Averting catastrophic tuberculosis costs in an Indian state: integration of Ayushman Bharat Arogya Karnataka with National Tuberculosis Elimination Program.

The WHO's "End TB" initiative aims to reduce catastrophic expenses, incidence, and mortality by 90%, 80%, and 0%, respectively by 2030 and Government of India has committed to reaching these goals by 2025. Despite tremendous progress, tuberculosis (TB) remains one of the main public health issues. To limit TB transmission and expedite reduction in incidence, further measures are needed. These milestones and objectives remain aspirational until we achieve "Universal access" to high-quality TB diagnosis and treatment. The goals of the study include outlining the process of 'Ayushman Bharat-Pradhan Mantri Jan Arogya Yojana-Arogya Karnataka' (AB-PMJAY-ArK) integration with the National TB Elimination Program (NTEP) in Karnataka, the types of TB patients who used AB-PMJAY-ArK services, and calculating the cost per TB patient at primary, secondary, and tertiary healthcare facilities, both public and private, stratified by type of service. Increased coverage, elimination of treatment delays, early and free treatment, and prevention of missing patients are benefits of integrating NTEP with Ayushman Bharat-PMJAY.

Self-driven solutions and resilience adapted by people with drug-resistant tuberculosis and their caregivers in Bengaluru and Hyderabad, India: a qualitative study.

Background: One-fifth of people with drug-resistance tuberculosis (DR-TB) who were initiated on newer shorter treatment regimen (with injection) had unfavourable treatment outcomes in India as on 2020. Evidence on self-driven solutions and resilience adapted by people with DR-TB (PwDR-TB) towards their multi-dimensional disease and treatment challenges are scarce globally, which we aimed to understand. Methods: In this qualitative study using positive deviance framework, we conducted semi-structured in-depth interviews among consenting adult PwDR-TB (7 women, 13 men) who completed shorter treatment regimen (including injections) with maximum treatment adherence. The study was conducted in the southern districts of Bengaluru and Hyderabad, India between June 2020 and December 2022. Caregivers (14 women, 6 men) and health providers (8 men, 2 women) of PwDR-TB were also interviewed. Interviews were conducted in local language (Kannada, Tamil, Telugu, Urdu and Hindi) and inquired about practices, behaviours, experiences, perceptions and attributes which enabled maximum adherence and resilience of PwDR-TB. Interviews were audio recorded, transcribed, and translated to English and coded for thematic analysis using inductive approach. Findings: Distinctive themes explanatory of the self-driven solutions and resilience exhibited by PwDR-TB and their caregivers were identified: (i) Self-adaptation towards the biological consequences of drugs, by personalised nutritional and adjuvant practices, which helped to improve drug ingestion and therapeutic effects. Also home remedies and self-plans for ameliorating injection pain. (ii) Perceptual adaptation towards drugs aversion and fatigue, by their mind diversion practices, routinisation and normalisation of drug intake process. and constant reinforcement and re-interpretation of bodily signs of disease recovery (iii) Family caregivers intense and participatory care for PwDR-TB, by aiding their essential life activities and ensuring survival, learning and fulfilling special nutritional needs and goal oriented actions to aid drug intake (iv) Health care providers care, marked by swift and timely risk mitigation of side-effects and crisis response (v) Acquired self-efficacy of PwDR-TB, by their decisive family concerns resulting in attitudinal change. Also being sensitised on the detrimental consequences of disease and being motivated through positive examples. Interpretation: Synthesised findings on self-driven solutions and resilience towards the multi-dimensional DR-TB challenges provides opportunity for developing and testing new interventions for its effectiveness in DR-TB care settings globally. Designing and testing personalised cognitive interventions for PwDR-TB: to inculcate attitudinal change and self-efficacy towards medication, developing cognitive reinforcements to address the perception burden of treatment, skill building and mainstreaming the role of family caregivers as therapeutic partners of PwDR-TB, curating self-adaptive behaviours and practices of PwDR-TB to normalise their drug consumptions experiences could be the way forward in building resilience towards DR-TB. Funding: United States Agency for International Development (USAID) through Karnataka Health Promotion Trust (KHPT), Bengaluru, India.

Tuberculosis treatment outcomes and patient support groups, southern India.

