Each year, in India, an estimated 28 lacs people develop tuberculosis (TB) disease and approximately 4.8 lacs people die from TB— World Health Organization's (WHO's) Global Report 2017.
A study of mortality in India has estimated that TB is among the top four causes of death between the ages of 30 and 69 years, with an impact similar to cancer. The socioeconomic impact of TB in India is devastating and India continues to incur huge costs due to TB amounting to nearly US$ 350 billion between 2006 and 2015.
India continues to have the highest TB burden though the epidemic is on the decline. The incidence of TB, human immunodeficiency virus (HIV) and TB (5%), and drug-resistant tuberculosis (DR-TB) varies from region to region. The urban areas have lower prevalence of TB with a higher annual risk of tuberculous infection (ARTI) and vice versa.
This is the reason why different approaches are necessary to tackle the problem. The National TB Programme of India (NTP) was initiated in 1962 and was originally designed for domiciliary treatment, using self-administered standard drug regimens. NTP had created an extensive infrastructure for TB control with a network of > 446 district TB centers, 330 TB clinics and > 47,600 TB beds. The NTP had also raised awareness of TB and TB treatment facilities, and had succeeded in placing > 1.3 million patients on treatment annually.
The problems are HIV-AIDS epidemic and the spread of multidrug-resistant (MDR) TB were threatening to further worsen in the situation.
Inadequate funding, an over reliance on X-ray for diagnosis, had frequent interrupted supplies of drug, and low rates of treatment completion. The government decided to give new thrust to TB control activities by revitalizing the NTP with assistance from international agencies in 1993. Revised National TB Control Programme (RNTCP) was piloted in a population of 2.4 million of five states. This was later expanded to cover 13 million people by 1995 and 20 million by 1996.
In 1997, the RNTCP was launched as national program with the plan to scale up in phased manner. It adopted the internationally recommended directly observed treatment short-course (DOTS) strategy, as the systematic and cost-effective approach to revitalize the TB control program in India.
Emboldened by its achievements, the program in 12th Five Year Plan (2012–2017) has articulated a vision of universal access to TB care with the following objectives: (i) To achieve 90% notification rate for all cases; (ii) to achieve 90% success rate for all new and 85% for retreatment cases; (iii) to significantly improve the successful outcomes of treatment of DR-TB cases; (iv) to achieve decreased morbidity and mortality of HIV-associated TB; and (v) to improve outcomes of TB care in the private sector.
National AIDS Control Programme and RNTCP have started a “National Framework of Joint TB/HIV Collaborative Activities” by engaging the private sector of medical care and professional bodies like Indian Medical Association (IMA). A case-based web-based platform “Nikshay” in 2012 has now been scaled up nationally.
STANDARDS FOR TB CARE IN INDIA (STCI)
The private sector holds a factual predominance of healthcare service delivery in India. There is very little information about TB patients from the private sector which is available to the program and little is known about their quality of treatment, including treatment outcomes.
“The National Strategic Plan (NSP) for TB Elimination (2017–2025) is a statement of commitment to eliminate TB by 2025 by the Ministry of Health and Family Welfare, Government of India.” The NSP builds on the success and learnings of the last NSP and encapsulates the bold and innovative steps required to eliminate TB in India. It is in line with other health sector strategies and global efforts, such as the National Health Policy 2015, WHO's End TB strategy, and the sustainable development goals (SDGs) of the United Nations (UN). It proposes bold strategies with commensurate resources to rapidly decline TB incidence and mortality in India by 2025, 5 years ahead of the global End TB targets and SDGs. The NSP 2017–2025 aims to notify 260 lacs TB patients in 8 years including public and private sector.
In the 12th Plan period (2012–2017), RNTCP was implemented under the umbrella of the National Health Mission (NHM).1 The same is proposed to be continued in the current plan period. The program has successfully achieved the Millennium Development Goal for incidence and prevalence of TB.
- The incidence of TB has come down from 289 per lac population in 2000 to 217 per lac (58%) population in 2015.
- The mortality from TB has reduced from 56 in 2000 to 36 per lac (28%) population in 2015.
