affect anyone but it is more prevalent in some communities which are vulnerable to TB disease due to various factors which are mentioned below:

Increased exposure of TB due to where they live or work

• prisoners
• slum dwellers
• miners
• hospital visitors
• healthcare workers

Limited access to Quality TB services

• Migrant workers
• Women in settings with gender disparity,
• Children
• Physically challenged
• Transgender population
• Tribal and population living in hard to reach areas
• Refugees or internally displaced people
• Illegal miners and undocumented migrants

Increased risk because of biological or behavioural factors that compromise immune functions in people who:

• People who live with HIV
• have diabetes or silicosis
• undergo immunosuppressive therapy
• are undernourished
• use tobacco
• suffer from alcohol use disorders.
• inject drugs 

As TB is an airborne infection, TB bacteria are released into the air when someone with infectious TB coughs or sneezes. The risk of infection can be reduced by taking simple precautions:

Figure: Measures for control and prevention of tuberculosis

TB Preventive Treatment(TPT) also has a very important role in prevention of TB. Presently, household contacts of sputum-positive TB patients are given TPT upon confirmation of TB infection and ruling our active Tuberculosis.

Resources:

• Technical and Operational Guidelines for TB Control in India 2016

Drug resistance in Mycobacterium tuberculosis occurs when there is acquisition of mutations in genes that code for anti-TB drug targets or drug-activating enzymes.

Drug resistance in Tuberculosis (TB) occurs through two main mechanisms shown in the figure below.

Figure: Mechanisms or Types of Drug Resistance in TB

The mechanism of transmission of drug-resistant (DR) and drug-sensitive (DS) TB is the same i.e., via infectious aerosols.

Acquired drug resistance is multi-factorial, and may be due to:​

• Lack of access to quality-assured anti-TB drugs for proper treatment
• Lack of adherence to the regimen or interrupted therapy which could be due to complex dosing strategies, serious adverse drug reactions and drug–drug interactions
• Inappropriate regimens
• Sub-therapeutic dosing
• Use of expired or substandard anti-TB drugs
• Malabsorption ​of oral anti-TB drugs which can be seen, for example, in HIV patients.

Resources

• Navisha Dookie et al. Evolution of Drug Resistance in Mycobacterium tuberculosis: A Review on the Molecular Determinants of Resistance and Implications for Personalized Care, Journal of Antimicrobial Chemotherapy, Volume 73, Issue 5, May 2018.
• Bento J, Duarte R, Brito MC, et al. Malabsorption of Antimycobacterial Drugs as a Cause of Treatment Failure in Tuberculosis, BMJ, September 2010.
• Biadglegne F, Sack U, Rodloff A. Multidrug-resistant Tuberculosis in Ethiopia: Efforts to Expand Diagnostic Services, Treatment and Care. Antimicrobial Resistance Infection Control, 2014.

Drug resistance is caused by a genetic mutation that makes the drug ineffective against the mutant bacilli.

The causes of drug-resistant TB can be enumerated as follows: 

1. Providers/ Programme Related Causes:

• Inadequate or poorly administered TB treatment regimen
• Unavailability or poor quality of anti-TB drugs
• Poor monitoring of TB treatment
• Delay in detection and management of DR-TB

2. TB Patient/ Host Related Causes:

• Clinical characteristics of TB patients leading to suboptimal drug levels in blood (e.g. Malabsorption syndrome)
• Irregular anti-TB treatment due to any reason (e.g. socio-economic barriers, substance abuse, Adverse Drug Reactions (ADRs), psychological and other factors)

There are two principal causal pathways leading to the development of drug-resistant TB:

• Primary drug resistance: It means that a person has been infected with a drug-resistant TB strain.​

• Acquired (Secondary) drug resistance: It is the result of inadequate, incomplete or poor treatment quality that allows the selection of mutant resistant strains. 

   

Resources

• Guidelines for PMDT in India, 2021.
• Companion Handbook to the WHO Guidelines for the Programmatic Management of Drug-resistant Tuberculosis.

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There are five principal ways to prevent Drug-resistant Tuberculosis (DR-TB), as given in the figure below.

Image

 Figure: Five Principal Ways to Prevent DR-TB; Source: Guideline for PMDT in India, 2021.

• Drug resistance cannot be prevented by mere diagnosis and treatment of DR-TB.
• Basic TB diagnostic and treatment services should receive priority for the prevention of drug resistance.
• Systems for early detection and treatment of DR-TB should be integrated into the existing TB services and the general health system.
• Healthcare facilities and congregate settings should be provided with proper infection control measures.
• Transmission should be prevented by addressing non-specific determinants like access to care, comorbidities and awareness.

Resources

• Guidelines for PMDT in India, 2021.
• Companion Handbook to the WHO Guidelines for the Programmatic Management of Drug-resistant Tuberculosis.

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Chemotherapy for TB is the use of an anti-TB drugs to kill, or prevent the replication of, TB mycobacteria in the patient’s body. Effective anti-TB chemotherapy renders the patient non-contagious and cures the patient, thereby interrupting the chain of transmission. Mortality rates of TB range from 50-80% in untreated smear-positive individuals and drop to lower than 5% under chemotherapy.

Most of the bacteria are killed during the first 8 weeks of treatment; however, there are persistent organisms that require longer treatment. TB disease must be treated for at least 6 months and in some cases even longer. The use of multi-drug therapy reduces the incidence of drug-resistant cases and increases the overall effectiveness of treatment.

If treatment is interrupted, any surviving bacteria may cause the patient to later become ill and infectious again, potentially with drug-resistant disease.

How infectious are tuberculosis patients under chemotherapy?

Under effective chemotherapy, there is a substantial decline in infectiousness in two weeks time, and may not be a major source of risk to any contacts. This decline is indicated by the rapid fall in the number of viable organisms in the sputum, and reduced frequency of coughing.  

Types of Chemotherapy in TB

1. Preventive Chemotherapy: Regimen for healthy but TB infected persons with a high risk of developing TB, in order to prevent them from developing TB.
2. Standard Chemotherapy: Two-phased chemotherapy for an average of 6-8 months based on the combination of at least four major drugs (HRZE) given for 2 months during the initial intensive phase of treatment and followed by a combination of at least 2 drugs given for at least 4 months during the continuation phase of treatment.
3. Chemotherapy for Drug-resistant TB: Two-phased chemotherapy varying from 9 - 24 months in patients having demonstrated resistance to drugs used in standard chemotherapy. The regimen varies with the drug to which the resistance is present, however, each regimen contains a mix of second-line anti-TB drugs including injectables.   

Resources

• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.
• Tuberculosis Infectiousness and Host Susceptibility, The Journal of Infectious Diseases, Vol. 216, suppl_6, 2017.
• Tuberculosis chemotherapy: Current Drug Delivery Approaches, Respiratory Research 7, Article no. 118, 2006.
• Tuberculosis Case-finding and Chemotherapy: Questions and Answers, K. Toman.

 Assessment

Incidence is an epidemiological measure of the occurrence of new cases of a disease in a population over a specified period of time. Tuberculosis (TB) incidence is the number of new cases of active TB disease during a certain time period (usually a year), and is better expressed as a rate, as shown in the figure below.

Figure: Deriving the Incidence of TB Disease for a Given Population

Tuberculosis incidence varies considerably in different populations and population segments.

In 2021, the Global TB incidence was 134 (125-143) per 100,000. The TB Incidence rate of India is  - 210 (178-244) per 100,000 in 2021 according to WHO Global TB Report 2022.

Resources

• India TB Report, 2022.
• Epidemiologic Basis of Tuberculosis Control, Hans L. Rieder, 1999.
• Morbidity Frequency Measures, Centers for Disease Control and Prevention.
• Global Tuberculosis Report 2022.

Prevalence is an epidemiological measure of the proportion of a population with a disease or a particular health condition at a specific point in time (point prevalence) or over a specified period of time (period prevalence).

Tuberculosis (TB) prevalence refers to the number of people with TB that are present in a particular population at a given time. Calculation of the TB prevalence rate is shown in the figure below.

Figure: Deriving the Prevalence of TB Disease for a Given Population

TB prevalence rate is derived by adding the number of persons that develop new TB disease (i.e., incident cases​) and those who already have the disease (i.e., existing cases), and dividing the sum by the total population from which the cases arose.

TB prevalence varies widely and is affected by a number of factors such as age, gender, population density, rural/urban settings, as well as socioeconomic factors.

Resources

• Epidemiologic Basis of Tuberculosis Control, Hans L. Rieder, 1999.

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TB notification rate is the number of TB cases notified over a specified time period for a specified population, usually per lakh. It indicates how many cases have been diagnosed and informed to the National TB Elimination Program.

It is mostly calculated annually, and the calculation formula is as follows: 

Figure: Deriving the Annualized TB Case Notification Rate

The National TB Elimination Program calculates TB notification rates based on TB cases notified using the digital surveillance system called Nikshay. Each state/district is provided with an annual target for TB case notification, the progress of which is measured periodically to understand efforts taken for the detection of TB cases.

Example

If the number of TB patients diagnosed in District X one year is 1000, and the mid-year population of District X is 10,00,000, then the annualized TB case notification rate is calculated as follows: 

100 cases/100 000/year

Resources

• NTEP training module for medical officers 5-9
• TB Notification Rate, TB Indicators WHO 2014

When an HIV-positive person dies from TB, the underlying cause is classified as HIV with TB as a contributory cause. However, the milestones and targets for reductions in TB deaths set at the End TB Strategy are for the combined total of deaths in HIV-positive and HIV-negative people.

Estimates of TB deaths in India:

In 2020, India accounted for 38% of global TB deaths among HIV-negative people, and for 34% of the combined total number of TB deaths in HIV-negative and HIV-positive people.  

Note: The International Classification of Diseases (ICD) defines TB deaths as ‘death from TB among HIV-negative people'. 

Resource

• India TB Report 2022, Central TB Division, MoHFW, India.

• Global TB Report 2020, World Health Organisation.

Assessment

The World Health Organisation End TB Strategy, adopted by the World Health Assembly in 2014, aims to end the global TB epidemic. The strategy draws on the opportunities presented by the Sustainable Development Goals (SDGs), especially those goals aimed at achieving universal health coverage and social protection from disease.

The table given below provides information on the vision, goal, milestones and targets for the End TB Strategy.

The National Strategic Plan (2017-2025) proposes bold strategies with commensurate resources to rapidly decline TB in the country by 2030 in line with the global End TB targets to attain the vision of a TB-free India.

Resources

• National Strategic Plan for Tuberculosis Elimination 2017–2025.
• The End TB Strategy, World Health Organisation, 2015.

Figure: Summary of the Sustainable Development Goals

• Goal 3 is related to Good Health and Well-being. It mentions that 'Each nation needs to ensure healthy lives and promote the well-being of all ages'.
• The United Nations Sustainable Development Goals (SDGs) include ending the TB epidemic by 2030 under Goal 3.
• Goal 3.3: By 2030, end the epidemics of AIDS, tuberculosis, malaria and neglected tropical diseases and combat hepatitis, water-borne diseases and other communicable diseases.

India is a signatory of the United Nations Sustainable Development Goals and has targeted TB elimination by 2025, five years ahead of the SDG timeline.

Resources

• United Nations, Department of Economic and Social Affairs. 
• SDG Booklet, UNDP.

The National Tuberculosis Control Program (NTP) of India was launched in 1962. It relied on BCG, X-ray based diagnosis and Streptomycin and INH based treatment centralized at district level.  

Based on a review of the NTP, and WHO recommendations of the DOTS Strategy, Government of India then revised the NTP and launched new program with the title Revised National Tuberculosis Control Program (RNTCP) in 1997. It used Sputum microscopy at DMC(Designated Microscopy Centres) for diagnosis, and multi-drug Short Course Anti-TB Therapy,  decentralized to the TU (TB Unit) level. 

In recognition of the rising drug resistance problem the DOTS Plus/ PMDT (Programmatic Management of Drug Resistant TB) was launched in 2006 and scaled up to the entire country by 2012. 

Further to strengthen the monitoring and supervision system - a case based notification system - Nikshay was introduced in 2012. The same year Tuberculosis was added as a notifiable disease at the point of diagnosis by all health care providers.

Other key milestones from 2012 to 2020 were the availability of the Standards of TB Care in India (STCI) in 2014, introduction of the Daily weight band wise Fixed Dose combination (FDC) in 2016 and new drugs like Bedaquilline  and Delaminid were started in 2017 and 2018 respectively. 

To emphasise the commitment of the Government of India and to accelerate the efforts towards TB elimination, RNTCP was renamed as "National Tuberculosis Elimination Programme (NTEP)" in 2020.

Figure: Key milestones under NTEP

Resources:

• TBC India Website
• National Stratergic Plan for Tuberculosis Elimination 2017 - 2025

The Government of India has committed to achieving the Sustainable Development Goals(SDG) targets related to ending TB by 2025 (5 years ahead of the global target).  This would mean that in 2025, the 2030 target of achieving 80% reduction in incidence, 90% reduction in deaths due to TB compared to that of 2015, is to be achieved.

Table: India's commitment to End TB by 2025.

Resources:

• National Strategic Plan (NSP) - 2017 - 2025
• Global TB report 2021
• END TB Strategy

The National Strategic Plan (NSP) for TB elimination 2017–25 is a bold strategic framework to drive the  acceleration of progress toward TB Elimination, and achieving the Sustainable Development Goal (SDG) and End TB targets for India. It expects to guide the activities of all stakeholders including the national and state governments, development partners, civil society organizations, international agencies, research institutions, private sector, and many others whose work is relevant to TB elimination in India. It is adopts strategies under four groups DETECT, TREAT, PREVENT, BUILD.

VISION: TB-Free India with zero deaths, disease and poverty due to tuberculosis
GOAL: To achieve a rapid decline in burden of TB, morbidity and mortality while working towards elimination of TB in India by 2025.

The results framework of the NSP outlines the various targets (impact and outcomes) to be achieved.

Resources

• Revised National Tuberculosis Control Program National Strategic Plan For Tuberculosis Elimination 2017–2025, Central TB Division, MoHFW, 2017

Assessment Questions

NSP 2012 - 2017 had the aim of achieving universal access to quality diagnosis and treatment. The NSP 2017-2025 which builds on the success and learnings of the last NSP, and articulates the bold and innovative steps required to move towards TB elimination. In 2020, RNTCP was renamed to "National Tuberculosis Elimination Programme" with the following objectives:

Figure: Objectives of NTEP

Resources:

• TBC India Website

The Standards for TB Care in India (STCI), which is a locally customized version of the International Standards of Tuberculosis Care, mentions 26 standards that every citizen of India should receive irrespective of the sector of treatment. 

STCI were developed based on a series of discussions involving various stakeholders including clinicians, public health specialists, community workers and patient advocates. 

STCI represent what is expected for quality TB care from the Indian healthcare system including both public and private systems. 

It was first published in 2014 and outlines standards across the four themes of TB diagnosis, TB treatment, public health action and social inclusion.

