Clinical profile of patients infected with suspected SARS-CoV-2 Omicron variant of concern, Tamil Nadu, India, December 2021-January 2022.

Background & objectives: COVID-19 cases have been rising rapidly in countries where the SARS-CoV-2 variant of concern (VOC), Omicron (B.1.1.529) has been reported. We conducted a study to describe the epidemiological and clinical characteristics and outcomes of COVID-19 patients with 'S' gene target failure (SGTF, suspected Omicron). Furthermore, their clinical outcomes with COVID-19 patients with non-SGTF (non-Omicron) were also compared. Methods: This study was conducted in Tamil Nadu, India, between December 14, 2021 and January 7, 2022 among patients who underwent reverse transcription-PCR testing for SARS-CoV-2 in four laboratories with facilities for S gene screening. Consecutively selected COVID-19 patients with SGTF were telephonically contacted, seven and 14 days respectively after their date of positive result to collect information on the socio-demographic characteristics, previous history of COVID-19, vaccination status and clinical course of illness along with treatment details. To compare their outcomes with non-SGTF patients, one randomly suspected non-Omicron case for every two suspected Omicron cases from the line-list were selected, matching for the date of sample collection and the testing laboratory. Results: A total of 1175 SGTF COVID-19 patients were enrolled for this study. Almost 6 per cent (n=72) reported a history of previous infection. 141 (13.5%) suspected Omicron cases were non-vaccinated, while 148 (14.2%) and 703 (67.4%) had received valid one and two doses of COVID-19 vaccines, respectively. Predominant symptoms reported included fever (n=508, 43.2%), body pain (n=275, 23.4%), running nose (n=261, 22.2%) and cough (n=249, 21.2%). Five (0.4%) of the 1175 suspected Omicron cases required oxygen supplementation as compared to ten (1.6%) of the 634 suspected non-Omicron cases. No deaths were reported among omicron suspects, whereas there were four deaths among suspected non-Omicron cases. Interpretation & conclusions: Majority of the suspected Omicron cases had a mild course of illness. The overall severity of these cases was less compared to the suspected non-Omicron cases.

Economic evaluation of implementing a decentralised Hepatitis B virus diagnostic intervention under National Viral Hepatitis Control Programme in Tamil Nadu, South India.

OBJECTIVE: To assess the cost-effectiveness of decentralised diagnostic programme for hepatitis B virus (HBV) implemented in Tamil Nadu, South India with specific focus on a selected key population at increased risk of HBV. METHODS: A combination of decision tree and Markov model was developed to compare cost-effectiveness of the new and standard strategy. Cost and health outcomes were calculated based on the proportion of cohort in each respective health state. Total costs, quality-adjusted life years (QALYs) and incremental cost-effectiveness ratio (ICER) of the intervention and comparator strategies were calculated. The model parameter uncertainties were evaluated by sensitivity analysis. RESULTS: Considering decentralised HBV diagnosis followed by early treatment and vaccination for negatives for a cohort of 1000 population resulted in 505 QALYs gained and incremental cost-saving of 180749 ($2620). The decentralised diagnostic strategy could avert 294 deaths, gain 293 life years and reduce out-of-pocket expenditure of 3274 ($47) per person for HBV management. CONCLUSION: Decentralised HBV diagnosis followed by early treatment and vaccination for negatives in Tamil Nadu can save lives and reduce out-of-pocket expenditures compared to standard strategy.

