Tuberculosis treatment in the private healthcare sector in India: an analysis of recent trends and volumes using drug sales data.

BACKGROUND: There is a pressing need for systematic approaches for monitoring how much TB treatment is ongoing in the private sector in India: both to cast light on the true scale of the problem, and to help monitor the progress of interventions currently being planned to address this problem. METHODS: We used commercially available data on the sales of rifampicin-containing drugs in the private sector, adjusted for data coverage and indication of use. We examined temporal, statewise trends in volumes (patient-months) of TB treatment from 2013 to 2016. We additionally analysed the proportion of drugs that were sold in combination packaging (designed to simplify TB treatment), or as loose pills. RESULTS: Drug sales suggest a steady trend of TB treatment dispensed by the private sector, from 18.4 million patient-months (95% CI 17.3-20.5) in 2013 to 16.8 patient-months (95% CI 15.5-19.0) in 2016. Overall, seven of 29 states in India accounted for more than 70% of national-level TB treatment volumes, including Uttar Pradesh, Maharashtra and Bihar. The overwhelming majority of TB treatment was dispensed not as loose pills, but in combination packaging with other TB drugs, accounting for over 96% of private sector TB treatment in 2017. CONCLUSIONS: Our findings suggest consistent levels of TB treatment in the private sector over the past 4 years, while highlighting specific states that should be prioritized for intervention. Drug sales data can be helpful for monitoring a system as large, disorganised and opaque as India's private sector.

Effect of gender, biochemical parameters & parathyroid surgery on gastrointestinal manifestations of symptomatic primary hyperparathyroidism.

BACKGROUND & OBJECTIVES: Information on gastrointestinal manifestations and then response after curative parathyroid surgery is scarce in symptomatic primary hyperparathyroidism (PHPT). This study was carried out to analyse gastrointestinal manifestations in patients with PHPT and their associations with biochemical parameters. METHODS: This retrospective study included 153 patients with symptomatic primary hyperparathyroidism (PHPT). The signs and symptoms pertaining to gastrointestinal system were analyzed. The difference of symptoms between men and women and difference in biochemical parameters in presence of different symptoms were evaluated. The relationship between serum calcium, phosphate and parathyroid hormone (PTH) levels with presence of gallstone and pancreatitis was also studied. RESULT: Of the 153 patients, 46 (30%) were men. The mean age was 39.2 ± 13.9 yr. Nearly 80 per cent of PHPT patients had at least one symptom/ sign related to gastrointestinal system. The most common gastrointestinal manifestations were abdominal pain 66 (43%), constipation 55 (36%), and nausea/or vomiting 46 (30%). Nearly one-fourth 34 (22%) of patients had a history of either gallstone disease or cholecystectomy or both. The prevalence of gallstone disease was higher in women (P<0.05). Imaging and biochemical evidence of pancreatitis was found in 27 (18%) patients. Pancreatitis was more common in men compared to women (P<0.05) despite the higher prevalence of gallstones in women. Serum calcium, phosphate or PTH levels were not associated with high risk for gallstone disease, however, serum calcium (P<0.05) was associated with 1.3 times higher risk of developing pancreatitis. In majority of patients, gastrointestinal manifestations resolved within three months of curative parathyroidectomy. Except two patients, none had recurrence of pancreatitis. INTERPRETATION & CONCLUSIONS: The study revealed that the gastrointestinal symptoms were common in patients with symptomatic PHPT. There was not much gender difference in gastrointestinal symptoms except higher occurrence of gallstones in women and pancreatitis in men. There was no difference in biochemical profile between those who had and did not have gastrointestinal symptoms.

Prevalence of Tuberculosis Infection among Various Risk Groups in India: A Systematic Review and Meta-Analysis.