Following are the list of the 26 Standards:

Table 1: Categorisation of the Standards for TB Care in India, Source: Standards for TB Care in India, World Health Organisation, pp. 13-23

Resources

• Standards for TB Care in India, World Health Organisation, 2014

Assessment

Figure 1: History of PMDT in India (2007 to 2020).; Source: Guidelines for PMDT in India, 2021 p.02 ​

• Programmatic Management of Drug-resistant Tuberculosis (PMDT) services were rolled out in India in 2007. ​
• From 2007 to 2012, services were expanded in terms of diagnostic and treatment facilities. ​
• Country-wide geographical coverage of PMDT services was achieved in 2013.​
• From 2012 to 2017, major policy shifts under PMDT were observed like introduction and expansion of Cartridge Based Nucleic Acid Amplification Test (CBNAAT), Universal Drug Susceptibility Testing (UDST), and introduction of newer drugs.​
• In 2017 to 2020, introduction and expansion of Truenat till sub-district level, national-wise coverage of UDST, shorter and longer oral multi-drug resistant tuberculosis (MDR-TB) regimen​ were achieved.

Resources​

• Guideline for Programmatic Management of Drug-resistant Tuberculosis (PMDT) in India, 2021 

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National Tuberculosis Elimination Programme (NTEP) is a centrally sponsored programme being implemented under the aegis of National Health Mission.

National Level: Managed by Central TB Division (CTD), the technical arm of the Ministry of Health and Family Welfare (MOHFW)

State Level: State TB Cell coordinates the overall TB elimination programme in state under the guidance of State Health Society. The training ,supervision, monitoring and evaluation NTEP at state level are looked after by STDC (State TB Training and Demonstration Centre).

District TB Centre (DTC) is the nodal point for all TB elimination activities in the district under the guidance of the District Health Society.

Tuberculosis Unit (TU) Level: NTEP activities at block/sub-district level are implemented through TU which comprises Designated Medical Officer (MO) supported by two full-time NTEP staff - STS (Senior Treatment Supervisor) & STLS (Senior TB Lab Supervisor).

PHI (Peripheral Health Institute): PHI is a health facility manned by a Medical Officer (MO). Some of the PHIs are also the Tuberculosis Diagnostic Centres, which are the most peripheral level laboratories in the NTEP structure. All the Private Health Facilities like Private Practitioners / Private Hospitals / Clinics / Nursing Homes are also PHI.

Figure: Organisational structure of NTEP

Resources:

• TB India Report 2021
• Technical and Operational Guidelines for TB Control in India 2016

The key level for the management of public health services is the district​ level. The District Tuberculosis Centre (DTC) is the nodal point for tuberculosis (TB) control activities in the district​.

Functions of the DTC

The primary role of the DTC is a managerial one. The DTC is the central program management unit of the district responsible for all activities related to National TB Elimination Programme (NTEP) implementation such as:

• Advocacy
• Active case finding
• Diagnosis, treatment (both for drug-susceptible and drug-resistant TB cases) and follow up
• Managing comorbidities
• Service delivery
• Maintaining diagnostic and treatment infrastructure
• Setting up Drug-resistant TB (DR-TB) centres
• Ensuring community engagement and TB forums
• Multi-sectorial involvement for drug management, and supervision and monitoring
• Financial management
• Drugs, logistics and supply chain management.

Components of the DTC

1. District Drug Store (DDS)
2. Nucleic Acid Amplification Test machine (Cartridge Based NAAT or TrueNAT)
3. Designated Microscopic Center (DMC)
4. Treatment Support Center
5. Drug Resistant TB (DR-TB) Center
6. X-Ray Unit

With expansion of TB services and ongoing collaboration with various national programs, the structure of DTC is highly integrated as part of general health system and some components may cater to non-TB patients as well e.g., the DMC may be a part of general laboratory, and X-ray unit can be functional for all departments and not just chest/TB section.

Human Resources Deployed at the DTC

The Chief District Health Officer (CDHO) / Chief District Medical Officer (CDMO) / Civil Surgeon or an equivalent functionary in the district is responsible for all medical and public health activities including control of TB.

A full-time District TB Officer (DTO), trained at the national level and based at the DTC, is responsible for planning, training, supervising and monitoring the programme in the district. The DTO is assisted by other technical and secretarial staff:

1. Medical Officer- District TB Center
2. District DR-TB-HIV Coordinator
3. District Public Private Mix Coordinator
4. District Program Coordinator
5. District Drug Store Pharmacist
6. District Data Entry Operator-Nikshay
7. District Accountant
8. Senior TB laboratory Supervisor
9. Senior Treatment Supervisor
10. Laboratory Technicians for DMC and NAAT site
11. Counsellor for District DR-TB center
12. TB Health Visitors

While the National TB Elimination Program (NTEP) approves the above positions through National Health Mission NTEP Project Implementation Plan, the district always has the flexibility for additional resource deployment based on the need and existing epidemic. The DTO and his/her team are supported by various other program officers/staff and non-governmental organizations working in the field for Tuberculosis and Health.

Resources

• NTEP Training Modules 1-4 for Programme Managers & Medical Officers, 2020.
• NTEP Training Modules 5-9 for Programme Managers & Medical Officers, 2020.

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Under the National Tuberculosis Elimination Programme (NTEP), a Peripheral Health Institute (PHI) is a health facility that is manned by at least a Medical Officer (MO), where diagnosis and management of Tuberculosis (TB) are done.

At this level, there are dispensaries, Primary Health Centres (PHCs), Community Health Centres (CHCs), referral hospitals, major hospitals, speciality clinics or hospitals (including other health facilities), TB hospitals, Anti-retroviral Treatment (ART) centres and medical colleges within the respective district.

All health facilities in the private and Non-government Organisation (NGO) sectors participating in NTEP are also considered PHIs. Some of these PHIs also function as Designated Microscopy Centres (DMCs).

Role of PHIs in Program Management for TB Elimination

• PHIs undertake tuberculosis case-finding and treatment activities as a part of the general health services.
• In situations where more than one MO is posted in any of the PHC, one of them may be identified and entrusted with the responsibilities of the NTEP.
• Additionally, NTEP provides 1 TB Health Visitor (TBHV) per one lakh urban population to support the urban TB control activities in urban settings/ medical colleges.

Resources

• NTEP Training Modules 1-4 for Programme Managers & Medical Officers, 2020.
• NTEP Training Modules 5-9 for Programme Managers & Medical Officers, 2020.

TB Aarogya Sathi empowers Citizens (including TB Patients under NTEP) and to serve as a Direct interface with the national TB program.

Citizen: The App is aimed at  increasing awareness among the citizens. It is available for all Citizens using the App (no login required to access this content)

• Information on TB (Symptoms, Side Effects)
• Health Facility Search
• BMI Assessment
• Nikshay Sampark Helpline
• Nutritional Advice

Patient: Patients registered with Nikshay will have access to the Adherence, Treatment Progress and DBT Details.

• Patients registered under Nikshay get access to their TB health record additional information (after login)
  • Adherence Details
  • Treatment Progress Details
  • DBT Details

TB Aarogya Sathi App is available in Google play store and can be download using this QR Code

Figure: TB Aarogya Sathi Application snapshot

Resources:

• Nikshay Training Material

Each of the stakeholder plays important role in DR-TB service delivery and has specific responsibility which is being monitored. 

The flow diagram below depicts the processes involved in the delivery of drug-resistant tuberculosis (DR-TB) services and specific functions of various stakeholders.

Figure 1: Cascade of DR-TB services and functions of various stakeholders
Source: Guidelines for PMDT in India, 2021, p.8

​

Resources

• Guidelines for Programmatic Management of Drug Resistant TB in India, 2021

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The National TB Elimination Programme (NTEP) in India has established well-organised Drug-resistant TB (DR-TB) management structures at the national, state and district level. 

Image

Figure: Diagrammatic representation  of the organisational structure of Programmatic Management of DR-TB (PMDT)

Abbr: NDR-TB: Nodal Drug-resistant TB; NAAT: Nucleic Acid Amplification Test; LPA: Line Probe Assay; CDST: Culture and Drug Sensitivity Test; DDR-TB: District DR-TB

The organisational structure and functions at different levels are described in the table below.

The organisational structure based on functional roles can be classified into diagnosis, treatment and drugs.

Diagnosis: 

Treatment:

Drugs:

Resources

• Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, NTEP, WHO, MoHFW, GoI, 2021.

Assessment

Drug-resistant Tuberculosis Centres (DR-TBCs) are specialized centres for the clinical management of Drug-resistant TB (DR-TB). ​

Each DR-TBC needs to have established a DR-TB committee to carry out the clinical management of DR-TB patients.​

DR-TBCs can be established in the public sector where appropriate facilities are available. ​

• The DR-TBC can also be established in the private sector on mutually agreeable terms and conditions based on the Guidance Document on Partnerships, 2019.

District level:  There are District Drug-resistant TB Centres (DDR-TBCs) to manage DR-TB cases. ​These centres will function under the guidance of Nodal Drug-resistant TB Centres (NDR-TBCs). Almost every district has a mandate to establish a DDR-TBC in India. There are around 620 DDR-TBCs established in the country.​

State/ Regional level: At the state/ regional/ division level, there are NDR-TBCs to manage seriously ill DR-TB cases. ​There are 173 NDR-TBCs established in India.​

Decentralized DR-TB services through an expanded network of DR-TB centres has helped the National TB Elimination Program in improving access to DR-TB services and has also resulted in improved DR-TB treatment linkage and better management of DR-TB patients.

Resources

• Guidelines for Programmatic Management of Drug-resistant TB in India, 2021.

Nodal Drug-resistant Tuberculosis Centres (NDR-TBCs) are established to manage all forms of DR-TB, including complicated cases. ​Therefore, the centre should have:

• Advanced general laboratory
• Allied investigation facilities for Pre-treatment Evaluation (PTE)
• Intensive Care Unit (ICU)
• Ventilator backup
• In-house lab/ linkages for PTE laboratory tests

The NDR-TBC is established as per the need and is generally in a tertiary care setting where expertise and facilities for the management of DR-TB are available. ​

The figure below shows an overview of services offered at the NDR-TBC.

Figure: Range of Services Available at NDR-TBCs

District DR-TB Centres (DDR-TBCs) are linked with the NDR-TBC for the referral and management of complicated DR-TB patients like those who have:​

• Additional resistance to second-line drugs, drug intolerance, serious adverse drug reactions, and contraindications ​
• Failing regimen, or patients returning after treatment interruption of more than 1 month​
• The emergence of any exclusion criteria for a standard regimen for rifampicin-resistant TB or H mono/ poly DR-TB regimen​
• Non-TB mycobacterial infections
• Need for palliative care or surgical interventions

Resources

• Guidelines for Programmatic Management of Drug-resistant TB in India, 2021.

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The requirements from institutions for establishing Nodal Drug-resistant Tuberculosis Centres (NDR-TBCs)​ are as follows:

• It should preferably be a tertiary care institute. ​
• Separate wards for male and female patients (including children) should be available with at least 10 beds in each NDR-TBC. ​
• An outpatient clinic and a separate well-ventilated waiting area in an open-air, shaded area should be made available as per the Airborne Infection Control (AIC) guidelines. ​
• Administrative, environmental, and personal protective measures for airborne infection control should be placed in all indoor and outdoor facilities.
• All investigations under Pre-treatment Evaluation (PTE) and other Programmatic Management of Drug-resistant Tuberculosis (PMDT) services should be provided free of cost to the patient. ​
• Ancillary drugs should be provided for the management of Adverse Drug Reactions (ADRs) as per the NDR-TBC committee`s advice at no cost to patients.​
• Oxygen and ventilators should be available for patients needing critical care support.  ​
• The NDR-TBC committee should be formally established with the required set of experts as per the guidelines.​
• All experts at NDR-TBC must be trained in the latest PMDT guidelines. ​
• Doctors, nursing and support staff should be available from the institute. ​
• Records and reports should be maintained for PMDT. Nikshay entries must be done on a real-time basis with regular electronic updates.​
• Financial requirements must be availed through the institute/ state budgets or under National Health Mission (NHM).

Resources

• Guidelines for Programmatic Management of Drug-resistant TB in India, 2021.

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In view of the availability of expertise in medical colleges, there is a felt need to leverage their strength to improve clinical, Adverse Drug Reactions (ADRs) and comorbidity management of patients with Drug-resistant Tuberculosis (DR-TB) across India. 

• Expansion of DR-TB services in the medical colleges will be helpful for enhancing the quality of care, treatment success and survival of these difficult-to-treat patients. 
• National Medical Commission (NMC) issued a gazette notification in October 2020, mandating all medical colleges to establish a facility for the management of DR-TB by the time of 3rd renewal (admission of 4th batch of MBBS students). 
• Private and Non-government Organisation (NGO) medical college hospitals are considered to serve as Nodal (N)/ District DR-TB Centre (DDR-TBC) at places where there is a need, either due to additional workload, non-availability of an appropriate public facility or preference of patients in the area. 
• Terms and conditions for establishing that centre may be arrived at the local level as per the prevailing market rates in concurrence of the state/ district health society of the National Health Mission (NHM).

Resources

• Guidelines for Programmatic Management of Drug Resistant TB in India, 2021. 
• Guidance Document of Partnerships, 2019.
• National Medical Commission, Gazette Notification, Government of India, 2020.

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District Drug-resistant TB Centres (DDR-TBCs) are dedicated centres for providing DR-TB services for patients and can be established at the district or sub-district level. ​

• It may be established in institutes like medical colleges, district hospitals, TB hospitals and private or corporate institutes, trust hospitals or other sector hospitals, with the availability of required clinical expertise. ​
• There should be at least one DDR-TBC available in each district. However, more than one DDR-TBC can be established to improve the access and preference of patients to seek care. ​
• DDR-TBC can be established on an Outpatient Department (OPD) basis as well. ​
• Central TB Division (CTD) should be informed about the up-gradation of any institute to a DDR-TBC.​
• Requirements for infrastructure and Human Resources (HR) may be proposed in the annual Programme Implementation Plan (PIP). 

TB Services Available at the DDR-TB Centre

Pre-treatment Evaluation (PTE): Basic investigations required for initiating DR-TB regimens, examples include:

• Complete Blood Count (CBC)
• Thyroid-stimulating Hormone (TSH) tests
• Renal function tests
• Liver function tests
• Electrocardiogram, etc.

Treatment Services: Trained experts can initiate all DR-TB regimens at the DDR-TBC.

Resources

• Guidelines for Programmatic Management of Drug-resistant TB in India, 2021.

The following functions and package of services should be offered at each District Drug-resistant Tuberculosis Centre (DDR-TBC):

Figure: Functions of DDR-TBCs

Abbr: NDR-TBC: National Drug-resistant TB Centre; AIC: Airborne Infection Control

Resources

• Guidelines for Programmatic Management of Drug-resistant TB in India, 2021.

