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Background Tuberculosis (TB) incidence in India continues to be high due, in large part, to long delays experienced by patients before successful diagnosis and treatment initiation, especially in the private sector. This diagnostic delay is driven by patients’ inclination to switch between different types of providers and providers’ inclination to delay ordering of accurate diagnostic tests relevant to TB. Our objective is to quantify the impact of changes in these behavioral characteristics of providers and patients on diagnostic delay experienced by pulmonary TB patients. Methods and findings We developed a discrete event simulation model of patients’ diagnostic pathways that captures key behavioral characteristics of providers (time to order a test) and patients (time to switch to another provider). We used an expectation-maximization algorithm to estimate the parameters underlying these behavioral characteristics, with quantitative data encoded from detailed interviews of 76 and 64 pulmonary TB patients in the 2 Indian cities of Mumbai and Patna, respectively, which were conducted between April and August 2014. We employed the estimated model to simulate different counterfactual scenarios of diagnostic pathways under altered behavioral characteristics of providers and patients to predict their potential impact on the diagnostic delay. Private healthcare providers including chemists were the first point of contact for the majority of TB patients in Mumbai (70%) and Patna (94%). In Mumbai, 45% of TB patients first approached less-than-fully-qualified providers (LTFQs), who take 28.71 days on average for diagnosis. About 61% of these patients switched to other providers without a diagnosis. Our model estimates that immediate testing for TB by LTFQs at the first visit (at the current level of diagnostic accuracy) could reduce the average diagnostic delay from 35.53 days (95% CI: 34.60, 36.46) to 18.72 days (95% CI: 18.01, 19.43). In Patna, 61% of TB patients first approached fully qualified providers (FQs), who take 9.74 days on average for diagnosis. Similarly, immediate testing by FQs at the first visit (at the current level of diagnostic accuracy) could reduce the average diagnostic delay from 23.39 days (95% CI: 22.77, 24.02) to 11.16 days (95% CI: 10.52, 11.81). Improving the diagnostic accuracy of providers per se, without reducing the time to testing, was not predicted to lead to any reduction in diagnostic delay. Our study was limited because of its restricted geographic scope, small sample size, and possible recall bias, which are typically associated with studies of patient pathways using patient interviews. Conclusions In this study, we found that encouraging private providers to order definitive TB diagnostic tests earlier during patient consultation may have substantial impact on reducing diagnostic delay in these urban Indian settings. These results should be combined with disease transmission models to predict the impact of changes in provider behavior on TB incidence., Sarang Deo and co-workers study providers' approaches to tuberculosis diagnosis in India., Author summary Why was this study done? India contributes more than a quarter of the 10 million global tuberculosis (TB) cases every year. Several studies capture long, circuitous care pathways followed by TB patients until their diagnosis. However, these studies do not quantify the link between diagnostic delay and underlying patient and provider behavior characteristics. What did the researchers do and find? We developed a quantitative simulation model to estimate the impact of behavioral characteristics of patients and providers on diagnostic delay and estimated the parameters of this model using data from detailed interviews of 76 patients from Mumbai and 64 patients from Patna. We found that earlier test ordering by providers would yield a much larger reduction in diagnostic delay than increasing their diagnostic accuracy. What do these findings mean? Policy-makers and implementing agencies should encourage early test ordering behavior by providers to reduce diagnostic delay, and, consequently, to reduce disease transmission.

BackgroundPrivate 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 findingsWe 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.ConclusionsAs 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.

