STEPS - a patient centric and low-cost solution to ensure standards of TB care to patients reaching private sector in India.

BACKGROUND: More than half of the TB patients in India seek care from the private sector. Two decades of attempts by the National TB Program to improve collaboration between the public and private sectors have not worked except in a few innovative pilots. The System for TB Elimination in Private Sector (STEPS) evolved in 2019 as a solution to ensure standards of TB care to every patient reaching the private sector. We formally evaluated the STEPS to judge the success of the model in achieving its outcomes and to inform decisions about scaling up of the model to other parts of the country. METHODS: An evaluation team was constituted involving all relevant stakeholders. A logic framework for the STEPS model was developed. The evaluation focused on (i) processes - whether the activities are taking place as intended and (ii) proximal outcomes - improvements in quality of care and strengthening of TB surveillance system. We (i) visited 30 randomly selected STEPS centres for assessing infrastructure and process using a checklist, (ii) validated the patient data with management information system of National TB Elimination Program (NTEP) by telephonic interview of 57 TB patients (iii) analysed the quality of patient care indicators over 3 years from the management information system (iv) conducted in-depth interviews (IDI) with 33 beneficiaries and stakeholders to understand their satisfaction and perceived benefits of STEPS and (v) performed cost analysis for the intervention from the perspective of NTEP, private hospital and patients. RESULTS: Evaluation revealed that STEPS is an acceptable model to all stakeholders. IDIs revealed that all patients were satisfied about the services received. Data in management information system of NTEP were consistent with the hospital records and with the information provided by the patient. Quality of TB care indicators for patients diagnosed in private hospitals showed improvements over years as proportion of TB patients notified from private sector with a microbiological confirmation of diagnosis improved from 25% in 2018 to 38% in 2020 and the documented treatment success rate increased from 33% (2018 cohort) to 88% (2019 cohort). Total additional programmatic cost (deducting cost for patient entitlements) per additional patient with successful treatment outcome was estimated to be 67 USD. Total additional expense/business loss for implementing STEPS for the hospital diagnosing 100 TB patients in a year was estimated to be 573 USD while additional minimum returns for the hospital was estimated to be 1145 USD. CONCLUSION: Evaluation confirmed that STEPS is a low cost and patient-centric strategy. STEPS successfully addressed the gaps in the quality of care for patients seeking care in the private sector and ensured that services are aligned with the standards of TB care. STEPS could be scaled up to similar settings.

Using a Pharmacy-Based Surveillance System to Improve Standards for TB Care in Kerala, India.

INTRODUCTION: Eleven anti-TB drugs were included in the Government of India's Schedule H1 drug regulations in 2014. The National Strategic Plan for TB Elimination in India 2017-2025 recognized the opportunity to strengthen the TB surveillance system and improve the quality of TB care by implementing the Schedule H1 regulation. However, there were no documented systematic large-scale efforts to use Schedule H1 regulation to support TB surveillance or improve the quality of care. We aimed to document the process of implementation of the Schedule H1 regulation to enhance the quality of TB care and strengthen the TB surveillance system in Kerala, India. METHODS: We conducted 33 in-depth interviews of the drugs control department enforcement officers, chemist shop owners, private-sector doctors, leaders of professional medical associations, and program managers and key staff of the TB Elimination Program in Kerala. Major themes identified were the process of implementation of Schedule H1 and how the National TB Elimination Program used the information. Findings from the qualitative interviews were corroborated with the quantitative information from the annual program performance reports and anti-TB drug sales data. RESULTS: The TB Elimination Program of Kerala used the information from the Schedule H1 drug register to identify the missing TB cases and strengthen TB notification, identify providers for engagement and extend support to them for ensuring standards of TB care, and provide feedback to providers regarding prescription practices. Stakeholders felt that implementation of Schedule H1 surveillance has helped to improve TB patient notifications from the private sector, build better public-private partnerships, and improve the quality of TB diagnosis and treatment in Kerala. CONCLUSION: Pharmacy-based drug sales data collected either through regulatory or non-regulatory methods have immense potential to support TB elimination programs.

STEPS: A Solution for Ensuring Standards of TB Care for Patients Reaching Private Hospitals in India.