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The following are requirements from institutions for establishing the district Drug-resistant Tuberculosis Centre (DDR-TBC):

Structural requirements:

• It should preferably be a secondary care institute. 
• Separate wards for male and female patients (including children) should be available with at least two beds in each for DDR-TBC. 
• An outpatient clinic and a separated well-ventilated waiting area in an open-air, shaded area to be made available as per the Airborne Infection Control (AIC) guidelines. 
• Administrative, environmental and personal protective measures for airborne infection control should be placed in all indoor and outdoor facilities. 

Infrastructure requirements:

• All investigations under Pre-treatment Evaluation (PTE) and other Programmatic Management of Drug-resistant Tuberculosis (PMDT) services should be provided free of cost to the patient. 
• Availability of oxygen and ventilators for patients needing critical care support.
• Ancillary drugs must be provided for the management of Adverse Drug Reactions (ADRs) at no cost to patients, as per the DDR-TBC committee's advice. 

Human resource requirements:

• The DDR-TBC committee should be formally established with the required set of experts as per guidelines.
• Services of specialists, if not available in the public facility, may be hired from the private sector under National Health Mission (NHM). 
• All experts at DDR-TBC must be trained in the latest PMDT guidelines. 
• Doctors, nursing and support staff should be available from the institute. 
• Records and reports to be maintained for PMDT. Nikshay entries must be done on a real-time basis with regular electronic updates.
• Financial requirements should be availed through institute/ state budgets or under the NHM.

​Resources

• Guidelines for Programmatic Management of Drug Resistant TB in India, 2021. 

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The Nodal Drug-resistant Tuberculosis Centre (NDR-TBC) committee is a clinical committee that is responsible for taking decisions regarding the management of DR-TB patients at the NDR-TBC.

The composition of the NDR-TBC committee is provided in the table below.

Functions of Nodal DR-TBC

1. Periodically review the implementation status of PMDT in the respective nodal DR-TB centre to ensure that NTEP PMDT policies and guidelines are being followed.
2. Coordinate with the IRL/ Culture and Drug Susceptibility Testing (C&DST) labs for Drug Susceptibility Testing (DST)/ Drug Resistance Testing (DRT) results and enter the details in Nikshay.
3. Arrange for examination of DR-TB patients referred for their treatment eligibility, open treatment book and start PMDT regimen for all eligible patients.
4. Admit DR-TB patients who may require the indoor facilities of the DR-TB centre.
5. Arrange tele/ video consultation with relevant specialists on a case-to-case basis as well as with linked DDR-TBC to provide required clinical decision support.
6. Empanel the private practitioners of various disciplines if the required specialist is not available in the public sector. In coordination with the respective State TB Officer (STO) and DTOs, ensure that drug ordering and distribution is managed in a timely and appropriate manner.
7. Account for the review of record, report, Nikshay data entry.
8. Monitor performance of DR-TB and PMDT in catchment geography using analysis of data from downloadable Nikshay reports and dashboard.

Resources

• Guidelines for Programmatic Management of Drug-resistant TB in India, 2021.

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The district drug-resistant tuberculosis centre (DDR-TBC) committee is a clinical committee where the dean/principal/ director of the institute is the chairperson.

• The Head of the Department (HoD) or a senior faculty member from the department of pulmonary medicine/general medicine is the nodal officer of the committee.
• The HoDs or senior faculty members of other specialties are the members of the committee.
• The clinical function of these committees must be adequately supported by the administrative or management committees of the institution in which district TB officer (DTO) is an ex-officio member.
• The composition of the DDR-TBC committee is shown in Figure 1.

Ob&Gy: Obstetrics and Gynaecology, ENT: Ear, nose and throat surgeon; MO: Medical Officer, WHO: World Health Organisation, NTEP: National TB Elimination Programme, TSN: Technical Support Network

Resources

• Guidelines for Programmatic Management of Drug Resistant TB in India, 2021

The Terms of Reference (ToR) for the District DR-TB Centre (DDR-TBC) committee are:

• Ensure arrangements for patient treatment initiation as per the Programmatic Management of Drug-resistant Tuberculosis (PMDT) guidelines. 
• Periodic review of treatment initiation, active Drug Safety Monitoring and Management (aDSM) and patient monitoring activities carried out at the DDR-TBC.
• Coordinate with the District TB Officer (DTO), TB Unit (TU), Health Facility (HF), other departments and Non-governmental Organisations (NGOs) to ensure the patient is linked with all essential services required. 
• Empanel the private practitioners of various disciplines which are not available in the committee and are required for the management of DR-TB. 
• Arrange tele/ video consultation with a relevant specialist on a case-to-case basis as well as with the linked nodal DR-TB centre to seek guidance required for clinical decision support. The DDR-TBC should also arrange tele/ video consultation with HFs on a case-to-case basis to provide required clinical decision support. 
• Account for review of record, report, and Nikshay data entry. 
• Monitor performance of DR-TB and PMDT in the catchment geography using analysis of data from downloadable Nikshay reports and dashboard. 

Resources

• Guidelines for Programmatic Management of Drug-resistant TB in India, 2021.

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Presumptive Drug-resistant TB (DR-TB) is identified by the health facility doctor during passive screening or by health staff/ community volunteers during Active Case Finding (ACF). 

Prompt referral and sample collection is an important step after identifying presumptive TB/ DR-TB. 

After detection, referrals should be made promptly by the Community Health Officer (CHO) at Health and Wellness Centre (HWC)/ Senior Treatment Supervisor (STS)/ Tuberculosis Health Visitor (TBHV) to the health facility or Nodal/ District DR-TB Centre (N/DDR-TBC) for pre-treatment evaluation and treatment initiation. Every district has DDR-TBC for the treatment of DR-TB cases. However, for complicated DR-TB cases,that need either super-speciality or complex medical equipment and intensive care (like invasive ventilators), such patients are referred to Nodal DDR-TBCs.

Referral linkages for further domiciliary treatment are to be ensured by health facility doctor, N/DDR-TBC, senior DR-TB TB-HIV supervisor, STS, TBHV, CHO and general health staff. 

Identification of suitable treatment supporters by CHO/ STS/ TBHV is essential, and the periodic follow-up of clinical/ bacteriological examination is to be managed.

The cascade of referral mechanism and function of various stakeholders is described below.

Image

Figure: Cascade of referral mechanism and function of various stakeholders; Source: Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, NTEP, CTD, WHO, MoHFW, 2021, p48.

Resources

• Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, NTEP, CTD, WHO, MoHFW, 2021.

Assessment

The Difficult-to-treat TB clinic (DT3C) is an initiative to support Drug-resistant TB Centres (DR-TBCs) for better patient management. 

The DT3C structure is intended to handhold and mentor District DR-TB centres (DDR-TBCs) for the effective management of Drug-resistant TB (DR-TB) cases.

Figure: Difficult-to-treat TB Clinic: Three-tier Structure

The DT3C operates via a three-tier structure which is intended to improve the quality of DR-TB care:

1. The DT3C is functional at the national level through the collaboration of the National Institute for Tuberculosis and Respiratory Diseases (NITRD), Central TB Division (CTD) and the National Task Force (NTF).
2. Experts involving various specialties are included in the team as mentors at state-level D3TC.
3. Information/ queries regarding the patient are shared in a standardized format by the DDR-TBC beforehand to facilitate discussions through the state nodal officer. 
    

All states should have at least one (more than one in larger states) DT3C established.

Resources

• Guidelines for Programmatic Management of Drug-resistant TB in India, 2021: Guidance on Establishment of State Level difficult-to-treat TB clinic (S-DT3C), p212-215.

Those who are suspected of having TB disease are first screened for symptoms like cough and fever for more than 2 weeks, blood stained sputum and weight-loss. If found positive on screening, then TB patients are referred for testing to the nearest health facility. If diagnosed with TB, then they are subsequently initiated on treatment. The TB patients initiated on treatment are regularly monitored with the help of field staff or digital interventions like 99DOTS and MERM (Medication Event Reminder Monitor) technology. NTEP staff also ensures that the TB patients are regularly followed up on monthly basis till their treatment completion.

Figure: Patient Flow

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The roles of the Drug-resistant TB (DR-TB) HIV Coordinator are:

1. Providing technical assistance to District TB Officer (DTO) for:

• Organising Programmatic Management of Drug-resistant TB (PMDT) services in the district
• Supporting District DR-TB Centre (DDR-TBC) for data management in Ni-kshay and their coordination with Anti-retroviral Therapy (ART) centre in the districts
• Organising TB-HIV coordination activities in the district
• Providing training to the staff of health facilities (public and private) under his/her jurisdiction to carry out PMDT and TB-comorbidity-related activities
• Conducting monthly reviews with TB Unit, National AIDS Control Programme (NACP), and Health and Wellness Centre (HWC) staff using dashboards and analysis of data from Ni-kshay periodically to address implementation and management gaps
• Activities related to drug and logistics supply chain management of drugs for PMDT, Cotrimoxazole Preventive Therapy (CPT) and Isoniazid Preventive Therapy (IPT) and modified TB regimen for People Living with HIV/AIDS (PLHA) with TB on second-line ART
• Coordinating regular sharing of the information related to TB-HIV coordination by assisting the nodal officer
• Mapping, prioritising, and engaging health facilities and laboratories in the private sector, Non-government Organisations (NGOs) and other sectors to improve access and quality of DR-TB care for all as per guidelines
• Preparing and maintaining a directory of Integrated Counselling and Testing Centres (ICTCs), ART centres/ Link ART Centres (LACs), community care centres, Non-communicable Disease (NCD) clinics, private health facilities and NGOs working for HIV, NCD in the district and the collaborating National TB ELimination Programme (NTEP) centres
• Providing a monthly activity report to the DDR-TBC committee and DTO.

2. Coordinating for smooth programme implementation

• Coordinate with all health staff and facilitate to subject all TB patients to universal Drug Susceptibility Testing (DST) at the linked decentralised Nucleic Acid Amplification (NAAT) sites and NTEP certified laboratories in the public and private sectors.
• Ensure that initial home visits are conducted by health workers to all newly diagnosed DR-TB patients of the district.
• Ensure that staff organises treatment support, all public health actions, follow-up reminders and transportation support for DR-TB patients.
• Help staff in proactive reach out to patients for follow-up cultures/ investigations as per schedule for every patient.
• Coordinate with and support TB Units, HWCs staff and private doctors to regularly update the directory of treatment supporters for DR-TB patients at the district level and facilitate their training.
• Facilitate the DR-TB treatment initiation at DDR-TBC.
• Ensure PMDT treatment books are updated for all patients at DDR-TBC, TB Units (TUs) and HWCs.
• Ensure and monitor the PMDT data completion in Ni-kshay and give periodic TU/ Peripheral Health Institute (PHI)-wise feedback to the DTO about the same.
• Liaise with respective Nodal Drug-resistant TB Centres (NDR-TBCs) for updating information on Ni-kshay and patient care.
• Ensure complete, correct and timely compilation and transmission of PMDT/ TB- HIV information.
• Establish linkages with the District TB Centre (DTC), District AIDS Prevention Control Unit (DAPCU), collaborating NGOs and hospitals of the district.
• Facilitate change management with respect to the use of Information, Communication and Technology (ICT) tools, Ni-kshay, Ni-kshay-Aushadhi for concerned data entry, validation & its use for public health action.
• Support DDR-TBC in updating the template with information to be shared with difficult-to-treat TB clinic for selected patients as per directions from the DDR-TBC committee and management of the patient based on recommended actions from the clinic.

3. Supervising and monitoring

• Monitor time to treatment of DR-TB patients and provide feedback on a periodic basis. 
• Supervise all DR-TB patients and treatment support centres along with concerned TB Units, HWCs staff and private providers.
• Evaluate referral systems between ICTCs, ART centres, NCD, and NTEP and promote providing feedback to the referring centre.
• Field visits in the districts for at least 15 days a month, including Joint TB-Comorbidity visits on a tour programme approved by DTO.

4. Capacity building and imparting skills

• Train and supervise the pharmacists/ responsible staff of district/ TB Unit/ HWC drug stores in maintaining adequate stock of second-line drugs.
• Train staff for preparation of monthly patient-wise boxes by regimen and weight band as well as initialisation of Medication Event Reminder Monitor (MERM) devices, as available, for every patient initiated on DR-TB treatment at the NDR-TBC as per guidelines.

Resources

DO Letter - TOR and Needs Norms for NTEP Staff, 2021. 

Assessment

The DR-TB HIV coordinator interacts with the TB patient care ecosystem as follows:

Patients: UDST at linked NAAT sites, treatment initiation, adherence monitoring and follow-up, ADR identification and management, contact tracing, linking with welfare schemes, linkage with the TB care ecosystem.

Treatment supporters: To ensure initial home visits, treatment support, and all public health actions.

STLS: To subject all TB patients to universal DST at the NAAT sites, to ensure complete DST and the laboratory follow-up of all the patients.

STS: Treatment initiation of DR-TB patients, necessary treatment support, Public health actions, and coordinate for follow-up cultures and investigations.

Medical officers: Facilitating DR-TB treatment initiation and management of ADR.

DR-TB Committee: Support DDR-TBC in providing the information about the DR-TB patients, and coordinate with the different staff to execute the decision of N/DDR-TBC. Updating the template with the information to be shared with difficult-to-treat TB clinic for supported patients.

Pharmacists/responsible staff of district/TB Unit/HWC drug stores: Maintaining adequate stock of second line drugs, preparation of monthly patient wise boxes by regimen and weight bands initialization of MERM devices.

Ni-kshay and Ni-kshayAushadhi: Use of ICT tools, Ni-kshay, Ni-kshay-Aushadhi for concerned data entry, validation and its use for public health action and monitoring the PMDT data completion in Ni-kshay and give periodic TU/PHI-wise feedback to the DTO about the same.

DTO/ Programme Managers: Seek overall guidance from DTO/Program managers for executing their duties and responsibilities. They also provide with necessary data and information about the PMDT facilitating supervision and monitoring and discuss and implement various solutions for the identified issues.

Resources

• DO Letter- TOR and Need Norms for NTEP Staff, MoHFW, GoI, 2021.

Assessment

Overview of the organisational structure of the health system in relation to the National TB Elimination Programme (NTEP) is shown in the figure below.

Image

• Sub-centre: Most peripheral units under the public health system are designed to bring about behavioural change and provide preventive health care services.
• Primary Health Centre (PHC): First contact point between the village, community and the medical officer envisaged to provide integrated, curative and preventive health care.
• Community Health Centre/ Sub-district Hospitals: Serve as a referral centre for four PHCs and provides facilities for obstetric care and specialist consultations.
• Peripheral Health Institute (PHI): Most Peripheral Unit under the NTEP provides TB treatment and diagnostic services to the population.
• Tuberculosis Units: Nodal point for TB elimination activities in the sub-district level and are also responsible for stacking and supply of drugs to the PHI.

Resources

• Operational Guidelines for TB Services at Ayushman Bharat Health and Wellness Centres, CTD, MoHFW, India, 2020.
• National Strategic Plan 2017-2025 for TB Elimination in India, CTD.

Assessment

• The public health system in India through the National Health Mission (NHM) visualises the attainment of Universal Health Coverage (UHC) for all its citizens, which provides access to equitable, affordable and quality health care services, which is also accountable and responsive to the needs of the people.

