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.

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.

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.

Strategy and way forward for TB elimination.

India's National Strategic Plan (NSP) for TB Elimination 2017-25 looks ambitious in terms of targets of TB notification aiming to reach 35 lakh TB patients annually, i.e. double that of current status. Strategies and interventions designed under the Plan with patient centered approaches, with synergistic public-private-patient partnership can make it possible to achieve real aim of reaching the unreached, by extending patient support systems and social protection to affected communities. In this review point, these strategies and commitments are summarized as future plan.

HIV Testing among Patients with Presumptive Tuberculosis: How Do We Implement in a Routine Programmatic Setting? Results of a Large Operational Research from India.

BACKGROUND: In March 2012, World Health Organization recommended that HIV testing should be offered to all patients with presumptive TB (previously called TB suspects). How this is best implemented and monitored in routine health care settings in India was not known. An operational research was conducted in Karnataka State (South India, population 64 million, accounts for 10% of India's HIV burden), to test processes and learn results and challenges of screening presumptive TB patients for HIV within routine health care settings. METHODS: In this cross-sectional study conducted between January-March 2012, all presumptive TB patients attending public sector sputum microscopy centres state-wide were offered HIV testing by the laboratory technician, and referred to the nearest public sector HIV counselling and testing services, usually within the same facility. The HIV status of the patients was recorded in the routine TB laboratory form and TB laboratory register. The laboratory register was compiled to obtain the number of presumptive TB patients whose HIV status was ascertained, and the number found HIV positive. Aggregate data on reasons for non-testing were compiled at district level. RESULTS: Overall, 115,308 patients with presumptive TB were examined for sputum smear microscopy at 645 microscopy centres state-wide. Of these, HIV status was ascertained for 62,847(55%) among whom 7,559(12%) were HIV-positive, and of these, 3,034(40%) were newly diagnosed. Reasons for non-testing were reported for 37,700(72%) of the 52,461 patients without HIV testing; non-availability of testing services at site of sputum collection was cited by health staff in 54% of respondents. Only 4% of patients opted out of HIV testing. CONCLUSION: Offering HIV testing routinely to presumptive TB patients detected large numbers of previously-undetected instances of HIV infection. Several operational challenges were noted which provide useful lessons for improving uptake of HIV testing in this important group.

The profile and treatment outcomes of the older (aged 60 years and above) tuberculosis patients in Tamilnadu, South India.

BACKGROUND: With changing demographic patterns in the context of a high tuberculosis (TB) burden country, like India, there is very little information on the clinical and demographic factors associated with poor treatment outcome in the sub-group of older TB patients. The study aimed to assess the proportion of older TB patients (60 years of age and more), to compare the type of TB and treatment outcomes between older TB patients and other TB patients (less than 60 years of age) and to describe the demographic and clinical characteristics of older TB patients and assess any associations with TB treatment outcomes. METHODS: A retrospective cohort study involving a review of records from April to June 2011 in the 12 selected districts of Tamilnadu, India. Demographic, clinical and WHO defined disease classifications and treatment outcomes of all TB patients aged 60 years and above were extracted from TB registers maintained routinely by Revised National TB Control Program (RNTCP). RESULTS: Older TB patients accounted for 14% of all TB patients, of whom 47% were new sputum positive. They had 38% higher risk of unfavourable treatment outcomes as compared to all other TB patients (Relative risk (RR)-1.4, 95% CI 1.2-1.6). Among older TB patients, the risk for unfavourable treatment outcomes was higher for those aged 70 years and more (RR 1.5, 95% CI 1.2-1.9), males (RR 1.5, 95% CI 1.0-2.1), re-treatment patients (RR 2.5, 95% CI 1.9-3.2) and those who received community-based Direct Observed Treatment (RR 1.4, 95% CI 1.1-1.9). CONCLUSION: Treatment outcomes were poor in older TB patients warranting special attention to this group - including routine assessment and recording of co-morbidities, a dedicated recording, reporting and monitoring of outcomes for this age-group and collaboration with National programme of non-communicable diseases for comprehensive management of co-morbidities.

What are the reasons for poor uptake of HIV testing among patients with TB in an Eastern India District?