However, India still accounts for an estimated 27% of the global incident TB cases (28 lacs) and 27% of the global MDR-TB cases (1.3 lacs).
The activities under the program currently ongoing would be continued and specific activities/focus areas proposed are as under:
- Increase participation of private sector TB care provider: TB notification has increased substantially in these pilot areas with providing free TB diagnostics and drugs provided either directly by state public health system or through nongovernmental organizations (NGOs) or agencies supporting the states. It is also proposed to provide incentives to the private sector TB care provider through direct beneficiary transfer to promote TB case notification, ensure treatment adherence, and treatment completion.
- Intensified TB control activities in high priority districts: Active case finding (ACF) or intensive case finding (ICF) activity is an activity with the primary objective of detecting TB cases early. Clinically, socially, and occupationally vulnerable populations are targeted by screening for TB symptoms, to conduct sputum examination of symptomatic using a high sensitive and specific tool in the field and to find and treat additional infectious TB patients.
- Providing incentive to prevent catastrophic expenditure to the TB patients and their families due to TB and for nutritional support: This interaction is particularly important in the Indian context where poverty and undernutrition coexist with a large burden of tuberculosis. It is proposed to launch a scheme to provide a monthly cash incentive for every TB patient through direct beneficiary transfer.
- Deploy a world-class national surveillance and tracking system for TB patients: Nikshay will be enhanced to establish comprehensive real time TB surveillance system. Information and communication technology (ICT) platform with handheld ICT devises for health staff, 250 seats call centers, adherence mechanisms through 99-DOTS, SMS reminders and other ICT-based platforms are proposed with corresponding HR and maintenance capacity.
Government of India envisages TB control as one of the key priority activities and is committed to an aspirational target of achieving this ahead of schedule—by the year 2025.
- India has developed NSP for TB in India. The NSP for TB elimination in India has essentially 4 pillars to address the major challenges for TB control, namely “Detect, Treat, Build and Prevent”.
- Priority for TB control in India are:
- The first priority is “reaching the unreached”. We have to ensure access to care for some vulnerable populations such as tribals, people in urban slums, etc.
- 25% of the budget is earmarked for patients managed in the private sector. This include free diagnosis with rapid molecular tests, free treatment with best quality drugs and regimens, financial and nutritional support to patients, online TB notification systems, mobile technology-based adherence monitoring system, interphase agencies for better private sector engagements, policy for transparent service purchase schemes, stronger community engagements, communication campaigns, regulatory systems to capture information on all those consuming anti-TB drugs, etc.
- To provide access to patients in difficult-to-reach areas, both socially and geographically.
- Policy have been in place now for using rapid molecular testing for TB diagnosis and universal drug resistance testing; now we have GenXpert tests available in every district.
- Recently validation and field feasibility tests of a “Make in India” rapid molecular test—“Trunat” has been completed.
- Daily fixed dose course (FDC) regimen for drug-sensitive TB has been now used in India with mobile-based adherence monitoring system (99-DOTS). For DR-TB patients, bedaquiline have been introduced and shorter MDR-TB regimen will be used for treatment.
- Patient support such as nutritional support and financial enablers are ready to be rolled out through JAN scheme [Jan Dhan Yojana (bank account to citizen), Aadhar (unique identity card), Nikshay (electronic TB notification system) linked, direct beneficiary transfer of financial incentives or nutritional support to TB patients]. 20% of NSP budget has been earmarked for financial and nutritional support to TB patients and families.
- Health system strengthening is one of the top priorities; in the NSP we have included a section called “Build”. For strengthening TB program management, we have now an efficient, transparent public finance management system (PFMS). An effective TB surveillance system is being developed in the country and, in 2 years, we expect to have a state of-the-art TB surveillance system in place to better understand and react to local TB epidemic.
- In India, a series of scientific ventures, including development of newer vaccines, newer molecular diagnostics, and treatment regimens are underway.
STRUCTURE OF RNTCP
The RNTCP works at five levels: national level, state level, district level, subdistrict level, and peripheral health institution level.
