Trends of Private Drugs' Sales and Costs Incurred by Patients on Anti-tuberculosis Drugs in Selected Districts of Jharkhand (2022): Results From Sub-national TB-Free Certification.

BACKGROUND: The government of India is committed to eliminating tuberculosis (TB) by 2025 under the National Tuberculosis Elimination Programme which provides free investigations and treatment as well as incentives for nutritional support during their treatment course. Many TB patients prefer to seek treatment from the private sector which sometimes leads to financial constraints for the patients. Our study aims to find the burden of TB patients in the private sector and the expenses borne by them for their treatment. METHODOLOGY: Sales data of rifampicin-containing formulation drug consumption in the private sector of six districts of Jharkhand was collected from Clearing and Forwarding agencies. Based on the drug sales data, the total incurring costs of the drugs, total number of patients, and cost per patient seeking treatment from the private sector were calculated for the year 2015-2021. ANOVA and the post hoc test (Tukey honestly significant difference (HSD)) were applied for analysis. RESULTS:  There was a marked difference amongst all the districts in relation to all the variables namely total costs, cost per patient, and total private patients seeking treatment from the private sector which was statistically significant (p < 0.001). East Singhbhum had the highest out-of-pocket expense and private patients as compared to all six districts. Lohardaga showed the sharpest decline in total private patients from 2015 to 2021. The average cost borne by private patients in 2015 was INR 1821 (95% CI 1086 - 2556) which decreased to INR 1033 (95% CI 507 - 1559) in 2021. CONCLUSION: From the study, it was concluded that the purchase of medicines for TB treatment from the private sector is one of the essential elements in out-of-pocket expenditure (OOPE) borne by TB patients. Hence, newer initiatives should be explored to foresee the future OOPE borne by the patients and decrease OOPE-induced poverty.

Nutritional supplementation to prevent tuberculosis incidence in household contacts of patients with pulmonary tuberculosis in India (RATIONS): a field-based, open-label, cluster-randomised, controlled trial.

BACKGROUND: In India, tuberculosis and undernutrition are syndemics with a high burden of tuberculosis coexisting with a high burden of undernutrition in patients and in the population. The aim of this study was to determine the effect of nutritional supplementation on tuberculosis incidence in household contacts of adults with microbiologically confirmed pulmonary tuberculosis. METHODS: In this field-based, open-label, cluster-randomised controlled trial, we enrolled household contacts of 2800 patients with microbiologically confirmed pulmonary tuberculosis across 28 tuberculosis units of the National Tuberculosis Elimination Programme in four districts of Jharkhand, India. The tuberculosis units were randomly allocated 1:1 by block randomisation to the control group or the intervention group, by a statistician using computer-generated random numbers. Although microbiologically confirmed pulmonary tuberculosis patients in both groups received food rations (1200 kcal, 52 grams of protein per day with micronutrients) for 6 months, only household contacts in the intervention group received monthly food rations and micronutrients (750 kcal, 23 grams of protein per day with micronutrients). After screening all household contacts for co-prevalent tuberculosis at baseline, all participants were followed up actively until July 31, 2022, for the primary outcome of incident tuberculosis (all forms). The ascertainment of the outcome was by independent medical staff in health services. We used Cox proportional hazards model and Poisson regression via the generalised estimating equation approach to estimate unadjusted hazard ratios, adjusted hazard ratios (aHRs), and incidence rate ratios (IRRs). This study is registered with CTRI-India, CTRI/2019/08/020490. FINDINGS: Between Aug 16, 2019, and Jan 31, 2021, there were 10 345 household contacts, of whom 5328 (94·8%) of 5621 household contacts in the intervention group and 4283 (90·7%) of 4724 household contacts in the control group completed the primary outcome assessment. Almost two-thirds of the population belonged to Indigenous communities (eg, Santhals, Ho, Munda, Oraon, and Bhumij) and 34% (3543 of 10 345) had undernutrition. We detected 31 (0·3%) of 10 345 household contact patients with co-prevalent tuberculosis disease in both groups at baseline and 218 (2·1%) people were diagnosed with incident tuberculosis (all forms) over 21 869 person-years of follow-up, with 122 of 218 incident cases in the control group (2·6% [122 of 4712 contacts at risk], 95% CI 2·2-3·1; incidence rate 1·27 per 100 person-years) and 96 incident cases in the intervention group (1·7% [96 of 5602], 1·4-2·1; 0·78 per 100 person-years), of whom 152 (69·7%) of 218 were patients with microbiologically confirmed pulmonary tuberculosis. Tuberculosis incidence (all forms) in the intervention group had an adjusted IRR of 0·61 (95% CI 0·43-0·85; aHR 0·59 [0·42-0·83]), with an even greater decline in incidence of microbiologically confirmed pulmonary tuberculosis (0·52 [0·35-0·79]; 0·51 [0·34-0·78]). This translates into a relative reduction of tuberculosis incidence of 39% (all forms) to 48% (microbiologically confirmed pulmonary tuberculosis) in the intervention group. An estimated 30 households (111 household contacts) would need to be provided nutritional supplementation to prevent one incident tuberculosis. INTERPRETATION: To our knowledge, this is the first randomised trial looking at the effect of nutritional support on tuberculosis incidence in household contacts, whereby the nutritional intervention was associated with substantial (39-48%) reduction in tuberculosis incidence in the household during 2 years of follow-up. This biosocial intervention can accelerate reduction in tuberculosis incidence in countries or communities with a tuberculosis and undernutrition syndemic. FUNDING: Indian Council of Medical Research-India TB Research Consortium.