Background There is scant evidence on the association between diagnosis delays and the receipt of test results in HIV Early Infant Diagnosis (EID) programs. We determine the association between diagnosis delays and other health care system and patient factors on result receipt. Methods We reviewed 703 infant HIV test records for tests performed between January 2008 and February 2009 at a regional referral hospital and level four health center in Uganda. The main outcome was caregiver receipt of the test result. The primary study variable was turnaround time (time between sample collection and result availability at the health facility). Additional variables included clinic entry point, infant age at sample collection, reported HIV status and receipt of antiretroviral prophylaxis for prevention of mother-to-child transmission. We conducted a pooled analysis in addition to separate analyses for each facility. We estimated the relative risk of result receipt using modified Poisson regression with robust standard errors. Results Overall, the median result turnaround time, was 38 days. 59% of caregivers received infant test results. Caregivers were less likely to receive results at turnaround times greater than 49 days compared to 28 days or fewer (ARR = 0.83; 95% CI = 0.70–0.98). Caregivers were more likely to receive results at the PMTCT clinic (ARR = 1.81; 95% CI = 1.40–2.33) and less likely at the pediatric ward (ARR = 0.54; 95% CI = 0.37–0.81) compared to the immunization clinic. At the level four health center, result receipt was half as likely among infants older than 9 months compared to 3 months and younger (ARR= 0.47; 95% CI = 0.25–0.93). Conclusion In this study setting, we find evidence that longer turnaround times, clinic entry point and age at sample collection may be associated with receipt of infant HIV test results.

Using a modelling approach, David Dowdy and colleagues investigate how different implementation strategies for Xpert MTB/RIF within the complex, fragmented healthcare system of India may affect tuberculosis control. Please see later in the article for the Editors' Summary, Background India has announced a goal of universal access to quality tuberculosis (TB) diagnosis and treatment. A number of novel diagnostics could help meet this important goal. The rollout of one such diagnostic, Xpert MTB/RIF (Xpert) is being considered, but if Xpert is used mainly for people with HIV or high risk of multidrug-resistant TB (MDR-TB) in the public sector, population-level impact may be limited. Methods and Findings We developed a model of TB transmission, care-seeking behavior, and diagnostic/treatment practices in India and explored the impact of six different rollout strategies. Providing Xpert to 40% of public-sector patients with HIV or prior TB treatment (similar to current national strategy) reduced TB incidence by 0.2% (95% uncertainty range [UR]: −1.4%, 1.7%) and MDR-TB incidence by 2.4% (95% UR: −5.2%, 9.1%) relative to existing practice but required 2,500 additional MDR-TB treatments and 60 four-module GeneXpert systems at maximum capacity. Further including 20% of unselected symptomatic individuals in the public sector required 700 systems and reduced incidence by 2.1% (95% UR: 0.5%, 3.9%); a similar approach involving qualified private providers (providers who have received at least some training in allopathic or non-allopathic medicine) reduced incidence by 6.0% (95% UR: 3.9%, 7.9%) with similar resource outlay, but only if high treatment success was assured. Engaging 20% of all private-sector providers (qualified and informal [providers with no formal medical training]) had the greatest impact (14.1% reduction, 95% UR: 10.6%, 16.9%), but required >2,200 systems and reliable treatment referral. Improving referrals from informal providers for smear-based diagnosis in the public sector (without Xpert rollout) had substantially greater impact (6.3% reduction) than Xpert scale-up within the public sector. These findings are subject to substantial uncertainty regarding private-sector treatment patterns, patient care-seeking behavior, symptoms, and infectiousness over time; these uncertainties should be addressed by future research. Conclusions The impact of new diagnostics for TB control in India depends on implementation within the complex, fragmented health-care system. Transformative strategies will require private/informal-sector engagement, adequate referral systems, improved treatment quality, and substantial resources. Please see later in the article for the Editors' Summary, Editors' Summary Background Tuberculosis—a contagious bacterial disease that usually infects the lungs—is a global public health problem. Each year, about 8.7 million people develop active tuberculosis and about 1.4 million people die from the disease. Mycobacterium tuberculosis, the bacterium that causes tuberculosis, is spread in airborne droplets when people with active disease cough or sneeze. The characteristic symptoms of tuberculosis are a persistent cough, fever, weight loss, and night sweats. Diagnostic tests for tuberculosis include sputum smear microscopy (microscopic analysis of mucus coughed up from the lungs), the growth of M. tuberculosis from sputum samples, and new molecular tests (for example, the automated Xpert MTB/RIF test) that rapidly and accurately detect M. tuberculosis in patient samples and determine its resistance