OBJECTIF: Evaluer le rapport coût-efficacité du programme de diagnostic décentralisé du virus de l'hépatite B (VHB) mis en œuvre au Tamil Nadu, dans le sud de l'Inde, avec un accent particulier sur une population clé sélectionnée à risque accru du VHB. MÉTHODES: Une combinaison d'arbre de décision et de modèle de Markov a été développée pour comparer la rentabilité de la stratégie nouvelle et standard. Les coûts et les résultats pour la santé ont été calculés sur base de la proportion de la cohorte dans chaque état de santé respectif. Les coûts totaux, les années de vie corrigées de la qualité (QALY), le rapport coût-efficacité supplémentaire de l'intervention et les stratégies de comparaison ont été calculés. Les incertitudes des paramètres du modèle ont été évaluées par analyse de sensibilité. RÉSULTATS: La prise en compte d'un diagnostic décentralisé du VHB suivi d'un traitement précoce et d'une vaccination des cas négatifs pour une cohorte de 1000 habitants a permis de gagner 505 QALY et d'économiser des coûts supplémentaires de ₹180.749 (2.620 USD). La stratégie de diagnostic décentralisée pourrait éviter 294 décès, gagner 293 années de vie et réduire les dépenses personnelles de ₹3274 (47 USD) par personne pour la prise en charge du VHB. CONCLUSION: Le diagnostic décentralisé du VHB suivi d'un traitement précoce et de la vaccination des cas négatifs au Tamil Nadu peut sauver des vies et réduire les dépenses personnelles par rapport à la stratégie standard.

Operational Challenges in Conducting a Subnational TB Prevalence Survey in India: Lessons Learned for Resource-Limited, High-Burden Settings.

Estimating the burden of TB at the subnational level is critical to planning and prioritizing resources for TB control activities according to the local epidemiological situation. We report the experiences and operational challenges of implementing a TB prevalence survey at the subnational level in India. Information was collected from research reports that gathered data from periodic meetings, informal discussions with study teams, letters of communication, and various site visit reports. During the implementation of the survey, several challenges were encountered, including frequent turnover in human resources, lack of survey participation and community engagement, breakdown of X-ray machines, laboratory issues that delayed sputum sample testing, delays in X-ray reading, and network and Internet connectivity issues that impeded data management. To help ensure the survey was implemented in a timely manner, we developed several solutions, including planning ahead to anticipate challenges, ensuring timely communication, having a high commitment from all stakeholders, having strong team motivation, providing repetitive hands-on training, and involving local leaders to increase community engagement. This experience may help future states and countries that plan to conduct TB prevalence surveys to address these anticipated challenges and develop alternative strategies well in advance.

Programmatic implications of a sub-national TB prevalence survey in India.

Subnational TB estimates are crucial for making informed decisions to tailor TB control activities to local TB epidemiology.A cross-sectional survey was conducted among 143,005 individuals in Tamil Nadu, India. Participants were screened for symptoms and underwent chest X-ray (CXR). Participants with symptoms of TB and/or abnormal CXR were tested for TB using Xpert, smear, and liquid culture.The prevalence of microbiologically confirmed pulmonary TB (MCPTB) was 212 (95% CI 184-239) per 100,000 population. The prevalence-to-notification ratio (P:N) in the state was 2.05 (95% CI 1.8-2.29). Low body mass index and diabetes together had a population attributable fraction of 54.15 (95% CI 45.68-61.97). Approximately 39% of the TB cases were asymptomatic and were identified only by CXR screening. In the general population, only 26.9% sought care at a health facility among those with symptoms suggestive of TB.The programme needs to prioritise screening with CXR to potentially detect cases earlier and curtail the transmission and upscale molecular tests in the selected population to increase the yield of case finding. Innovative health education strategies must be devised to address health-seeking behaviour..

Contribution of infection and vaccination to population-level seroprevalence through two COVID waves in Tamil Nadu, India.

This study employs repeated, large panels of serological surveys to document rapid and substantial waning of SARS-CoV-2 antibodies at the population level and to calculate the extent to which infection and vaccination separately contribute to seroprevalence estimates. Four rounds of serological surveys were conducted, spanning two COVID waves (October 2020 and April-May 2021), in Tamil Nadu (population 72 million) state in India. Each round included representative populations in each district of the state, totaling ≥ 20,000 persons per round. State-level seroprevalence was 31.5% in round 1 (October-November 2020), after India's first COVID wave. Seroprevalence fell to 22.9% in round 2 (April 2021), a roughly one-third decline in 6 months, consistent with dramatic waning of SARS-Cov-2 antibodies from natural infection. Seroprevalence rose to 67.1% by round 3 (June-July 2021), with infections from the Delta-variant induced second COVID wave accounting for 74% of the increase. Seroprevalence rose to 93.1% by round 4 (December 2021-January 2022), with vaccinations accounting for 63% of the increase. Antibodies also appear to wane after vaccination. Seroprevalence in urban areas was higher than in rural areas, but the gap shrunk over time (35.7 v. 25.7% in round 1, 89.8% v. 91.4% in round 4) as the epidemic spread even in low-density rural areas.

