The Swasthya Nagaram Project is implementing a Pragmatic Randomized Controlled Trial of population level TB Screening interventions designed to reduce TB burden over a time period of three years. Two intervention arms are proposed evaluating different approaches for population level TB Screening.
India, with an estimated 2.8 million incident TB cases and 413,000 deaths in 2023, is the highest TB burden country in the world. India’s National TB Elimination Programme (NTEP) has set ambitious targets to reduce the TB incidence rate by 80% and the number of TB deaths by 90% by the year 2025 relative to 2015. Early diagnosis and prompt treatment of all TB cases is essential for reducing the burden and is one of the key components for the first pillar of the global End TB Strategy.
In India, TB is often undiagnosed, misdiagnosed or diagnosed late, thereby contributing to the ongoing TB transmission in the country. Active case finding (ACF i.e., detecting TB at the community level by systematically screening non-health care seeking persons for TB disease) is one of the key interventions being implemented for early and comprehensive TB case detection especially among key and vulnerable populations.
In this context, there is an urgent need to explore alternative, relatively cost-effective strategies for community-wide systematic TB screening that can achieve similar outcomes of rapid reduction in disease burden with fewer resources, strengthen the evidence base on the use of community-wide systematic screening from a broader range of high prevalence areas, beyond the exceptionally high 0.5% prevalence threshold currently recommended.
Arm-1: Community-wide screening with chest X-ray
The chest X-ray will be offered to all eligible clients in this study arm regardless of the symptoms. Sputum samples from all the individuals with abonarmal chest x- ray will be subjected to NAAT MTB assay for detection of bacteriologically confirmed TB.
Arm-2: Community-wide Screening with mIRD test
The mIRD ICMR-recommended rapid molecular screening cum diagnostic test will be offered to all eligible clients in this study arm. The mIRD that will be used in the study is Quantiplus® MTB FAST Detection Kit PI/QLFMTB-03. The sputum samples or tongue swab (when not able to produce sputum) specimen collected from all the eligible population will be subjected to mIRD. Clients who have symptoms suggestive of TB or mIRD positive for MTB will be considered presumptive TB and offered NAAT MTB assay for detecting bacteriologically-confirmed TB.
Arm 3: Routine programmatic care:
In this study arm, routine programmatic care will be provided, which is largely passive case finding but may include intensified case finding and active case finding campaigns. Intensified case finding involves screening all patients presenting to a healthcare facility, irrespective of the presenting complaints, for the four cardinal TB symptoms and then using radiological, clinical and microbiological tests to diagnose TB in that individual.
Project Timeline:
2025-2028
Study locations
The study will be conducted in the Peerzadiguda, Boduppal and Pocharam municipal corporations of the Greater Hyderabad Metropolitan Corporation in Telangana state. The selected three municipal corporations are adjacent to each other and situated in the Medchal-Malkajgiri district.
In total, there are 72 wards in three municipal corporations with a total estimated adult population of 2,25,000 individuals. The Peerzadiguda municipal corporation has an adult population of 1,30,000 spread across 26 wards, Boduppal has a 65,000 adult population in 28 wards, and Pocharam has a 30,000 adult population in 18 wards.
Informed consent
Every study-eligible person living in the geographical area of the study will be given information about the study procedures and implications of test positive and negative results in the local languages (Telugu or Hindi). Only those who consent will be recruited into the study. All the enumerated adults (≥18 years of age) are eligible clients for the interventions delivered through the project in arm-1 and arm-2. Those who are pregnant will be excluded from getting X-ray and those who are already on anti-TB treatment will be excluded from further interventions. The community volunteers will try to meet all the clients individually, explain the study procedures in detail by handing over participant information sheet in Telugu, and obtain informed electronic consent to participate in the study. The consent will be collected electronically using hand-drawn signature on the screen. The community volunteers will meet all the clients available in the house during the initial visit. The clients unavailable during the initial house visit will be contacted over the phone, and a convenient time for the meeting will be scheduled. The community volunteers will make three home visits to meet all the enumerated clients and obtain informed consent. The clients who are not willing to provide informed electronic consent will be marked as “not consented,” and the community volunteers will not further engage with the client.