Treatment of tuberculosis (TB) infection (TBI) to prevent active TB disease is a key component of the National Strategic Plan to end TB in India, without which the strategies to end TB would be futile. There is a need to rapidly scale up access to effective shorter regimens for tuberculosis preventive treatment (TPT) to a wider set of risk groups. This applies for identifying high-risk groups for TPT expansion. Thus, our aim with this review is to determine the TBI prevalence in different risk groups in India. We searched databases like Embase, Medline, Scopus, and CINAHL for studies published between 2012 and 2023 to estimate TBI in different risk groups in India. The PRISMA guidelines were followed when reviewing the publications, and a predetermined search strategy was used to find relevant sources across various databases. Using MetaXL (MS excel) software, we pooled data based on a random-effects model, along with heterogeneity testing using Cochrane's Q and I2 statistic. A total of 68 studies were included from 10,521 records. TBI pooled prevalence was estimated using the IGRA data, while in the absence of IGRA data, TST data were utilized. The key findings revealed a total of 36% pooled TBI prevalence for all risk factors, 59% among smokers, 53% among diabetics and alcoholics, 48% among malnourished, 47% among contacts of TB patients, 44% among HIV, 36% among pregnant women, 35% among COVID-19 patients, 31% among healthcare workers, 18% among sarcoidosis patients, and 15% among rheumatoid arthritis patients in India. Our review depicted a high TBI burden among groups such as diabetes mellitus, smokers, malnourished, and alcoholics. WHO has yet to recommend for systematic screening and treatment for TBI among these groups for want of evidence which this study provides, highlighting the need to reprioritize the risk groups for tailored TPT strategies.

Private Doctors' Perspective towards "Patient First" in TB Diagnostic Cascade, Hisar, India.

TB diagnosis has been simplified in India following advances in available diagnostic tools. This facilitates private doctors' "patient first" approach toward early diagnosis; however, costs remain high. India's NTEP established a TB diagnostic network, which is free for patients and incentivizes private doctors to participate. Drawing from this context led to the design and implementation of the One-Stop TB Diagnostic Solution model, which was conducted in the Hisar district, Haryana, allowing specimens from presumptive TB patients from private doctors to be collected and tested as per NTEPs diagnostic algorithm. A subset of data pertaining to private doctors was analyzed for the project period. Qualitative data were also collected by interviewing doctors using a snowball method to capture doctors' perception about the model. Out of 1159 specimens collected from 60 facilities, MTB was detected in 32% and rifampicin resistance was detected in 7% specimens. All specimens went through the diagnostic algorithm. Thirty doctors interviewed were satisfied with the services offered and were appreciative of the program that implements this "patient centric" model. Results from implementation indicate the need to strengthen private diagnostics through a certification process to ensure provision of quality TB diagnostic services.

Bridging the "know-do" gap to improve active case finding for tuberculosis in India: A qualitative exploration into national tuberculosis elimination program staffs' perspectives.

BACKGROUND: In 2022, India's national tuberculosis (TB) elimination program (NTEP) commissioned a national level evaluation of active case finding (ACF) for TB to guide evidence-based strategic planning. As part of this evaluation, based on secondary data analysis we observed that the quality of ACF was suboptimal in 2021. Hence, this study aimed to understand the enablers, barriers, and suggested solutions to improve ACF for TB in India from NTEP staff (provider) perspective. METHODS: This was a descriptive qualitative study involving key informant interviews from six districts and eight states, conducted between February and August 2023. We purposively selected key state- district- and sub-district-level program managers and implementers who were experienced and vocal. The interviews were audio recorded and transcribed verbatim by research interns and investigators. Two investigators independently did manual descriptive thematic analysis, and a third investigator resolved inconsistencies. The themes and categories emerged by collating together the results of the coding process. RESULTS: A total of 34 key informant interviews were conducted and of these, four were repeat interviews. Adequate budgets for ACF including incentives, performance review mechanism, engagement of all stakeholders, adopting a community friendly approach, use of rapid diagnostic tests and digitalization were the perceived enablers. In some states ACF was implemented in general population (not restricted to high-risk population) following directives at state level. There were limited mechanisms to ensure ACF quality indicators were met before disbursing incentives and cross-verification of the aggregate ACF care cascade numbers that were reported in Ni-kshay (electronic TB information management system under NTEP). In addition to the state and district level implementers having limited understanding of concepts around ACF (quality indicators, number needed to screen and yield), we also inferred the presence of a 'know-do' gap for many activities under ACF. The suggested solutions were around capacity building and quality improvement strategies. CONCLUSION: The existing national ACF guidance should be revised to emphasize capacity building, need to carry out ACF in high-risk (not general) population, quality control-linked incentives, and regular implementation monitoring of the activities. This should contribute towards better coverage and improved quality translating into better ACF outcomes.