Quality of comprehensive assessment among severely ill TB patients referred after triaging in southern India.

To reduce TB deaths, Tamil Nadu, a southern Indian state, implemented the first state-wide differentiated TB care strategy starting April 2022. Triage-positive severely ill patients are prioritised for comprehensive assessment and inpatient care. Routine program data during October-December 2022 revealed that documentation of total score after comprehensive assessment was available in only 39%, possibly indicating poor quality of comprehensive assessment. We confirmed this using operational research. The case record form to record comprehensive assessment was used only in 26% and among these, the completeness and correctness in filling out the form were sub-optimal. There is a clear need to enhance the quality of comprehensive assessments.

Depuis avril 2022, le Tamil Nadu, un État du sud de l'Inde, a mis en œuvre la première stratégie de soins différenciés pour la TB à l'échelle de l'État afin de réduire le nombre de décès dus à la TB. Les personnes gravement malades ayant obtenu un résultat positif au triage sont prioritaires pour une évaluation complète et des soins hospitaliers. Les données du programme de routine entre octobre et décembre 2022 ont révélé que la documentation du score total après l'évaluation complète n'était disponible que dans 39% des cas, ce qui pourrait indiquer une mauvaise qualité de l'évaluation complète. Nous l'avons confirmé par le biais d'une recherche opérationnelle. Le formulaire de dossier pour enregistrer l'évaluation complète n'a été utilisé que dans 26% des cas et, parmi ceux-ci, l'exhaustivité et l'exactitude du remplissage du formulaire n'étaient pas optimales. Il est manifestement nécessaire d'améliorer la qualité de l'évaluation complète.

Prevalence of Noncommunicable Disease (NCDs) risk factors in Tamil Nadu: Tamil Nadu STEPS Survey (TN STEPS), 2020.

BACKGROUND: Noncommunicable diseases (NCDs) account for nearly 75% of all deaths in Tamil Nadu. The government of Tamil Nadu has initiated several strategies to control NCDs under the Tamil Nadu Health Systems Reform Program (TNHSRP). We aimed to estimate the prevalence of NCD risk factors and determine the predictors of diabetes and hypertension, which will be helpful for planning and serve as a baseline for evaluating the impact of interventions. METHODS: A state-wide representative cross-sectional study was conducted among 18-69-year-old adults in Tamil Nadu in 2020. The study used a multi-stage sampling method to select the calculated sample size of 5780. We adapted the study tools based on WHO's STEPS surveillance methodology. We collected information about sociodemographic factors, NCD risk factors and measured blood pressure and fasting capillary blood glucose. The predictors of diabetes and hypertension were calculated using generalised linear models with 95% confidence intervals (95% CI). RESULTS: Due to the COVID-19 pandemic lockdown, we could cover 68% (n = 3800) of the intended sample size. Among the eligible individuals surveyed (n = 4128), we had a response rate of 92%. The mean age of the study participants was 42.8 years, and 51% were women. Current tobacco use was prevalent in 40% (95% CI: 33.7-40.0) of men and 7.9% (95% CI: 6.4-9.8) of women. Current consumption of alcohol was prevalent among 39.1% (95% CI: 36.4-42.0) of men. Nearly 28.5% (95% CI: 26.7-30.4) of the study participants were overweight, and 11.4% (95% CI: 10.1-12.7) were obese. The prevalence of hypertension was 33.9% (95% CI: 32.0-35.8), and that of diabetes was 17.6% (95% CI: 16.1-19.2). Older age, men, and obesity were independently associated with diabetes and hypertension. CONCLUSION: The burden of NCD risk factors like tobacco use, and alcohol use were high among men in the state of Tamil Nadu. The prevalence of other risk factors like physical inactivity, raised blood pressure and raised blood glucose were also high in the state. The state should further emphasise measures that reduce the burden of NCD risk factors. Policy-based and health system-based interventions to control NCDs must be a high priority for the state.