BACKGROUND: In India, the private sector diagnoses and treats more patients with TB than the public sector. Gaps in the TB care cascade were observed more among the patients diagnosed in the private sector. CONCEPT: The System for TB Elimination in Private Sector (STEPS) model evolved as a solution to address gaps in the quality of care for patients in the private sector by ensuring standards of TB care. STEPS has 3 components: a consortium of private hospitals, a coalition of all professional medical associations, and a STEPS center in each private hospital. STEPS centers act as a single window for notification, linkage for social welfare measures, contact investigation, chemoprophylaxis, direct benefit transfers, and treatment adherence support. INTERVENTION: STEPS was piloted in 14 districts in the state of Kerala. All 14 districts formed consortiums of private hospital management for policy support and a coalition of professional medical associations for advocacy with doctors. STEPS centers were established in 318 private hospitals. RESULTS: Notification to National TB Elimination Program from the private sector improved by 26% when compared to the previous year. Among the patients notified from the private sector, microbiologically confirmed cases increased by 81%, rifampicin resistance testing at baseline increased by 56%, and the percentage of those informed of their HIV status increased by 95%. The percentage of patients notified from the private sector with their treatment outcome reported improved from 39% (2018) to 99% (2019). CONCLUSION: The STEPS model demonstrated that a low-cost locally customized private sector engagement model is feasible and is beneficial to society. STEPS could be one of the major solutions for supporting patients reaching the private sector.

A SARS-CoV-2-Human Protein-Protein Interaction Map Reveals Drug Targets and Potential Drug-Repurposing.

An outbreak of the novel coronavirus SARS-CoV-2, the causative agent of COVID-19 respiratory disease, has infected over 290,000 people since the end of 2019, killed over 12,000, and caused worldwide social and economic disruption 1,2 . There are currently no antiviral drugs with proven efficacy nor are there vaccines for its prevention. Unfortunately, the scientific community has little knowledge of the molecular details of SARS-CoV-2 infection. To illuminate this, we cloned, tagged and expressed 26 of the 29 viral proteins in human cells and identified the human proteins physically associated with each using affinity-purification mass spectrometry (AP-MS), which identified 332 high confidence SARS-CoV-2-human protein-protein interactions (PPIs). Among these, we identify 66 druggable human proteins or host factors targeted by 69 existing FDA-approved drugs, drugs in clinical trials and/or preclinical compounds, that we are currently evaluating for efficacy in live SARS-CoV-2 infection assays. The identification of host dependency factors mediating virus infection may provide key insights into effective molecular targets for developing broadly acting antiviral therapeutics against SARS-CoV-2 and other deadly coronavirus strains.

A point source outbreak of acute gastroenteritis among school students in Kerala, India.

An outbreak investigation was initiated following an outbreak of acute gastroenteritis among schoolchildren in Kottarakara. Steps included active search for cases at schools, describing the outbreak in terms of person, place, and time, generating hypothesis based on the findings from descriptive study, environmental observations, and testing the hypothesis using a case-control design. The final line list consisted of 871 children from different schools who attended a Republic Day parade. Having consumed the lemon juice near railway station (odds ratio [OR] 29.14; 95% confidence interval CI 9.06-93.67) during Republic day parade was associated with the outbreak. The time frame of the disease occurrence, laboratory results, and the results of the analytical study indicated the point source of acute gastroenteritis outbreak as the contaminated water used for lemon juice distributed during the parade. The findings warrant effective food and water safety surveillance, especially during mass gatherings.

Anaemia among schoolchildren from southern Kerala, India: A cross-sectional study.

BACKGROUND: Iron deficiency anaemia remains a major nutritional problem among adolescents in India. The weekly iron and folic acid supplementation programme was launched in Kerala in 2013-14. We aimed to estimate the prevalence of anaemia among schoolchildren in Kollam district, Kerala and determine the associated factors. METHODS: The haemoglobin level of 1600 boys and 1600 girls belonging to class V to IX in 32 randomly selected schools in Kollam district was measured using HemoCue 301 photometers by trained nurses. They also recorded details about the intake of food as well as iron tablets by the students. The anaemia status was evaluated as per the WHO guidelines. Univariate analysis for factors associated with anaemia was done and selected variables were entered into a logistic regression model. RESULTS: The prevalence of anaemia among the students was estimated to be 31.4% (95% CI 29.76-33.04). About 1% had severe, 11.9% had moderate and 18.5% had mild anaemia. Among them 35.3%, 22.3% and 45.3% reported that they were not in the habit of consuming meat, green leafy vegetables and citrus fruits, respectively, at least once a week. Anaemia among schoolgoing children was associated with irregular consumption of weekly iron folic acid supplementation tablets (adjusted OR 1.39, 95% CI 1.08-1.82) and regular intake of tea/coffee along with major meals (adjusted OR 1.41, 95% CI 1.21-1.66). CONCLUSION: Anaemia among schoolgoing adolescents in Kollam district is a public health problem and is more among those who consumed less quantities of weekly iron and folic acid supplementation tablets and those who regularly consumed tea/coffee along with major meals. It may be helpful to introduce a comprehensive school health anaemia prevention package with effective behaviour change communication for dietary modification as well as strategies to improve the coverage of the iron and folic acid supplementation programme along with its monitoring and evaluation.