At the central level, the RNTCP is managed by the Central TB Division (CTD) under Ministry of Health and Family Welfare (MoHFW). Joint Secretary of Health from the administrative arm of the MoHFW and a national program manager—Deputy Director General-TB (DDG-TB), is in-charge of RNTCP.2,3 The CTD is assisted by six national level institutes, namely the National Tuberculosis Institute (NTI) in Bengaluru, the National Institute for Research in Tuberculosis (NIRT) in Chennai, the National Institute of TB and Respiratory Diseases (NITRD) in New Delhi, National Japanese Leprosy Mission for Asia (JALMA), Institute of Leprosy and other Mycobacterial Diseases in Agra, Bhopal Memorial Hospital and Research Centre (BMHRC) in Bhopal, and Regional Medical Research Centre (RMRC) in Bhubaneswar.
At the state level, the state TB officer (STO) does the planning, training, supervising, and monitoring of the program in their respective states. The STO, based at the state TB cell, is answerable to their respective state governments, whilst implementing the technical policies and guidelines issued by the CTD. The state TB cells (STC) have been provided with equipment, infrastructure, and RNTCP contractual staff to carry out its functions. The State TB Training and Demonstration Centre (STDC) has three units: A training unit, supervision, and monitoring unit and an intermediate reference laboratory (IRL). There is state drug store (SDS) for the effective management of anti-TB drug logistics. One SDS per 50 million populations is established in all larger states.
The District TB Centre (DTC) is the nodal point for all TB control activities in the district. In RNTCP, the primary role of the DTC has shifted from clinical to managerial functions. The district TB officer (DTO) at the DTC has the overall responsibility of management of RNTCP at the district level as per the program guidelines and the guidance of the District Health Society.
Subdistrict Level (Tuberculosis Unit Level)
The tuberculosis unit consists of a designated Medical Officer-Tuberculosis Control (MO-TC) who does RNTCP work in addition to other responsibilities. There are two full-time RNTCP contractual supervisory staff exclusively for TB work: A Senior TB Treatment Supervisor (STS) and a Senior TB Laboratory Supervisor (STLS). These tuberculosis units cover a population of approximately 200,000–250,000.
There is one RNTCP designated microscopy center (DMC) for every 100,000 population under a TB unit (50,000 in tribal, desert, remote, and hilly regions). DMCs are also established in medical colleges, corporate hospitals, Employees State Insurance Corporation hospitals and railway health facilities, NGOs, private hospitals, etc., depending upon the requirement.
Peripheral Health Institutions
For the purpose of RNTCP, a peripheral health institution (PHI) is a health facility which is manned by at least a medical officer.
The RNTCP has developed clear definitions for pulmonary TB cases that allow clinicians to categorize patients in terms of their diagnostic status and outcomes of treatment.
Many TB patients do not have their diagnosis confirmed by a positive microbiological test either due to the limitations of the diagnostic tests currently available, or lack of access to a microbiological test. These patients are often treated based on the clinician's suspicion alone (empirical treatment).
- Microbiologically confirmed TB case refers to a presumptive TB patient with biological specimen positive for acid fast bacilli, or positive for Mycobacterium tuberculosis on culture, or positive for TB through quality assured rapid diagnosis molecular test.
- Clinically diagnosed TB case refers to presumptive TB patient who is microbiologically confirmed, he has been diagnosed with active TB by a clinician on the basis of X-ray abnormalities. Histopathology or clinical signs with the design to treat the patient with full course of anti-TB treatment.
In children, clinically diagnosed TB case is diagnosed based on the presence of abnormalities consistent with TB radiography a history of exposure to an infectious case, evidence of TB infection [Positive tuberculin skin test (TST)] and clinical findings suggestive of TB in children in event of negative or unavailable microbiological result.
Microbiologically confirmed or clinically diagnosed case of TB are also classified according to:
- Anatomical site of disease
- History of previous treatment.
Classification based on anatomical site of disease:
- Pulmonary tuberculosis (PTB) refers to any microbiologically confirmed or clinically diagnosed case of TB involving the lungs parenchyma or tracheobronchial tree.