• Under the umbrella of NHM, the National TB Elimination Programme (NTEP) ensures the provision of free TB services (diagnostics and drugs) and management of TB as per the Standards for TB Care in India (STCI).

• Furthermore, the NHM, under the Ayushman Bharat initiative has taken measures to strengthen the primary care facilities including Primary Health Centres (PHCs) and Sub Health Centres (SHCs) in the Ayushman Bharat Health & Wellness Centres (AB-HWCs).

Need for integration of NTEP with the Health System at Different Levels

1. Closer to community TB Services: The integration of TB services with the health system provides an opportunity for the TB programme to leverage the resources under the Ayushman Bharat initiative to take TB interventions closer to the community which were otherwise provided at the primary care level.
2. Improved population coverage: Active empanelment and HWC database will help to monitor and identify the left-out population and contribute significantly to the NTEPs case finding activity coverage.
3. Improved population health outcomes: Improved availability, access and utilisation of advanced TB treatment services under the ambit of UHC is essential in reducing morbidity and mortality from TB which may in turn also contribute to overall equitable health outcomes.
4. Reduced out-of-pocket expenditure: The integration will improve the access to TB services, assure within-reach TB medicines and diagnostic services, provide linkages for care coordination with Medical Officers/ specialists across various levels of care, etc., all of which will reduce the catastrophic expenditures faced by the patients and their families.
5. Decreased crowding at the secondary and tertiary health facilities: A strong network of peripheral level TB care services would facilitate in reduction of the overcrowding and the case burden at the secondary and tertiary facilities, which could be utilised for cases with follow-up referral to higher level facilities.
6. Increased responsiveness and addressal of social determinants of TB: Provision of TB treatment at the nearest point of care for the communities and engaging the most peripheral workers from the health system like the Accredited Social Health Activists (ASHA) in the TB programme may lead to comfort in accessing the care by the patients and also enable addressing psycho-social determinants of TB.

Resources

• Operational Guidelines for TB Services at Ayushman Bharat Health and Wellness Centres, CTD, MoHFW, India, 2020.
• National Strategic Plan 2017-2025 for TB Elimination in India, CTD.

Assessment

The National Health Mission (NHM) was launched by the Government of India in 2013, subsuming the National Rural Health Mission (NRHM) and National Urban Health Mission (NUHM). Figure 1 shows the history of the NHM.

The vision of NHM is “Attainment of Universal Access to Equitable, Affordable and Quality health care services, accountable and responsive to people's needs, with effective intersectoral convergent action to address the wider social determinants of health.”

Image

Figure 1: History and Make-up of the NHM; Source: Annual Report 2015-16, Ministry of Health and Family Welfare (MoHFW)

NHM further aims to support the existing national programmes of health and family welfare (Figure 2) including reproductive and child health, malaria, blindness control, iodine deficiency, filariasis, kala-azar, tuberculosis (TB), leprosy, and integrated disease surveillance.

Image

NHM and the National Tuberculosis Elimination Program (NTEP)

Integrating the NTEP with the health system increases the effectiveness and efficiency of TB care and control. India's TB control programme has been mainstreamed efficiently with the NHM.

The overall responsibility for the financial management of the NTEP is with the MoHFW, Director General of Health Services (DGHS) through the NHM.

At the state level, the State Health Society or its equivalent under the NHM of the state manages the financing of the TB Control Programme.

At the sub-district level, the TB Unit (TU) is the nodal point for TB control activities. TUs are based mainly in NHM health blocks with the aim of aligning with the NHM Block Programme Management Unit (BPMU) for optimum resource utilization and appropriate monitoring.

Resources

• Annual Report 2015-16, Chapter 2: NHM, Ministry of Health and Family Welfare (MoHFW).
• Information on the NHM, NHM India, 2020.
• NTEP Training Modules 1-4 for Programme Managers & Medical Officers, 2020.

The private sector for tuberculosis (TB) care is everything outside the ambit of government-run public health initiatives. It consists of a wide range of providers from individual medical practitioners of many different systems of medicine, including:

• Modern medicine
• Indian systems of medicine
• Homeopathy
• Paramedics
• Traditional healers
• Private hospitals and nursing homes
• Non-governmental organization-run hospitals
• Corporate sector health care institutions

As per the National Sample Survey Organization report of the 75th round, more than 70% of patients seek care in private clinics or hospitals.

Challenges with TB care in the private sector:

• Delays in diagnosis
• Over-diagnosis of TB due to an over-dependence on X-rays
• Use of multiple non-standard regimens for inappropriate durations
• Lack of a mechanism to ensure the full course of treatment and to record treatment outcomes

Regulatory tools to improve TB care services: The following are existing regulatory tools to improve TB care services in the private sector:

• Standards for TB care in India
• Mandatory TB notification on Nikshay
• Ban on sero-diagnostics
• Amendments in H1 schedule

Regulatory tools, however, are limited, and partnership is preferred. 

Steps/approaches to strengthen private sector engagement:

Partnership approaches include:

• An expanded acceptance by National TB Elimination Program (NTEP) of internationally approved diagnostic and treatment protocols
• Reliance on market forces rather than normative exhortation, that is, engaging and prioritising health care providers that offer the highest market value
• Increased use of accreditation and contracting

Other NTEP initiatives include:

1. Outreach to private laboratories
2. Increased control of TB drugs
3. Innovative use of information and communication technologies for TB notification and treatment adherence monitoring

NTEP has systematically mapped private healthcare providers (single and multispecialty hospitals), private laboratories and chemists in the Nikshay online portal through which these health facilities can notify TB patients.

Resources

• Training Modules (1-4) for Programme Managers & Medical Officers, 2020.
• Key Indicators of Social Consumption in India: Health, NSS 75th Round Report, Ministry of Statistics and Programme Implementation, 2019.
• JEET Brochure.

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Integrated patient-centred care and prevention are one of the pillars of the End TB strategy. This requires TB services to be made affordable and accessible by integrating them with the general health system. 

In 2005, the National Rural Health Mission (NRHM) was established and was merged with the National Urban Health Mission (NUHM) in 2013, to form the National Health Mission (NHM).The National TB Elimination Programme (NTEP) is a flagship programme under the NHM and fund allocation to NTEP occurs through the NHM.

NTEP integrates with the public healthcare system at various levels as follows:

• Community level – Accredited Social Health Activists (ASHA)/ Community Health Volunteers (CHVs)/ Multipurpose Workers (MPWs)
• Ayushman Bharath Health and Wellness Centre - Sub Health Centre (ABHWC - SHC)
• Ayushman Bharath Health and Wellness Centre - Primary Health Centre (ABHWC - PHC)
• Community Health Centre (CHC)
• District/ Taluka hospital
• Medical Colleges
• Other health institutions in the public sector – ESI, railways, ports and the ministries of mines, steel, coal, etc.

Note: As far as NTEP is concerned, a Peripheral Health Institution (PHI) is a health facility headed by a Medical Officer

TB services are provided free of cost through the public health system.

Services provided include:

1. Advocacy, Communication and Social Mobilisation (ACSM) and Information Education and Communication (IEC)
2. Screening for TB – Active Case Finding (ACF), Passive Case Finding (PCF), Intensified Case finding (ICF)
3. Diagnosis of TB and drug resistance – Designated Microscopy Centre (DMC) or TB diagnostic centres. Some of the PHIs themselves act as DMCs or Sputum Collection Centres
4. Treatment for DS-TB and H Mono/Poly DR-TB through PHIs
5. Treatment for DR-TB through District/Nodal DR-TB Centres
6. Treatment Support through out treatment course
7. Clinical follow-up and comorbidity management
8. Referral services for those with Adverse Drug Reactions (ADRs)
9. Screening for Tobacco and Alcohol addiction and linkage to de-addiction services
10. TB preventive therapy
11. Data management in Ni-kshay

References

• Technical and Operational Guidelines for Tuberculosis, 2016.                        
• National Strategic Plan 2017-2025 for TB Elimination in India, CTD. 
• Detect-Treat-Prevent-Build: Strategy for TB Elimination in India by 2025, Indian J Community Med., 2018.

Assessment

Ayushman Bharat (AB) is an attempt to move from a selective approach to health care to deliver comprehensive range of services spanning from preventive, promotive, curative, rehabilitative and palliative care. AB-HWCs are envisaged to deliver expanded range services that go beyond maternal and child health care services to include care for non-communicable diseases, palliative and rehabilitative care, oral, eye and ear nose and throat care, mental health and first level care for emergencies and trauma, including free essential drugs and diagnostic services.

It has two components which are complementary to each other.

1. Under its first component, 1,50,000 Health and Wellness Centres (HWCs) will be created to deliver Comprehensive Primary Health Care, which is universal and free to users, with a focus on wellness and the delivery of an expanded range of services closer to the community.
2. The second component is the Pradhan Mantri Jan Arogya Yojana (PM-JAY) which provides health insurance cover of Rs. 5 lakhs per year to over 10 crore poor and vulnerable families for seeking secondary and tertiary care.

On 14th April 2018, the Honorable Prime Minister of India launched the first Health and Wellness Centre at Jangla, Bijapur, Chhattisgarh. Health Sub-Center (HSC), PHC (Primary Health Center) and Urban PHCs are currently being upgraded to reach a goal of 1.5 lakhs AB-HWC by 2022.

The National TB Elimination Program (NTEP) has also integrated TB services as part of the health and wellness center service delivery package.

Resources

• Operational Guidelines for TB Services at Ayushman Bharat Health and Wellness Centres, MoHFW, 2021.
• Ayushman Bharat - Health and Wellness Centre Website, Government of India.

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Medical colleges in the country are integrated with the National TB Elimination Programme (NTEP) to widen access and improve the quality of TB services. Medical colleges provide specialized services for seriously ill TB patients.

The integration of medical colleges in the program is in a structured task force mechanism at different levels:

• National
• Zonal
• State  

One national and six zonal task forces have been formed under the programme along with task forces for all states. A core committee is also formed in each medical college. These task forces are created with defined roles and responsibilities for the effective involvement of medical colleges in the programme.

Core Committee

Every medical college will have core committees representing various hospital departments and NTEP nodal officers. These committees meet quarterly and review the implementation of the program in the medical college.

Functions of the core committee:

• They organise sensitisation workshops and training for faculty members, postgraduates, undergraduates, interns, paramedical staff, etc. ​
• Ensure that teachings on TB/ NTEP form part of the curriculum for all medical colleges.
• Coordinate between various departments so that patients get the services under one roof.
• Coordinate with the district TB programme. ​

​Role of Medical College in NTEP

1. Medical colleges coordinate with the district TB programme for participation in quality assurance, supervision, monitoring, review and evaluation.
2. Operational research is one of the important activities of medical colleges. 
3. Every medical college should have TB detection facility and treatment support centres. These centres are equipped with trained additional human resources such as medical officers, laboratory technicians and TB health visitors.
4. The National Medical Commission insists that all Medical Colleges should also have facilities to manage DR-TB patients.
5. Medical colleges undertake advocacy for the programme.
6. Medical colleges also functions as peripheral health institutes (PHI), maintain TB notification registers and submit monthly PHI reports​: They have Nikshay user access and need to enter TB-related data on a real-time basis. 

Resources

RNTCP Technical and Operational Guidelines for Tuberculosis Control in India, 2016.

Assessment

Integrated Counselling and Testing Centre (ICTC) is a hub where HIV Counselling and Testing Services (HCTS) are offered to an individual of his/her own will or as suggested by a medical care provider.

Types of ICTC

1. Standalone ICTC (SA - ICTC)

2. Facility integrated ICTC (F - ICTC)

The SA-ICTC facility is a confirmatory facility and it should be located at an easily accessible place with proper signages to direct and guide people to the location.

The SA-ICTC facility should consist of at least two rooms, one for counselling and the other for testing.

ICTCs are aligned to the National TB Elimination Programme (NTEP) diagnostic facilities.

• All individuals attending the ICTC are screened for the four symptoms of fever, cough, night sweats, and weight loss.
• Presumptive TB cases are referred for TB diagnosis to TB Detection centres(TDCs).
• Link the referred individual to the NTEP centre by providing a linkage form in Triplicate.
• Provide them with a duly filled NTEP referral form for diagnosis to fast track. 
• Line list of all the Presumptive TB should be maintained and should be reviewed with NTEP monthly to ensure that all the cases have undergone testing.

Resources

• National HIV Counselling and Testing Services (HCTS) Guidelines, National AIDS Control Organisation, Government of India, 2016.

Assessment

Facility-integrated Integrated Counselling and Testing Centre (F-ICTC) takes HIV Counselling and Testing Services (HCTS ) closer to the people, increasing the uptake of services while reducing transportation costs and waiting times. F-ICTC s can be mobile or fixed.

Proper signage should direct and guide people to reach the F- ICTC.

The health facility should earmark a suitable room to ensure privacy and confidentiality and with good cross-ventilation to prevent air-borne infection.

Any positive HIV results at F-ICTC are only provisional - The facility uses whole blood finger-prick test kits for HIV screening.

If found reactive on HIV screening, link the individual to the linked SA-ICTC for confirmation of HIV diagnosis and further necessary action, using the Linkage Form. 

If found non-reactive on HIV screening, the laboratory report duly signed by the medical officer should be given to the individual during post-test counselling on the same day as the screening.

Verbal screening for the four symptom complex of TB is done for all the clients and appropriate referral to NTEP diagnostic facilities if indicated. The provisions for Presumptive TB testing is applicable for ICTCs too.

Resources

• National HIV Counselling and Testing Services (HCTS) Guidelines, National AIDS Control Organisation, Government of India, 2016.

Assessment

Anti-retroviral Therapy (ART) Centre is a facility to provide a comprehensive package of care, support and treatment services to persons living with HIV/AIDS (PLHIV).

ART Centre - TB  Diagnosis and Treatment  

Image

DR TB   cases are referred to  DR TB centre.

Referrals for TB  diagnosis are documented in the HIV TB line list which will be updated with the help of Senior Treatment Supervisor (STS) according to the test reports. 

TB HIV registers are maintained in the ART centres to document TB cases.

INH preventive Therapy (IPT)  - is initiated for all eligible PLHIV  at ART centre

Resources

• Operational Guidelines for ART Services, NACO, GoI, 2012.
• TB/ HIV Module for ART Centre Staff National AIDS Control Organisation and Central TB Division, Ministry of Health & Family Welfare, GoI, 2010.

Assessment

Link ART Centre (LAC) aims for easy accessibility of treatment services for People Living with HIV (PLHIV) by reducing the distance, cost, and waiting hours for Anti-retroviral Treatment (ART) and thereby increasing treatment adherence. They are linked to a Nodal ART centre.

Link ART Centre Plus (LAC Plus) is LAC which performs pre-ART management also. This will help to bridge the gap between Integrated Counselling and Testing Centre (ICTC) and Care, Support & Treatment (CST) services. These patients shall be followed up at LAC plus till they become eligible for ART or are referred to the ART centre for any other reason.