Quality of active case-finding for tuberculosis in India: a national level secondary data analysis.

BACKGROUND: India has been implementing active case-finding (ACF) for TB among marginalised and vulnerable (high-risk) populations since 2017. The effectiveness of ACF cycle(s) is dependent on the use of appropriate screening and diagnostic tools and meeting quality indicators. OBJECTIVES: To determine the number of ACF cycles implemented in 2021 at national, state (n = 36) and district (n = 768) level and quality indicators for the first ACF cycle. METHODS: In this descriptive study, aggregate TB program data for each ACF activity that was extracted was further aggregated against each ACF cycle at the district level in 2021. One ACF cycle was the period identified to cover all the high-risk populations in the district. Three TB ACF quality indicators were calculated: percentage population screened (≥10%), percentage tested among screened (≥4.8%) and percentage diagnosed among tested (≥5%). We also calculated the number needed to screen (NNS) for diagnosing one person with TB (≤1538). RESULTS: Of 768 TB districts, ACF data for 111 were not available. Of the remaining 657 districts, 642 (98%) implemented one, and 15 implemented two to three ACF cycles. None of the districts or states met all three TB ACF quality indicators' cut-offs. At the national level, for the first ACF cycle, 9.3% of the population were screened, 1% of the screened were tested and 3.7% of the tested were diagnosed. The NNS was 2824: acceptable (≤1538) in institutional facilities and poor for population-based groups. Data were not consistently available to calculate the percentage of i) high-risk population covered, ii) presumptive TB among screened and iii) tested among presumptive. CONCLUSION: In 2021, India implemented one ACF cycle with sub-optimal ACF quality indicators. Reducing the losses between screening and testing, improving data quality and sensitising stakeholders regarding the importance of meeting all ACF quality indicators are recommended.

Estimation of tuberculosis incidence at subnational level using three methods to monitor progress towards ending TB in India, 2015-2020.

OBJECTIVES: We verified subnational (state/union territory (UT)/district) claims of achievements in reducing tuberculosis (TB) incidence in 2020 compared with 2015, in India. DESIGN: A community-based survey, analysis of programme data and anti-TB drug sales and utilisation data. SETTING: National TB Elimination Program and private TB treatment settings in 73 districts that had filed a claim to the Central TB Division of India for progress towards TB-free status. PARTICIPANTS: Each district was divided into survey units (SU) and one village/ward was randomly selected from each SU. All household members in the selected village were interviewed. Sputum from participants with a history of anti-TB therapy (ATT), those currently experiencing chest symptoms or on ATT were tested using Xpert/Rif/TrueNat. The survey continued until 30 Mycobacterium tuberculosis cases were identified in a district. OUTCOME MEASURES: We calculated a direct estimate of TB incidence based on incident cases identified in the survey. We calculated an under-reporting factor by matching these cases within the TB notification system. The TB notification adjusted for this factor was the estimate by the indirect method. We also calculated TB incidence from drug sale data in the private sector and drug utilisation data in the public sector. We compared the three estimates of TB incidence in 2020 with TB incidence in 2015. RESULTS: The estimated direct incidence ranged from 19 (Purba Medinipur, West Bengal) to 1457 (Jaintia Hills, Meghalaya) per 100 000 population. Indirect estimates of incidence ranged between 19 (Diu, Dadra and Nagar Haveli) and 788 (Dumka, Jharkhand) per 100 000 population. The incidence using drug sale data ranged from 19 per 100 000 population in Diu, Dadra and Nagar Haveli to 651 per 100 000 population in Centenary, Maharashtra. CONCLUSION: TB incidence in 1 state, 2 UTs and 35 districts had declined by at least 20% since 2015. Two districts in India were declared TB free in 2020.

Engaging with the private healthcare sector for the control of tuberculosis in India: cost and cost-effectiveness.