- Extrapulmonary tuberculosis (EPTB) refers to microbiologically confirmed or clinically diagnosed case of TB involving organ other than the lungs such as pleura, lymph nodes, intestine, genitor urinary tract, joint and bones, meninges of brain, etc.
- Miliary TB is classified such as PTB because there are lesions in the lungs. A patient with both PTB and EPTB should be classified as case of PTB.
Classification based on history of TB treatment:
- New case: A TB patient who has never had treatment for TB or has taken anti-TB drug for < 1 month is considered as new case.
- Recurrent TB case: A TB patient previously declared as successfully treated, cured or treatment completed and subsequently found to be microbiologically confirmed TB case is recurrent TB case.
- 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 has received treatment in tuberculosis unit, after being registered for treatment in another TB unit is considered as case of transferred in.
Classification based on drug resistance:
- Mono resistance (MR): A TB patient whose biological specimen is resistant to one first line anti-TB drug only.
- Poly drug resistance (PDR): A TB patient whose specimen is resistant to more than one first line anti-TB drug, other than both isoniazid (INH) and rifampicin.
- Multidrug resistance: A TB whose biological specimen is resistant to both isoniazid and rifampicin with or without resistance to other first-line drug based on the result from a quality assured laboratory.
- Extensive drug resistance (XDR): An MDR-TB case whose biological specimen is additionally resistance to a fluoroquinolone (ofloxacin, levofloxacin, or moxifloxacine) and a second line injectable anti-TB drug (kanamycin, amikacin, or capreomycin).
Definition under RNTCP
Working Case Definitions
Presumptive case: A patient with symptoms and signs of EPTB who needs investigation
Bacteriologically confirmed case: A patient with microbiological diagnosis of EPTB, based on positive microscopy, culture or a validated PCR (polymerase chain reaction)-based test.
Clinically diagnosed case: A patient with negative microbiological tests for TB (microscopy, culture and validated PCR-based tests), but with strong clinical suspicion and other evidence of EPTB, such as compatible imaging findings, histological findings, ancillary diagnostic tests or response to anti-TB treatment. A presumptive case started on antitubercular therapy (ATT) empirically, without microbiological testing, should also be considered a clinically diagnosed case (empirically treated). A clinically diagnosed case subsequently found to be bacteriologically positive (before or after starting treatment) should be reclassified as bacteriologically confirmed.
Non-EPTB case: A patient who has been investigated for EPTB and has been diagnosed with a different condition, with no microbiological evidence of EPTB found.
Presumptive relapse: A patient who was declared successfully treated and now presents again with symptoms and signs of any form of TB.
Bacteriologically confirmed relapse: A patient with presumptive relapse who has microbiological evidence of persisting M. tuberculosis infection on subsequent diagnostic sampling.
Clinically diagnosed relapse: A patient with presumptive relapse who does not have microbiological evidence of persisting M. tuberculosis infection on repeat diagnostic sampling.
A patient with presumptive relapse who is started on ATT empirically without repeat microbiological tests should also be considered a clinically diagnosed relapse (empirically treated). A clinically diagnosed relapse subsequently found to be bacteriologically positive (before or after starting treatment) should be reclassified as bacteriologically confirmed relapse.
Ancillary diagnostic tests refer to organ system-specific tests such as pleural fluid adenosine deaminase activity (ADA) in pleural TB, or cerebrospinal fluid (CSF) biochemistry and differential cell count in TB meningitis.
Working Outcome Definitions1
Successfully treated: A TB patient who has clinical and radiological evidence of resolution of active TB at the end of ATT. Some people have residual tissue damage that causes ongoing symptoms or radiological change (sequelae) despite resolution of TB infection.
Completed treatment: A TB patient who completed treatment without clinical evidence of failure but with no record to show complete resolution by radiological or bacteriological evidence of persisting infection by the last month of treatment because tests were not done.
Presumptive treatment failure: A patient who has no satisfactory clinical or imaging response to treatment after completing 3–6 months ATT.
Bacteriologically confirmed treatment failure: A patient with presumptive treatment failure who has microbiological evidence of persisting M. tuberculosis infection on repeat diagnostic sampling.