Process evaluation of a complex, multilevel, multicomponent scheme for the prevention and control of non-communicable diseases in Tamil Nadu, India: A mixed-methods protocol.

Background: Non-communicable diseases (NCDs) are the leading cause of morbidity and mortality in India, necessitating development of multilevel and multicomponent interventions. Makkalai Thedi Maruthuvam (MTM) is a complex multilevel, multicomponent intervention developed and implemented by the south Indian State of Tamil Nadu. The scheme aims to deliver services for preventing and controlling diabetes, and hypertension at doorstep. This paper describes the protocol for planning and conducting the process evaluation of the MTM scheme. Methods and analysis: The process evaluation uses mixed methods (secondary data analysis, key informant interviews, in-depth interviews, conceptual content analysis of documents, facility-based survey and non-participant observation) to evaluate the implementation of the MTM scheme. The broad evaluation questions addressed the fidelity, contexts, mechanisms of impact and challenges encountered by the scheme using the Consolidated Framework for Implementation Research (CFIR) framework. The specific evaluation questions addressed selected inputs and processes identified as critical to implementation by the stakeholders. The CFIR framework will guide the thematic analysis of the qualitative interviews to explore the adaptations and deviations introduced during implementation in various contexts. The quantitative data on the indicators developed for the specific evaluation questions will be cleaned and descriptively analysed.

Seropersistence of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine): 6-month follow-up of a randomized, controlled, observer-blind, phase 2/3 immuno-bridging study in Indian adults.

AZD1222 (ChAdOx1 nCoV-19) is a replication-deficient adenoviral vectored coronavirus disease-19 (COVID-19) vaccine that is manufactured as SII-ChAdOx1 nCoV-19 by the Serum Institute of India Pvt Ltd following technology transfer from Oxford University/AstraZeneca. The non-inferiority of SII-ChAdOx1 nCoV-19 with AZD1222 was previously demonstrated in an observer-blind, phase 2/3 immuno-bridging study (trial registration: CTRI/2020/08/027170). In this analysis of immunogenicity and safety data 6 months post first vaccination (Day 180), 1,601 participants were randomized 3:1 to SII-ChAdOx1 nCoV-19 or AZD1222 (immunogenicity/reactogenicity cohort n = 401) and 3:1 to SII-ChAdOx1 nCoV-19 or placebo (safety cohort n = 1,200). Immunogenicity was measured by anti-severe acute respiratory syndrome coronavirus 2 spike (anti-S) binding immunoglobulin G and neutralizing antibody (nAb) titers. A decline in anti-S titers was observed in both vaccine groups, albeit with a greater decline in SII-ChAdOx1 nCoV-19 vaccinees (geometric mean titer [GMT] ratio [95% confidence interval (CI) of SII-ChAdOx1 nCoV-19 to AZD1222]: 0.60 [0.41-0.87]). Consistent similar decreases in nAb titers were observed between vaccine groups (GMT ratio [95% CI]: 0.88 [0.44-1.73]). No cases of severe COVID-19 were reported following vaccination, while one case was observed in the placebo group. No causally related serious adverse events were reported through 180 days. No thromboembolic or autoimmune adverse events of special interest were reported. Collectively, these data illustrate that SII-ChAdOx1 nCoV-19 maintained a high level of immunogenicity 6 months post-vaccination. SII-ChAdOx1 nCoV-19 was safe and well tolerated.

Referral mechanism and beneficiary adherence in cervical cancer screening program in Tiruchirappalli district, Tamil Nadu state, India, 2012-2015.