In addition to the existing infrastructure of ICTC where LAC is being established, at least one additional room is required for the nurse provided by the institution, for record keeping and other LAC functions.

Only patients from the designated nodal ART centre shall be linked to the attached LAC/ LAC plus.

Patients satisfying all of the following conditions shall be linked out to Link ART centres:

1. PLHIV on ART for a minimum of six months at the nodal ART centre

2. Those who have exhibited an increase in CD4 count and clinical improvement after 6 months of initiating ART

3. Do not have any active OI

4. The patient is a resident of an area closer to the LAC than to the nodal ART centre

5. Those who are willing to be linked out and collect their ARV drugs from the LAC, once the above conditions are fulfilled

Copy of Link out/in format to be exchanged between nodal ART centre and LAC while linking out or linking in the patients and a soft copy of these are to be maintained by both nodal ART centre & LAC/ LAC plus in a separate folder.

LAC/ LAC plus shall not initiate/ modify ART in any patient at any time.

Resources

• Operational Guidelines for Link ART Centres and LAC PLUS, NACO, Department of AIDS Control, MoHFW, GoI, 2012.

Assessment

Centres of Excellence (CoE) in HIV care were established with an objective to set up model treatment centres, impart high-quality training, and undertake operational and clinical research about HIV/ AIDS on a larger scale.

Structure and Activities of Centre of Excellence

Image

The Anti-retroviral Treatment (ART) CoE are located in medical colleges and tertiary care centres of high technical repute. The CoE ideally should have an environment that is comfortable for the care provider as well as the beneficiary to obtain optimal results.

• The ART centre of the institution should be an integral part of the CoE as the key centre providing clinical HIV care for persons infected/ affected by HIV.
• There should be a functional integration of the ART centre with CoE.
• Paediatric CoE/ paediatric department, Prevention of Parent to Child Child Transmission (PPTCT) services, laboratory services and inpatient care in the institution should be linked to the CoE to ensure comprehensive HIV care.

Manpower in CoE

• Programme Director - Faculty of the institution associated with the National AIDS Control Organisation (NACO) programme 
• Deputy Programme Director- identified from the institution

Additionally recruited staff on a contract basis include:

• Research Fellow (Clinical) - 1
• Research Fellow (Non-clinical) - 1
• SACEP Coordinator -1
• Data Analyst – 1
• Training and Mentoring Coordinator – 1
• Laboratory Technician – 1
• Nutritionist – 1
• Outreach Workers/ Social Workers- 2

CoE Team - Multidisciplinary team headed by the Head of the institution. It should consist of trained faculty from the departments of Medicine, Microbiology, Obstetrics & Gynaecology, Paediatrics, Community Medicine, Dermatology and Venereology. This team reviews the functioning of the CoE. Members of this team will also be engaged as resource persons in various training programmes organised by NACO/ State AIDS Prevention and Control Societies (SACS) after their certification as national trainers.

Steering Committee - Headed by the head of the institution. Members of this Committee should include the Programme Director, Deputy Programme Director, Director of concerned SACS and a NACO representative. This committee should meet once in 3 months to review of the functioning of CoE and to sort out any issues related to its functioning.

State AIDS Clinical Expert Panel (SACEP ) consists of - 1) Programme Director of CoE/ Deputy Programme Director/ Nodal Officer of ART centre 2) External ART expert 3) Regional Coordinator/ Joint Director (Care Support and Treatment)/ Consultant (CST) at SACS.

Treatment Linkage to CoE

Patients from ART centres experiencing treatment failure with first-line ART or drug toxicity are referred to the CoE for further evaluation and second-line treatment/ Alternate first-line treatment as per the linkage plan.

Resources

• Scheme for Centres of Excellence in HIV Care, NACO, MoHFW, GoI, 2012.

Assessment

National Tuberculosis Elimination Programme (NTEP) strives for all presumptive TB patients to be microbiologically confirmed. Under NTEP, the acceptable methods for microbiological diagnosis of TB are: 

Rapid diagnostic molecular test: Rapid molecular tests that use techniques like NAAT are very specific. They amplify the genomic material in the patient sample and hence enhances detection

• Nucleic Acid Amplification Test (NAAT) e.g., GeneXpert, TrueNat

  

  Figure: Genxpert Machine for CBNAAT

  

  Figure:  Truenat Machine

• Line Probe Assay

The two methods available for laboratory diagnosis of drug resistance/ susceptibility are as follows: 

Figure: Laboratory Diagnosis Methods: Drug Resistance Testing (DRT) and Drug Susceptibility Test (DST)

Resources

• Guidelines for Programmatic Management of Drug-resistant TB in India, 2021.

Cartridge Based Nucleic Acid Amplification Test (CBNAAT) is a rapid molecular diagnostic test. It is used for diagnosis of Tuberculosis (TB) and Rif-resistant Tuberculosis (RR-TB) in NTEP. Results are obtained from unprocessed sputum samples in about 2hours which helps in early detection and treatment of TB patients. 

India has vast number of CBNAAT laboratories which are utilized for TB/RR-TB detection and Universal Drug Susceptibility Testing (UDST) under the National TB Elimination Program (NTEP).  

Figure: CBNAAT Cartridge and Machine in Use (Image courtesy: USAID supported Challenge TB Project)

The CB-NAAT system detects DNA sequences specific for Mycobacterium tuberculosis complex and rifampicin resistance by Polymerase Chain Reaction (PCR). It concentrates Mycobacterium tuberculosis bacilli from sputum samples, isolates genomic material from the captured bacteria by sonication and subsequently amplifies the genomic DNA by PCR. The process identifies clinically relevant rifampicin resistance-inducing mutations in the RNA polymerase beta (rpoB) gene in the Mycobacterium tuberculosis genome in a real-time format using fluorescent probes called molecular beacons.

Video: Cartridge-Based Nucleic Acid Amplification Test [CBNAAT] - GeneXpert Technology 

Resources

• Training Module (1-4) for Program Managers and Medical Officers, NTEP, MoHFW, 2020.
• India TB Report 2021, National TB Elimination Program (NTEP), MoHFW, 2021.

Assessment Questions

Truenat is an indigenous rapid molecular test platform that is currently under use in NTEP for diagnosis of TB and Rif Resistance. It is a platform utilising real-time Polymerase Chain Reaction (PCR) technology built into micro-PCR chips.

Testing on Truenat involves three components:

1. Workstation (consisting of 2 devices)
   • Trueprep AUTO Universal Cartridge-based Sample Prep Device for the automated extraction and purification of DNA
   • Truelab Real-time micro PCR Analyzer for performing real-time PCR. It is available as 1 (Uno), 2 (Duo) or 4 (Quattro) chip ports.
2. Cartridge and Chip
3. Reagent kits (Sample Pre-treatment and Prep kits)

Figure: Truenat  Source: MolBio Products.

Test results for MTB detection and Rif Resistance has a turn around time of 1-2 hours. Depending on the micro-PCR chips used various tests can be performed using Truenat. Truenat MTB micro-PCR chips detect Mycobacterium tuberculosis bacteria for TB diagnosis. Truenat MTB RIF micro-PCR chip is used as a reflex test to detect resistance to Rifampicin (RIF), the first-line drug for TB treatment

Truenat has many advantages. Truenat is designed to be mobile and is battery operated (~8 hours on full charge). It can be deployed in peripheral laboratories and microscopy centres with minimal or no added facilities and hence it is more point-of-care. Biosafety requirements are similar to smear microscopy. However, it is multi staged and partially automated, requiring the presence of a Lab Technician through out the test.

Resources

1. Truenat MTB Kit Insert.
2. Trueprep AUTO Universal Cartridge-based Sample Prep Device.
3. Practical Guide to Implementation of Truenat Tests for the Detection of TB and Rifampicin-resistance, 2021.

Assessment

Line Probe Assay (LPA) is a rapid molecular test available at centralised laboratories.

The assay is based on Polymerase Chain Reaction (PCR) that can simultaneously detect Mycobacterium tuberculosis complex as well as drug sensitivity to anti-TB drugs.

Figure 1: The GenoType MTBDRplus Molecular LPA Procedure; Source: Molecular Detection of Drug-resistant Tuberculosis by Line Probe Assay.

Advantages of LPA

• Rapid molecular test. (Turnaround time: 3-5 days)
• Highly sensitive and specific.
• Performed directly from sputum smear-positive specimens and on isolates of M. tuberculosis complex grown from smear-negative and smear-positive specimens.
• Detects multiple gene mutations in anti-TB drugs.
  • First-line LPA detects mutations to rifampicin and isoniazid
  • Second-line LPA detects mutations to fluoroquinolones and aminoglycosides.
• Suitable for low and high-throughput labs.

Disadvantages of LPA

• Cannot be used as a point-of-care test.
• Requires appropriate laboratory infrastructure, equipment and biosafety precautions.
• Different rooms (DNA extraction, pre-amplification, amplification, post-amplification/ hybridization) are required to perform different steps (Figure 2).
• Requires trained manpower to perform tests and interpret test results.
• Stringent internal quality control is required to prevent contamination.

Figure 2: Amplification (A) and Post-amplification Laboratory (B) for LPA; Source: Molecular Detection of Drug-resistant Tuberculosis by Line Probe Assay.

Resources

• Guidelines for PMDT in India, 2021.
• Molecular Detection of Drug-resistant Tuberculosis by Line Probe Assay.

Assessment

Culturing TB Bacilli is well known and historic method for detection/ confirmation of Tuberculosis. It is a highly sensitive and specific phenotypic test; it can detect even a few viable bacilli in the sample (Upto 10 Colony Forming Units- CFUs). TB bacilli multiply in the culture and form colonies of TB bacilli which can are easily be identified.

Based on the growth media used Culture is divided in to two types, Solid and Liquid Culture methods. Types Culture:

• Solid Culture on Lowenstein Jensen media : Historic gold standard culture test. Results take usually upto 2 months (60 days).
• Modern Liquid culture systems: (e.g. BACTEC MGIT 960, BacT Alert or Versatrek etc.) Results take usually up to 42 days. 

Uses

1. Solid culture is the gold standard diagnostic test for TB. But it is not used for the purpose of TB diagnosis due to the long turn around time of 2 months. It is largely used for research purposes where it is used as the baseline test on which the sensitivity and specificity of other tests are calculated.
2. Liquid Culture is being used for follow-up monitoring of patients on drug resistant TB treatment to detect treatment failure. Liquid culture is also used for long term follow up patients who have successfully completed treatment to detect recurrence.
3. Liquid culture is used as a previous step to grow bacilli and obtain isolates prior to Drug Susceptibility Testing.
4. Liquid cultures are also used in TB prevalence surveys for its high sensitivity and specificity

Resources

• Guidelines for Programmatic Management of Drug Resistant Tuberculosis in India 2021

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Culture Drug Susceptibility Testing (CDST) is a growth-based phenotypic method used to check the susceptibility of Mycobacterium tuberculosis strains to various first and second line anti-TB drugs. Mycobacterial resistance to a particular drug is identified if there is growth observed in culture in presence of that drug.

In NTEP CDST is the standard method to detect resistance in samples of patients who have tested positive on followup. While CDST is possible on both Solid and Liquid culture, currently, the NTEP utilizes only liquid culture as a method for DST, due to faster Turn around times.

CDST testing services are available under NTEP in designated, specialized laboratories called CDST Labs both in public and private sector. Currently there are 80 such laboratories (60 certified for First Line and 49 for Second line drugs). Such designated laboratories are subject to regular external quality assessment, often by the National Reference Laboratory at that region.

Quality assured DST to R, H, Z, Mfx, Lfx, Lzd, Am, Km and Cm are available across the country. 

Resources

• Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, 2021.
• Training Manual for Mycobacterium tuberculosis Culture & Drug Susceptibility Testing, NTEP, 2009.
• RNTCP Laboratory Network Overview, CTD, 2009.

The concept of Patient Turnaround Time (P-TAT) is to find out how much time was taken from the identification of the patient for a test to getting the result of that test and initiation of patient's treatment based on the test result.

The National TB Elimination Programme (NTEP) have set benchmarks to monitor the P-TAT as provided in the table below. 

Programme officers/ staff needs to ensure that the P-TAT relative to the laboratory technology used, should be well within the minimum acceptable timeline as detailed in this table to improve patient treatment outcomes.

Resources

• Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021.

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NTEP laboratory network is comprising of National Reference Laboratories (NRLs), state level Intermediate reference laboratories (IRLs), Culture & Drug Susceptibility Testing (C & DST) laboratories and peripheral level laboratories. Peripheral level laboratories consist of  designated microscopy centres (DMCs) and NAAT labs.

NTEP has a quality assured laboratory network for bacteriological examination of sputum in a 3-tiered system.

Figure: Laboratory network of NTEP

Resources:

• TB India Report 2021

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Under the National Tuberculosis Elimination Programme (NTEP), many labs are established at the regional level within states for providing Culture and Drug Susceptibility Testing (C&DST) facilities for presumptive TB/DRTB and for TB/DRTB patients. C&DST laboratories are mostly located in intermediate reference laboratories (IRLs) or medical colleges. There are 42 C&DST laboratories established under the programme in different geographies. Dedicated human resources are provided for the laboratories under the programme. Districts are linked with laboratories for providing facilities for Culture and DST using: Phenotypic Methods (Solid – Lowenstein Jensen (LJ), and Liquid Culture – Mycobacteria Growth Indicator Tube (MGIT)) Genotypic technology (Line Probe Assay (LPA) and Cartridge Based Nucleic Acid Amplification Test (CBNAAT))

Figure: Culture and Drug Susceptibility Testing (C&DST) facility, Source: The Foundation For Innovative New Diagnostics (FIND)

Resources

• Guidelines for Programmatic Management of Drug Resistant TB in India, 2021
• Training Modules (1-4) for Programme Managers and Medical Officers; New Delhi, India: Central TB Division, July 2020

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The National Tuberculosis (TB) Elimination Program (NTEP) has a network of Nucleic Acid Amplification Tests (NAAT) laboratories coupled with Designated Microscopy Centers (DMCs) to form the backbone of the diagnostic component of TB services.

Nucleic Acid Amplification Tests (NAAT) laboratories includes Cartridge-based NAAT (CBNAAT) and TrueNat tests. These tests detect tuberculosis as well as rifampicin resistance and are more sensitive than smear microscopy.

Functions of Nucleic Acid Amplification Test (NAAT) Laboratories:

1. Acting as a hub for collection of samples from public and private health facilities (spokes)
2. Universal Drug Susceptibility Testing (UDST) to rule out rifampicin resistance among confirmed TB patients
3. Timely provision of NAAT test result to the TB patient, medical officer of the concerned health facility and NTEP staff for related actions
4. Acting as a sample dispatch center for the Culture DST laboratory for subsequent processing of samples for first-line line probe assay (LPA) and second-line drug resistance testing utilizing second line LPA and liquid culture DST
5. Recording and reporting including digitization of diagnostic process from collection to test result in NTEP Nikshay portal and Laboratory Information Management System
6. Management of supplies and logistic associated with laboratory logistic (CBNAAT cartridges and TrueNAT chips) and reporting any additional requirement thereof
7. Supporting the quality assurance activities undertaken by District or Intermediate Reference Laboratory under NTEP
8. Support health system in carrying out special drives for vulnerable and at-risk population and their testing directly by CBNAAT (slum population, diabetic population, smoker, malnourished people, patients of silicosis and kidney dialysis etc.)