BACKGROUND: The control of tuberculosis (TB) in India is complicated by the presence of a large, disorganised private sector where most patients first seek care. Following pilots in Mumbai and Patna (two major cities in India), an initiative known as the 'Public-Private Interface Agency' (PPIA) is now being expanded across the country. We aimed to estimate the cost-effectiveness of scaling up PPIA operations, in line with India's National Strategic Plan for TB control. METHODS: Focusing on Mumbai and Patna, we collected cost data from implementing organisations in both cities and combined this data with models of TB transmission dynamics. Estimating the cost per disability adjusted life years (DALY) averted between 2014 (the start of PPIA scale-up) and 2025, we assessed cost-effectiveness using two willingness-to-pay approaches: a WHO-CHOICE threshold based on per-capita economic productivity, and a more stringent threshold incorporating opportunity costs in the health system. FINDINGS: A PPIA scaled up to ultimately reach 50% of privately treated TB patients in Mumbai and Patna would cost, respectively, US$228 (95% uncertainty interval (UI): 159 to 320) per DALY averted and US$564 (95% uncertainty interval (UI): 409 to 775) per DALY averted. In Mumbai, the PPIA would be cost-effective relative to all thresholds considered. In Patna, if focusing on adherence support, rather than on improved diagnosis, the PPIA would be cost-effective relative to all thresholds considered. These differences between sites arise from variations in the burden of drug resistance: among the services of a PPIA, improved diagnosis (including rapid tests with genotypic drug sensitivity testing) has greatest value in settings such as Mumbai, with a high burden of drug-resistant TB. CONCLUSIONS: To accelerate decline in TB incidence, it is critical first to engage effectively with the private sector in India. Mechanisms such as the PPIA offer cost-effective ways of doing so, particularly when tailored to local settings.

Paradigm shift in efforts to end TB by 2025.

TB is a deadly infectious disease, in existence since time immemorial. This article traces the journey of TB developments in the last few decades and the path breaking moments that have accelerated the efforts towards Ending TB from National Tuberculosis Control Program (NTCP 1962-1992) to Revised National Tuberculosis Control Program (RNTCP - 1992-2019) and to National Tuberculosis Elimination Program (NTEP) as per the vision of Honorable Prime Minister of India. From increased funding for TB, the discovery of newer drugs and diagnostics, increased access to health facilities, greater investment in research and expanded reach of public health education, seasoned with TB activism and media's proactive role, private sector participation to political advocacy and community engagement, coupled with vaccine trials has renewed the hope of finding the elusive and miraculous breakthrough to END TB and it seems the goal is within the realms of the possibility. The recent paradigm shift in the policy and the drive of several states & UTs to move towards TB free status through rigorous population-based vulnerability mapping and screening coupled with active case finding is expected to act as the driving force to lead the country towards Ending TB by 2025. Continued investments in research, innovations and availability of more effective drugs and the vaccines will add to existing armamentarium towards Ending TB.

Modelling the impact of effective private provider engagement on tuberculosis control in urban India.

In India, the country with the world's largest burden of tuberculosis (TB), most patients first seek care in the private healthcare sector, which is fragmented and unregulated. Ongoing initiatives are demonstrating effective approaches for engaging with this sector, and form a central part of India's recent National Strategic Plan: here we aimed to address their potential impact on TB transmission in urban settings, when taken to scale. We developed a mathematical model of TB transmission dynamics, calibrated to urban populations in Mumbai and Patna, two major cities in India where pilot interventions are currently ongoing. We found that, when taken to sufficient scale to capture 75% of patient-provider interactions, the intervention could reduce incidence by upto 21.3% (95% Bayesian credible interval (CrI) 13.0-32.5%) and 15.8% (95% CrI 7.8-28.2%) in Mumbai and Patna respectively, between 2018 and 2025. There is a stronger impact on TB mortality, with a reduction of up to 38.1% (95% CrI 20.0-55.1%) in the example of Mumbai. The incidence impact of this intervention alone may be limited by the amount of transmission that has already occurred by the time a patient first presents for care: model estimates suggest an initial patient delay of 4-5 months before first seeking care, followed by a diagnostic delay of 1-2 months before ultimately initiating TB treatment. Our results suggest that the transmission impact of such interventions could be maximised by additional measures to encourage early uptake of TB services.