Background: A screening program for cervical cancer was established in 2011 in Tamil Nadu. Since the inception of the program, coverage, and dropout of screening has not been analyzed. We conducted a study to describe the referral mechanism in the cervical cancer screening program implemented in Tamil Nadu, to estimate the level of adherence to the referral process by the beneficiaries, and to identify strengths and weaknesses related to the referral mechanism in the program. Methods: ">This descriptive study was conducted during 2015-2016 in the Tiruchirappalli administrative district of Tamil Nadu. All women aged 30 years and above, who were screened in public health facilities, were the participants. Using a structured form, we collected the data maintained in the registers at the district health administration. We estimated the screening coverage, follow-up evaluation, and dropout rates at different stages of the referral mechanism. We used SPSS and Epi Info software for analysis. Results: Coverage of cervical cancer screening was 4,838(41.6%). We estimated 4,838(41.6%) of screened positives were lost to follow-up for a colposcopy examination. Biopsy samples were obtained from 3425(84%) of those who required a biopsy. Cervical cancer was diagnosed in 159(4.6%) and precancerous lesions in 528(15.4%) women. Conclusion: More than half of the target population was screened in public health facilities. The dropout rate was less than half of those screened at the colposcopy evaluation level. Major pitfalls of the program were human resource issues at referral centers and poor maintenance of meaningful data.

Case report: An outbreak of viral conjunctivitis among the students and staff of visually impaired school, Tamil Nadu, India, 2020.

Introduction: On February 2, 2020, the head of a visually impaired school notified similar eye symptoms among the students. We investigated the cluster to confirm the diagnosis, identify potential exposures, and propose recommendations. Methodology: We defined a case as redness/watering/discharge from any eye among the students and staff, January-February 2020. We actively searched for the cases and calculated attack rates. We drew epicurve by date of symptoms onset. We conducted a retrospective cohort study of students and staff. We collected data on potential exposures and calculated Risk Ratio (RR), 95% Confidence Interval (95%CI), and Population Attributable Risk (PAR). We sent a conjunctival swab of the three cases for microbiological analysis. Results: We diagnosed the cases as acute conjunctivitis and identified 39 (76%) cases among 51 individuals. All the 39 cases reported watering and redness; 28 (72%) and 12 (31%) reported eye pain and discharge, respectively. The median age of the case was 11 years (range: 6-48 years). The attack rate didn't differ significantly between males [77% (20/26)] and females [76% (19/25), p = 0.9]. The attack rate was higher among the students [86%, (38/44)] than staffs [14%, (1/7), p = <0.01]. Contact with a case [RR = 2.5, 95%CI = 1.3-4.8, PAR = 51%] and staying inside campus [RR = 6.0, 95%CI = 1.0-37.3, PAR = 81%] were associated with the acute conjunctivitis outbreak. All the three conjunctival swabs were negative for bacterial growth. Conclusion: Close contact with the case and staying inside the campus led to the outbreak of acute conjunctivitis among the students and staff of the visually impaired school.

Health-related quality of life among COVID-19 individuals: A cross-sectional study in Tamil Nadu, India.

INTRODUCTION: The EQ-5D-5L questionnaire is a tool that is a very generic and preference-based instrument to describe the health-related quality of life. We have generated the stratified index utility value for the Tamil Nadu population and compared the utility values based on socio-demographic and clinical characteristics. METHODS: We conducted a community-based analytical cross-sectional study using telephonic interviews from November 2020 till December 2020 among individuals aged 18 years and above who were infected by the coronavirus confirmed with an RT-PCR within 30 days in Tamil Nadu State. EQ-5D-5L profile, socio-demographic and clinical characteristics of the study participants were collected and analysed. RESULTS: We interviewed 372 participants, with 57.5% were males, and their mean age was 44.5 ± 15.3 years. About 40% of participants reported as having comorbidities, such as diabetes (19.4%), hypertension (12.4%), heart disease (2.4%), kidney disease (0.8%) and others. The mean EQ-5D utility score was 0.925 ± 0.150, and the mean EQ-VAS was 90.68 ± 11.81. Overall, men had a higher utility value (0.938 ± 0.130) than women, (0.907 ± 0.170). Individuals with comorbidities, requiring longer hospitalisation were having lower utility scores than their counterparts. CONCLUSION: We report the EQ-5D-5L utility values for the COVID-19 illness. These values would help to estimate quality-adjusted life years in health economic evaluation studies.