Resources

• RNTCP Technical and Operational Guidelines for TB Control in India, 2016.
• Guidelines for Programmatic Management of Drug Resistant Tuberculosis in India, 2021.

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Diagnostic services are provided free of cost at all public health laboratories, for patient referrals from the private sector. Laboratory services are also purchased from certified private sector laboratories through partnership schemes.

• The Initiative for Promoting Affordable and Quality TB Tests (IPAQT) was initiated in 2013 to bring World Health Organization (WHO)-approved tuberculosis tests at affordable prices to patients in the private sector. 
• IPAQT is an initiative of not-for-profit stakeholders and private sector labs/ hospitals (collection centres) with a pan-India presence. IPAQT brought together various private laboratories with the support of test manufacturers and other major stakeholders to:
  • Bring down the price for quality TB tests by up to 50% in the private sector (see table below)
  • Promote the use of these tests by building awareness among health providers, laboratories and patients

It's the responsibility of District TB Officers (DTOs) to ensure that, patients diagnosed through IPAQT laboratories are notified in the National TB Elimination Programme (NTEP) surveillance system and appropriate public health actions are initiated.

Resources

• Guidelines for Programmatic Management of Drug-resistant TB in India, 2021.
• IPAQT.

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Sputum microscopy diagnostic services under the National TB Elimination Programme (NTEP) are provided by the Designated Microscopy Centres (DMCs) established at the Peripheral Health Institution (PHI) level, where a functional binocular microscope and a trained Laboratory Technician (LT) is available. Light Emission Diode Fluorescent microscopes are provided to high-load PHI-DMCs such as that of the medical colleges. 

Based on latest directives, a DMCs may be established at all PHIs (Public and Private) of the country as needed. It is mandatory to have a DMC at all medical colleges in the country.

As molecular technologies like Truenat are also used in DMCs, NTEP has planned to rename DMCs as TB Diagnosis Centres (TDCs).

Criteria to be a DMC

The DMCs should satisfy the following criteria:

1. NTEP-trained Laboratory Technician (LT) should be present.
2. A functional binocular microscope should be present in the laboratory.
3. Physical infrastructure in the laboratory should meet NTEP guidelines.
4. Daily new adult outpatient cases of at least 60-100 and/or workload of at least 3-5 sputum smears per day for the LT in the laboratory.

DMCs in the public sector, at the onset of the programme, are provided with funds to undertake minor civil works to build up their physical infrastructure and are provided with binocular microscopes.

Human Resources Norms

• For the purpose of NTEP, a PHI is a health facility which is manned by at least a Medical Officer (MO).
• In addition to the MO and LT, there is 1 TB Health Visitor (TBHV) per one lakh urban population to support the urban TB control activities.

Other Criteria

Microscopy Centres may be established beyond population norms in medical colleges, corporate hospitals, Employee State Insurance Corporation (ESIC), railways, Non-government organisations (NGOs), private hospitals, Ayushman Bharat - Health and Wellness Centres (AB-HWCs), etc.

Before designating a DMC in other sectors, there should be a formal agreement by the hospital/ laboratory to take part in the External Quality Assurance (EQA) and to allow the concerned NTEP staff to supervise as per the NTEP guidelines.

If the above criteria are met by any private laboratory, the lab is considered for establishing a DMC.

• To provide better access for diagnosis of TB, all PHIs, wherever LTs and binocular microscopes are available, can be upgraded to a DMC irrespective of the population norms or OPD attendance.
• All DMCs should comply with the Quality Assurance (QA) mechanisms as per the EQA guidelines.

Resources

• NTEP Training Modules 1-4 for Programme Managers & Medical Officers, 2020.
• Operational Guidelines for TB Services at Ayushman Bharat Health and Wellness Centres.

Assessment Questions

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To increase access to diagnostic services, NTEP has a provision for sputum collection centres in areas where the health facility is not equipped with key requirements to conduct sputum microscopy, molecular tests, drug susceptibility testing or follow up examinations.

Sputum collection centres are dedicated locations where sputum samples are collected, packaged and then transported to nearby TB diagnostic centres. It could be attached to any near-by health-facility as well.

Requirements of a Sputum Collection Centre

To function as sputum collection centres, the following is essential:

• Linkage/ mapping (time and distance) to testing laboratory
• Availability of adequate number of sputum cups and falcon tubes, logistics for sample packaging and transport
• Identification of open areas for sputum collection
• Staff trained in NTEP guidelines on sputum collection, sample packaging and transport, complete and correct documentation of laboratory request form, and infection control practices
• Feasibility and financial measures required for sample transport
• Inclusion of local volunteers, courier services, sample transportation under National Health Mission Free Diagnostic Services or other mechanisms as decided by the state/district
• Availability of Information, Education and Communication (IEC) material, training modules, and job-aids
   

 Sputum collection centres are established in:

• Ayushman Bharat Health and Wellness Centres/Sub-centres
• Urban primary health centres
• Tribal, hilly, desert and difficult-to-reach areas of the country

Resources

• Training Modules for Programme Managers and Medical Officers
• Operational Guidelines for TB Services at Ayushman Bharat Health and Wellness Centres
• Mycobacteriology Laboratory Manual, GLI Initiative, 2014

Assessment:

• Good quality sputum collection is of paramount importance in tuberculosis diagnosis.
• Once a person is identified as presumptive TB, s/he is referred to the Designated Microscopy Centre (DMC) for sputum collection.
• For TB diagnosis two sputum samples are collected - one is the supervised ‘spot’ sample collected at the DMC (labelled Specimen A) and the other is the early morning sample collected by patient themselves at his/her home (labelled Specimen B).
• If the patient is coming from a long distance or s/he is unlikely to return to give the second specimen, two spot specimens may be collected with a gap of at least one hour.

Figure: Flowchart for Sputum Collection and Transport

Sputum Collection

• The (NTEP) request form required for the biological specimen examination need to be filled.
• The Lab Technician (LT) should instruct the patient to thoroughly rinse the mouth with clean water and demonstrate to inhale deeply 2-3 times and cough out the sputum from the depth of the chest into a sterile 50 ml sputum container, in a well-ventilated space.
• After collecting the sputum, close the lid of the containers and wipe the surface of the tube with 5% phenol to disinfect and allow it to air dry.
• Label the tubes with patient details, date and time of collection, specimen identification, lab no. using a permanent marker.

Sputum Transport

• The sputum collected should be transported immediately to the Nucleic Acid Amplification Testing (NAAT)/ Culture and Drug Susceptibility Testing (C&DST) laboratory. In case of any unavoidable delays, the sample should be refrigerated.
• The programme mandates triple layer packaging for the transport of the sputum specimens.
• Firstly, seal the joint between the cap and neck of the sputum containers with a parafilm strip (primary receptacle package).
• Wrap the sputum containers individually in absorbent cotton, place them in a zip lock pouch and secure them with a rubber band (secondary receptacle package).
• Fold and place the NTEP request form in another zip lock pouch.
• Place the zip lock pouch with sputum containers in a thermocol box along with two pre-frozen coolant gel packs and the zip lock pouch with the NTEP request form is placed on top.
• The dimensions of the thermocol box used for sputum transport are: thickness - 2.5 cm; Outer dimensions: length - 18.5 cm, breadth - 13 cm, height - 12 cm (without lid), height -14 cm (with lid); Inner dimensions: length - 14.5 cm, breadth - 8 cm, height - 12 cm (without lid), height - 13 cm (with inner part of lid).
• The coolant gel packs should be conditioned in the deep freezer in a temperature between -20 to -15^o C for a minimum 48 hours to a maximum 72 hours before use so that they can maintain a temperature between 12-20^o C for up to approximately 48 hours in tightly packed thermocol boxes while the average outside temperature is 35^o C. 
• Seal the thermocol box with duct tape and affix ‘To’ and ‘From’ address, biohazard sticker on the box (tertiary receptacle package).
• Weight of the fully packed consignment box should be up to 400 grams and the thermocol boxes and gel packs should not be reused. 
• Transport the box through NTEP identified courier/ speed post service.

Resources

• Training Module (1-4) for Programme Managers and Medical Officers, NTEP, MoHFW, 2020.
• Guidelines for Programmatic Management of Drug-resistant TB in India, 2021.
• Module for Laboratory Technician, CTD, MoHFW, India, 2005.

Assessment

Screening for active tuberculosis (TB) a process to filter out people who are less likely to have TB, from a group. Screened positive people are likely to have TB and are confirmed subsequently using a TB diagnostic test. This will allow finite diagnostic testing resources to be used on the remaining.

Screening in TB may be performed ​using simple field tools (4 Symptom complex) and tests such as Chest X-ray, or a combination of both. ​Combination of both is the most effective, but is often not applied due to the practical difficulties in making a chest X-ray conveniently available.

Screening is an integral part of any general case finding effort. It is also applied systematically in specific situations.

1. At health care facilities (intensified case finding): Here those visiting are screened using the 4 symptom complex, often at the point of entry to the facility. Those screened positive may be fast-tracked to TB Diagnostic testing.
2. In vulnerable populations in active case finding efforts: Here the entire population identified for active case finding are screened using the pre-decided protocols by going door to door. 

Resources

• Systematic Screening for Active Tuberculosis; Principles and Recommendations, WHO 2013.
• National Strategic Plan for Tuberculosis Elimination 2020–2025.

Drug Susceptibility Testing (DST) refers to in-vitro testing using either of the phenotypic methods to determine susceptibility. Drug Resistance Testing (DRT) refers to in-vitro testing using genotypic methods (molecular techniques) to determine resistance.    

• Universal Drug Susceptibility Testing (UDST) refers to universal access to rapid DST for at least Rifampicin (R), and further DST for at least Fluoroquinolones (FQs) among all TB patients with rifampicin-resistance.
• UDST is essential to identify patients who can be initiated on Drug-resistant TB (DR-TB) treatment instead of Drug-sensitive TB (DS-TB) treatment, especially in a situation where the drug-resistance level is high.
• It should be done preferably before initiation of treatment to a maximum within 15 days of diagnosis.
• UDST is a part of national policy under the National TB Elimination Programme (NTEP).
• NTEP has undertaken decentralization of quality assured diagnostics for scale up of UDST across the country which has helped in early detection of DR-TB treatment and reducing associated morbidity and mortality. 

Resources​
 

• Guidelines for Programmatic Management of Drug-resistant TB in India, 2021.

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Video: UDST Report

People who have been exposed to patients with infectious TB are known as TB contacts; they constitute a high-risk group for TB. Case finding investigation contributes to the early detection of TB cases, and results in identifying a significant number of additional patients.

Figure: Approaches to Tuberculosis Case Finding

Active case-finding requires systematic screening and clinical evaluation of populations who are at high risk of developing TB, such as people living in slums, tribal areas, congregate settings, persons who are household contacts of TB cases

Resources:

• Assessing TB Case-Finding

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Systematic screening of all individuals of a defined population is known as active case finding.  It is applied outside of health facilities at the community level by the health system.

Objective of ACF is to:

1. identify cases early, initiate prompt treatment, reduce risk of poor treatment outcomes and reduce risk of further transmission of TB
2. to provide access to diagnosis services to populations that would have been otherwise unreached

It is effort intensive and is recommended only in population groups where there is estimated high case load. In NTEP, ACF is recommended only to be performed in Key / vulnerable population.

ACF can also be clubbed with suitable ACSM campaigns to create awareness about the signs and symptoms and about TB in the target population/ community. It can also be combined with other health activities/ campaigns (such as Pulse Polio/ Leprosy screening/ population based screening for NCDs) for increased efficiency.

Resources

1. Training Modules for Programme Managers and Medical Officers.
2. Active TB Case Finding, Guidance Document.
3. WHO recommendations for Systematic Screening for Active Tuberculosis

Assessment

Passive case finding is essentially where the patient self reports to the health care provider with symptoms. This requires that affected individuals are aware of their symptoms, have access to health facilities, and are evaluated by health workers or volunteers who recognise the symptoms of TB and link those individuals for TB testing services.

This approach to case finding has the least effort and cost and is a minimum expectation. In a Peripheral Health Institution (PHI), it is estimated that about 2-3% of new adult outpatients are symptomatic that require referral for TB diagnosis (presumptive TB cases).

Passive case finding may miss TB patients if :

1. The disease is mild/ transient.
2. Access to healthcare is poor.
3. Health providers do not have an adequate index of suspicion and are unable to reliably link respiratory symptoms to TB. 

Resources

1. Training Modules for Programme Managers and Medical Officers.

Assessment

Intensified Case Finding (ICF) is a case finding approach between Active and Passive approaches. Here individuals coming in contact with the health system through any activity are screened actively for symptoms of TB and referred for testing.

This approach brings the benefit of active case finding approach by active screening for TB symptoms, but does limit the extensive effort required by restricting to only those people who has some or the other healthcare problem. This approach is considered for people attending a healthcare facility.

Some examples of ICF are screening for TB symptoms and referral for testing in:

• all cases attending an HIV clinic.
• among children with malnourishment who attend a nutrition clinic.
• all mothers attending the antenatal clinics

Resources

1. Technical and Operational Guidelines.
2. Assessing TB Case Finding.

Assessment

Bidirectional screening is a method to identify cases in diseases which have predisposition to each other or has a significant influence on each other. For example TB and HIV, where having HIV increases risk of developing TB and cases with TB would have poor outcomes if co-infected with HIV.

Screening for TB is done through four-symptoms complex based screening or through Chest X-ray. Screening for the linked disease is carried out as per the policies of the corresponding health program.

Bi-directional screening policies are implemented by various disease control programs. For example, with NTEP the following disease control efforts implement a bidirectional screening policy:

1. HIV through NACO 
2. COVID19 
3. Diabetes Mellitus (DM) through NPCDCS
4. Tobacco  through National Tobacco Control Program

Both programs monitor bidirectional screening, referral and testing as per their own policies.

Resources

1. National Strategic Plan for TB Elimination.

Assessment

Why important, how is it done,

Persons with cough of more than 2 weeks, with or without other symptoms suggestive of TB, should be promptly identified as presumptive pulmonary TB patients.

Under NTEP, they are to be referred to the designated microscopy centre (DMC) for sputum examination using the Request form for examination of biological specimen.

Patients belonging to the key population EPTB, HIV and Paediatrics groups (after X-ray screening in case of children) can be directly referred for NAAT.