Objective: To assess treatment outcomes in tuberculosis patients participating in support group meetings in five districts of Karnataka and Telangana states in southern India. Methods: Tuberculosis patients from five selected districts who began treatment in 2019 were offered regular monthly support group meetings, with a focus on patients in urban slum areas with risk factors for adverse outcomes. We tracked the patients' participation in these meetings and extracted treatment outcomes from the Nikshay national tuberculosis database for the same patients in 2021. We compared treatment outcomes based on attendance of the support groups meetings. Findings: Of 30 706 tuberculosis patients who started treatment in 2019, 3651 (11.9%) attended support groups meetings. Of patients who attended at least one support meeting, 94.1% (3426/3639) had successful treatment outcomes versus 88.2% (23 745/26 922) of patients who did not attend meetings (adjusted odds ratio, aOR: 2.44; 95% confidence interval, CI: 2.10-2.82). The odds of successful treatment outcomes were higher in meeting participants than non-participants for all variables examined including: age ≥ 60 years (aOR: 3.19; 95% CI: 2.26-4.51); female sex (aOR: 3.33; 95% CI: 2.46-4.50); diabetes comorbidity (aOR: 3.03; 95% CI: 1.91-4.81); human immunodeficiency virus infection (aOR: 3.73; 95% CI: 1.76-7.93); tuberculosis retreatment (aOR: 1.69; 1.22-2.33); and drug-resistant tuberculosis (aOR: 1.93; 95% CI: 1.21-3.09). Conclusion: Participation in support groups for tuberculosis patients was significantly associated with successful tuberculosis treatment outcomes, especially among high-risk groups. Expanding access to support groups could improve tuberculosis treatment outcomes at the population level.

Screening for Severe Illness at Diagnosis Has the Potential to Prevent Early TB Deaths: Programmatic Experience From Karnataka, India.

Due to the coronavirus disease (COVID-19) pandemic and its associated response, TB deaths increased for the first time in a decade. In any potentially fatal illness, an assessment of severity is essential. This is not systematically done for adults with TB, mostly due to a lack of policy and/or limited availability of diagnostic and clinical capacity. We developed a screening tool using simple and easily measurable indicators that can be used by paramedical TB program staff to quickly identify people with severe illness. During October-November 2020 in Karnataka, India, the paramedical program staff from 16 districts screened people with TB (aged ≥15 years) notified by public facilities for "high risk of severe illness," which was defined as the presence of any of the following indicators: (1) body mass index (BMI) ≤14.0 kg/m2; (2) BMI ≤16.0 kg/m2 with bilateral leg swelling; (3) respiratory rate >24/minute; (4) oxygen saturation <94%; (5) inability to stand without support. In this cohort study, we determined the incidence of program-recorded early deaths (within 2 months) and its association with high risk of severe illness. Of 3,010 people with TB, 1,529 (50.8%) were screened at diagnosis/notification, of whom 537 (35.1%) had a high risk of severe illness. There were 195 (6.5%, 95% CI=5.7, 7.4) early deaths: 59 (30.2%) within a week and 100 (51.3%) within 2 weeks of treatment initiation. The incidence of early deaths was significantly higher among those with high risk of severe illness (8.9%) at diagnosis compared to those without (3.8%) [adjusted relative risk: 2.36 (95% confidence interval=1.57, 3.55)]. To conclude, early deaths were especially high during the first 2 weeks and strongly associated with a high risk of severe illness at diagnosis/notification. Screening for severe illness should be explored as a potential strategy to end TB deaths.

Screening People with Tuberculosis for High Risk of Severe Illness at Notification: Programmatic Experience from Karnataka, India.

Due to limited availability of diagnostics and capacity, people with tuberculosis do not always undergo systematic assessment for severe illness (requiring inpatient care). In Karnataka (south India), para-medical programme staff used a screening tool to identify people at 'high risk of severe illness', defined using indicators of very severe undernutrition, abnormal vital signs and poor performance status (any one): (i) body mass index (BMI) ≤ 14.0 kg/m2 (ii) BMI ≤ 16.0 kg/m2 with bilateral leg swelling (iii) respiratory rate > 24/min (iv) oxygen saturation < 94% (v) inability to stand without support. Of 3020 adults notified from public facilities (15 October to 30 November 2020) in 16 districts, 1531 (51%) were screened (district-wise range: 13-90%) and of them, 538 (35%) were classified as 'high risk of severe illness'. Short median delays in screening from notification (five days), and all five indicators being collected for 88% of patients, suggests the feasibility of using this tool in programme settings. However, districts with poor screening coverage require further attention. To end tuberculosis deaths, screening should be followed by referral to higher facilities for comprehensive clinical evaluation, to assess the need for inpatient care. Future studies should assess the validity (especially sensitivity in picking severely ill patients) of this screening tool.