Trend in seroprevalence of SARS-CoV-2 (IgG antibody) among tribal-dominated population: Findings from Jharkhand, India.

Background & objectives: Serosurvey of COVID-19 provides a better estimation of people who have developed antibodies against the infection. Undertaking such a serosurvey in certain districts of India which are densely populated with prominent tribes can provide valuable information regarding seropravelance of SARS-CoV-2 antibodies among such indigenous populations. In this context, two rounds of population-based, cross-sectional serosurveys for SARS-CoV-2 IgG antibody were carried out in Jharkhand, a tribal-dominated State of India, to compare the seroprevalence of SARS-CoV-2 infection and to determine the associated demographic risk factors. Methods: The surveys were carried out in June 2020 and February 2021 in ten districts of the State of Jharkhand. Blood samples were collected from the residents of the selected districts by random sampling and tested for anti-SARS-CoV-2 antibodies using an automated chemiluminescence immunoassay platform. A total of 4761 and 3855 eligible participants were included in round 1 and round 2, respectively. Results: The age- and gender-standardized seroprevalence for COVID-19 during round 1 was 0.54 per cent (0.36-0.80) that increased to 41.69 per cent (40.16-43.22) during round 2 with a gap of eight months in between. The seropositivity among male and female participants was 0.73 and 0.45 per cent, respectively, during the first round and 51.35 and 33.70 per cent, respectively, during the second round. During the first round, 17.37 per cent of the participants were tribal with seropositivity of 0.24 per cent (0.02-0.87), and during the second round, 21.14 per cent were tribal with seropositivity of 39.14 per cent (35.77-42.59). Compared to tribal group, non-tribal participants had an adjusted odds of 1.24 (95% confidence interval=1.04-1.48) for SARS-CoV-2 seropositivity. Interpretation & conclusions: COVID-19 seroprevalence was found to be low during the first round (0.54%) of the survey, possibly due to the travel restrictions during lockdown better adherence to social distancing and wearing of face masks among the people. Understanding the dynamics of SARS-CoV-2 transmission and the susceptibility to infection at the individual as well as community level will inform decision and help policy makers to design and implement effective public health strategies to mitigate the pandemic in this State.

SARS-CoV-2 seroprevalence among the general population and healthcare workers in India, December 2020-January 2021.

BACKGROUND: Earlier serosurveys in India revealed seroprevalence of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) of 0.73% in May-June 2020 and 7.1% in August-September 2020. A third serosurvey was conducted between December 2020 and January 2021 to estimate the seroprevalence of SARS-CoV-2 infection among the general population and healthcare workers (HCWs) in India. METHODS: The third serosurvey was conducted in the same 70 districts as the first and second serosurveys. For each district, at least 400 individuals aged ≥10 years from the general population and 100 HCWs from subdistrict-level health facilities were enrolled. Serum samples from the general population were tested for the presence of immunoglobulin G (IgG) antibodies against the nucleocapsid (N) and spike (S1-RBD) proteins of SARS-CoV-2, whereas serum samples from HCWs were tested for anti-S1-RBD. Weighted seroprevalence adjusted for assay characteristics was estimated. RESULTS: Of the 28,598 serum samples from the general population, 4585 (16%) had IgG antibodies against the N protein, 6647 (23.2%) had IgG antibodies against the S1-RBD protein, and 7436 (26%) had IgG antibodies against either the N protein or the S1-RBD protein. Weighted and assay-characteristic-adjusted seroprevalence against either of the antibodies was 24.1% [95% confidence interval (CI) 23.0-25.3%]. Among 7385 HCWs, the seroprevalence of anti-S1-RBD IgG antibodies was 25.6% (95% CI 23.5-27.8%). CONCLUSIONS: Nearly one in four individuals aged ≥10 years from the general population as well as HCWs in India had been exposed to SARS-CoV-2 by December 2020.

The RATIONS (Reducing Activation of Tuberculosis by Improvement of Nutritional Status) study: a cluster randomised trial of nutritional support (food rations) to reduce TB incidence in household contacts of patients with microbiologically confirmed pulmonary tuberculosis in communities with a high prevalence of undernutrition, Jharkhand, India.