An economic evaluation of implementing a decentralized dengue screening intervention under the National Vector Borne Disease Control Programme in Tamil Nadu, South India.

BACKGROUND: Lack of effective early screening is a major obstacle for reducing the fatality rate and disease burden of dengue. In light of this, the government of Tamil Nadu has adopted a decentralized dengue screening strategy at the primary healthcare (PHC) facilities using blood platelet count. Our objective was to determine the cost-effectiveness of a decentralized screening strategy for dengue at PHC facilities compared with the current strategy at the tertiary health facility (THC) level. METHODS: Decision tree analysis followed a hypothetical cohort of 1000 suspected dengue cases entering the model. The cost-effectiveness analysis was performed at a 3% discount rate for the proposed and current strategy. The outcomes are expressed in incremental cost-effectiveness ratios (ICERs) per quality-adjusted life years gained. One-way sensitivity analysis and probabilistic sensitivity analysis were done to check the uncertainty in the outcome. RESULTS: The proposed strategy was found to be cost-saving and ICER was estimated to be -41 197. PSA showed that the proposed strategy had a 0.84 probability of being an economically dominant strategy. CONCLUSIONS: The proposed strategy is cost-saving, however, it is recommended to consider optimal population coverage, costs to economic human resources and collateral benefits of equipment.

All-cause mortality during the COVID-19 pandemic in Chennai, India: an observational study.

BACKGROUND: India has been severely affected by the ongoing COVID-19 pandemic. However, due to shortcomings in disease surveillance, the burden of mortality associated with COVID-19 remains poorly understood. We aimed to assess changes in mortality during the pandemic in Chennai, Tamil Nadu, using data on all-cause mortality within the district. METHODS: For this observational study, we analysed comprehensive death registrations in Chennai, from Jan 1, 2016, to June 30, 2021. We estimated expected mortality without the effects of the COVID-19 pandemic by fitting models to observed mortality time series during the pre-pandemic period, with stratification by age and sex. Additionally, we considered three periods of interest: the first 4 weeks of India's first lockdown (March 24 to April 20, 2020), the 4-month period including the first wave of the pandemic in Chennai (May 1 to Aug 31, 2020), and the 4-month period including the second wave of the pandemic in Chennai (March 1 to June 30, 2021). We computed the difference between observed and expected mortality from March 1, 2020, to June 30, 2021, and compared pandemic-associated mortality across socioeconomically distinct communities (measured with use of 2011 census of India data) with regression analyses. FINDINGS: Between March 1, 2020, and June 30, 2021, 87 870 deaths were registered in areas of Chennai district represented by the 2011 census, exceeding expected deaths by 25 990 (95% uncertainty interval 25 640-26 360) or 5·18 (5·11-5·25) excess deaths per 1000 people. Stratified by age, excess deaths numbered 21·02 (20·54-21·49) excess deaths per 1000 people for individuals aged 60-69 years, 39·74 (38·73-40·69) for those aged 70-79 years, and 96·90 (93·35-100·16) for those aged 80 years or older. Neighbourhoods with lower socioeconomic status had 0·7% to 2·8% increases in pandemic-associated mortality per 1 SD increase in each measure of community disadvantage, due largely to a disproportionate increase in mortality within these neighbourhoods during the second wave. Conversely, differences in excess mortality across communities were not clearly associated with socioeconomic status measures during the first wave. For each increase by 1 SD in measures of community disadvantage, neighbourhoods had 3·6% to 8·6% lower pandemic-associated mortality during the first 4 weeks of India's country-wide lockdown, before widespread SARS-CoV-2 circulation was underway in Chennai. The greatest reductions in mortality during this early lockdown period were observed among men aged 20-29 years, with 58% (54-62) fewer deaths than expected from pre-pandemic trends. INTERPRETATION: Mortality in Chennai increased substantially but heterogeneously during the COVID-19 pandemic, with the greatest burden concentrated in disadvantaged communities. Reported COVID-19 deaths greatly underestimated pandemic-associated mortality. FUNDING: National Institute of General Medical Sciences, Bill & Melinda Gates Foundation, National Science Foundation. TRANSLATION: For the Hindi translation of the abstract see Supplementary Materials section.