Community health workers augment the cascade of TB detection to care in urban slums of two metro cities in India.

BACKGROUND: Tuberculosis Health Action Learning Initiative (THALI) funded by USAID is a person-centered initiative, supporting vulnerable urban populations to gain access to TB services. THALI trained and placed 112 Community health workers (CHWs) to detect and support individuals with TB symptoms or disease within urban slums in two cities, Hyderabad and Bengaluru, covering a population of about 3 million. METHODS: CHWs visited the slums once in a fortnight. They conducted TB awareness activities. They referred individuals with TB symptoms for sputum testing to nearest public sector laboratories. They visited those testing TB positive, once a fortnight in the intensive phase, and once a month thereafter. They supported TB patients and families with counselling, contact screening and social scheme linkages. They complemented the shortfall in urban TB government field staff numbers and their capacity to engage with TB patients. Data on CHWs' patient referral for TB diagnosis and treatment support activities was entered into a database and analyzed to examine CHWs' role in the cascade of TB care. We compared achievements of six monthly referral cohorts from September 2016 to February 2019. RESULTS: Overall, 31 617 (approximately 1%) of slum population were identified as TB symptomatic and referred for diagnosis. Among the referred persons, 23 976 (76%) underwent testing of which 3841 (16%) were TB positive. Overall, 3812 (99%) were initiated on treatment and 2760 (72%) agreed for regular follow up by the CHWs. Fifty-seven percent of 2952 referred were tested in the first cohort, against 86% of 8315 in the last cohort. The annualized case detection rate through CHW referrals in Bengaluru increased from 5.5 to 52.0 per 100 000 during the period, while in Hyderabad it was 35.4 initially and increased up to 118.9 per 100 000 persons. The treatment success rate was 87.1% among 193 in the first cohort vs 91.3% among 677 in the last cohort. CONCLUSIONS: CHWs in urban slums augment TB detection to care cascade. Their performance and TB treatment outcomes improve over time. It would be important to examine the cost per TB case detected and successfully treated.

Is a differentiated care model needed for patients with TB? A cohort analysis of risk factors contributing to unfavourable outcomes among TB patients in two states in South India.

BACKGROUND: TB is a preventable and treatable disease. Yet, successful treatment outcomes at desired levels are elusive in many national TB programs, including India. We aim to identify risk factors for unfavourable outcomes to TB treatment, in order to subsequently design a care model that would improve treatment outcomes among these at-risk patients. METHODS: We conducted a cohort analysis among TB patients who had been recently initiated on treatment. The study was part of the internal program evaluation of a USAID-THALI project, implemented in select towns/cities of Karnataka and Telangana, south India. Community Health Workers (CHWs) under the project, used a pre-designed tool to assess TB patients for potential risks of an unfavourable outcome. CHWs followed up this cohort of patients until treatment outcomes were declared. We extracted treatment outcomes from patient's follow-up data and from the Nikshay portal. The specific cohort of patients included in our study were those whose risk was assessed during July and September, 2018, subsequent to conceptualisation, tool finalisation and CHW training. We used bivariate and multivariate logistic regression to assess each of the individual and combined risks against unfavourable outcomes; death alone, or death, lost to follow up and treatment failure, combined as 'unfavourable outcome'. RESULTS: A significantly higher likelihood of death and experiencing unfavourable outcome was observed for individuals having more than one risk (AOR: 4.19; 95% CI: 2.47-7.11 for death; AOR 2.21; 95% CI: 1.56-3.12 for unfavourable outcome) or only one risk (AOR: 3.28; 95% CI: 2.11-5.10 for death; AOR 1.71; 95% CI: 1.29-2.26 for unfavourable outcome) as compared to TB patients with no identified risk. Male, a lower education status, an initial weight below the national median weight, co-existing HIV, previous history of treatment, drug-resistant TB, and regular alcohol use had significantly higher odds of death and unfavourable outcome, while age > 60 was only associated with higher odds of death. CONCLUSION: A rapid risk assessment at treatment initiation can identify factors that are associated with unfavourable outcomes. TB programs could intensify care and support to these patients, in order to optimise treatment outcomes among TB patients.