Clinically diagnosed treatment failure: A presumptive treatment failure case who does not have microbiological evidence of persisting M. tuberculosis infection on repeat diagnostic sampling and has no evidence of another disease process, but has strong clinical suspicion of treatment failure and other evidence of active TB, such as imaging findings.
SEQUELAE OF EXTRAPULMONARY TUBERCULOSIS
The difficulty in defining treatment end-points in EPTB is due to the development of sequelae as a result of the inflammation and subsequent fibrosis.4 Patients with sequelae though may have complete microbiological cure, but continue to have symptoms. In EPTB at times, sequelae can mimic the signs and symptoms of active TB infection, and to declare the patient successfully treated difficult.
Early accurate diagnosis of TB and enhancing case finding efficiency, identification of presumptive TB cases and avail the best available diagnostic tests are of paramount importance to interrupt the transmission of TB disease. RNTCP screens around 20 million TB symptomatic by microscopy and initiates around 1.5 million cases of TB on treatment annually since 2007–2008. Rapid molecular diagnostics and line probe assay and cartridge based-nucleic acid amplification test (CBNAAT) testing is available throughout the country. In 2016, 520,000 patients have been tested and 35,000 rifampicin resistant (RR)/MDR-TB patients are diagnosed using these tests. Second-line drug susceptibility testing (DST) using liquid culture systems are available in the entire country. RNTCP has a three-tier laboratory network system. The National Reference Laboratory (NRL), IRL, DMCs, and all the laboratories under RNTCP follow the quality assurance (QA) protocol for all technologies as per the WHO guidelines.
The program has a very well established QA mechanism which follows the WHO system of hierarchal control from the highest level of NRLs to state.
Strengthening of these patient-centered treatment services in RNTCP with enhanced capacity to rapidly accommodate new drugs and treatment modalities will be the cornerstone of the current NSP.
Patients are classified based on drug sensitive and drug-resistant patterns like mono, poly, multi, and extensive drug resistance. For drug-sensitive TB patients, thrice-weekly regimen being followed since program inception has been switched to daily regimen for treatment of all TB patients.
The principles of treatment for TB are:
- Compulsory screening of all patients for rifampicin-resistance and additional drugs as clinically decided.
- For drug-sensitive TB, administer daily fixed dose combinations of first-line anti-tuberculosis drugs including four-drug fixed-dose combinations (FDCs) in the intensive phase and three-drug FDCs in the continuation phase.
- All RR or MDR-TB patients are subjected to baseline kanamycin and levofloxacin.
- Rifampicin-resistant or MDR-TB patients without additional drug resistance are treated with standard short course treatment regimen for MDR-TB. and, mixed patterns of resistance, standard MDR-TB regimens were modified.
- Essential optimized regimen for patients diagnosed with drug resistance other than MDR-and XDR-TB.
- Maximize adherence through innovative patient support strategies and real time monitoring.
As part of new drug and treatment services introduction, the program plans to introduce shorter MDR-TB regimen as per WHO treatment guidelines. With extended DST for second-line drugs being available upfront, the NSP 2017–2025 also envisages countrywide scale up of new drugs like bedaquiline (being currently provided in six sites across the country) and delamanid.
PROGRAMMATIC MANAGEMENT OF DRUG-RESISTANT TUBERCULOSIS
The World Health Organization's Global TB Report 2015 estimates approximately 71,000 cases of MDR-TB that emerge annually from the notified cases of pulmonary TB in India. Based on subnational drug resistance surveys carried out in three states of India, ~3% among new TB cases and 12–17% among previously-treated TB cases have MDR-TB.
Strategies for controlling DR-TB include: (i) Sustained high-quality DOTS implementation, daily regimen in high-risk groups and patient-friendly treatment to improve treatment adherence; (ii) implementing airborne infection control (AIC) measures; cut down diagnostic delays with rapid diagnostics, offer universal DST and prompt appropriate decentralized treatment; (iii) strengthening procurement, supply chain: Strengthen the procurement, supply and availability of second-line anti-TB drugs in India; (iv) nutritional assessment and supplementation: Linkages with public distribution systems, Panchayati Raj institutions, corporate social responsibility, etc.; and (v) improving adherence through counseling support: One DR-TB counselor per DR-TB center and district each for both institutional and home-based counseling.