Economic Evaluation of Implementing a Rapid Point-of-Care Screening Test for the Identification of Hepatitis C Virus under National Viral Hepatitis Control Programme in Tamil Nadu, South India.

INTRODUCTION: Viral hepatitis is a crucial public health problem in India. Hepatitis C virus (HCV) elimination is a national priority and a key strategy has been adopted to strengthen the HCV diagnostics services to ensure early and accurate diagnosis. METHODS: To conduct an economic evaluation of implementing a rapid point-of-care screening test for the identification of HCV among the selected key population under the National Viral Hepatitis Control Programme in Tamil Nadu, South India. Economic evaluation of a point-of-care screening test for HCV diagnosis among the key population attending the primary health care centers. A combination of decision tree and Markov model was developed to estimate cost-effectiveness of point-of-care screening test for HCV diagnosis at the primary health care centers. Total costs, quality-adjusted life years (QALYs) of the intervention and comparator, and incremental cost-effectiveness ratio (ICER) were calculated. The model parameter uncertainties which would influence the cost-effectiveness outcome has been evaluated by one-way sensitivity analysis and probabilistic sensitivity analysis. RESULTS: When compared to the tertiary level diagnostic strategy for HCV, the point-of-care screening for selected key population at primary health care level results in a gain of 57 undiscounted QALYs and 38 discounted QALYs, four undiscounted life years and two discounted life years. The negative ICER of the new strategy indicates that it is less expensive and more effective compared with the current HCV diagnosis strategy. CONCLUSIONS: The proposed strategy for HCV diagnosis in the selected key population in Tamil Nadu is dominant and cost-saving compared to the current strategy.

A phase 2/3, participant-blind, observer-blind, randomised, controlled study to assess the safety and immunogenicity of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine) in adults in India.

BACKGROUND: This phase 2/3 immunobridging study evaluated the safety and immunogenicity of the ChAdOx1 nCoV-19 Coronavirus Vaccine (Recombinant) (SII-ChAdOx1 nCoV-19), manufactured in India at the Serum Institute of India Pvt Ltd (SIIPL), following technology transfer from the AstraZeneca. METHODS: This participant-blind, observer-blind study randomised participants 3:1 to SII-ChAdOx1 nCoV-19 or AZD1222 (ChAdOx1 nCoV-19) (immunogenicity/reactogenicity cohort) and 3:1 to SII-ChAdOx1 nCoV-19 or placebo (safety cohort). The study participants were enrolled from 14 hospitals across India between August 25 and October 31, 2020. Two doses of study products were given 4 weeks apart. The primary objectives were to demonstrate non-inferiority of SII-ChAdOx1 nCoV-19 to AZD1222 in terms of geometric mean titre (GMT) ratio of anti-SARS-CoV-2 spike IgG antibodies 28 days after the second dose (defined as lower limit of 95% CI >0·67) and to determine the incidence of serious adverse events (SAEs) causally related to SII-ChAdOx1 nCoV-19. The anti-spike IgG response was assessed using a multiplexed electrochemiluminescence-based immunoassay. Safety follow-up continued until 6 months after first dose. Trial registration: CTRI/2020/08/027170. FINDINGS: 1601 participants were enrolled: 401 to the immunogenicity/reactogenicity cohort and 1200 to the safety cohort. After two doses, seroconversion rates for anti-spike IgG antibodies were more than 98·0% in both the groups. SII-ChAdOx1 nCoV-19 was non-inferior to AZD1222 (GMT ratio 0·98; 95% CI 0·78-1·23). SAEs were reported in ≤ 2·0% participants across the three groups; none were causally related. A total of 34 SARS-CoV-2 infections were reported; of which 6 occurred more than 2 weeks after the second dose; none were severe. INTERPRETATION: SII-ChAdOx1 nCoV-19 has a non-inferior immune response compared to AZD1222 and an acceptable safety/reactogenicity profile. Pharmacovigilance should be maintained to detect any safety signals. FUNDING: SIIPL funded the contract research organisation and laboratory costs, while the site costs were funded by the Indian Council of Medical Research. The study vaccines were supplied by SIIPL and AstraZeneca.

