National Tuberculosis Institute

The Institute's primary goal was to develop a National TB Control Programme that was practical, scientifically sound, economically feasible, and widely accepted. Since its establishment in 1959, the Epidemiology Division of NTI has been consistently engaged in TB-related activities, including burden estimation, risk factor analysis, identifying programme implementation challenges and transmission studies. Through extensive research, primarily led by the Epidemiology and Research Division, the first National Tuberculosis Control Programme was formulated in 1962, incorporating clinical, epidemiological, programmatic, and sociological aspects. Further research also identified shortcomings in the initial program, leading to significant policy modifications and the creation of the Revised National TB Control Programme in 1997. Furthermore, operational research on prevalence and program implementation supported the scaling up of TB control efforts, culminating in the formation of the National TB Elimination Programme by the Central TB Division.

Functions:

• To plan and conduct community and facility-based epidemiological, operational and implementation research in TB
• To Build capacity of programme managers/Medical college faculty in Protocol development, conducting research and for publication in association with CTD, State TB cells or UNION.
• To Conduct Research dissemination workshop for aiding programme and policy advocacy
• To Collaborate with various Institutions and Organizations for conducting multicentric operational/implementation research, TB surveys, mathematical modelling and regulatory clinical trials.
• To conduct Quality Improvement and Health System Resilience workshops for Programme Managers aimed at strengthening the TB care services to achieve the long-term goal of ending TB.

Activities:

The ERD team have immensely contributed to development of protocols, imparting training in operational research, preparation of standard operating procedures, apart from conducting operational research. The division has been collaborating with World Health Organization, the UNION, STOP TB Partnership, SEARO, ICMR etc., for organizing protocol development and research methodology trainings Recently, studies related to extrapulmonary TB, MDR-TB and qualitative studies were undertaken by the Division. Another milestone was the registration of the NTI-Institutional Ethics Committee with the Central Drugs Standards and Control Organization (CDSCO) on 27^th March 2019. This enabled NTI for the first time to conduct a Regulatory clinical trial (Vaccine trial for prevention of TB disease) in association with ICMR Headquarters.

A. INTRAMURAL STUDIES-

1. Implementation of the New Integrated Algorithm for diagnosis of Drug-Resistant Tuberculosis in Karnataka State, India: how well are we doing?

• Status-The paper was published in the peer-reviewed, open-access journal PLoS One on January 6th, 2021.

2. INDEX guidelines for Extra-pulmonary tuberculosis: Knowledge and practice among clinicians in Bengaluru, Karnataka

• Status-The research paper was published in the International Journal of Community Medicine and Public Health in September 2023.

B. EXTRAMURAL RESEARCH

1. A Phase III randomized, double blind, three arm placebo-controlled trial to evaluate the efficacy and safety of two vaccines VPM1002 and Immuvac (Mw) in preventing Tuberculosis (TB) in healthy household contacts of newly diagnosed sputum positive pulmonary TB patients.

• Status- Under progress. The enrolment was completed on 31^st Dec 2020 and the follow-up completed as on 31^st March 2024.

2. DLSS: Sentinel Surveillance for Tuberculosis burden in India 2023-2024” under the project strengthening and monitoring of Tuberculosis Elimination in India.

• Status- Under progress. The training and desk planning are ongoing and the filed works are about to start shortly.