BACKGROUND: National policy in India recommends HIV testing of all patients with TB. In West Bengal state, only 28% of patients with TB were tested for HIV between April-June, 2010. We conducted a cross-sectional survey to understand patient, provider and health system related factors associated with low uptake of HIV testing among patients with TB. METHODS: We reviewed TB and HIV program records to assess the HIV testing status of patients registered for anti-TB treatment from July-September 2010 in South-24-Parganas district, West Bengal, assessed availability of HIV testing kits and interviewed a random sample of patients with TB and providers. RESULTS: Among 1633 patients with TB with unknown HIV status at the time of diagnosis, 435 (26%) were tested for HIV within the intensive phase of TB treatment. Patients diagnosed with and treated for TB at facilities with co-located HIV testing services were more likely to get tested for HIV than at facilities without [RR = 1.27, (95% CI 1.20-3.35)]. Among 169 patients interviewed, 67 reported they were referred for HIV testing, among whom 47 were tested. During interviews, providers attributed the low proportion of patients with TB being referred and tested for HIV to inadequate knowledge among providers about the national policy, belief that patients will not test for HIV even if they are referred, shortage of HIV testing kits, and inadequate supervision by both programs. DISCUSSION: In West Bengal, poor uptake of HIV testing among patients with TB was associated with absence of HIV testing services at sites providing TB care services and to poor referral practices among providers. Comprehensive strategies to change providers' beliefs and practices, decentralization of HIV testing to all TB care centers, and improved HIV test kit supply chain management may increase the proportion of patients with TB who are tested for HIV.

Feasibility and effectiveness of provider initiated HIV testing and counseling of TB suspects in Vizianagaram district, South India.

BACKGROUND: Though internationally recommended, provider initiated HIV testing and counseling (PITC) of persons suspected of tuberculosis (TB) is not a policy in India; HIV seroprevalence among TB suspects has never been reported. The current policy of PITC for diagnosed TB cases may limit opportunities of early HIV diagnosis and treatment. We determined HIV seroprevalence among persons suspected of TB and assessed feasibility and effectiveness of PITC implementation at this earlier stage in the TB diagnostic pathway. METHODS: All adults examined for diagnostic sputum microscopy (TB suspects) in Vizianagaram district (population 2.5 million), in November-December 2010, were offered voluntary HIV counseling and testing (VCT) and assessed for TB diagnosis. RESULTS: Of 2918 eligible TB suspects, 2465(85%) consented to VCT. Among these, 246(10%) were HIV-positive. Of the 246, 84(34%) were newly diagnosed as HIV (HIV status not known previously). To detect a new case of HIV infection, the number needed to screen (NNS) was 26 among 'TB suspects', comparable to that among 'TB patients'. Among suspects aged 25-54 years, not diagnosed as TB, the NNS was 17. CONCLUSION: The seroprevalence of HIV among 'TB suspects' was as high as that among 'TB patients'. Implementation of PITC among TB suspects was feasible and effective, detecting a large number of new HIV cases with minimal additional workload on staff of HIV testing centre. HIV testing of TB suspects aged 25-54 years demonstrated higher yield for a given effort, and should be considered by policy makers at least in settings with high HIV prevalence.

HIV prevalence among persons suspected of tuberculosis: policy implications for India.

BACKGROUND: HIV testing of persons referred for tuberculosis diagnosis (TB suspects) is recommended by World Health Organization but is not a policy in India, where HIV prevalence among TB suspects has never been reported. The current Indian policy of offering HIV testing only to TB cases may limit opportunities for early HIV diagnosis and treatment. METHODS: All adult TB suspects examined for diagnostic sputum microscopy in Mandya district (2 million population), in December 2010, were offered voluntary HIV counseling and testing. Participants were assessed for subsequent TB diagnosis. RESULTS: Of 1668 eligible TB suspects, HIV status was ascertained for 1539 (92%). Among these, 108 (7%) were HIV positive. Of the 108, 43 (40%) were newly diagnosed as HIV (ie, not previously known to have HIV infection). To detect a new case of HIV infection, the number needed to screen among TB patients was 13, as compared to an number needed to screen of 37 among "TB suspects not diagnosed as TB". Applied annually in 2010, HIV testing of TB suspects in 2010 could have identified approximately 534 newly diagnosed HIV cases, a 51% increase in district HIV case finding. CONCLUSIONS: Routine HIV testing of TB suspects was feasible and yielded a large number of HIV cases in absolute terms and would increase district HIV case finding by 51%. The number of patients needed to be HIV tested to find a previously undetected HIV case among TB suspects was greater than for TB cases but was potentially acceptable. Given heterogeneity of HIV epidemic in India, broader surveillance is required before national policy decision.

