Case fatality and recurrent tuberculosis among patients managed in the private sector: A cohort study in Patna, India.

BACKGROUND: A key component of the WHO End TB Strategy is quality of care, for which case fatality is a critical marker. Half of India's nearly 3 million TB patients are treated in the highly unregulated private sector, yet little is known about the outcomes of these patients. Using a retrospective cohort design, we estimated the case fatality ratio (CFR) and rate of recurrent TB among patients managed in the private healthcare sector in Patna, India. METHODS: World Health Partners' Private Provider Interface Agencies (PPIA) pilot project in Patna has treated 89,906 private sector TB patients since 2013. A random sample of 4,000 patients treated from 2014 to 2016 were surveyed in 2018 for case fatality and recurrent TB. CFR is defined as the proportion of patients who die during the period of interest. Treatment CFRs, post-treatment CFRs and rates of recurrent TB were estimated. Predictors for fatality and recurrence were identified using Cox proportional hazards modelling. Survey non-response was adjusted for using inverse probability selection weighting. RESULTS: The survey response rate was 56.0%. The weighted average follow-up times were 8.7 months in the treatment phase and 26.4 months in the post-treatment phase. Unobserved patients were more likely to have less than one month of treatment adherence (32.0% vs. 13.5%) and were more likely to live in rural Patna (21.9% vs. 15.0%). The adjusted treatment phase CFR was 7.27% (5.97%, 8.49%) and at 24 months post-treatment was 3.32% (2.36%, 4.42%). The adjusted 24 month post-treatment phase recurrent TB rate was 3.56% (2.54%, 4.79%). CONCLUSIONS: Our cohort study provides critical estimates of TB patient outcomes in the Indian private sector, and accounts for selection bias. Patients in the private sector in Patna experienced a moderate treatment CFR but rates of recurrent TB and post-treatment fatality were low.

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.

One year of COVID-19 and its impact on private provider engagement for TB: A rapid assessment of intermediary NGOs in seven high TB burden countries.

The COVID-19 pandemic has impacted health systems and health programs across the world. For tuberculosis (TB), it is predicted to set back progress by at least twelve years. Public private mix (PPM)has made a vital contribution to reach End TB targets with a ten-fold rise in TB notifications from private providers between 2012 and 2019. This is due in large part to the efforts of intermediary agencies, which aggregate demand from private providers. The COVID-19 pandemic has put these gains at risk over the past year. In this rapid assessment, representatives of 15 intermediary agencies from seven countries that are considered the highest priority for PPM in TB care (the Big Seven) share their views on the impact of COVID-19 on their programs, the private providers operating under their PPM schemes, and their private TB clients. All intermediaries reported a drop in TB testing and notifications, and the closure of some private practices. While travel restrictions and the fear of contracting COVID-19 were the main contributing factors, there were also unanticipated expenses for private providers, which were transferred to patients via increased prices. Intermediaries also had their routine activities disrupted and had to shift tasks and budgets to meet the new needs. However, the intermediaries and their partners rapidly adapted, including an increased use of digital tools, patient-centric services, and ancillary support for private providers. Despite many setbacks, the COVID-19 pandemic has underlined the importance of effective private sector engagement. The robust approach to fight COVID-19 has shown the possibilities for ending TB with a similar approach, augmented by the digital revolution around treatment and diagnostics and the push to decentralize health services.

Experience seeking abortion among unmarried young women in Bihar and Jharkhand, India: delays and disadvantages.

Studies suggest that the experiences of unmarried young women seeking abortion in India differ from those of their married counterparts, but the evidence is limited. Research was undertaken among nulliparous young women aged 15-24 who had abortions at the clinics of a leading NGO in Bihar and Jharkhand. Over a 14-month period in 2007-08, 246 married and 549 unmarried young abortion seekers were surveyed and 26 who were unmarried were interviewed in depth. Those who were unmarried were far more likely to report non-consensual sexual relations. As many as 25% of unmarried young women, compared to only 9% of married young women, had had a second trimester abortion. The unmarried were far more likely to report non-consensual sexual relations leading to pregnancy. They were also more likely to report such obstacles to timely abortion as failure to recognise the pregnancy promptly, exclusion from abortion-related decision-making, seeking confidentiality as paramount in selection of abortion facility, unsuccessful previous attempts to terminate the pregnancy, and lack of partner support. After controlling for background factors, findings suggest that unmarried young women who also experienced these obstacles were, compared to married young women, most likely to experience second trimester abortion. Programmes need to take steps to improve access to safe and timely abortion for unmarried young women.