Secondary attack rate of COVID-19 among contacts and risk factors, Tamil Nadu, March-May 2020: a retrospective cohort study.

OBJECTIVE: To describe the characteristics of contacts of patients with COVID-19 case in terms of time, place and person, to calculate the secondary attack rate (SAR) and factors associated with COVID-19 infection among contacts. DESIGN: A retrospective cohort study SETTING AND PARTICIPANTS: Contacts of cases identified by the health department from 14 March 2020to 30 May 2020, in 9 of 38 administrative districts of Tamil Nadu. Significant proportion of cases attended a religious congregation. OUTCOME MEASURE: Attack rate among the contacts and factors associated with COVID-19 positivity. RESULTS: We listed 15 702 contacts of 931 primary cases. Of the contacts, 89% (n: 14 002) were tested for COVID-19. The overall SAR was 4% (599/14 002), with higher among the household contacts (13%) than the community contacts (1%). SAR among the contacts of primary cases with congregation exposure were 5 times higher than the contacts of non-congregation primary cases (10% vs 2%). Being a household contact of a primary case with congregation exposure had a fourfold increased risk of getting COVID-19 (relative risk (RR): 16.4; 95% CI: 13 to 20) than contact of primary case without congregation exposure. Among the symptomatic primary cases, household contacts of congregation primaries had higher RR than household contacts of other cases ((RR: 25.3; 95% CI: 10.2 to 63) vs (RR: 14.6; 95% CI: 5.7 to 37.7)). Among asymptomatic primary case, RR was increased among household contacts (RR: 16.5; 95% CI: 13.2 to 20.7) of congregation primaries compared with others. CONCLUSION: Our study showed an increase in disease transmission among household contacts than community contacts. Also, symptomatic primary cases and primary cases with exposure to the congregation had more secondary cases than others.

Does the Distribution of Empanelled Hospitals have an Impact on the Utilization of Services under State Insurance Scheme?

CONTEXT: Tamil Nadu's Chief Minister's Comprehensive Health Insurance Scheme (CMCHIS) aims at reducing inequity by making the health service affordable and available by roping in both the public and private providers. AIMS: This study aims to find if there exist any inter-district disparity in the distribution of hospitals empaneled and utilization of services under the CMCHIS scheme. SETTINGS AND DESIGN: A secondary data analysis was done using the CMCHIS data on hospitals empanelled and number of claims made in the scheme for the year 2018. SUBJECTS AND METHODS: The districts were classified into high-developed district (HDD), middle-developed district (MDD), and low-developed district (LDD) based on the Human Development Index. Availability of hospital services was calculated as the number of empanelled hospitals/100,000 families enrolled. Utilization was calculated as the number of claims made by people living in the district per one lakh families enrolled and number of claims made by hospitals under CMCHIS/100,000 enrolled. STATISTICAL ANALYSIS USED: The relationship between enrolment ratio, hospital availability, number of claims made, and Human Development Index across districts was examined using the Pearson's Correlation analysis. RESULTS: Enrolment was highest in the LDDs (22.8%), followed by MDDs (21.9%) and HDDs (18.7%). The number of hospitals per 100,000 families enrolled was the highest in HDDs (8.0) and lowest in LDDs (4.6). The utilization was the highest in HDD followed by MDD and lowest in LDD. CONCLUSIONS: The disparity in the hospitals availability and utilization between districts should be addressed by adopting a targeting approach giving priorities to empanelling hospitals in the less-developed districts.