INTRODUCTION: India has the largest burden of cases and deaths related to tuberculosis (TB). Undernutrition is the leading risk factor accounting for TB incidence, while severe undernutrition is a common risk factor for mortality in patients with TB in India. The impact of nutritional supplementation on TB incidence is unknown, while few underpowered studies have assessed its impact on TB mortality. We designed an open-label, field-based cluster randomised trial to assess the impact of nutritional supplementation (with food rations) on TB incidence in a group at higher risk of TB infection and disease, viz household contacts (HHC) of patients with microbiologically confirmed pulmonary TB (PTB) in Jharkhand, a state with a high prevalence of undernutrition. METHODS AND ANALYSIS: We shall enrol 2800 adult patients with PTB of the national TB programme, across 28 treatment units in 4 districts, and their approximately 11 200 eligible contacts. The sample size has 80% power to detect the primary outcome of 50% reduction in incidence of active TB in HHC over 2 years of follow-up. Patients and HHC in both the arms will undergo nutritional assessment and counselling. Patients will receive monthly food rations (supplying 1200 kcal and 52 g proteins/day) and multivitamins along with antitubercular treatment. The HHC in the intervention arm will receive food rations (supplying 750 kcal and 23 g proteins/day) and multivitamins while HHC in control arm will be on usual diet. The secondary outcomes in HHC will include effects on nutritional status, non-TB infections. Secondary outcomes in patients are effects on TB mortality, adherence, adverse effects, nutritional and performance status. Substudies will examine micronutrient status and effects on dietary intake, body composition, muscle strength and immune function. ETHICS AND DISSEMINATION: The institutional ethics committee of ICMR-NIRT, Chennai, approved the study (289/NIRT-IEC/2018). The results will be disseminated in publications and presentations. TRIAL REGISTRATION NUMBER: Clinical Trial Registry of India: CTRI/2019/08/020490.

"Is there a difference in treatment outcome of tuberculosis patients: Rural Healthcare Providers versus Community Health Workers?"

INTRODUCTION: Rural healthcare providers (RHCPs) are the first point of contact for majority of patients in rural parts of India. A total of 75 RHCPs were trained and engaged in Hazaribagh to identify presumptive tuberculosis (TB) patients (PrTBPs) and refer them for diagnosis. Patients diagnosed with TB were initiated on directly observed treatment short course (DOTS) under the programme. Based on patients' choice, the treatment providers were either RHCPs or community health workers (CHWs). In this paper, we aim to compare the treatment outcomes of TB patients who received DOTS from RHCPs with CHWs. METHOD: This is a retrospective cohort study using secondary data routinely collected through project and Revised National TB Control Programme. RESULTS: Over the period of 24 months, 57 RHCPs continued to be engaged with project and a total of 382 referrals were made out of which 72 (19%) were diagnosed with TB. Based on choice made, 40 (55%) of TB patients chose RHCPs and 32 (45%) CHWs as their treatment provider. The mean successful treatment completion rate was 87% in the RHCP group compared with 81% for CHWs (P value 0.464). The percentages of unsuccessful outcomes were similar for both groups. CONCLUSIONS: Our study demonstrates the process to engage RHCPs in TB prevention and care. The study highlights community preference for RHCPs as DOT provider who can produce similar TB treatment success rates as that of CHWs identified by programme.

Impact of Advocacy, Communication, Social Mobilization and Active Case Finding on TB Notification in Jharkhand, India.

Community-level benefits of screening for active tuberculosis (TB) disease remain uncertain. Project Axshya (meaning free of TB) conducted advocacy, communication, social mobilization, and active case finding among vulnerable/marginalized populations of India. Among 15 districts of Jharkhand state, the project was initiated in 36 subdistrict level administrative units - tuberculosis units (TUs) in a staggered manner between April 2013 and September 2014, and continued till the end of 2015. Seven TUs did not implement the project. We assessed the relative change in the quarterly TB case finding indicators (n = 4) after inclusion of a TU within the project. By fitting four multilevel models (mixed-effects maximum likelihood regression using random intercept), we adjusted for secular (over previous five quarters) and seasonal trends, baseline differences within Axshya and non-Axshya TUs, and population size and clustering within districts and within TUs. After inclusion of a TU within the project, we found a significant increase [95% confidence interval (CI)] in TU-level presumptive TB sputum examination rate, new sputum-positive TB Case Notification Rate (CNR), sputum-positive TB CNR, and all forms TB CNR by 12 (5.5, 18.5), 1.1 (0.5, 1.7), 1.3 (0.6, 2.0), and 1.2 (0.1, 2.2) per 100,000 population per quarter, respectively. Overall, the project resulted in an increase (95% CI) in sputum examination and detection of new sputum-positive TB, sputum-positive TB and all forms of TB patients by 22,410 (10,203, 34,077), 2066 (923, 3210), 2380 (1162, 3616), and 2122 (203, 4059), respectively. This provides evidence for implementing project Axshya over and above the existing passive case finding.