What would it cost to scale-up private sector engagement efforts for tuberculosis care? Evidence from three pilot programs in India.

BACKGROUND: Private providers dominate health care in India and provide most tuberculosis (TB) care. Yet efforts to engage private providers were viewed as unsustainably expensive. Three private provider engagement pilots were implemented in Patna, Mumbai and Mehsana in 2014 based on the recommendations in the National Strategic Plan for TB Control, 2012-17. These pilots sought to improve diagnosis and treatment of TB and increase case notifications by offering free drugs and diagnostics for patients who sought care among private providers, and monetary incentives for providers in one of the pilots. As these pilots demonstrated much higher levels of effectiveness than previously documented, we sought to understand program implementation costs and predict costs for their national scale-up. METHODS AND FINDINGS: We developed a common cost structure across these three pilots comprising fixed and variable cost components. We conducted a retrospective, activity-based costing analysis using programmatic data and qualitative interviews with the respective program managers. We estimated the average recurring costs per TB case at different levels of program scale for the three pilots. We used these cost estimates to calculate the budget required for a national scale up of such pilots. The average cost per privately-notified TB case for Patna, Mumbai and Mehsana was estimated to be US$95, US$110 and US$50, respectively, in May 2016 when these pilots were estimated to cover 50%, 36% and 100% of the total private TB patients, respectively. For Patna and Mumbai pilots, the average cost per case at full scale, i.e. 100% coverage of private TB patients, was projected to be US$91 and US$101, respectively. In comparison, the national TB program's budget for 2015 averages out to $150 per notified TB case. The total annual additional budget for a national scale up of these pilots was estimated to be US$267 million. CONCLUSIONS: As India seeks to eliminate TB, extensive national engagement of private providers will be required. The cost per privately-notified TB case from these pilots is comparable to that already being spent by the public sector and to the projected cost per privately-notified TB case required to achieve national scale-up of these pilots. With additional funds expected to execute against national TB elimination commitments, the scale-up costs of these operationally viable and effective private provider engagement pilots are likely to be financially viable.

Assessment of Tuberculosis Prevalence in Newly Diagnosed Human Immunodeficiency Virus-Infected Adults Attending Care and Treatment Center in Gujarat, India.

BACKGROUND: Tuberculosis (TB) is first opportunistic infection and leading cause of death among human immunodeficiency virus (HIV)/AIDS. Certainly, the prevalence of TB is expected to differ between general population and HIV-infected persons. This study was conducted to determine the prevalence of TB among newly diagnosed HIV-infected adults attending antiretroviral therapy (ART) center in the state of Gujarat, India. MATERIALS AND METHODS: Cross-sectional study was carried out among newly diagnosed HIV-infected persons attending ART center from July 2012 to September 2012. Screening of TB symptoms and chest X-ray was done for those who consented. Sputum samples were collected for microscopy with Ziehl-Neelsen method for all presumptive TB cases and those diagnosed as pulmonary TB, culture, and drug susceptibility test was done. Blood samples were collected for CD4+ T-cells count and hemoglobin. RESULTS: Out of 2021 eligible HIV-infected persons, 63.5% were males and 68.2% were in the age group of 26-45 years. The prevalence of TB was 17.8%. Among 360 patients with TB, 102 (28%) had smear positive TB, 86 (24%) had smear-negative TB, and 172 (48%) were diagnosed as extrapulmonary TB. Two hundred and thirty-eight (27%) TB patients with CD4+ T-Cell count below 200 compared to 122 (11%) patients above 200. CONCLUSION: A high prevalence of TB was found among newly diagnosed HIV-infected adults attending ART center for care and treatment. The prevalence of pulmonary and extrapulmonary TB was almost equal. Chances of TB disease were more with depletion of CD4 counts. The study highlights urgent need of intensive case finding as well as periodic screening of newly diagnosed HIV-infected individuals.

Evaluation of use of line probe assay on smear-positive direct specimen from extra-pulmonary tuberculosis site.

