Estimation of tuberculosis incidence at subnational level using three methods to monitor progress towards ending TB in India, 2015-2020.

OBJECTIVES: We verified subnational (state/union territory (UT)/district) claims of achievements in reducing tuberculosis (TB) incidence in 2020 compared with 2015, in India. DESIGN: A community-based survey, analysis of programme data and anti-TB drug sales and utilisation data. SETTING: National TB Elimination Program and private TB treatment settings in 73 districts that had filed a claim to the Central TB Division of India for progress towards TB-free status. PARTICIPANTS: Each district was divided into survey units (SU) and one village/ward was randomly selected from each SU. All household members in the selected village were interviewed. Sputum from participants with a history of anti-TB therapy (ATT), those currently experiencing chest symptoms or on ATT were tested using Xpert/Rif/TrueNat. The survey continued until 30 Mycobacterium tuberculosis cases were identified in a district. OUTCOME MEASURES: We calculated a direct estimate of TB incidence based on incident cases identified in the survey. We calculated an under-reporting factor by matching these cases within the TB notification system. The TB notification adjusted for this factor was the estimate by the indirect method. We also calculated TB incidence from drug sale data in the private sector and drug utilisation data in the public sector. We compared the three estimates of TB incidence in 2020 with TB incidence in 2015. RESULTS: The estimated direct incidence ranged from 19 (Purba Medinipur, West Bengal) to 1457 (Jaintia Hills, Meghalaya) per 100 000 population. Indirect estimates of incidence ranged between 19 (Diu, Dadra and Nagar Haveli) and 788 (Dumka, Jharkhand) per 100 000 population. The incidence using drug sale data ranged from 19 per 100 000 population in Diu, Dadra and Nagar Haveli to 651 per 100 000 population in Centenary, Maharashtra. CONCLUSION: TB incidence in 1 state, 2 UTs and 35 districts had declined by at least 20% since 2015. Two districts in India were declared TB free in 2020.

Does mobile phone instructional video demonstrating sputum expectoration improve the sputum sample quality and quantity in presumptive pulmonary TB cases? Protocol for a prospective pragmatic non-randomised controlled trial in Karnataka state, India.

INTRODUCTION: Sputum smear microscopy is the cornerstone of tuberculosis (TB) diagnosis under the Revised National Tuberculosis Control Programme (RNTCP) in India. Instructions on how to produce a good sputum sample are a part of RNTCP training manuals, but its assessment is not emphasised. Healthcare provider's instruction to expectorate a good sputum sample has limitations. Presumptive TB patients often submit inadequate (in quantity and/or quality) sputum samples, which may result in false-negative results. Objectives of the study are, among the selected RNTCP designated microscopy centres in Dakshina Kannada district, Karnataka, India, (a) to assess the effectiveness of mobile phone instructional video demonstrating sputum expectoration on sputum quality and quantity and (b) to explore the mobile phone video implementation challenges as perceived by the healthcare providers. METHODS AND ANALYSIS: This is a pragmatic, prospective, non-randomised controlled trial in two pairs of RNTCP Designated Microscopy Centres (located at secondary and primary healthcare facilities) of Dakshina Kannada district, India. Presumptive pulmonary TB patients aged ≥18 years will be included. We will exclude who are severely ill, blind, hearing impaired, patients who have already brought their sputum for examination, and transported sputum. In the intervention group, participants will watch a mobile phone instructional video demonstrating submission of an adequate sputum sample. The control group will follow the usual ongoing procedure for sputum submission. This study would require 406 participants for each group to achieve a power of 90% for detecting a difference of 15% between the two groups. The participant enrolment started in December 2019. ETHICS AND DISSEMINATION: Yenepoya University Ethics Committee, Mangaluru, India, has approved the study protocol (YEC-1/158/2019). It complies with the Declaration of Helsinki, local laws, and the International Council for Harmonization-good clinical practices. Investigators will present the results in scientific forums, publish in a scientific journal, and share with RNTCP officers. TRIAL REGISTRATION NUMBER: Clinical Trial Registry of India (CTRI/2019/06/019887).