Use of Verbal Autopsy to Determine Underlying Cause of Death during Treatment of Multidrug-Resistant Tuberculosis, India.

Of patients with multidrug-resistant tuberculosis (MDR TB), <50% complete treatment. Most treatment failures for patients with MDR TB are due to death during TB treatment. We sought to determine the proportion of deaths during MDR TB treatment attributable to TB itself. We used a structured verbal autopsy tool to interview family members of patients who died during MDR TB treatment in India during January-December 2016. A committee triangulated information from verbal autopsy, death certificate, or other medical records available with the family members to ascertain the underlying cause of death. For 66% of patient deaths (47/71), TB was the underlying cause of death. We assigned TB as the underlying cause of death for an additional 6 patients who died of suicide and 2 of pulmonary embolism. Deaths during TB treatment signify program failure; accurately determining the cause of death is the first step to designing appropriate, timely interventions to prevent premature deaths.

"Who has to do it at the end of the day? Programme officials or hospital authorities?" Airborne infection control at drug resistant tuberculosis (DR-TB) centres of Karnataka, India: a mixed-methods study.

BACKGROUND: Drug resistant tuberculosis (DR-TB) centers admit patients with DR-TB for initiation of treatment and thereby concentrate the patients under one setting. It becomes imperative to assess the compliance of DR-TB centres to national airborne infection control (AIC) guidelines and explore the provider perspectives into reasons for unsatisfactory compliance. METHODS: This mixed methods study (triangulation design) was carried out across all the six DR-TB centers of Karnataka state, India, between November 2016 and April 2017. Non-participant observation using a structured format was carried out at the DR-TB wards (n = 6), outpatient departments (n = 6), patient waiting areas outside outpatient departments (n = 6) and culture and drug susceptibility testing laboratories (n = 3). Structured interviews of admitted patients (n = 30) were done to assess the knowledge on cough hygiene and sputum disposal. Key informant interviews (KIIs) of health care providers (n = 20) were done. Manual descriptive content analysis was done to analyse the transcripts of KIIs. RESULTS: The findings related to compliance in non-participant observation were corroborated by KIIs. All the laboratories were consistently implementing the AIC guidelines. Compliance to hand hygiene, wet mopping and ventilation measures were satisfactory in four or more DR-TB wards. The non-availability of N95 masks in wards as well as outpatient departments was staggering. Sputum disposal without prior disinfection and the lack of display materials on cough hygiene and patient education was common. Patient fast tracking in outpatient department waiting areas and visitor restrictions in wards were lacking. Trainings on AIC measures were uncommon. About half and one-third of patients admitted had satisfactory knowledge regarding sputum disposal and situations demanding mask respectively. The reasons for unsatisfactory compliance to AIC guidelines were poor coordination between programme and hospital authorities leading to lack of ownership; ineffective or non-existent infection control committees; vacant posts of medical officers; and attitudes of health care delivery staff. CONCLUSION: Compliance with AIC guidelines in DR-TB centers of Karnataka was sub-optimal. The reasons identified require urgent attention of the programme managers and hospital authorities.

HIV-infected presumptive tuberculosis patients without tuberculosis: How many are eligible for antiretroviral therapy in Karnataka, India?

For certain subgroups within people living with the human immunodeficiency virus (HIV) [active tuberculosis (TB), pregnant women, children <5years old, and serodiscordant couples], the World Health Organization recommends antiretroviral therapy (ART) irrespective of CD4 count. Another subgroup which has received increased attention is "HIV-infected presumptive TB patients without TB". In this study, we assess the proportion of HIV-infected presumptive TB patients eligible for ART in Karnataka State (population 60million), India. This was a cross-sectional analysis of data of HIV-infected presumptive TB patients diagnosed in May 2015 abstracted from national TB and HIV program records. Of 42,585 presumptive TB patients, 28,964 (68%) were tested for HIV and 2262 (8%) were HIV positive. Of the latter, 377 (17%) had active TB. Of 1885 "presumptive TB patients without active TB", 1100 (58%) were already receiving ART. Of the remaining 785 who were not receiving ART, 617 (79%) were assessed for ART eligibility and of those, 548 (89%) were eligible for ART. About 90% of "HIV-infected presumptive TB patients without TB" were eligible for ART. This evidence supports a public health approach of starting all "HIV-infected presumptive TB patients without TB" on ART irrespective of CD4 count in line with global thinking about 'test and treat'.