BACKGROUND: Line probe assay (LPA) is used for first-line drug susceptibility testing (DST) of smear-positive pulmonary tuberculosis (TB) patients. For extra-pulmonary (EP) and smear-negative TB patients, the samples are inoculated in culture and isolates of Mycobacterium tuberculosis (MTB) are tested on LPA. This results in considerable delay and loses the benefit of rapid diagnostics. In the present study, smear-positive EP specimens were tested directly on LPA and their results were compared with LPA conducted on culture isolates of same specimens. METHOD: All EP specimens received from different parts of Gujarat State in 2014 were subjected to ZN smear microscopy and inoculated on liquid culture. Smear-positive samples were directly tested with LPA. Simultaneously, culture isolates of MTB were also subjected to LPA. Results of LPA conducted on both direct specimen and culture isolates were compared. RESULT: Of 391 extra-pulmonary specimens, 177 were smear positive and tested directly on LPA. Simultaneously, 88 were culture positive and their isolates were tested on LPA. With LPA on direct specimen, 127 (32%) had valid results with median time to diagnose rifampicin resistance of 5 days (IQR 2-7). In comparison, 88 (23%) specimens had valid results with culture isolates tested on LPA and with longer turnaround time (18-40 days). Among 51 samples, with valid LPA results both on direct samples and isolates, 50 (98%) had concordance for drug resistance pattern. CONCLUSION: There is advantage in testing extra-pulmonary smear-positive samples directly on LPA and the results would also be available rapidly.

Has introduction of rapid drug susceptibility testing at diagnosis impacted treatment outcomes among previously treated tuberculosis patients in Gujarat, India?

BACKGROUND: Revised National TB Control Programme (RNTCP) in India recommends that all previously-treated TB (PT) patients are offered drug susceptibility testing (DST) at diagnosis, using rapid diagnostics and screened out for rifampicin resistance before being treated with standardized, eight-month, retreatment regimen. This is intended to improve the early diagnosis of rifampicin resistance and its appropriate management and improve the treatment outcomes among the rest of the patients. In this state-wide study from Gujarat, India, we assess proportion of PT patients underwent rapid DST at diagnosis and the impact of this intervention on their treatment outcomes. METHODS: This is a retrospective cohort study involving review of electronic patient-records maintained routinely under RNTCP. All PT patients registered for treatment in Gujarat during January-June 2013 were included. Information on DST and treatment outcomes were extracted from 'presumptive DR-TB patient register' and TB treatment register respectively. We performed a multivariate analysis to assess if getting tested is independently associated with unfavourable outcomes (death, loss-to-follow-up, failure, transfer out). RESULTS: Of 5,829 PT patients, 5306(91%) were tested for drug susceptibility with rapid diagnostics. Overall, 71% (4,113) TB patients were successfully treated - 72% among tested versus 60% among non-tested. Patients who did not get tested at diagnosis had a 34% higher risk of unsuccessful outcomes as compared to those who got tested (aRR - 1.34; 95% CI 1.20-1.50) after adjusting for age, sex, HIV status and type of TB. Unfavourable outcomes (particularly failure and switched to category IV) were higher among INH-resistant patients (39%) as compared to INH-sensitive (29%). CONCLUSION: Offering DST at diagnosis improved the treatment outcomes among PT patients. However, even among tested, treatment outcomes remained suboptimal and were related to INH resistance and high loss-to-follow-up. These need to be addressed urgently for further progress.

Use of Xpert MTB/RIF in Decentralized Public Health Settings and Its Effect on Pulmonary TB and DR-TB Case Finding in India.