to certain antibiotics. Tuberculosis can be cured by taking several antibiotics daily for at least six months, although the recent emergence of multidrug-resistant (MDR) tuberculosis is making the disease increasingly hard to treat. Why Was This Study Done? About 25% of all tuberculosis cases occur in India. Most people in India with underlying tuberculosis initially seek care for cough from the private health-care sector, which comprises informal providers with no formal medical training and providers with some training in mainstream or alternative medicine. Private providers rarely investigate for tuberculosis, and patients often move between providers, with long diagnostic delays. The public sector ultimately diagnoses and treats more than half of tuberculosis cases. However, the public sector relies on sputum smear microscopy, which misses half of cases, and the full diagnostic process from symptom onset to treatment initiation can take several months, during which time individuals remain infectious. Could the rollout of molecular diagnostic tests improve tuberculosis control in India? The Indian Revised National Tuberculosis Control Programme (RNTCP) is currently introducing the Xpert MTB/RIF test (Xpert) as a rapid method for drug susceptibility testing in the public sector in people at high risk of MDR tuberculosis, but is this the most effective rollout strategy? Here, the researchers use a mathematical transmission model to investigate the likely effects of the rollout of Xpert in India using different implementation strategies. What Did the Researchers Do and Find? The researchers explored the impact of several rollout strategies on the incidence of tuberculosis (the number of new cases of tuberculosis in the population per year) by developing a mathematical model of tuberculosis transmission, care-seeking behavior, and diagnostic/treatment practices in India. Compared to a baseline scenario of no improved diagnostic testing, provision of Xpert to 40% of public-sector patients at high risk of MDR tuberculosis (scenario 1, the current national strategy) reduced the incidence of tuberculosis by 0.2% and the incidence of MDR tuberculosis by 2.4%. Implementation of this strategy required 2,500 additional courses of MDR tuberculosis treatment and the continuous use of 60 Xpert machines, about half the machines procured in India during 2013. A scenario that added access to Xpert for 20% of all individuals with tuberculosis symptoms seeking diagnosis in the public sector and 20% of individuals seeking care from qualified private practitioners to scenario 1 reduced the incidence of tuberculosis by 14.1% compared to the baseline scenario but required more than 2,200 Xpert machines and reliable treatment referral. Notably, a scenario that encouraged informal providers to refer suspected tuberculosis cases to the public sector for smear-based diagnosis (no Xpert rollout) had a greater impact on the incidence of tuberculosis than Xpert scale-up within the public sector. What Do These Findings Mean? These findings are subject to considerable uncertainty because of the assumptions made in the transmission model about private-sector treatment patterns, patient care-seeking behavior, and infectiousness, and the quality of the data fed into the model. Nevertheless, these findings suggest that the rollout of Xpert (or other new diagnostic methods with similar characteristics) could substantially reduce the burden of tuberculosis due to poor diagnosis in India. Importantly, these findings highlight how the impact of Xpert rollout relies not only on the accuracy of the test but also on the behavior of patients and providers, the level of access to new tools, and the availability of treatment following diagnosis. Thus, to ensure that new diagnostic methods have the maximum impact on tuberculosis in India, it is necessary to engage the whole private health-care sector and to provide adequate referral systems, improved treatment quality, and increased resources across all health-care sectors. Additional Information Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001674. The World Health Organization (WHO) provides information (in several languages) on all aspects of tuberculosis, including general information on tuberculosis diagnostics and specific information on the roll out of the Xpert MTB/RIF test; further information about WHO's endorsement of Xpert MTB/RIF is included in a Strategic and Technical Advisory Group for Tuberculosis report; the Global Tuberculosis Report 2013 provides information about tuberculosis around the world, including in India The Stop TB Partnership is working towards tuberculosis elimination and provides patient stories about tuberculosis (in English and Spanish); the Tuberculosis Vaccine Initiative (a not-for-profit organization) also provides personal stories about tuberculosis The US Centers for Disease Control and Prevention has information about tuberculosis and its diagnosis (in English and Spanish) The US National Institute of Allergy and Infectious Diseases also has detailed information on all aspects of tuberculosis TBC India provides information about tuberculosis control in India, including information on the RNTCP The Initiative for Promoting Affordable and Quality TB Tests promotes WHO-endorsed TB tests in India MedlinePlus has links to further information about tuberculosis (in English and Spanish)