Can community pharmacists improve tuberculosis case finding? A mixed methods intervention study in India.

INTRODUCTION: India has the world's highest burden of tuberculosis (TB). Private retail pharmacies are the preferred provider for 40% of patients with TB symptoms and up to 25% of diagnosed patients. Engaging pharmacies in TB screening services could improve case detection. METHODS: A novel TB screening and referral intervention was piloted over 18 months, under the pragmatic staggered recruitment of 105 pharmacies in Patna, India. The intervention was integrated into an ongoing public-private mix (PPM) programme, with five added components: pharmacy training in TB screening, referral of patients with TB symptoms for a chest radiograph (CXR) followed by a doctor consultation, incentives for referral completion and TB diagnosis, short message service (SMS) reminders and field support. The intervention was evaluated using mixed methods. RESULTS: 81% of pharmacies actively participated in the intervention. Over 132.49 pharmacy person-years of observation in the intervention group, 1674 referrals were made and 255 cases of TB were diagnosed. The rate of registration of symptomatic patients was 62 times higher in the intervention group compared with the control group (95% CI: 54 to 72). TB diagnosis was 25 times higher (95% CI: 20 to 32). Microbiological testing and test confirmation were also significantly higher among patients diagnosed in the intervention group (p<0.001). Perceived professional credibility, patient trust, symptom severity and providing access to a free screening test were seen to improve pharmacists' engagement in the intervention. Workload, patient demand for over-the-counter medicines, doctor consultation fees and programme documentation impeded engagement. An additional 240 cases of TB were attributed to the intervention, and the approximate cost incurred per case detected due to the intervention was US$100. CONCLUSIONS: It is feasible and impactful to engage pharmacies in TB screening and referral activities, especially if working within existing public-private mix (PPM) programmes, appealing to pharmacies' business mindset and among pharmacies with strong community ties.

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.

Feasibility of expanding the medication abortion provider base in India to include ayurvedic physicians and nurses.

CONTEXT: The availability of trained abortion providers is limited in India. Allowing ayurvedic physicians and nurses to perform medication abortions may improve women's access to the procedure, but it is unclear whether these clinicians can provide these services safely and effectively. METHODS: Allopathic physicians, ayurvedic physicians and nurses (10 of each), none of whom had experience in abortion provision, were trained to perform medication abortions. In 2008-2010, these providers performed medication abortions in five clinics in Bihar and Jharkhand for 1,225 women with a pregnancy of up to eight weeks' gestation. A two-sided equivalence design was used to test whether providers' assessments of client eligibility and completeness of abortion matched those of an experienced physician "verifier," and whether medication abortions performed by nurses and ayurvedic physicians were as safe and effective as those done by allopathic physicians. RESULTS: Failure rates were low (5-6%), and those for nurses and ayurvedic physicians were statistically equivalent to those for allopathic physicians. Provider assessments of client eligibility and completeness of abortion differed from those of the verifier in only a small proportion of cases (3-4% for eligibility and 4-5% for completeness); these proportions, and rates of loss to follow-up, were statistically equivalent among provider types. No serious complications were observed, and services by all three groups of providers were acceptable to women. CONCLUSION: Findings support amending existing laws to improve women's access to medication abortion by expanding the provider base to include ayurvedic physicians and nurses.

Can nurses perform manual vacuum aspiration (MVA) as safely and effectively as physicians? Evidence from India.

BACKGROUND: Although legal, access to safe abortion remains limited in India. Given positive experiences of task-shifting from other developing countries, there is a need to explore the feasibility of expanding the manual vacuum aspiration (MVA) provider base to include nurses in India. STUDY DESIGN: A prospective, two-sided equivalence study was undertaken in five facilities of a non-government organisation in Bihar and Jharkhand to explore whether efficacy and safety rates associated with MVA provided by newly trained nurses were equivalent to those provided by physicians. Eight hundred and ninety-seven consenting women with gestation ages of ≤ 10 weeks were recruited. RESULTS: Nurses were as skilled as physicians in assessing gestation age and completed abortion status, performing MVA and obtaining patient compliance. Overall failure and complication rates were low and equivalent between the two provider types, and both provider types were equally acceptable to women who underwent the procedure (98%). CONCLUSION: Findings of the study make a compelling case for amending existing laws to expand the MVA provider base in order to increase access to safe abortion in India.