BACKGROUND: Xpert MTB/RIF, the first automated molecular test for tuberculosis, is transforming the diagnostic landscape in high-burden settings. This study assessed the impact of up-front Xpert MTB/RIF testing on detection of pulmonary tuberculosis (PTB) and rifampicin-resistant PTB (DR-TB) cases in India. METHODS: This demonstration study was implemented in 18 sub-district level TB programme units (TUs) in India in diverse geographic and demographic settings covering a population of 8.8 million. A baseline phase in 14 TUs captured programmatic baseline data, and an intervention phase in 18 TUs had Xpert MTB/RIF offered to all presumptive TB patients. We estimated changes in detection of TB and DR-TB, the former using binomial regression models to adjust for clustering and covariates. RESULTS: In the 14 study TUs, which participated in both phases, 10,675 and 70,556 presumptive TB patients were enrolled in the baseline and intervention phase, respectively, and 1,532 (14.4%) and 14,299 (20.3%) bacteriologically confirmed PTB cases were detected. The implementation of Xpert MTB/RIF was associated with increases in both notification rates of bacteriologically confirmed TB cases (adjusted incidence rate ratio [aIRR] 1.39; CI 1.18-1.64), and proportion of bacteriological confirmed TB cases among presumptive TB cases (adjusted risk ratio (aRR) 1.33; CI 1.6-1.52). Compared with the baseline strategy of selective drug-susceptibility testing only for PTB cases at high risk of drug-resistant TB, Xpert MTB/RIF implementation increased rifampicin resistant TB case detection by over fivefold. Among, 2765 rifampicin resistance cases detected, 1055 were retested with conventional drug susceptibility testing (DST). Positive predictive value (PPV) of rifampicin resistance detected by Xpert MTB/RIF was 94.7% (CI 91.3-98.1), in comparison to conventional DST. CONCLUSION: Introduction of Xpert MTB/RIF as initial diagnostic test for TB in public health facilities significantly increased case-notification rates of all bacteriologically confirmed TB by 39% and rifampicin-resistant TB case notification by fivefold.

Feasibility of decentralised deployment of Xpert MTB/RIF test at lower level of health system in India.

BACKGROUND: Xpert MTB/RIF is an automated cartridge-based nucleic acid amplification test that has demonstrated its potential to detect tuberculosis and rifampicin resistance with high accuracy. To assist scale-up decisions in India, a feasibility assessment of Xpert MTB/RIF implementation was conducted within microscopy centres of 18 RNTCP TB units. METHODS: As part of programme-based demonstration of Xpert MTB/RIF implementation, we recorded and analysed association between key implementation factors and the ability of test to produce valid results. Factors contributing to test failures were analysed from GeneXpert software data which provides 'failure codes' and causes for test failures. RESULTS: From March'12 to January'13, total 40,035 suspects were tested by Xpert MTB/RIF, and 39,680 (99.1%) received valid results (Cumulative: 37157 (92.8%) on first attempt, 39410 (98.4%) on second attempt, 39637 (99.0%) on third attempt and 39680 (99.1%) on more attempts). Overall initial test failure was 2,878 (7.2% (4%-17%)); of these, 2,594 (90.1%) were re-tested and produced valid results. Most frequent reason of test failure was inadequate sample processing or equipment malfunction (3.9%). Other reasons included power failure (1.1%), cartridge integrity/component failure (0.8%), device-computer communication error (0.5%), and temperature-related errors (0.08%). Significant variation was observed in failure rates both across instruments and over time; furthermore, substantial variation was observed in failure rate in two cartridges lots. CONCLUSION: Installation required minimal infrastructure modifications and concerns about adequacy of human resources under public sector facilities and temperature extremes proved unfounded. Under routine conditions, Xpert MTB/RIF provided 99.1% valid results in TB suspects with low overall failure rates (7.2% initial failure, 0.9% final failure); devices provided valuable real-time feedback on reasons for test failure, which were used for rapid corrective action. High modular replacement (32%) and inter-lot cartridge performance variation remain sources of concern, and warrant close monitoring of failure rates as a key quality indicator.

Enhancing TB case detection: experience in offering upfront Xpert MTB/RIF testing to pediatric presumptive TB and DR TB cases for early rapid diagnosis of drug sensitive and drug resistant TB.