All presumptive TB patients in the public and private sector must be evaluated for TB based on the diagnostic algorithm for pulmonary and extra-pulmonary TB (EPTB) and the following points must be considered:

• All presumptive pulmonary TB patients must be subjected to sputum smear examination. In places where TB diagnostic laboratories are upgraded to NAAT testing, NAAT can be offered for all presumptive TB patients upfront
• If both the chest X-ray and sputum smear (NAAT in integrated places) results are negative, but the physician considers the patient as presumptive TB, the patient needs to be referred to a chest physician for further evaluation
• NAAT testing will be performed to rule out Rif. resistance before treatment initiation (In places where transition has not yet been happened to NAAT for diagnosis)
• NAAT results will decide if the patient is MTB detected with either Rif. Resistance or Rif. Sensitive
• Upfront NAAT is offered for key populations like PLHIV/children/EPTB
• M.TB detected on NAAT will be further subjected for FL–LPA, SL-LPA, LC DST and based on the results DR-TB regimen may be initiated

Resources

• Technical and Operational Guidelines for TB Control in India 2016
• Revised PMDT Guidelines in India 2021

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It is crucial to make an effort for microbiological confirmation in presumptive Extrapulmonary Tuberculosis (EPTB) cases. Appropriate specimens from the Extrapulmonary (EP) site are collected and, depending on the specimen type and availability of facilities, the specimens are sent for:

• Cartridge-based Nucleic Acid Amplification Testing (CBNAAT)
• Culture and Drug Susceptibility Testing (C&DST) for M. tuberculosis 
• Histopathological examination

The diagnostic algorithm (see the figure below) to be followed for EPTB cases depends on 2 main factors:

1. Availability of appropriate specimens from the EP site
2. Availability of CBNAAT (preferred test)

Figure: Diagnostic Algorithm of EPTB

• If an appropriate specimen from the EP site is available, specimens from the presumed sites of involvement must be tested with CBNAAT.
• CBNAAT detects MTB and RIF status and helps to identify microbiologically confirmed EPTB cases.
• If CBNAAT is not available, the specimen is sent for Liquid Culture (LC) at the C&DST lab. If the LC is positive, it is identified as a microbiologically confirmed EPTB case.
• If there is high clinical suspicion of TB even after a negative culture result, other diagnostic tools are used to clinically diagnose EPTB (usually with a specialist). If these tests indicate TB, they may be treated as clinically diagnosed EPTB or else arrive at an alternate diagnosis.

Clinical Diagnosis of EP-TB

If an appropriate specimen from the EP site is not available, in the presence of high clinical suspicion of TB, other modalities of diagnosis are used in consultation with a specialist. If with other diagnostic modalities, TB diagnosis still cannot be established, the specialist may explore an alternate diagnosis. 

A clinical diagnosis of EPTB is made if a consultative decision is made to treat with a full course of anti-TB drugs in spite of the situations listed above. Chest X-ray (CXR), ultrasonography, Computerised Tomography (CT) scan, Magnetic Resonance Imaging (MRI) and biochemical examinations are supporting tests that can be used to help arrive at a diagnosis.

Resources

• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.
• Technical Operational Guidelines, Chapter 3: Case Finding and Diagnosis Strategy, NTEP.

Assessment

​

All children with persistent fever with/without cough for two or more weeks; close contact with TB patients in the last 2 years; unexplained sudden weight loss or signs of malnutrition despite good nutrition, should be subjected to Chest X-ray (CXR).

1) If the CXR is normal, the child should be checked for signs of Extrapulmonary TB (EPTB) and referred for detailed investigations to higher centres in case of any symptoms.

2) If the CXR is suggestive of TB, the child should be subjected to a sputum test/ gastric aspiration / induced sputum for Mycobacterium tb (MTB) testing.

               - If the report is MTB positive, the child is microbiologically confirmed for TB and should be further tested for Rifampicin (Rif)-resistance and treated accordingly for Drug-sensitive (DS)/ Drug-resistant (DR) TB, based on Rif results.

               - If the report is MTB negative, look for significantly enlarged peripheral lymph nodes and also repeat the sputum test with a good sample and refer to a higher centre if required.

3) If the CXR displays non-specific shadows prescribe antibiotics (amoxiclav/ amoxicillin) if not already taken. Do not prescribe quinolones or linezolid and review the shadow and symptoms.

4) If CXR displays pleural effusion send the pleural fluid for examination at Nucleic Acid Amplification Testing (NAAT) lab as well for cytology and biochemical examinations.

              - If pleural fluid turns out MTB positive at the NAAT, treat as per guidelines

              - If the pleural fluid is MTB negative, but is a straw-coloured exudative effusion, treat the child as clinically diagnosed probable TB.

Image

Figure: Diagnostic Algorithm for Paediatric TB; Source: Standard Treatment Workflows of India: Special Edition on Paediatric and Extrapulmonary Tuberculosis, 2022.

Resources

• Standard Treatment Workflows of India: Special Edition on Paediatric and Extrapulmonary Tuberculosis, ICMR, MoHFW, GoI, CTD, 2022.
• Guidelines on Programmatic Management of Drug Resistant TB (PMDT) in India, CTD, MoHFW, GoI, 2021.

Assessment

Drug-resistant TB (DR-TB) diagnosis is predominantly based on laboratory diagnosis. Presumptive-TB/ DR-TB is identified by the health facility doctor during passive screening or by health staff/ community volunteers during Active Case Finding (ACF). 

The vision of National TB Elimination Programme (NTEP) is to provide early diagnosis to all persons with any form of DR-TB through Universal Drug Susceptibility Testing (UDST).

All diagnosed TB patients are eligible for a NAAT test to know their Rifampicin sensitivity status. The integrated diagnostic algorithm for diagnosis of TB offers upfront Nucliec Acid Amplification Test (NAAT) for diagnosis of TB to vulnerable population. Among other eligible groups for NAAT are: non-responders to treatment and contacts of DR-TB patients are also offered upfront NAAT.

Rapid identification of DR-TB is achieved by using a combination of NAAT (CBNAAT/ Truenat) followed by sequential testing by first- and second-line Line Probe Assay (LPA) and Liquid Culture (LC) and Drug Susceptibility Testing (DST) for specific drugs as described below:

• When Rifampicin resistance is not detected by NAAT, the patient is offered First-line (FL) LPA.FL-LPA provides information on Isoniazid resistance.
• For Rif resistance/Inh resistance cases, SL-LPA  is done and it provides information on resistance to Levofloxacin, Moxifloxacin and Amikacin.
• For all Rif resistance cases, LC and DST is done for Pyrazinamid, Moxifloxacin (if resistance detected by LPA), Linezolid, Clofazimine*, Bedaquiline* and Delamanid*.

(* when available)

Resources

• Guidelines for PMDT in India, 2021.

Assessment

Check

Presumptive Drug-resistant TB (DR-TB) in Children

It occurs mostly in children who:

• Are contacts of adults with Multidrug-resistant (MDR)/ DR-TB
• Are lost to follow-up after initiating treatment
• Present with recurrence of disease after previous treatment
• Do not respond to treatment with first-line drugs
• Are Children Living with HIV (CLHIV).

All efforts must be taken to ensure microbiological confirmation of DR-TB diagnosis among children through getting an appropriate body fluid sample for both pulmonary or extrapulmonary-TB cases.

Sputum (or other relevant samples, e.g., gastric aspirate, induced sputum, bronchoscopic lavage, lymph node aspiration, Cerebro Spinal Fluid (CSF), tissue biopsies) needs to be collected in all children with presumed DR-TB for diagnosis.

The diagnosis of DR-TB in children is done based on Nucleic Acid Amplification Test (NAAT) or Line Probe Assay (LPA) results. If these are invalid, Culture and Drug Susceptibility Testing (C&DST) will be carried out to establish the diagnosis.

In a presumptive DR-TB patient, if there is no bacteriological confirmation, bacteriologically negative clinically diagnosed probable DR-TB can be considered after ruling out alternative diagnosis.

Resources

• Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, 2021.

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All childhood TB patients’ sputum and other relevant samples (e.g. gastric aspirate, induced sputum, bronchoscopic lavage, lymph node aspiration, CSF, tissue biopsies etc.) should be subjected to genotypic or the phenotypic Drug Susceptibility Tests (DSTs). Based on the bacteriological confirmation, the child should be treated for DS/DR TB as required.

But in cases where the child’s DST is unknown, the source patient’s DST should be considered.

If the source is a known DS TB, treat the child for DS TB. If the child responds poorly to the DS TB treatment consult the pediatrician and re attempt the necessary investigations.

If the source patient is a known DR TB patient, consult with the pediatrician and re-attempt DST on an appropriate specimen from the child and treat as per the child’s DST (if the report is conclusive), if not then treat the child as DR TB after the source patient.

If the source patient’s DST status is not known perform DST on the child’s and the source patient’s specimen and treat the child as per the DST of the child or the source patient, whichever report is conclusive.

Pediatric TB patients should be presented to and discussed with a DR-TBC Committee (including the pediatrician) to decide the treatment.

Image

Figure:  Diagnostic Algorithm for Paediatric DR-TB; Source: Guidelines on Programmatic Management of Drug-resistant TB (PMDT) in India,2021, CTD, MoHFW, India, p39. 

Abbr: DR-TB: Drug-resistant TB; DS-TB: Drug-sensitive TB; NAAT: Nucleic Acid Amplification Test; MGIT: Mycobacterium Growth Indicator Tube; DST: Drug Susceptibility Testing; DRT: Drug Resistance Testing; BAL: Bronchoalveolar Lavage.

Resources

• Standard Treatment Workflows of India: Special Edition on Paediatric and Extrapulmonary Tuberculosis.

• Guidelines on Programmatic Management of Drug Resistant TB (PMDT) in India, 2021, CTD, MoHFW, India.

Assessment

Based on the site of disease, Tuberculosis can be classified as-

1. Pulmonary tuberculosis (PTB) refers to any microbiologically confirmed or clinically diagnosed TB involving the lung parenchyma or the tracheo-bronchial tree.
2. Extra Pulmonary tuberculosis (EPTB) refers to any microbiologically confirmed or clinically diagnosed TB involving organs other than the lungs such as pleura, lymph nodes, intestine, genitourinary tract, joint and bones, meninges of the brain etc. 

Note: Miliary TB is classified as PTB because there are lesions in the lungs. A patient with both pulmonary and extra-pulmonary TB should be classied as a case of Pulmonary TB.

• New case - A TB patient who has never had treatment for TB or has taken anti-TB drugs for less than one month is considered as a new case. 
• Previously treated patients have received 1 month or more of anti-TB drugs in the past. They could be further classified as:
• Recurrent TB case - A TB patient previously declared as successfully treated(cured/treatment completed) and is subsequently found to be microbiologically confirmed TB case is a recurrent TB case. 
• Treatment After failure patients are those who have previously been treated for TB and whose treatment failed at the end of their most recent course of treatment.  
• Treatment after loss to follow-up A TB patient previously treated for TB for 1 month or more and was declared lost to follow-up in their most recent course of treatment and subsequently found microbiologically confirmed TB case 
• Other previously treated patients are those who have previously been treated for TB but whose outcome after their most recent course of treatment is unknown or undocumented. 
• Transferred In: A TB patient who is received for treatment in a Tuberculosis Unit, after registered for treatment in another TB unit is considered as a case of transfer in.
• Transferred Out : A patient who has been transferred to another recording and reporting unit and whose treatment outcome is unknown.

Resources:

• Guidelines for Programmatic Management of Drug Resistant Tuberculosis in India, March 2021 
• WHO Consolidated Guidelines on Tuberculosis: Module 4-Treatment: Drug resistant TB Treatment, 2020

On the basis of diagnosis, Tuberculosis (TB) can be classified into 2 main types:

1. Microbiologically confirmed TB
2. Clinically diagnosed TB

Microbiologically Confirmed TB

• Microbiologically confirmed TB refers to a presumptive TB case from which a biological specimen is positive for acid-fast bacilli/ Mycobacterium tuberculosis on smear microscopy, culture, or on a rapid diagnostic molecular test (such as Cartridge-based Nucleic Acid Amplification Test (CBNAAT)/ Truenat).
• All such diagnosed cases should be notified at the source, regardless of whether TB treatment has started.

Clinically Diagnosed TB

• Clinically diagnosed TB refers to a presumptive TB case that is not microbiologically confirmed but has been diagnosed with active TB by a clinician who has decided to give the patient a full course of anti-TB treatment.
• This definition includes cases diagnosed on the basis of X-ray abnormalities or suggestive histology or extrapulmonary cases without laboratory confirmation.
• Clinically diagnosed cases subsequently found to be microbiologically positive (before or after starting treatment) should be reclassified as microbiologically confirmed.

Resources

• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.
• Definitions and Reporting Framework for Tuberculosis, WHO, 2013.

Assessment

The goals of tuberculosis treatment are:

• Rendering the patient non-infectious, breaking the chain of transmission and decreasing the infection​ pool

• Decreasing case fatality and morbidity by ensuring relapse-free cure

• Minimising and preventing the development of drug resistance.  ​

To meet the goals of treatment, the regimens should be:

• Safe, easy to administer and aid treatment adherence
• Long enough to achieve the long-term cure of the disease, and short enough to increase patient compliance.

Any treatment regimen which reduces the pill count but increases the overall treatment success is an ideal regimen to meet the goals of tuberculosis treatment.  

Resources

• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.

Assessment

​

Under the National TB Elimination Programme (NTEP), strategies adopted in the treatment of TB are based on the available scientific and operational researches. These strategies are combined to ensure better treatment outcomes for the TB patients. The main strategies include:

Domiciliary Treatment

• This is a strategy that allows for the treatment of TB in a patient’s home.
• Domiciliary chemotherapy proved to be as effective as sanatoria treatment (which was the historical way of treating TB) and achieved higher cure rates.
• The patients having the social benefits of being at home. 

Short Course Chemotherapy (SCC)

• Chemotherapy of TB underwent revolutionary changes in the 70s owing to the availability of two well-tolerated and highly effective drugs – rifampicin and pyrazinamide.
• These drugs allowed for SCC and made it possible to simplify treatment and reduce its duration without reducing the therapeutic effect.
• Now with SCC regimens, it is possible to treat and cure TB patients in 6 months.
• When given daily, these regimens are effective, achieve high cure rates, prevent the emergence of drug resistance and minimize relapses.
• The shorter duration also contributes to improvement in treatment adherence.

Directly Observed Treatment (DOT)

DOT is a method whereby a trained healthcare worker or another trained designated person (treatment supporter) watches a patient swallow each dose of anti-TB drugs and document it.

• DOT can reduce the development of drug resistance, treatment failure, or relapse after the end of treatment.
• Many patients who do not receive directly observed treatment stop taking drugs once they feel better.
• Hence, by providing DOT, the NTEP ensures that patients receive the right drugs, in the right doses, at the right intervals and for the right duration.

The modern treatment strategy is based on standardized short-course chemotherapy regimens largely administered on a domiciliary basis, utilising the DOTS strategy and proper case management to ensure completion of treatment and cure.

Resources

• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.
• Treatment of Tuberculosis Disease, CDC, 2006.
• Guide on Tuberculosis Control for Primary Health Care Providers, WHO, 2015.
• Treatment of Tuberculosis: Guidelines for National Programmes, WHO, 2003.