The key features from programmatic management of DR-TB (PMDT) guidelines are described here.
Diagnosis of Multidrug or Extensively Drug-resistant TB
Decentralized diagnosis with with specimen transported to laboratory in cold chain. Rapid molecular DST [CBNAAT or line probe assay (LPA)] is the first choice of DST. All failures of first-line regimen, contacts of known MDR-TB case, all retreatment cases at diagnosis, any patient with smear positive follow up results, and all TB-HIV cases are offered DST.
Apart from these, presumptive TB cases among people living with HIV/AIDS (PLHA) are prioritized for early diagnosis of TB using CBNAAT and the resulting DR-TB cases detected are also considered for treatment under PMDT. Baseline second-line drug in confirmed MDR-TB cases with a fluoroquinolone and second-line injectables. The patients diagnosed with ofloxacin/kanamycin (Ofx/Km) resistance are treated with modified MDR-TB regimen whereas the Ofx/Km resistance among nonresponders and failures of MDR-TB regimen are treated with XDR-TB regimen.
Treatment of Multidrug or Extensively Drug-resistant Tuberculosis
Treatment is based on DR or DST results. Initial hospitalization is done at DR-TB center followed by ambulatory care. A standardized treatment regimen is used for MDR-TB—daily DOT that consists of 6–9 months of kanamycin; levofloxacin; cycloserine; ethionamide; pyrazinamide; ethambutol or 18 months of levofloxacin; cycloserine; ethionamide; ethambutol. Para-aminosalicylic acid (PAS) is used as a substitute drug in case of intolerance.
Standardized treatment regimen for XDR-TB—daily DOT, consisting of 6–12 months of capreomycin; PAS; moxifloxacin; high-dose isoniazid; clofazimine; linezolid; amoxycillin-clavulanic acid or 18 months of PAS, moxifloxacin, high-dose isoniazid, clofazimine; linezolid; amoxycillin-clavulanic acid. Clarithromycin and thiacetazone are used as a substitute drug in case of intolerance.
TUBERCULOSIS–HUMAN IMMUNODEFICIENCY VIRUS COLLABORATIVE ACTIVITIES
Tuberculosis is commonest opportunistic infection in HIV-infected individuals and HIV-infection is an important risk factor for acquiring TB infection and its progression to active TB. About 120,000 HIV-associated TB patients are emerging annually in India and accounts for about 10% of the global burden of HIV-associated TB. The mortality in among TB/HIV coinfected patients is 38,000 people every year.
The interventions to reduce the burden of TB among PLHA include the early provision of antiretroviral therapy (ART) for people living with HIV in line with WHO guidelines and the three I's for HIV/TB—intensified TB case finding followed by high quality ATT, isoniazid preventive therapy (IPT), and infection control for TB.
The National Framework for Joint TB-HIV Collaborative Activities was developed in 2007 and has been updated based on experiential learning and scientific evidence. Currently, the TB/HIV package is being implemented nationwide by both the programs.
PROGRESS SO FAR
In 2014, 74% TB patients knew their HIV status and 44,067 were diagnosed as HIV positive. The 93% HIV-TB patients were provided co-trimoxazole preventive therapy (CPT) and 91% coinfected patients are put on ART.
The 4% additional TB cases were diagnosed with intensified TB case finding activities at HIV care settings.
The success rate among the HIV-TB coinfected patients for patients registered in 2013 was 76% with high death rate 13% and default rate was 6%.
TUBERCULOSIS AND NONCOMMUNICABLE COMORBIDITIES (TOBACCO, DIABETES)
The increasing co-occurrence of TB with tobacco consumption and diabetes mellitus (DM) is well evident. Smoking is three times more prevalent in TB patients and is strongly associated with increased rates of TB infection. Similarly, the prevalence of DM is as high as 13% and the prevalence even goes higher in MDR-TB cases. Patients with TB may have lung damage that is aggravated by continued tobacco use.
