JMIR Publications

ABSTRACT

Background:

India is set to eliminate tuberculosis (TB) from the country by 2025, five years ahead of the global target. A complicating factor in optimising the pathway to managing TB care is that about 60-70% of the patients with TB symptoms seek care in the private healthcare sector. This vast sector is highly unregulated, and a high rate of under-notification of cases to the national registry is suspected. To improve the notification of TB among private providers and improve patient management in the private sector, the National Tuberculosis Elimination Program (NTEP), India has implemented the Patient Provider Support Agency (PPSA). PPSA is a model under which a state/ city/district Tuberculosis unit selects a third-party agency to engage private-sector doctors in treating TB patients. It also provides end-to-end services, such as diagnosis, notification, patient adherence and support, and treatment linkages.

Objective:

The objective of this study is to assess the (cost)-effectiveness and feasibility of introducing PPSA in the National TB elimination program to improve patient management by improving TB case notification, drug-resistant TB case notification, treatment outcome and reducing loss to follow up as compared to the baseline ongoing program.

Methods:

A cohort study will be conducted in two parallel groups in the private sector to assess the impact of the PPSA intervention on the primary and secondary outcomes of the National TB Elimination Program. Eligible TB patients within a span of a quarter will be recruited and allocated to either the intervention or control group. The intervention group will receive all the facilities and benefits under the PPSA model under the National TB Elimination Program. The control group will receive care under usual conditions. The study will consist of three parts: 1) Impact assessment study, 2) Cost-effectiveness study, and 3) Feasibility and Accessibility study. The primary outcome shall be TB case notification, drug-resistant TB case notification, treatment outcome and loss to follow-up. Secondary outcomes include the time between the onset of symptoms and treatment initiation, treatment adherence, adverse drug reaction management, improvement in Quality of life and societal costs. Outcome assessments will be done using questionnaires at baseline, after 3 months, at the completion of treatment and six month after the completion of treatment.

Results:

The study received Institutional ethical approval.

Conclusions:

Our work will add to other implementation studies capturing the role of the private sector in TB care in India. A strength of the current work is that it is informed by unique, detailed patient pathway data from the study site, suggesting that engaging the private sector will meet the country’s aspirations for TB elimination. Such measures would also lay the foundations for TB control by maximising the quality and coordination of essential TB services across India’s vast and fragmented healthcare system.