BACKGROUND: Diagnosis of pulmonary tuberculosis (PTB) in children is challenging due to difficulties in obtaining good quality sputum specimens as well as the paucibacillary nature of disease. Globally a large proportion of pediatric tuberculosis (TB) cases are diagnosed based only on clinical findings. Xpert MTB/RIF, a highly sensitive and specific rapid tool, offers a promising solution in addressing these challenges. This study presents the results from pediatric groups taking part in a large demonstration study wherein Xpert MTB/RIF testing replaced smear microscopy for all presumptive PTB cases in public health facilities across India. METHODS: The study covered a population of 8.8 million across 18 programmatic sub-district level tuberculosis units (TU), with one Xpert MTB/RIF platform established at each study TU. Pediatric presumptive PTB cases (both TB and Drug Resistant TB (DR-TB)) accessing any public health facilities in study area were prospectively enrolled and tested on Xpert MTB/RIF following a standardized diagnostic algorithm. RESULTS: 4,600 pediatric presumptive pulmonary TB cases were enrolled. 590 (12.8%, CI 11.8-13.8) pediatric PTB were diagnosed. Overall 10.4% (CI 9.5-11.2) of presumptive PTB cases had positive results by Xpert MTB/RIF, compared with 4.8% (CI 4.2-5.4) who had smear-positive results. Upfront Xpert MTB/RIF testing of presumptive PTB and presumptive DR-TB cases resulted in diagnosis of 79 and 12 rifampicin resistance cases, respectively. Positive predictive value (PPV) for rifampicin resistance detection was high (98%, CI 90.1-99.9), with no statistically significant variation with respect to past history of treatment. CONCLUSION: Upfront access to Xpert MTB/RIF testing in pediatric presumptive PTB cases was associated with a two-fold increase in bacteriologically-confirmed PTB, and increased detection of rifampicin-resistant TB cases under routine operational conditions across India. These results suggest that routine Xpert MTB/RIF testing is a promising solution to present-day challenges in the diagnosis of PTB in pediatric patients.

Awareness of HIV/AIDS among rural youth in India: a community based cross-sectional study.

INTRODUCTION: More than one third of reported cases of HIV/AIDS in India are among youth and 60 percent of these reside in rural areas. Assessment of the awareness of HIV/AIDS in the youth is important for determining the impact of previous and current awareness programs as well as the need for interventions. This study aimed to assess the knowledge of rural youth regarding HIV/AIDS and to explore the epidemiological determinants of awareness among them. METHODOLOGY: A community-based cross-sectional study was conducted among youths aged 15-24 years in rural areas of the Saurashtra region of Gujarat, India. A cluster sampling design was used, surveying 50 subjects from each of 30 clusters. Data was collected through house-to-house visits using a semi-structured questionnaire. Proportions and logistic regression were used for analysis. RESULTS: Out of a total of 1,237 subjects who participated in survey, 60% knew something about HIV. Of those who had heard of HIV, more than 90% subjects knew the modes of transmission and more than 80% were aware of modes of prevention of HIV/AIDS. One fifth of the subjects had misconceptions in relation to HIV/AIDS. On applying multiple logistic regression, age, education, occupation, and mass media exposure were found to be the major determinants of their knowledge with regard to HIV/AIDS. CONCLUSIONS: Basic knowledge of HIV/AIDS is still lacking in two fifths of the rural youth. Literacy and media exposure are factors that determine awareness of HIV among them and can be helpful to raise their knowledge regarding this scourge.

Study on obesity and influence of dietary factors on the weight status of an adult population in jamnagar city of gujarat: a cross-sectional analytical study.

BACKGROUND: Obesity has reached epidemic proportions globally and is a major contributor to the global burden of chronic diseases. Dietary factors are the major modifiable factors through which many of the external forces promoting weight gain act. OBJECTIVES: The objectives were to find the prevalence of overweight and obesity in the urban population of Jamnagar and to explore the effect of dietary factors on the weight status of the people. MATERIALS AND METHODS: A cross-sectional study was conducted among the adult population of Jamnagar city. Cluster sampling technique was used to select study samples. Data were collected in a prestructured questionnaire by interviewing subjects through house-to-house visits. Data were analyzed in Epi Info and appropriate statistical methods were used. RESULTS: The prevalence of overweight and obesity was found to be 22.04% and 5.20%, respectively. Overweight was more prevalent in females than males. The prevalence rose with an increase in age up to 60 years. Among dietary factors, the total calorie intake and habit of snacking had a positive association with weight gain (P < 0.05). The mean intake of oil was more and the mean intake of vegetables was less among overweight subjects than nonoverweight subjects (P < 0.05). CONCLUSION: The prevalence of overweight and obesity in the urban population in Jamnagar was found to be 22.04% and 5.20%, respectively. Total calorie intake as well as composition of diet was the important dietary factor affecting weight gain.