Feasibility of including tobacco cessation activities with RNTCP, a TB tobacco pilot project was conducted in Gujarat by Government of India in 2010. The pilot projects done by the TB-DM collaborative group has demonstrated at eight tertiary care centers that missed opportunities can be addressed through developing routine screening system in RNTCP with no additional cost to program.
As per the Global Report on TB 2014, there were an estimated 550,000 TB cases among children (under 15 years of age) and 80,000 TB deaths (among HIV-negative children) in 2013 (6% and 8% of the global totals, respectively). It is one of the top 10 causes of childhood mortality.
Revised National TB Control Programme in association with Indian Academy of Pediatrics (IAP) has revised the pediatric TB guideline in 2012. It laid down specific algorithm diagnosis of TB among children. The treatment strategy comprises two key components. First, as in adults, children with TB are treated with standard SCC, given under direct observation and the disease status is monitored during the course of treatment. Second, patient wise boxes designed according to weight bands for complete course of anti-TB drugs.
In 2014, 72,307 new TB cases were notified accounting for 6% of all cases. This is in the range of the expected incidence by WHO report. The contact screening is one of the ways for intensified case finding activity which RNTCP has implemented since its inception.
The National Technical Working Group on pediatric TB has been constituted to examine the policy and practices and provides suggestions to CTD for improving situation of childhood TB.
To accelerate access to quality TB diagnosis for pediatric, RNTCP has initiated a project in four major cities in India’: RNTCP United States Agency for International Development (USAID) Foundation for Innovative New Diagnostics (FIND) Pediatric TB Xpert Project.
PUBLIC–PRIVATE MIX DOTS IN RNTCP
In India, the private sector is the first point of care in many episodes of ill health. While most TB cases are ultimately treated by the RNTCP, most patients by then have already approached the private sector for TB diagnosis and treatment.
After experiences of implementing models of private sector collaboration, CTD published guidelines for the participation of the NGOs (in 2001) and private practitioners (in 2002). Currently, 24 partnership options for involvement of NGOs, corporates, private practitioners and research institutions are incorporated under the National Guidelines for Partnership.
Indian Medical Association has been engaged with the program through Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) supported project in 16 states and union territories. Similarly, civil society organization, CBCI-CARD (The Catholic Bishops’ Conference of India-Coalition for AIDS and Related Diseases) is working under GFATM project of RNTCP, to improve access to the diagnostic and treatment services provided by the RNTCP within the Catholic Church Healthcare Facilities (CHFs)
In addition, partners like UNION, World Vision, and FIND also support the program. RNTCP has partnered with more than 350 medical colleges in India and, in 2014, they have contributed in a major way in finding more TB cases, especially smear negative and EPTB cases.
ADVOCACY COMMUNICATION AND SOCIAL MOBILIZATION
Advocacy communication and social mobilization (ACSM) is an inbuilt component of RNTCP and is recognized as an important element.
Information, education and communication (IEC) materials are developed at the national level and shared with states for use—“as it is” or post modification to suit local requirements. Several of these materials including television spots, radio jingles and posters are available in nearly 13 regional languages. Advocacy communication and social mobilization module is incorporated in all health workers training on basic DOTS.
TUBERCULOSIS-PATIENT SUPPORT SYSTEMS IN INDIA
In addition to better diagnostic tool and treatment regimens, other patient supportive initiatives including better nutrition, counseling and financial support are equally essential. WHO's “End TB strategy” has this important target of “no affected family face catastrophic costs due to TB”.
However, the free diagnosis and treatment is only accessible to those patients seeking care under RNTCP. Large number of patients seeking care in private sector has to bear substantial cost for TB care. Though large part of cost of treatment is borne by the program, patients still have to bear expenditures such as cost for travel to the facilities, loss of wages due to sickness, etc. The support activities are implemented through departments such as social welfare department, public distribution system, NGOs, CSR funding, etc.