Assessment

Tuberculosis treatment and its different regimens have scientific backgrounds for their formulations. To understand this, we need to know about the mode of action of each anti-TB drug first.

Mode of Action of Anti-TB Drugs

Anti-TB drugs have the following three actions:

1. Early bactericidal activity: Killing of actively growing bacilli (in the phase of rapid multiplication and uninhibited metabolic activity).
2. Sterilizing activity of persisting bacilli, i.e., metabolically inhibited organisms in a quasi-dormant state.
3. Ability to prevent the emergence of drug resistance.

The ranking of first-line drugs with respect to their type of activity is indicated in Table 1 below.

Table 1: Ranking of first-line anti-TB drugs used in the treatment of drug-sensitive TB, based on the mode of action and activity

Thus, each drug has unique characteristics and drug combinations will make the regimen more effective.

Need for Long Duration of Treatment of TB

• Anti-TB drugs mostly kill actively multiplying tubercle bacilli.
• When bacilli have low metabolic activity, i.e., when bacterial growth has almost come to a standstill and the organisms are “dormant”, they are not killed by otherwise bactericidal drugs. Such organisms are referred to as persisters*.
• Though they may survive in the presence of drugs, behaving as if they were drug-resistant, they are in fact susceptible to the drugs.
• Thus, if for some reason these organisms regain their ability to multiply freely, they would be killed by the very drugs that had not harmed them before.
• When dormant bacilli again become metabolically active and start multiplying during effective chemotherapy, they are soon killed.
• Once chemotherapy has been completed, the revived bacilli may continue to multiply and thus cause relapse.
• This explains why conventional chemotherapy needs to be of long duration.

Resources

• Training Modules (1-4) for Programme Managers and Medical Officers, 2020.
• Tuberculosis Case-finding and Chemotherapy: Questions and Answers, K. Toman.

 Assessment

Standard TB Treatment is divided into two phases

• Intensive Phase(IP): In this phase,
  • Kills most of the TB bacteria during the first 8 weeks of treatment, but some bacteria can survive longer
  • Therefore, more drugs are administered to kill the bacteria and reduce the severity of disease.
  • Treatment in this phase usually is of short duration(2 to 6 Months or more) in comparison to Continuation Phase(CP)

• Continuation Phase(CP): In this phase,
  • All the remaining TB bacteria are in the dormant stage i.e., stage when growth and development of bacteria are temporarily stopped.
  • Therefore, fewer but powerful antibiotics are administered to kill those bacteria. 
  • Treatment in this phase usually lasts longer than Intensive Phase(IP)(4 to 18 Months or more)

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Fixed-dose combinations (FDCs) are drug formulations where two or more drugs are combined physically into one formulation such as a tablet or pill.

This is more convenient to the patients taking medicines and it also simplifies the supply chain.

Resources:

• Technical and Operational Guidelines for TB Control in India 2016

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Fixed-Dose Combination(FDC) provides a simple approach to deliver the correct number of drugs at the right dosage as all the necessary drugs are combined in a single tablet. By altering the number of pills according to the patient’s body weight, complete treatment is delivered without the need for calculation of dose

Figure: Advantages of Fixed Dose Combination(FDC)

A regimen means a prescribed systematic form of treatment for a course of drug(s). For TB treatment, Multi drug combination of regimen is followed. 

All TB drug regimens have an initial intensive phase(IP) followed by a continuation phase(CP). 

Following are some of the main TB drug regimens used based on the drug resistance pattern detected for TB patients.

• First-Line Anti TB Drugs(Prescribed for Drug Sensitive TB DS-TB)
  • Daily weight band wise FDC

• Second-Line Anti TB Drugs (Prescribed for Drug Resistance TB - DR-TB)
  • H Mono Poly Regimen
  • Shorter oral Bedaquiline containing MDR-TB regimen
  • Longer oral Bedaquiline containing regimen
  • Shorter injectable containing MDR-TB regimen

It is extremely important for any type of TB patient to be initiated on the right treatment at the earliest in order to have better treatment outcomes. Therefore as soon as the patient is diagnosed, s/he should immediately be traced with the help of the Community Health Officer (CHO) of the Health and Wellness Centres (HWC), TB Health Visitors (TBHV) / Senior Treatment Supervisor(STS) and the health facility doctors and initiated on the appropriate treatment regimen.

Steps in TB Treatment Initiation

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Figure: Flowchart-Treatment Initiation

Resources

• Guidelines on Programmatic Management of Drug-resistant TB (PMDT) in India, CTD, MoHFW, India, 2021.
• Training Modules (1-4) for Programme Managers and Medical Officers, CTD, MoHFW, India.

Assessment

To know the TB treatment response and to determine that if patient is cured, TB patients are clinically evaluated at the end of every four weeks of treatment, and they are also followed up by performing sputum test at end of each treatment phase (i.e. Intensive phase and Continuation phase)

TB patients during clinical evaluations are assessed to

• Identify possible adverse reactions to medications;
• Check for any comorbid conditions;
• Weight change;
• monitor adherence; and determine treatment efficacy by observing their symptoms

Although each patient responds to treatment at a different pace, all TB symptoms should gradually improve and eventually go away.

Patients whose symptoms do not improve during the first 2 months of treatment, or whose symptoms worsen after improving initially, should be re-evaluated for adherence issues and development of drug resistance.

When a TB patient consumes all the doses under the prescribed regimen, then Treatment Outcome is declared for a Patient.

Treatment success is considered when a TB patient either Cured or Treatment completed is accounted in treatment success

Adverse Drug Reaction (ADR): An unwanted or harmful reaction experienced following the administration of a drug or a combination of drugs, under normal conditions of use, and is suspected to be related to the drug.

Adverse Event (AE):  Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease that presents in a patient during the course of treatment or the procedure, regardless of whether it is considered related to the medical treatment or procedure.

• An AE does not necessarily have a causal relationship with the treatment.
• ​​Suspected ADR and actual ADRs are a subset of AEs, as can be seen in the figure below. 

Figure: Relationship between adverse events, suspected adverse reactions and adverse reactions 

The table below highlights the difference between an ADR and an AE.

Resources

• Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021.
• Ready Reckoner for Medical Officer - Adverse Drug Reactions Associated with Anti-TB Drugs Identification and Management, 2019. 
• WHO - A Practical Handbook on the Pharmacovigilance of Medicines Used in the Treatment of Tuberculosis, 2012.
• Technical and Operational Guidelines for TB in India, 2016.

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Adverse Drug Events are classified on the basis of severity:

1. Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:

• Results in death
• Is life-threatening (subject was at risk of death at the time of the event. It does not refer to an event that hypothetically might have caused death if it is more severe)
• Requires inpatient hospitalization or prolongation of existing hospitalization
• Results in persistent or significant disability/incapacity
• Results in a congenital anomaly/birth defect
• Results in suspected transmission of any infectious agent via the medicinal product
• Is medically important

​

2. Non-serious Adverse Drug Reaction (ADR) Associated with the Use of Drugs: Any adverse drug reaction that does not meet the above criteria to be a serious AE and is considered associated with the use of the drug .

4. Life-threatening: Any event in which the patient was at risk of death at the time of the event; but does not refer to an event, which hypothetically might have caused death if it were more severe.

5. Associated with Use of the Drug: An adverse event is considered associated with use of the drug if the attribution is possible, probable or very likely.

Resources

• Guidelines for Programmatic Management of Drug Resistant Tuberculosis in India, March 2021
• Ready Reckoner for Medical Officer - Adverse Drug Reactions Associated with Anti-TB Drugs Identification and Management, 2019 
• WHO - A Practical Handbook on the Pharmacovigilance of Medicines Used in the Treatment of Tuberculosis, 2012
• Technical and Operational Guidelines for TB in India, 2016

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Adverse Drug Reactions(ADR) are classified into serious and non-serious ADR depending upon the intensity of symptoms experienced by the patient. Below is the brief overview

1. Counsel and reassure the patient as the common occurring adverse effects usually resolve with time.
2. Advise the patient to take all the drugs together.
3. Advise patient to take light meal (biscuits, bread, rice etc.) before taking drugs.
4. Inform patients that they may take drugs embedded in banana or at the bedtime to reduce their associated side effects.
5. Encourage patients to keep themselves hydrated by increasing fluid intake.
6. Provide ORS (Oral Rehydration Solution) to counter dehydration due to loose motion and vomiting.

Figure: Referral to PHI for ADR

Resources:

• Training Guide for Peripheral Health Workers on Adverse Drug Reactions

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Follow-up Sputum Examination is useful for the clinical follow-up which helps in assessing the response to treatment, and to establish cure or failure at the end of treatment.

Significance:

The most important tool in the diagnosis of tuberculosis is direct microscopic examination of appropriately stained sputum specimens for acid-fast bacilli (AFB). The technique is simple and inexpensive, and used in the detection of tuberculosis. Sputum microscopy is also useful for the clinical follow up which helps in assessing the response to treatment, and to establish cure or failure at the end of treatment.

Schedule

In case of Drug-sensitive Tuberculosis (DS-TB), the follow-up is done at the end of Intensive Phase (IP) and at the end of Continuation Phase (CP).

In case of Drug-resistant Tuberculosis (DR-TB), the follow up schedule is different for all the three regimen described below:

Isoniazid (H) mono/ poly DR-TB regimen

• Monthly from month 3 onwards, till the end of treatment
• Conduct sputum microscopy within 7 days, if the smear at month 4 or later is positive to rapidly ascertain bacteriological conversion/ reversion.

Shorter oral Bedaquiline-containing Multidrug-Resistant (MDR)/ Rifampicin-Resistant (RR)-TB regimen

• Monthly from 3^rd month onwards, till end of IP
• Monthly in extended IP, only if previous month S+ve
• Conduct sputum microscopy within 7 days, if the smear at 6 months is positive to rapidly ascertain bacteriological conversion/ reversion.

Longer oral M/ XDR-TB regimen

• With culture at Culture and Drug Susceptibility (C&DST) lab
• Conduct sputum microscopy within 7 days if any smear at 6 month or later is positive to rapidly ascertain bacteriological conversion/ reversion.

Post Treatment Follow-Up

After completion of treatment, the patients should be followed-up at the end of 6, 12, 18 & 24 months for detecting recurrence of TB at the earliest. In presence of any clinical symptoms and/or cough, sputum microscopy and/or culture should be considered. This is important in detecting recurrence of TB at the earliest.

Implications

The sputum follow-up examination is a quick and reliable method which helps in monitoring the progress of the treatment and gives an early indication of any recurrence.

Assessment

The Tuberculosis Treatment Card is a paper-based recording form that is kept in the institution treating the TB patient under the National TB Elimination Programme (NTEP). It is a pre-requisite documentation related to treatment services offered to TB patients under NTEP.

Uses of the TB Treatment Card

The TB treatment card is primarily used for:

1. Documenting administered drugs with their dosages
2. Documenting follow-up investigation results
3. Monitoring adherence to treatment
4. Recording adverse events
5. Recording treatment outcomes

There are two pages in the TB treatment card and details in each page is delineated in the table below.

Important Points to Note

• The TB treatment card is filled at the Peripheral Health Institution (PHI) when a patient is initiated on treatment.
• The original TB treatment card is kept at the PHI and updated fortnightly.
• A duplicate treatment card is to be given to the treatment supporter for documentation of daily events. 
• The treatment supporter should be trained on how to record the treatment card. 
• Details on the patient’s HIV status are not included in the treatment supporter’s copy to maintain confidentiality.

The figure below shows the 1^st page of the TB treatment card. Click here to access the full form in the NTEP Training Modules 1-4 for Programme Managers & Medical Officers, p. 223.

Figure: First Page of the TB Treatment Card; Source: NTEP Training Modules 1-4 for Programme Managers & Medical Officers, p. 223

Resources

• NTEP Training Modules 1-4 for Programme Managers & Medical Officers, 2020.

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In the National TB Elimination Programme (NTEP), the ‘NTEP TB identity card’ is provided for their identification and record of clinical follow-ups.

The identity card is completed for each patient who has a Tuberculosis (TB) Treatment Card, and it is kept with the patient. Information from the TB Treatment Card is used to complete the identity card.

There are 3 parts in the NTEP TB identity card and details in each part is delineated in Table 1.

The information contained in this card will help to continue treatment in case the patient is transferred or admitted to any other health facility any time during the treatment period. The TB identity card is shown in Figure 1.

Figure 1: NTEP TB Identity Card; Source: NTEP Training Modules 1-4 for Programme Managers & Medical Officers, 2020

Resources

• NTEP Training Modules 1-4 for Programme Managers & Medical Officers, 2020

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The Programmatic Management of Drug-resistant Tuberculosis (PMDT) treatment book is a document that is issued to all patients who are diagnosed with DR-TB and are placed on a regimen for DR-TB. It is given in annexure 31 under the PMDT guidelines 2021.

The PMDT treatment book is to be kept with the patient and should be brought along whenever s/he comes to Drug-resistant TB Centre (DR-TBC) or District TB Centre (DTC) or Health Facility (HF) for clinical follow-up or for Adverse Drug Reaction (ADR) management and should be filled out by the healthcare provider.

The PMDT treatment book contains the following sections:

• Details about the patient, treatment supporter, TB unit from where the patient is availing treatment
• Reason for testing, previous TB treatment history, type of TB, current TB treatment regimen with the date of diagnosis and treatment initiation
• Information on an initial home visit, Drug Susceptibility Test (DST) results for different anti-TB drugs, contact investigation, DR-TB committee meetings
• Information about weight and height of the patient, different weight bands for DR-TB regimen, different types of anti-TB drugs prescribed to patients and their dosages, eligibility and consent of patient if a new drug has been prescribed
• Information on investigations, follow-up results, details about monthly administration of drugs with the weight of patient for the full duration of treatment
• Information on retrieval action taken for a patient who has missed doses, any ADR reported and their management
• Detailed clinical notes written by the treating physician during each visit
• Information about treatment outcome and post-treatment periodic follow-up
• General information about the TB disease, mode of transmission, treatment, drugs in the regimen, side effects of drugs, and a few important do’s and don’ts for the patient.

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Figure: PMDT Treatment Book; Source: Guidelines on Programmatic Management of Drug-resistant TB (PMDT) in India, 2021, CTD, MoHFW, India.

Resources

• Guidelines on Programmatic Management of Drug-resistant TB (PMDT) in India, CTD, MoHFW, India, 2021.
• Guidelines on Programmatic Management of Drug-resistant TB (PMDT) in India, CTD, MoHFW, India, 2017.

Assessment

This is a line list of confirmed DRTB cases on treatment based on current health facilities.

Description: This register gives details about the tests and final interpretation based on the treatment start date and notification date:

• Health Facility ( Diagnosing & current facility details, ie.. State/District/ TU/PHI).
• Date of diagnosis and basis of diagnosis.
• Date of TB treatment initiation and regimen type.
• CBNAAT and Truenat Details - CBNAAT MTB Result, Rif Resistance, final interpretation and date reported.
• F line LPA and S line LPA Final interpretation.