According to the WHO’s Global Tuberculosis Report 2021, the Covid-19 pandemic has reversed years of progress in providing essential Tuberculosis (TB) services and reducing the disease burden, with India being one of the worst-affected countries. In 2020, India was the highest contributor to the global gap between estimated TB incidence and the number of people newly diagnosed with TB and reported. The Union health ministry, in its National Strategic Plan (NSP) for Tuberculosis Elimination 2017-2025, called TB India’s “severest health crisis”, as it kills an estimated 4,80,000 Indians every year and around 1,400 every day.

On the occasion of World Tuberculosis Day, we bring you details of three interesting TB-related studies happening at ISB’s Max Institute of Healthcare Management (MIHM) currently. We are working with global organisations and partners to understand some of the critical gaps in its care and management in India and how they can be plugged.

Incentivising private providers to widen TB care net

Traditionally, TB patients prefer to seek private healthcare thus making the private providers the first point of contact for TB patients in India. Several private provider engagement (PPE) approaches have been implemented by the government in the recent past in various parts of the country to extend high-quality diagnostic tools and treatment regimens to privately treated patients.

MIHM has received a grant from the Bill & Melinda Gates Foundation (BMGF) to conduct a quantitative and qualitative study to evaluate the impact of private sector engagement on patient outcomes, both health and operational. This study will evaluate the Patient Provider Support Agency (PPSA) model to understand how TB care can be improved via patient subsidies and provider incentives. For the same, we have partnered with FMR and the Central TB Division (CTD) with an aim to assess the impact of the PPE strategy on patient pathways for diagnosis and treatment initiation, quality of care, the financial burden to patients and their families, and treatment outcomes.

This in-depth statistical analysis of primary and secondary data from five states (over a period of five years) will establish the exposure of patients to various elements of PPE strategy at the patient, provider, and community levels and then measure their impact on the relevant health and operational outcomes. This is the first large-scale comprehensive study on the PPSA model. While we conduct a mixed-methods evaluation study, The George Institute for Global Health will do the cost analysis. The results from these two studies will then feed into the epidemiological transmission analysis to be done by the Imperial College. This exercise will provide an estimated impact of PPE strategy on population-level metrics such as TB incidence, mortality, disability-adjusted life years (DALYs) and/or years of life lost (YLLs) averted.

Involving for-profit organisations to improve the quality of TB care in the private sector

India had the largest share (26%) in the global burden of TB in 2019. The NSP acknowledges serious gaps in the programme and emphasises that the public-private mix is an important component for TB elimination in India. While the Joint Effort for Elimination of Tuberculosis (JEET) looks to address inefficiencies in every step of the patient care cascade for TB and to build the programme management capacity, the question of how the private sector in the urban agglomerates could be leveraged at all levels – national, state, and district/cities/towns – to combat this disease looms large.

Clinton Health Access Initiative (CHAI) is running a few pilots in Gujarat and Faridabad with Tata 1mg – a for-profit private digital consumer healthcare platform – to provide PPSA services, ranging from drug delivery, sample collection and transport, patient counselling, and online consultations to patients seeking TB care in the private sector.

MIHM is conducting a mixed-methods study and costing exercise to evaluate these models to understand the uptake and quality of service of the 1mg pilots vis-à-vis existing donor-funded PPSAs and the costing of 1mg pilots. The quantitative exercise will be conducted in a retrospective setting using secondary datasets. We will also conduct primary qualitative interviews with patients and service providers to capture their experiences and behaviour during the pilot. We will also use the activity-based costing (ABC) technique to explore the cost-driving activities and to calculate the time and resources consumed per unit of activity. The study is funded by CHAI.

A randomised control trial to evaluate and understand the effectiveness and cost of DATs in the private sector

Typically, an active TB patient is required to take six months of medication to cure the disease. However, irregular adherence or non-adherence to pills is a common occurrence. This increases the increase the risk of death, chances of relapse, and drug resistance among the patients. The Central TB Division (CTD) launched an Integrated Digital Adherence Technology Initiative (IDAT) in 2019 to deliver more patient-centric monitoring and management at scale. But an interim assessment indicated that while IDAT had achieved significant coverage of digital adherence technologies (DATs) over a brief period, several barriers at the level of the health system, health workers and patients needed to be overcome to achieve their desired impact on patient outcomes. Furthermore, currently, the adoption and expansion of DATs is the largest in the public sector. But it is predicted that the impact would be greater if these tools are extended to privately treated TB patients.

MIHM has received a grant from BMGF to conduct a multi-year, multi-faceted, comprehensive study to evaluate three adherence monitoring methods from both patient and healthcare worker’s perspectives against the standard of care in the private sector. The four key objectives are to (i) quantify the impact of these monitoring methods on patients’ medication adherence and clinical outcomes, (ii) identify the underlying mechanisms and pathways (“the how”) of the impact of these monitoring methods, (iii) optimise the effect of these monitoring methods on the workflow processes of frontline workers, and (iv) estimate the programmatic costs of their implementation and scale-up.

The study will be structured as a multi-site randomised controlled trial embedded in mixed methods operational research and guided by economics and behavioural sciences to meet the study objectives. Qualitative studies, informed by behavioural sciences, will identify barriers and facilitators for optimal engagement with DATs among patients and healthcare workers. A Time-and-Motion study will be conducted to capture the effect of information generated by digital technologies on the workflows of frontline health workers. Advanced analytic methods such as machine learning will be used to recommend optimal use of limited health worker capacity and findings from these analyses will be integrated with estimates of detailed programmatic costs to arrive at the relative cost-effectiveness of the various monitoring methods.

This project is being implemented in partnership with BMGF and World Health Partners with guidance from the Central TB Division and is aimed at generating rigorous evidence to guide national decision-making on the scale-up of digital adherence management and implementation protocols along with their cost-effectiveness and budget impact.

 

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