Airborne Infection Control
Acute respiratory infections (ARIs) are the leading cause of morbidity and mortality affecting the youngest and oldest people in low- and middle-income nations. These infections, typically caused by viruses or mixed viral–bacterial infections, can be contagious and spread rapidly. Although knowledge of transmission modes is ever-evolving, current evidence indicates that the primary mode of transmission of most acute respiratory diseases is through droplets, but transmission through contact (including hand contamination followed by self-inoculation) or infectious respiratory aerosols at short range can also happen for some pathogens in particular circumstances.
In RNTCP, contact screening has been a clinical function and the end result expected is that most TB patients will have their contacts screened, with secondary cases detected and treated.
- All close contacts, especially household contacts by X-rays
- In case of pediatric TB patients, reverse contact tracing for active TB case in the household of the child.
Use of chest X-rays upfront for screening of contacts will be prioritized during the NSP period. Setting specific screening approaches (for example in prisons, urban slums, etc.) according to the RNTCP technical and operational guidelines (TOG) will be undertaken.
All close contacts of DR-TB cases will be identified through contact tracing and evaluated for active TB disease as per RNTCP guidelines. If the contact is found to be suffering from pulmonary TB disease irrespective of the smear results, he will be identified as “presumptive MDR-TB”.
Preventive Therapy or Latent Tuberculosis Infection Treatment
Tuberculosis infection is the seedbed for developing TB disease and continued transmission. The lifetime risk of reactivation of latent tuberculosis infection (LTBI) in healthy HIV-uninfected individuals is 10%, with 5% developing TB disease during the first 2–5 years after infection. The risk of reactivation is greatly increased in the context of immunosuppression, primarily due to HIV infection. Child contacts living in TB-affected households are particularly vulnerable populations for progression to TB and severe disease forms such as disseminated and meningeal TB. WHO has included scaling up TB preventive therapy for persons at high risk of developing TB in its End TB strategy and increasing coverage of contact investigations and TB preventive therapy for people living with HIV (PLHIV) and child contacts are important strategies. Scaling up TB preventive therapy is therefore important to meet the goals of ending TB in India.
India, with one-fourth of the global burden of TB, has 40% of the population infected with M. tuberculosis . Treating 40% of the population for LTBI based on TST positivity or interferon-gamma release assay is neither rational nor practicable, thus emphasizing the need for a focused approach. The selection of the risk group that will be prioritized for screening, investigation to rule out TB and treatment is as follows:
- People living with HIV
- Child PTB contacts
- Patients with silicosis
- All patients where clinically indicated (high risk),e.g., points in immunosuppressants
- High-risk adult contacts.
Isoniazid Preventive Therapy
Children <6 years of age, who are close contacts of a TB patient, will be evaluated for active TB by a medical officer/pediatrician. After excluding active TB, he/she will be given INH preventive therapy irrespective of their Bacillus Calmette–Guérin (BCG) vaccine or nutritional status. The dose of INH for preventive therapy is 10 mg/kg body weight daily for 6 months be collected on monthly basis. INH preventive therapy:
- For all HIV infected children with known exposure to an infectious TB case or are TST positive (≥5 mm induration) but have no active TB disease.
- All TST-positive children receiving immunosuppressive therapy (e.g., children with nephrotic syndrome, acute leukemia, etc.).
- Ministry of Health and Family Welfare. (2017). National Strategic Plan for Tuberculosis Elimination 2017-2025. Revised National Tuberculosis Control Programme. [online] Available from https://tbcindia.gov.in/WriteReadData/NSP%20Draft%2020.02.2017%201.pdf. [Last accessed January, 2020].
- MGMIS Sevagram. (2018). National Strategic Plan (NSP) for Tuberculosis Step Towards ending TB by 2025. [online] Available from http://www.jmgims.co.in/article.asp?issn=0971-9903;year=2019;volume=24;issue=1;spage=17;epage=18;aulast=Khaparde. [Last accessed January, 2020].
- Revised National Tuberculosis Control Programme Technical and Operational Guideline 2016, Directorate General of Health Services, MOHFW, New Delhi.
- Sharma SK, Ryan H, Khaparde S, Sachdeva KS, Singh AD, Mohan A, et al. Index TB: Guidelines for extra pulmonary tuberculosis in India. 2017;145(4):448–63.