Updated current (2012) national guidelines for paediatric tuberculosis in India.

A national consultation was organised in January 2012, in order to reconcile between global and national guidelines, to review the evidence base and update the RNTCP guidelines in consensus with Indian Academy of Paediatrics. The consultation had come up with wider recommendations in diagnosing and treating paediatric tuberculosis patients which has been incorporated in the programme.

Will adoption of the 2010 WHO ART guidelines for HIV-infected TB patients increase the demand for ART services in India?

BACKGROUND: In 2010, WHO expanded previously-recommended indications for anti-retroviral treatment to include all HIV-infected TB patients irrespective of CD4 count. India, however, still limits ART to those TB patients with CD4 counts <350/mm(3) or with extrapulmonary TB manifestations. We sought to evaluate the additional number of patients that would be initiated on ART if India adopted the current 2010 WHO ART guidelines for HIV-infected TB patients. METHODS: We evaluated all TB patients recorded in treatment registers of the Revised National TB Control Programme in June 2010 in the high-HIV prevalence state of Karnataka, and cross-matched HIV-infected TB patients with ART programme records. RESULTS: Of 6182 TB patients registered, HIV status was ascertained for 5761(93%) and 710(12%) were HIV-infected. 146(21%) HIV-infected TB patients were on ART prior to TB diagnosis. Of the remaining 564, 497(88%) were assessed for ART eligibility; of these, 436(88%) were eligible for ART according to 2006 WHO ART guidelines. Altogether, 487(69%) HIV-infected TB patients received ART during TB treatment. About 80% started ART within 8 weeks of TB treatment and 95% received an efavirenz based regimen. CONCLUSION: In Karnataka, India, about nine out of ten HIV-infected TB patients were eligible for ART according to 2006 WHO ART guidelines. The efficiency of HIV case finding, ART evaluation, and ART initiation was relatively high, with 78% of eligible HIV-infected patients actually initiated on ART, and 80% within 8 weeks of diagnosis. ART could be extended to all HIV-infected TB patients irrespective of CD4 count with relatively little additional burden on the national ART programme.

Risk factors for treatment default among re-treatment tuberculosis patients in India, 2006.

SETTING: Under India's Revised National Tuberculosis Control Programme (RNTCP), >15% of previously-treated patients in the reported 2006 patient cohort defaulted from anti-tuberculosis treatment. OBJECTIVE: To assess the timing, characteristics, and risk factors for default amongst re-treatment TB patients. METHODOLOGY: For this case-control study, in 90 randomly-selected programme units treatment records were abstracted from all 2006 defaulters from the RNTCP re-treatment regimen (cases), with one consecutively-selected non-defaulter per case. Patients who interrupted anti-tuberculosis treatment for >2 months were classified as defaulters. RESULTS: 1,141 defaulters and 1,189 non-defaulters were included. The median duration of treatment prior to default was 81 days (25%-75% interquartile range 44-117 days) and documented retrieval efforts after treatment interruption were inadequate. Defaulters were more likely to have been male (adjusted odds ratio [aOR] 1.4, 95% confidence interval [CI] 1.2-1.7), have previously defaulted anti-tuberculosis treatment (aOR 1.3 95%CI 1.1-1.6], have previous treatment from non-RNTCP providers (AOR 1.3, 95%CI 1.0-1.6], or have public health facility-based treatment observation (aOR 1.3, 95%CI 1.1-1.6). CONCLUSIONS: Amongst the large number of re-treatment patients in India, default occurs early and often. Improved pre-treatment counseling and community-based treatment provision may reduce default rates. Efforts to retrieve treatment interrupters prior to default require strengthening.